Biobeat BB-613 Wrist Watch

Description:

The Biobeat BB-613 Wrist Watch is a dual monitor for blood pressure and oxygen saturation. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements and oxygen saturation measurements are taken from the wrist. It is intended for ambulatory monitoring.

Assessment:

The technology used in the Biobeat BB-613 Wrist Watch, to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol. It has also been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4. There appears to be no peer-reviewed clinical validation information available on the technology used in the Biobeat BB-613 Wrist Watch to measure peripheral oxygen saturation.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
BP	FDA (US)	510(k)	510(k) K181006

Device Family:

Biobeat BB-613 Wrist WatchF, Biobeat BB-613WP (Wrist-monitor)F, Biobeat BB-613WP (Chest-monitor)F
Legend: F FDA 510(k)

Validation Publications:

Eisenkraft A, Nachman D. Human study of the Biobeat device allowing for non-invasive wireless continuous measurement of blood pressure. (US) Military Health System Research Symposium 2018. Epub: 2018 Sep. doi: 10.13140/RG.2.2.16570.03527. Available from: www.biobeat.cloud. Poster presentation.

Ad Hoc protocol General population (Note: ESH-IP 2010 criteria applied to sample for which it may not be applicable)

The results of the study have only been published in poster form and their validity cannot be verified.

Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Biobeat BB-613WP (Wrist-monitor)

Nachman D, Gepner Y, Goldstein N, Kabakov E, Ishay AB, Littman R, Azmon Y, Jaffe E, Eisenkraft A. Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device. Sci Rep.;10:16116. Epub: 2020 Sep 30. doi: 10.1038/s41598-020-73172-3.

Ad Hoc protocol General population (Note: Partial ISO 81060-2:2013 criteria applied to large sample but for which BP and other distribution requirements are not provided.)