Medel Idea (91913)

Device Name:

Idea

Device Model:

91913

Manufacturer:

Brand: Medel Group S.p.A., Via Micheli 9, 43056 San Polo di Torrile (Parma), ITALY.

OBL: Beurer GmbH, Söflinger Straße 218, 89077 Ulm, GERMANY.

OEM: SensaCare Ltd., Unit 803, 9 Wing Hong Street, Cheung Sha Wan, Kowloon, HONG KONG PRC.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Discontinued but still available

Description:

The Medel Idea (91913) 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 upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Medel Idea (91913), to measure blood pressure, has been compared to a clinically validated device, but not 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	ESH (Europe)	Self-measurement	Published evidence

Device Family:

Medel Idea (91913)D, SensaCare SAA-102D
Legend: D DET 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.

SensaCare SAA-102

Zaetta V, Daniele L, Perkovic D, Pratticò F, Barisa M, Perfetti P, Gabrieli A, Buonocore F, Winnicki M. Validation of the SAA-102 home blood pressure monitor according to the protocols of the European Society of Hypertension, the Association for the Advancement of Medical Instrumentation and the British Society of Hypertension. Blood Press Monit. 2007 Dec;12(6):363-8. PMID: 18004104.

ESH-IP:2002 - Pass General population

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

SP10:1996 - Pass General population