BTL BTL-08 ABPM (V2)

Device Name:

BTL-08 ABPM

Manufacturer:

OBL: BTL Industries Inc., 47 Loring Drive Framingham, MA 01702, UNITED STATES.

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 BTL BTL-08 ABPM (V2) 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 BTL BTL-08 ABPM (V2) to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer, 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:

BTL BTL-08 ABPM (V2)Z, Tensiomed TensiodayB, Unimedic TensiodayB
Legend: B BIHS Derivative, 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.

Tensiomed Tensioday

Németh Z, Móczár K, Deák G. Evaluation of the Tensioday ambulatory blood pressure monitor according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 2002 Jun;7(3):191-7. PMID: 12131077.

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

SP10:1992 - Pass General population