Welch Allyn ABPM 6100

Description:

The Welch Allyn ABPM 6100 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. This device is now obsolete.

Assessment:

While the technology used in the Welch Allyn ABPM 6100, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared 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.
BP	BIHS (UK and IRL)	ABPM	Manufacturer declaration of equivalence to the Suntech Oscar 2
BP	ESH (Europe)	ABPM	The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
BP	FDA (US)	510(k)	510(k) K021756

Device Family:

Riester ri-cardioB, Suntech Oscar 2B, Welch Allyn ABPM 6100B
Legend: B BIHS Derivative

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.

Suntech Oscar 2

Jones SC, Bilous M, Winship S, Finn P, Goodwin J. Validation of the OSCAR 2 oscillometric 24-hour ambulatory blood pressure monitor according to the International Protocol for the validation of blood pressure measuring devices. Blood Press Monit. 2004 Aug;9(4):219-23. PMID: 15311149.

ESH-IP:2002 - Pass General population

Goodwin J, Bilous M, Winship S, Finn P, Jones SC. Validation of the Oscar 2 oscillometric 24-h ambulatory blood pressure monitor according to the British Hypertension Society protocol. Blood Press Monit. 2007 Apr;12(2):113-7. PMID: 17353655.

ESH-IP:2002 - Pass General population