Avita BPM11 (v2)

Device Model:

BPM11

Manufacturer:

AViTA Corporation, 9F No. 78 Sec 1, Gwang-Fu Road, Sanchong Dist., New Taipei City 24158, TAIWAN ROC.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Wrist

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Description:

The Avita BPM11 (v2) 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 wrist. It is intended for self-measurement and home use.

Assessment:

The technology used in the Avita BPM11 (v2), 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	Equivalence claim without published evidence

Device Family:

Avita BPM15 (v1)Z, Avita BPM11 (v2)P, Avita BPM15 (v2)Z, Avita BPM15SP, LotFancy 11C-1863-Q2Z
Legend: P Stride Equivalence, Z Almost Certain

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 BPM15S

Kang YY, Zeng WF, Zhang L, Li Y, Wang JG. Validation of the AVITA BPM15S wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Jun;19(3):183-6. doi: 10.1097/MBP.0000000000000041. PMID: 24695213.

ESH-IP:2010 - Pass General population