| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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3-188
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| Standard | |
ISO 81060-3 First edition 2022-12
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type |
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Scope/AbstractThis document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient.
This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer.
This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document.
NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values.
The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers.
NOTE 2 Subject populations can, for example, be represented by age or weight ranges.
NOTE 3 This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject).
This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document.
This document is not applicable to:
- the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1,
- the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2,
- an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or
- invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
- 4.5.1.b.3 regarding number of subjects (k) and Table 2: Relationship between r and the minimum k depending on the estimated intra-class correlation coefficient
- 5.1.4.a (page 16), 5.1.4.b (page 16), and 5.2.4.a regarding acceptance criteria
- 5.3.5 regarding acceptance criteria
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Note: Special subject populations may vary depending on intended use and technology. We encourage you to contact the review division prior to initiating the clinical investigation(s) for your device.
This standard is recognized in part because:
- Subclause 4.5.1.b.3 is in conflict with another recognized standard, see subclause 4.5.3 of IEEE Std 1708 listed below (ref #1).
- Subclause 5.1.4.a (page 16), subclause 5.1.4.b (page 16), and subclause 5.2.4.a, are in conflict with another recognized standard, see subclause 6.2.6 of ISO 81060-2 listed below (ref # 2).
- Subclause 5.3.5 provides acceptance criteria without justification and is in conflict with published literature, see Conclusions section of Huhle et al below (ref #3). |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.1130 |
System, Measurement, Blood-Pressure, Non-Invasive
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Class 2
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DXN
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Relevant FDA Guidance and/or Supportive Publications*
1. IEEE Std 1708-2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)].
2. ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)].
3. Huhle R, Richter T, Gama de Abreu M. Tracking blood pressure changes by means of non-invasive intermittent blood pressure measurements in clinical application: Tracking capabilities of non-invasive intermittent blood pressure measurement devices fulfilling DIN EN ISO 81060-2 - A simulation study. Current Directions in Biomedical Engineering. 2021;7(2): 815-818.
4. Friedman BA, Alpert BS, Osborn D, Prisant LM, Quinn DE, Seller J. Assessment of the validation of blood pressure monitors: a statistical reappraisal. Blood Press Monit. 2008 Aug;13(4):187-91.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
