CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR870]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
					
SUBCHAPTER H - MEDICAL DEVICES
					
							PART 870CARDIOVASCULAR DEVICES

Subpart A - General Provisions

Sec. 870.1 Scope.

(a) This part sets forth the classification of cardiovascular devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) To avoid duplicative listings, a cardiovascular device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

[52 FR 17735, May 11, 1987, as amended at 68 FR 61344, Oct. 28, 2003; 78 FR 18233, Mar. 26, 2013]

Sec. 870.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

[52 FR 17735, May 11, 1987]

Sec. 870.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(9) For near patient testing (point of care).

[65 FR 2314, Jan. 14, 2000]

Subpart B - Cardiovascular Diagnostic Devices

Sec. 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a) Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

(b) Classification. Class II (special controls). The guidance document entitled "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" will serve as the special control. See § 870.1 for the availability of this guidance document.

[68 FR 61344, Oct. 28, 2003]

Sec. 870.1100 Blood pressure alarm.

(a) Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.

(b) Classification. Class II (performance standards).

Sec. 870.1110 Blood pressure computer.

(a) Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.

(b) Classification. Class II (performance standards).

Sec. 870.1120 Blood pressure cuff.

(a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

(b) Classification. Class II (performance standards).

Sec. 870.1130 Noninvasive blood pressure measurement system.

(a) Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

(b) Classification. Class II (performance standards).

Sec. 870.1140 Venous blood pressure manometer.

(a) Identification. A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.

(b) Classification. Class II (performance standards).

Sec. 870.1200 Diagnostic intravascular catheter.

(a) Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

(b) Classification. Class II (performance standards).

Sec. 870.1210 Continuous flush catheter.

(a) Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

(b) Classification. Class II (performance standards).

Sec. 870.1220 Electrode recording catheter or electrode recording probe.

(a) Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

(b) Classification. Class II (performance standards).

Sec. 870.1230 Fiberoptic oximeter catheter.

(a) Identification. A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

(b) Classification. Class II (performance standards).

Sec. 870.1240 Flow-directed catheter.

(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

(b) Classification. Class II (performance standards).

Sec. 870.1250 Percutaneous catheter.

(a) Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

(b) Classification. Class II (performance standards).

Sec. 870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.

(a) Identification. This device is a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the following:

(A) Delivery, deployment, and retrieval, including quantifying deployment and retrieval forces, and procedural time; and

(B) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.

(ii) Tensile strengths of joints and components, tip flexibility, torque strength, torque response, and kink resistance.

(iii) Flow characteristics.

(A) The ability of the filter to not impede blood flow.

(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.

(iv) Characterization and verification of all dimensions.

(2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:

(i) Delivery, deployment, and retrieval, including quantifying procedural time.

(ii) Device compatibility and lack of interference with the transcatheter intracardiac procedure and device.

(iii) Flow characteristics.

(A) The ability of the filter to not impede blood flow.

(B) The amount of time the filter can be deployed in position and/or retrieved from its location without disrupting blood flow.

(iv) Gross pathology and histopathology assessing vascular injury and downstream embolization.

(3) All patient contacting components of the device must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.

(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(6) Labeling for the device must include:

(i) Instructions for use;

(ii) Compatible transcatheter intracardiac procedure devices;

(iii) A detailed summary of the clinical testing conducted; and

(iv) A shelf life and storage conditions.

(7) Clinical performance testing must demonstrate:

(i) The ability to safely deliver, deploy, and remove the device;

(ii) The ability of the device to filter embolic material while not impeding blood flow;

(iii) Secure positioning and stability of the position throughout the transcatheter intracardiac procedure; and

(iv) Evaluation of all adverse events including death, stroke, and vascular injury.

[83 FR 4140, Jan. 30, 2018]

Sec. 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.

(a) Identification. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate:

(i) The ability to safely deliver, deploy, and remove the device;

(ii) The ability of the device to create an arteriovenous fistula;

(iii) The ability of the arteriovenous fistula to attain a blood flow rate and diameter suitable for hemodialysis;

(iv) The ability of the fistula to be used for vascular access for hemodialysis;

(v) The patency of the fistula; and

(vi) The rates and types of all adverse events.

(2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:

(i) Delivery, deployment, and retrieval of the device;

(ii) Compatibility with other devices labeled for use with the device;

(iii) Patency of the fistula;

(iv) Characterization of blood flow at the time of the fistula creation procedure and at chronic followup; and

(v) Gross pathology and histopathology assessing vascular injury and downstream embolization.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, activation, and retrieval of the device;

(ii) Tensile strengths of joints and components;

(iii) Accurate positioning and alignment of the device to achieve fistula creation; and

(iv) Characterization and verification of all dimensions.

(4) Electrical performance, electrical safety, and electromagnetic compatibility (EMC) testing must be performed for devices with electrical components.

(5) Software verification, validation, and hazard analysis must be performed for devices that use software.

(6) All patient-contacting components of the device must be demonstrated to be biocompatible.

(7) Performance data must demonstrate the sterility of the device components intended to be provided sterile.

(8) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(9) Labeling for the device must include:

(i) Instructions for use;

(ii) Identification of system components and compatible devices;

(iii) Expertise needed for the safe use of the device;

(iv) A detailed summary of the clinical testing conducted and the patient population studied; and

(v) A shelf life and storage conditions.

[87 FR 9241, Feb. 18, 2022]

Sec. 870.1255 Balloon aortic valvuloplasty catheter.

(a) Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The device must be demonstrated to be biocompatible.

(2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components.

(3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal.

(4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis.

(5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device.

[82 FR 34852, July 27, 2017]

Sec. 870.1270 Intracavitary phonocatheter system.

(a) Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.

(b) Classification. Class II (performance standards).

Sec. 870.1280 Steerable catheter.

(a) Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

(b) Classification. Class II (performance standards).

Sec. 870.1290 Steerable catheter control system.

(a) Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

(b) Classification. Class II (performance standards).

Sec. 870.1300 Catheter cannula.

(a) Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

(b) Classification. Class II (performance standards).

Sec. 870.1310 Vessel dilator for percutaneous catheterization.

(a) Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

(b) Classification. Class II (performance standards).

Sec. 870.1330 Catheter guide wire.

(a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

(b) Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]

Sec. 870.1340 Catheter introducer.

(a) Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

(b) Classification. Class II (performance standards).

Sec. 870.1342 Reverse central venous recanalization system.

(a) Identification. A reverse central venous recanalization system is a prescription device for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must fulfill the following:

(i) Demonstrate the ability to safely deliver, deploy, and remove the device; and

(ii) Evaluate all adverse events including death, bleeding, damage to non-target tissue and organs, blood vessel perforation or rupture, and hematoma.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, and retrieval of the system;

(ii) Compatibility with other devices labeled for use with the device;

(iii) Tensile strengths of joints and components;

(iv) Kink resistance of system components;

(v) Radiopacity of components used to monitor procedure under fluoroscopy;

(vi) Characterization and verification of all dimensions; and

(vii) Leakage of air or fluid.

(3) All patient contacting components of the device must be demonstrated to be biocompatible.

(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.

(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(6) Labeling for the device must include:

(i) Instructions for use, including a description of compatible devices;

(ii) A detailed summary of the clinical testing conducted and;

(iii) Shelf life and storage conditions.

[87 FR 26991, May 6, 2022]

Sec. 870.1345 Intravascular bleed monitor.

(a) Identification. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) In vivo animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate the following:

(i) Device performance characteristics;

(ii) Adverse effects, including gross necropsy and histopathology; and

(iii) Device usability, including device preparation, device handling, and user interface.

(2) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Tensile testing of joints and materials;

(ii) Mechanical integrity testing;

(iii) Friction testing;

(iv) Flush testing;

(v) Air leakage and liquid leakage testing;

(vi) Latching and unlatching testing;

(vii) Kink and bend testing;

(viii) Insertion force testing;

(ix) Torque testing;

(x) Corrosion testing; and

(xi) Dimensional tolerance testing.

(3) Performance data must support the sterility and pyrogenicity of the device components intended to be provided sterile.

(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.

(5) The patient contacting components of the device must be demonstrated to be biocompatible.

(6) Software verification, validation, and hazard analysis must be performed.

(7) Performance data must demonstrate electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety.

(8) Human factors performance evaluation must demonstrate that the user can correctly use the device, based solely on reading the directions for use.

(9) Labeling must include:

(i) Instructions for use;

(ii) A shelf life and storage conditions;

(iii) Compatible procedures;

(iv) A sizing table; and

(v) Quantification of blood detected.

[87 FR 34778, June 8, 2022]

Sec. 870.1350 Catheter balloon repair kit.

(a) Identification. A catheter balloon repair kit is a device used to repair or replace the balloon of a balloon catheter. The kit contains the materials, such as glue and balloons, necessary to effect the repair or replacement.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any catheter balloon repair kit that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a catheter balloon repair kit that was in commercial distribution before May 28, 1976. Any other catheter balloon repair kit shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996]

Sec. 870.1360 Trace microsphere.

(a) Identification. A trace microsphere is a radioactively tagged nonbiodegradable particle that is intended to be injected into an artery or vein and trapped in the capillary bed for the purpose of studying blood flow within or to an organ.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any trace microsphere that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a trace microsphere that was in commercial distribution before May 28, 1976. Any other trace microsphere shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996]

Sec. 870.1370 Catheter tip occluder.

(a) Identification. A catheter tip occluder is a device that is inserted into certain catheters to prevent flow through one or more orifices.

(b) Classification. Class II (performance standards).

Sec. 870.1380 Catheter stylet.

(a) Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

(b) Classification. Class II (performance standards).

Sec. 870.1390 Trocar.

(a) Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

(b) Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]

Sec. 870.1405 Interventional cardiovascular implant simulation software device.

(a) Identification. An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient's cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Software verification, validation, and hazard analysis, with identification of appropriate mitigations, must be performed, including a full verification and validation of the software according to the predefined software specifications.

(2) Computational modeling verification and validation activities must be performed to establish the predictive capability of the device for its indications for use.

(3) Performance validation testing must be provided to demonstrate the accuracy and clinical relevance of the modeling methods for the intended implantation simulations, including the following:

(i) Computational modeling results must be compared to clinical data supporting the indications for use to demonstrate accuracy and clinical meaningfulness of the simulations;

(ii) Agreement between computational modeling results and clinical data must be assessed and demonstrated across the full intended operating range (e.g., full range of patient population, implant device sizes and patient anatomic morphologies). Any selection criteria or limitations of the samples must be described and justified;

(iii) Endpoints (e.g., performance goals) and sample sizes established must be justified as to how they were determined and why they are clinically meaningful; and

(iv) Validation must be performed and controls implemented to characterize and ensure consistency (i.e., repeatability and reproducibility) of modeling outputs:

(A) Testing must be performed using multiple qualified operators and using the procedure that will be implemented under anticipated conditions of use; and

(B) The factors (e.g., medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data.

(4) Human factors evaluation must be performed to evaluate the ability of the user interface and labeling to allow for intended users to correctly use the device and interpret the provided information.

(5) Device labeling must be provided that describes the following:

(i) Warnings that identify anatomy and image acquisition factors that may impact simulation results and provide cautionary guidance for interpretation of the provided simulation results;

(ii) Device simulation inputs and outputs, and key assumptions made in the simulation and determination of simulated outputs; and

(iii) The computational modeling performance of the device for presented simulation outputs, and the supporting evidence for this performance.

[87 FR 79803, Dec. 28, 2022]

Sec. 870.1415 Coronary vascular physiologic simulation software device.

(a) Identification. A coronary vascular physiologic simulation software device is a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Adequate software verification and validation based on comprehensive hazard analysis, with identification of appropriate mitigations, must be performed, including:

(i) Full characterization of the technical parameters of the software, including:

(A) Any proprietary algorithm(s) used to model the vascular anatomy; and

(B) Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications;

(ii) Adequate consideration of privacy and security issues in the system design; and

(iii) Adequate mitigation of the impact of failure of any subsystem components (e.g., signal detection and analysis, data storage, system communications and cybersecurity) with respect to incorrect patient reports and operator failures.

(2) Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement; and

(3) Clinical data supporting the proposed intended use must be provided, including the following:

(i) Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner;

(ii) Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests (e.g., from literature analysis);

(iii) Statistical performance of the device within clinical risk strata (e.g., age, relevant comorbidities, disease stability) must be reported;

(iv) The dataset must be adequately representative of the intended use population for the device (e.g., patients, range of vessel sizes, imaging device models). Any selection criteria or limitations of the samples must be fully described and justified;

(v) Statistical methods must consider the predefined endpoints:

(A) Estimates of probabilities of incorrect results must be provided for each endpoint,

(B) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification, and

(vi) Sensitivity and specificity must be characterized across the range of available measurements;

(vii) Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements;

(viii) Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and

(ix) If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation, and it must be justified as to how it was determined and clinically validated;

(4) Adequate validation must be performed and controls implemented to characterize and ensure consistency (i.e., repeatability and reproducibility) of measurement outputs:

(i) Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified, and

(ii) Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency (i.e., repeatability and reproducibility) of the output that is representative of the range of data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment;

(A) Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device, and

(5) Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention; and

(6) Device labeling must be provided that adequately describes the following:

(i) The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended;

(ii) Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements;

(iii) Key assumptions made in the calculation and determination of simulated measurements;

(iv) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data;

(v) A detailed description of the patients studied in the clinical validation (e.g., age, gender, race or ethnicity, clinical stability, current treatment regimen) as well as procedural details of the clinical study (e.g., scanner representation, calcium scores, use of beta-blockers or nitrates); and

(vi) Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results.

[80 FR 63673, Oct. 21, 2015]

Sec. 870.1420 Coronary artery disease risk indicator using acoustic heart signals.

(a) Identification. A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must fulfill the following:

(i) Testing must include a discussion of the patient population and any statistical techniques used for analyzing the data; and

(ii) Testing must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.

(2) Acoustic performance testing must evaluate microphone sensitivity, sound acquisition bandwidth, and amplitude accuracy. The acoustic sensor specifications and mechanism used to capture heart sounds must be described.

(3) A scientific justification for the validity of the algorithm(s) must be provided. This justification must fulfill the following:

(i) All inputs and outputs of the algorithm must be fully described;

(ii) The procedure for segmenting, characterizing, and classifying the acoustic signal must be fully described; and

(iii) This justification must include verification of the algorithm calculations and validation using an independent data set.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) Software verification, validation, and hazard analysis must be performed.

(6) Human factors/usability testing must demonstrate that the user can correctly use the device, including device placement, based solely on reading the directions for use.

(7) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device.

(8) Labeling must include the following:

(i) A description of what the device measures and outputs to the user;

(ii) Instructions for proper placement of the device;

(iii) Instructions on care and cleaning of the device;

(iv) Warnings identifying sensor acquisition factors that may impact measurement results and instructions for mitigating these factors; and

(v) The expected performance of the device for all intended use populations and environments.

[87 FR 32990, July 1, 2022]

Sec. 870.1425 Programmable diagnostic computer.

(a) Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

(b) Classification. Class II (performance standards).

Sec. 870.1435 Single-function, preprogrammed diagnostic computer.

(a) Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

(b) Classification. Class II (performance standards).

Sec. 870.1450 Densitometer.

(a) Identification. A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

(b) Classification. Class II (performance standards).

Sec. 870.1650 Angiographic injector and syringe.

(a) Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

(b) Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]

Sec. 870.1660 Indicator injector.

(a) Identification. An indicator injector is an electrically or gas-powered device designed to inject accurately an indicator solution into the blood stream. This device may be used in conjuction with a densitometer or thermodilution device to determine cardiac output.

(b) Classification. Class II (performance standards).

Sec. 870.1670 Syringe actuator for an injector.

(a) Identification. A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.

(b) Classification. Class II (performance standards).

Sec. 870.1750 External programmable pacemaker pulse generator.

(a) Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.

(b) Classification. Class II (performance standards).

Sec. 870.1800 Withdrawal-infusion pump.

(a) Identification. A withdrawal-infusion pump is a device designed to inject accurately drugs into the bloodstream and to withdraw blood samples for use in determining cardiac output.

(b) Classification. Class II (performance standards).

Sec. 870.1875 Stethoscope.

(a) Manual stethoscope - (1) Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

(b) Electronic stethoscope - (1) Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

(2) Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001; 84 FR 71811, Dec. 30, 2019]

Sec. 870.1915 Thermodilution probe.

(a) Identification. A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

(b) Classification. Class II (performance standards).

Subpart C - Cardiovascular Monitoring Devices

Sec. 870.2050 Biopotential amplifier and signal conditioner.

(a) Identification. A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.

(b) Classification. Class II (performance standards).

Sec. 870.2060 Transducer signal amplifier and conditioner.

(a) Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.

(b) Classification. Class II (performance standards).

Sec. 870.2100 Cardiovascular blood flowmeter.

(a) Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

(b) Classification. Class II (performance standards).

Sec. 870.2120 Extravascular blood flow probe.

(a) Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

(b) Classification. Class II (performance standards).

Sec. 870.2200 Adjunctive cardiovascular status indicator.

(a) Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:

(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);

(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;

(iii) Specification of acceptable incoming sensor data quality control measures; and

(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.

(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.

(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.

(4) Clinical data must be provided in support of the intended use and include the following:

(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;

(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;

(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and

(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.

(5) Labeling must include the following:

(i) The type of sensor data used, including specification of compatible sensors for data acquisition;

(ii) A description of what the device measures and outputs to the user;

(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;

(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;

(v) Key assumptions made in the calculation and determination of measurements;

(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and

(vii) A detailed description of the patients studied in the clinical validation (e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.

[82 FR 35067, July 28, 2017]

Sec. 870.2210 Adjunctive predictive cardiovascular indicator.

(a) Identification. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must be provided, including:

(i) A full characterization of the software technical parameters, including algorithms;

(ii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;

(iii) A description of sensor data quality control measures;

(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy;

(v) A description of the expected time to patient status or clinical event for all expected outputs, accounting for differences in patient condition and environment; and

(vi) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form.

(2) A scientific justification for the validity of the predictive cardiovascular indicator algorithm(s) must be provided. This justification must include verification of the algorithm calculations and validation using an independent data set.

(3) A human factors and usability engineering assessment must be provided that evaluates the risk of misinterpretation of device output.

(4) A clinical data assessment must be provided. This assessment must fulfill the following:

(i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data.

(ii) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.

(iii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.

(iv) The assessment must evaluate how the device output correlates with the predicted event or status.

(5) Labeling must include:

(i) A description of what the device measures and outputs to the user;

(ii) Warnings identifying sensor acquisition factors that may impact measurement results;

(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;

(iv) A specific time or a range of times before the predicted patient status or clinical event occurs, accounting for differences in patient condition and environment;

(v) Key assumptions made during calculation of the output;

(vi) The type(s) of sensor data used, including specification of compatible sensors for data acquisition;

(vii) The expected performance of the device for all intended use populations and environments; and

(viii) Relevant characteristics of the patients studied in the clinical validation (including age, gender, race or ethnicity, and patient condition) and a summary of validation results.

[87 FR 8191, Feb. 14, 2022]

Sec. 870.2220 Adjunctive hemodynamic indicator with decision point.

(a) Identification. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Software description, verification, and validation based on comprehensive hazard analysis and risk assessment must be provided, including:

(i) Full characterization of technical parameters of the software, including algorithm(s);

(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;

(iii) Specification of acceptable incoming sensor data quality control measures;

(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on output accuracy; and

(v) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form for clinically meaningful pre-specified time windows consistent with the device output.

(2) Scientific justification for the validity of the hemodynamic indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm must use an independent data set.

(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.

(4) Clinical data must support the intended use and include the following:

(i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data;

(ii) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output represents the measure(s) that the device provides in an accurate and reproducible manner;

(iii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;

(iv) Where continuous measurement variables are displayed, agreement of the output with the reference measure(s) must be assessed across the full measurement range; and

(v) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.

(5) Labeling must include the following:

(i) The type of sensor data used, including specification of compatible sensors for data acquisition, and a clear description of what the device measures and outputs to the user;

(ii) Warnings identifying factors that may impact output results;

(iii) Guidance for interpretation of the outputs, including warning(s) specifying adjunctive use of the measurements;

(iv) Key assumptions made in the calculation and determination of measurements; and

(v) A summary of the clinical validation data, including details of the patient population studied (e.g., age, gender, race/ethnicity), clinical study protocols, and device performance with confidence intervals for all intended use populations.

[87 FR 79254, Dec. 27, 2022]

Sec. 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a) Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

(b) Classification. Class II (performance standards).

Sec. 870.2310 Apex cardiograph (vibrocardiograph).

(a) Identification. An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer.

(b) Classification. Class II (performance standards).

Sec. 870.2320 Ballistocardiograph.

(a) Identification. A ballistocardiograph is a device, including a supporting structure on which the patient is placed, that moves in response to blood ejection from the heart. The device often provides a visual display.

(b) Classification. Class II (performance standards).

Sec. 870.2330 Echocardiograph.

(a) Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.

(b) Classification. Class II (performance standards).

Sec. 870.2340 Electrocardiograph.

(a) Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

(b) Classification. Class II (performance standards).

Sec. 870.2345 Electrocardiograph software for over-the-counter use.

(a) Identification. An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing under anticipated conditions of use must demonstrate the following:

(i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and

(ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.

(2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.

(3) Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set.

(4) Human factors and usability testing must demonstrate the following:

(i) The user can correctly use the device based solely on reading the device labeling; and

(ii) The user can correctly interpret the device output and understand when to seek medical care.

(5) Labeling must include:

(i) Hardware platform and operating system requirements;

(ii) Situations in which the device may not operate at an expected performance level;

(iii) A summary of the clinical performance testing conducted with the device;

(iv) A description of what the device measures and outputs to the user; and

(v) Guidance on interpretation of any results.

[86 FR 2549, Jan. 18, 2022]

Sec. 870.2350 Electrocardiograph lead switching adaptor.

(a) Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.

(b) Classification. Class II (performance standards).

Sec. 870.2360 Electrocardiograph electrode.

(a) Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled "Class II Special Controls Guidance Document: Electrocardiograph Electrodes." See § 870.1(e) for availability information of guidance documents.

[45 FR 7907, Feb. 5, 1980, as amended at 76 FR 43585, July 21, 2011]

Sec. 870.2370 Electrocardiograph surface electrode tester.

(a) Identification. An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes.

(b) Classification. Class II (performance standards).

Sec. 870.2390 Phonocardiograph.

(a) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

Sec. 870.2400 Vectorcardiograph.

(a) Identification. A vectorcardiograph is a device used to process the electrical signal transmitted through electrocardiograph electrodes and to produce a visual display of the magnitude and direction of the electrical signal produced by the heart.

(b) Classification. Class II (performance standards).

Sec. 870.2450 Medical cathode-ray tube display.

(a) Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

(b) Classification. Class II (performance standards).

Sec. 870.2600 Signal isolation system.

(a) Identification. A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

Sec. 870.2620 Line isolation monitor.

(a) Identification. A line isolation monitor is a device used to monitor the electrical leakage current from a power supply electrically isolated from the commercial power supply received from a utility company.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

Sec. 870.2640 Portable leakage current alarm.

(a) Identification. A portable leakage current alarm is a device used to measure the electrical leakage current between any two points of an electrical system and to sound an alarm if the current exceeds a certain threshold.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

Sec. 870.2675 Oscillometer.

(a) Identification. An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

Sec. 870.2700 Oximeter.

(a) Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

(b) Classification. Class II (performance standards).

Sec. 870.2710 Ear oximeter.

(a) Identification. An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

(b) Classification. Class II (performance standards).

Sec. 870.2750 Impedance phlebograph.

(a) Identification. An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measuring electrical impedance changes in a region of the body.

(b) Classification. Class II (performance standards).

Sec. 870.2770 Impedance plethysmograph.

(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

Sec. 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a) Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.

(b) Classification. Class II (performance standards).

Sec. 870.2785 Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

(a) Identification. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate. This device is not intended to independently direct therapy.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:

(i) A full characterization of the software technical parameters, including algorithms;

(ii) If required image acquisition hardware is not included with the device, full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements;

(iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;

(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and

(v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.

(2) Clinical data must be provided. This assessment must fulfill the following:

(i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.

(ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.

(iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner.

(3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.

(4) Labeling must include:

(i) A description of what the device measures and outputs to the user;

(ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results;

(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;

(iv) The expected performance of the device for all intended use populations and environments; and

(v) Robust instructions to ensure correct system setup.

[88 CFR 6167, Jan. 31, 2023]

Sec. 870.2786 Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

(a) Identification. The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rates. This device is not intended to independently direct therapy.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:

(i) A full characterization of the software technical parameters, including algorithms;

(ii) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and

(iii) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.

(2) Performance testing must demonstrate the safety of any illuminating optics.

(3) Clinical data must be provided. This assessment must fulfill the following:

(i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.

(ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.

(iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner.

(4) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.

(5) Labeling must include:

(i) A description of what the device measures and outputs to the user;

(ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results;

(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;

(iv) The expected performance of the device for all intended use populations and environments; and

(v) Robust instructions to ensure correct system setup.

[88 FR 976, Jan. 6, 2023]

Sec. 870.2790 Photoplethysmograph analysis software for over-the-counter use.

(a) Identification. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.

(3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality.

(4) Human factors and usability testing must demonstrate the following:

(i) The user can correctly use the device based solely on reading the device labeling; and

(ii) The user can correctly interpret the device output and understand when to seek medical care.

(5) Labeling must include:

(i) Hardware platform and operating system requirements;

(ii) Situations in which the device may not operate at an expected performance level;

(iii) A summary of the clinical performance testing conducted with the device;

(iv) A description of what the device measures and outputs to the user; and

(v) Guidance on interpretation of any results.

[87 FR 6419, Feb. 4, 2022]

Sec. 870.2800 Medical magnetic tape recorder.

(a) Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

(b) Classification. Class II (performance standards).

Sec. 870.2810 Paper chart recorder.

(a) Identification. A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

Sec. 870.2840 Apex cardiographic transducer.

(a) Identification. An apex cardiographic transducer is a device used to detect motion of the heart (acceleration, velocity, or displacement) by changes in the mechanical or electrical properties of the device.

(b) Classification. Class II (performance standards).

Sec. 870.2850 Extravascular blood pressure transducer.

(a) Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

(b) Classification. Class II (performance standards).

Sec. 870.2855 Implantable Intra-aneurysm Pressure Measurement System.

(a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System." See § 870.1 (e) for the availability of this guidance document.

[71 FR 7871, Feb. 15, 2006]

Sec. 870.2860 Heart sound transducer.

(a) Identification. A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.

(b) Classification. Class II (performance standards).

Sec. 870.2870 Catheter tip pressure transducer.

(a) Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

(b) Classification. Class II (performance standards).

Sec. 870.2880 Ultrasonic transducer.

(a) Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.

(b) Classification. Class II (performance standards).

Sec. 870.2890 Vessel occlusion transducer.

(a) Identification. A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partially occluded vessel. This device includes motion, sound, and ultrasonic transducers.

(b) Classification. Class II (performance standards).

Sec. 870.2900 Patient transducer and electrode cable (including connector).

(a) Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

(b) Classification. Class II (performance standards).

Sec. 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a) Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

(b) Classification. Class II (performance standards).

Sec. 870.2920 Telephone electrocardiograph transmitter and receiver.

(a) Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

(b) Classification. Class II (performance standards).

Subpart D - Cardiovascular Prosthetic Devices

Sec. 870.3250 Vascular clip.

(a) Identification. A vascular clip is an implanted extravascular device designed to occlude, by compression, blood flow in small blood vessels other than intracranial vessels.

(b) Classification. Class II (performance standards).

Sec. 870.3260 Vena cava clip.

(a) Identification. A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel.

(b) Classification. Class II (performance standards).

Sec. 870.3300 Vascular embolization device.

(a) Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

(b) Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices." For availability of this guidance document, see § 870.1(e).

[69 FR 77899, Dec. 29, 2004]

Sec. 870.3375 Cardiovascular intravascular filter.

(a) Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.

(b) Classification. Class II. The special controls for this device are:

(1) "Use of International Standards Organization's ISO 10993 'Biological Evaluation of Medical Devices Part I: Evaluation and Testing,' " and

(2) FDA's:

(i) "510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)" and

(ii) "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions."

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 65 FR 17144, Mar. 31, 2000]

Sec. 870.3450 Vascular graft prosthesis.

(a) Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

(b) Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled "Guidance Document for Vascular Prostheses 510(k) Submissions."

[66 FR 18542, Apr. 10, 2001]

Sec. 870.3460 Endovascular Suturing System.

(a) Identification. An endovascular suturing system is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The device should be demonstrated to be biocompatible;

(2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components;

(3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment;

(4) Non-clinical testing should evaluate the compatibility of the device in an magnetic resonance (MR) environment;

(5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety;

(6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and

(7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.

[77 FR 8119, Feb. 14, 2012]

Sec. 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a) Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

(b) Classification. Class II (performance standards).

Sec. 870.3535 Intra-aortic balloon and control system.

(a) Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.

(b) Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:

(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;

(ii) Software verification, validation, and hazard analysis must be performed;

(iii) The device must be demonstrated to be biocompatible;

(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;

(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and

(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.

(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.

(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[78 FR 79303, Dec. 31, 2013]

Sec. 870.3545 Ventricular bypass (assist) device.

(a) Identification. A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before November 21, 2011, for any ventricular bypass (assist) device that was in commercial distribution before May 28, 1976, or that has, on or before November 21, 2011, been found to be substantially equivalent to any ventricular bypass (assist) device that was in commercial distribution before May 28, 1976. Any other ventricular bypass (assist) device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 76 FR 50666, Aug. 16, 2011]

Sec. 870.3600 External pacemaker pulse generator.

(a) Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.

(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (i.e., battery power, AC mains connections, or both).

(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:

(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;

(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;

(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and

(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.

(4) Appropriate software verification, validation, and hazard analysis must be performed.

(5) Labeling must include the following:

(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;

(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (â??) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;

(iii) The labeling must list all pacing modes available in the device;

(iv) Labeling must include a detailed description of any special capabilities (e.g., overdrive pacing or automatic mode switching); and

(v) Appropriate electromagnetic compatibility information must be included.

[81 FR 22529, Apr. 18, 2016]

Sec. 870.3605 Pacing system analyzer.

(a) Identification. A pacing system analyzer (PSA) is a prescription device that combines the functionality of a pacemaker electrode function tester (§ 870.3720) and an external pacemaker pulse generator (EPPG) (§ 870.3600). It is connected to a pacemaker lead and uses a power supply and electronic circuits to supply an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential. A PSA may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.