Avita BPM83 - Medaval

Description:

The Avita BPM83 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the Avita BPM83, to measure blood pressure, has 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	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Stride BP	Self-measurement for adults (Preferred)	Equivalence claim without published evidence

Device Family:

Avita BPM64 (v1)P, Avita BPM64 (v2)P, Avita BPM68P, Avita BPM82P, Avita BPM83P
Legend: P Stride Equivalence

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.

Avita BPM64 (v1)

Kang YY, Chen Q, Liu CY, Li Y, Wang JG. Validation of the AVITA BPM64 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2018 Feb;23(1):45-8. Epub: 2017 Oct 18. doi: 10.1097/MBP.0000000000000296. PMID: 29049094.

ESH-IP:2010 - Pass General population

Avita BPM82

Menti A, Ntousopoulos V, Theodosiadi A, Stathopoulou P, Kollias A, Stergiou GS. Validation of the automated oscillometric upper-arm cuff home blood pressure monitor AVITA BPM82 in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Blood Press Monit. 2024 Apr 1;29(2):89-92. Epub: 2023 Nov 6. doi: 10.1097/MBP.0000000000000682. PMID: 37937605.

81060-2:2020 - Pass General population