VectraCor ABPM-05

Device Name:

ABPM-05

Manufacturer:

OBL: VectraCor Inc., 785 Totowa Road, Totowa, New Jersey 07512, UNITED STATES.

OEM: Meditech Ltd., Mikszath Kalman utca 24, 1184 Budapest, HUNGARY.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for ambulatory blood pressure monitoring

Measurement Site:

Upper Arm

Measurement Occurrence:

Intermittent measurements at specified intervals or times

Availability:

Available Currently

Description:

The VectraCor ABPM-05 is an ambulatory 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 ambulatory blood pressure monitoring.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the VectraCor ABPM-05 to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven according to a protocol compliant 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.

Device Family:

BIOS ABP-01Z, BTL Cardiopoint BTL-08 ABPM (V1)B, Meditech ABPM-04B,D, Meditech ABPM-05B,D, Meditech card(X)ploreD, Omron M24/7 (ABPM-BP5)B, VectraCor ABPM-05Z
Legend: B BIHS Derivative, D DET 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.

Meditech ABPM-04

Barna I, Keszei A, Dunai A. Evaluation of Meditech ABPM-04 ambulatory blood pressure measuring device according to the British Hypertension Society protocol. Blood Press Monit. 1998;3(6):363-8. PMID: 10212378.

BHS:1993 - Pass (B/B) General population

SP10:1992 - Pass General population