InBody BPBIO320S

Description:

The InBody BPBIO320S is a waiting-room blood pressure monitor. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood pressure measurements are taken from the upper arm. It is intended for use as a public facility.

Assessment:

The technology used in the InBody BPBIO320S, to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol. It has also been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

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	Hypertension Canada	Public use (Previous) (Gold)	Manufacturer declaration of equivalence
BP	Stride BP	Public use for adults (Preferred)	Equivalence claim without published evidence

Device Family:

InBody BPBIO320B,P, InBody BPBIO320NP, InBody BPBIO750B,P, InBody BPBIO320SP, InBody BPBIO330P, InBody BPBIO330NP
Legend: B BIHS Derivative, P Stride Equivalence

Validation Publications:

Moon JH, Kang MK, Choi CE, Min J, Lee HY, Lim S. Validation of a wearable cuff-less wristwatch-type blood pressure monitoring device. Sci Rep. 2020 Nov 4;10(1):19015. doi: 10.1038/s41598-020-75892-y. PMID: 33149118. Available from: PMC7642418.

Ad Hoc protocol General population

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.

InBody BPBIO320

Kollias A, Stambolliu E, Kyriakoulis KG, Papadatos SS, Stergiou GS. Validation of the single-cuff oscillometric blood pressure monitor InBody BPBIO320 for public use according to the 2010 European Society of Hypertension International Protocol. Blood Press Monit. 2019 Feb;24(1):30-32. Epub: 2018 Dec 7. doi: 10.1097/MBP.0000000000000359. PMID: 30531495.

ESH-IP:2010 - Pass General population

InBody BPBIO750

Ntineri A, Prapa S, Bountzona I, Menti A, Stergiou GS. Validation of the single-cuff oscillometric blood pressure monitor InBody BPBIO750 for public spaces according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard. Blood Press Monit. 2021 Apr 1;26(2):146-148. Epub: 2020 Dec 14. doi: 10.1097/MBP.0000000000000507. PMID: 33323723.

81060-2:2019 - Pass General population