A&D TM-2440 - Medaval

Description:

The A&D TM-2440 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:

The technology used in the A&D TM-2440, 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	BIHS (UK and IRL)	ABPM	Manufacturer declaration of equivalence to the A&D TM-2441
BP	Hypertension Canada	ABPM (Previous) (Gold)	Manufacturer declaration of equivalence
BP	Stride BP	ABPM for adults (Preferred)	Equivalence claim without published evidence
BP	AMA VDL (US)	ABPM	Equivalence claim without published evidence

Device Family:

A&D TM-2655J,P, A&D TM-2655P (v2)J, A&D TM-2440B,P, A&D TM-2441B,P, A&D TM-2655VPJ
Legend: B BIHS Derivative, J JHS Implied Equivalence, 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.

A&D TM-2441

Kario K, Hoshide S, Saito K, Sato K, Hamasaki H, Suwa H, Tomitani N. Validation of the TM-2441 ambulatory blood pressure measurement device according to the ISO 81060-2 2013 standard. Blood Press Monit. 2019 Feb;24(1):38-41. Epub: 2018 Nov 29. doi: 10.1097/MBP.0000000000000357. PMID: 30507622.

81060-2:2013 - Pass General population (Note: Primary 85-subject study)

81060-2:2013 - Pass General population (Note: 35-subject exercise study, as required for ABPM devices)

Both the main and exercise studies are completed; 13 subjects were included in both studies.

A&D TM-2655

Kobalava ZD, Kotovskaya YV, Babaeva LA, Moiseev VS. Validation of TM-2655 oscillometric device for blood pressure measurement. Blood Press Monit. 2006 Apr;11(2):87-90. PMID: 16534410.

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

A&D TM-2655P (v2)

Kobalava ZD, Kotovskaya YV, Babaeva LA, Moiseev VS. Validation of TM-2655 oscillometric device for blood pressure measurement. Blood Press Monit. 2006 Apr;11(2):87-90. PMID: 16534410.

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