| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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3-168
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| Standard | |
IEEE Std 1708-2014
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
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Scope/Abstract| The intent of this standard is to establish objective performance evaluation of wearable, cuffless blood pressure (BP) measuring devices. The standard is independent of the form of the device or the vehicle to which the device is attached or in which it is embedded. The standard is applicable to all types of wearable BP measurement devices that have different modes of operation (e.g., to measure short-term, long-term, snapshot, continuous, beat(s)-to-beat(s) BP, or BP variability). This standard is, however, limited to evaluation of devices that do not use a cuff during measurement and does not cover evaluation of all sphygmomanometers that are used with an occluding or inflatable cuff for the indirect determination of BP on the upper arm or wrist. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 4.2 Observer training and measurement
Clause 4.2.2 Observer measurement
Clause 4.3.3 e) Special patient populations and confounding factors
Clause 4.4.3 Test with blood pressure change
Table 2 of Clause 4.4.3 Test with blood pressure change
Clause 4.4.4 Test after a certain period of time
Clause 4.5.3.2 Accuracy at different BP change levels
Clause 7 Communication |
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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.
This standard is recognized in part because:
Clause 4.2 is not recognized for cuffless blood pressure monitors with "continuous, beat(s)-to-beat(s) BP, or BP variability" modes of operation (which are within the scope of this standard), because, the auscultatory reference method used to validate these modes conflicts with published literatures. Table 1 of the "Frontiers of medicine" publication below (ref #8) and page 208 of "The Handbook of Cuffless Blood Pressure Monitoring" book below (ref # 9) show that the auscultatory reference method is unsuitable for testing continuous or quick changes in blood pressure.
Clause 4.2.2 does not provide measurement specifications that result in valid measurements. In particular, the measurement specifications are in conflict with clause 5.2 of the FDA recognized ISO 81060-2:2018 standard.
Clause 4.3.3 e) does not provide adequate scientific rationale as to why non-pre-eclamptic pregnancies would not be considered a special population. The Cardiology Clinics 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 Hypertension publication also shows that "devices intended for use in pregnant women should be validated in this population".
Clause 4.4.3 is not recognized for cuffless blood pressure monitors with "continuous, beat(s)-to-beat(s) BP, or BP variability" modes of operation (which are within the scope of this standard), because, as stated in published literature, "the capability for the cuffless device to follow quick blood pressure changes" can only be verified by comparing to simultaneously performed gold standard continuous reference blood pressure measurement with appropriate time resolution (see page 208 of "The Handbook of Cuffless Blood Pressure Monitoring" book below (ref #9)).
Table 2 of Clause 4.4.3 does not provide requirements on the induced blood pressure changes which would be representative of blood pressure changes during the intended use of the device. In particular, Table 2 of Clause 4.4.3 conflicts with findings from published literature about circadian variation of blood-pressure.
Clause 4.4.4 does not specify how often the device needs to be challenged between two consecutive calibration times. This is in conflict with published literature, which states, "The IEEE standard suggests performing two test measurements within two calibration points; directly after initial calibration and before the next calibration is required. However, when performing only an initial and end-testing the device might not be accurate in-between these tests." (See page 207 of "The Handbook of Cuffless Blood Pressure Monitoring" book below (ref # 9)).
Clause 4.5.3.2 does not provide statistical justification for the proposed acceptance criterion. In particular, Clause 4.5.3.2 conflicts with the statistically justified acceptance criteria shown in Table 3 of Clause 4.5.1 of this IEEE Std 1708 standard, which are based on a statistical rationale that is also leveraged by the FDA-recognized ISO 81060-2:2018 standard.
Clause 7 does not provide specifications for risk management of wireless technologies used for communication. In particular, it conflicts with the expectations of FDA's Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff guidance document, as well as the following FDA recognized standards: AAMI TIR69:2017 and ANSI/IEEE C63.27:2017.
Please contact FDA regarding the use of the device prior to using this standard to support claims for use during patient transport, ambulatory monitoring, motion artifact, stress and/or exercise testing. |
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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. ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type.
2. Ogedegbe, G., and Pickering, T. (2010). Principles and techniques of blood pressure measurement, Cardiology Clinics, 28(4): 571-586.
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. MW Millar-Craig, CN Bishop, EB Raftery - The Lancet, 1978 - Elsevier, Circadian variation of blood-pressure.
5. Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 2013.
6. AAMI TIR 69:2017 Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems.
7. ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence.
8. Chung E, Chen G, Alexander B, Cannesson M. Non-invasive continuous blood pressure monitoring: a review of current applications. Front Med. 2013 Mar;7(1):91-101.
9. The Handbook of Cuffless Blood Pressure Monitoring: A Practical Guide for Clinicians, Researchers, and Engineers, edited by Josep Solà, and Ricard Delgado-Gonzalo, Springer International Publishing AG, 2019.
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. |
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