Custo Med custo screen 310

Description:

The Custo Med custo screen 310 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 ABPM, along with central aortic pressure.

Assessment:

The technology used in the Custo Med custo screen 310, 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	Stride BP	ABPM for children (Preferred)	Equivalence to the Custo Med custo screen Pediatric claim without published evidence

Device Family:

Custo Med custo screen 300P,X, Custo Med custo screen 400X, Custo Med custo screen PediatricP, Custo Med custo screen 310P
Legend: P Stride Equivalence, X Equivalence claim in publication

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.

Custo Med custo screen 400

Bramlage P, Deutsch C, Krüger R, Wolf A, Müller P, Zwingers T, Beime B, Mengden T. Validation of the custo screen 400 ambulatory blood pressure-monitoring device according to the European Society of Hypertension International Protocol revision 2010. Vasc Health Risk Manag. 2014 May 13;10:303-9. doi: 10.2147/VHRM.S63602. PMID: 24868162. Available from: PMC4027883.

ESH-IP:2010 - Pass General population

Custo Med custo screen Pediatric

Beime B, Deutsch C, Krüger R, Wolf A, Müller P, Hammel G, Bramlage P. Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. Eur J Pediatr. 2017 May;176(5):573-80. Epub: 2017 Feb 24. doi: 10.1007/s00431-017-2874-3. PMID: 28236027.

ESH-IP:2010 - Pass Children, aged 3 to 12 years (n=33)