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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR870.1252]
See Related Information on Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. in CDRH databases



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

PART 870 -- CARDIOVASCULAR DEVICES

Subpart B - Cardiovascular Diagnostic Devices

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]

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