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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 3-166
Standard
ISO 81060-2 Third edition 2018-11
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
Scope/Abstract
This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation.

This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 5.1.4.b) Limb distribution.
Clause 5.1.6 b) Special patient populations.
Examples 3 & 6 of Clause 5.2.4.1.2 Data analysis.
Examples 3 & 6 of Clause 5.2.4.2.2 Data analysis.
Clause 6.1.4. b) Limb distribution.
Clause 6.1.6 b) Special patient populations.
Clause 7 Pregnant patient populations.
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.

This standard is recognized in part because:

Clause 5.1.4.b) and Clause 6.1.4.b) conflict with the scope of the standard (Clause 1), as they allow validation of unspecified number of "multiple CUFFs" with a single sphygmomanometer in a single clinical investigation.
Clause 5.1.4.b) and Clause 6.1.4.b) do not provide statistical methods to report the performance of the sphygmomanometer when it is used with each of the "multiple CUFFs" it is tested with, and they do not provide adequate statistical justification for the number of subjects assigned to each of the multiple cuffs. Therefore, they allow for aggregation of results from tests of the sphygmomanometer using unspecified number of multiple cuffs. Aggregation of results would obscure adequate evaluation of the performance of each cuff, which depends on the characteristics of each cuff (e.g., intended arm circumference range) as reported in the recent "Blood pressure monitoring" publication below (ref #5).

Clause 5.1.6 b), Examples 3 & 6 of Clause 5.2.4.1.2, Examples 3 & 6 of Clause 5.2.4.2.2, and Clause 6.1.6 b) do not provide adequate statistical justification for the number (i.e. 35 for the auscultatory reference, and 7 for the invasive reference) of additional special population patients that are needed to validate the device for the specific target population. Please see FDA's guidance documents below for the level of scientific evidence that is needed to indicate a device for a specific target population (such as a special population). Please see the original SP10 standard below, which had provided the statistical justification for a sample of 85 for a given population.

Clause 7 does not provide adequate statistical justification for the number of pregnant patients that are needed to validate the device for this particular special population. In addition, the rationale for clause 7 (in Annex A) does not provide adequate scientific evidence as to why "non-pre-eclamptic pregnancies" would not be considered a special population. The ccl publication below shows that "in normal pregnancy there is a fall of blood pressure, together with an increase of cardiac output and a large decrease of peripheral resistance." The AHA publication below shows that "devices intended for use in pregnant women should be validated in this population." Please see the original SP10 standard below, which had provided the statistical justification for a sample of 85 for a given population.

Clause 5.1.6 b) and Clause 7 b) are inconsistent with Clause 5.1.1 a), which specifies a statistically justified sample of 85 subjects for a given population, in terms of the numbers of special population subjects (i.e. 35 subjects) and pregnant subjects (i.e. 45 subjects).

Contact FDA prior to using this standard to support claims for use during patient transport, ambulatory monitoring, stress and/or exercise testing.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.1130 System, Measurement, Blood-Pressure, Non-Invasive Class 2 DXN
Relevant FDA Guidance and/or Supportive Publications*
1. ANSI/AAMI SP10:2002/(R)2008, Manual, Electronic, or Automated Sphygmomanometers.

2. Liao, J.J (2010). Sample calculation for an agreement study, Pharmaceutical Statistics, 9(2), 125-132.

3. Bello, N.A., Woolley, J.J. Cleary, K.L et al., (2018). Accuracy of Blood Pressure Measurement Devices in Pregnancy A Systematic Review of Validation Studies, Hypertension 71(2): 326-335.

4. Ogedegbe, G., and Pickering, T. (2010). Principles and techniques of blood pressure measurement, Cardiology Clinics, 28(4): 571-586.

5. Sprague E, Padwal RS. Adequacy of validation of wide-range cuffs used with home blood pressure monitors: a systematic review. Blood Press Monit. 2018 Oct;23(5):219-224.
FDA Technical Contacts
 Charles Ho
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-6320
  charles.ho@fda.hhs.gov
 Sandy Weininger
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2582
  sandy.weininger@fda.hhs.gov
 Taddese, Biniyam
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  240-402-6570
  Biniyam.Taddese@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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