Welch Allyn SureBP Algorithm (Unspecified Device)

Description:

The Welch Allyn SureBP Algorithm (Unspecified Device) is an algorithm for measuring blood pressure. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for use only as a reasearch version.

Assessment:

The technology used in the Welch Allyn SureBP Algorithm (Unspecified Device), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol
BP	ESH (Europe)	Professional use for children	Published evidence
BP	MDR Criteria	Adults	Validation with amended protocol - may require further study

Device Family:

Welch Allyn Connex ProBP 3400 with SureBPA, Hillrom Connex Vital Signs 6000 SeriesA, Welch Allyn SureBP Algorithm (Unspecified Device)A, Hillrom Connex SpotA, Hillrom Spot Vital Signs 4400A
Legend: A Same validated algorithm

Validation Publications:

Alpert BS. Validation of the Welch Allyn SureBP (inflation) and StepBP (deflation) algorithms by AAMI standard testing and BHS data analysis. Blood Press Monit. 2011 Apr;16(2):96-8. doi: 10.1097/MBP.0b013e328345232f. PMID: 21412074.

SP10:2006 - Pass General population

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.

Welch Allyn Connex ProBP 3400 with SureBP

Alpert BS. Validation of the Welch Allyn ProBP 3400: a device for modern medical practice. Blood Press Monit. 2011 Jun;16(3):156-8. doi: 10.1097/MBP.0b013e328346d61b. PMID: 21527848.

SP10:2002 - Pass General population (Note: Cirterion 1 only (n=92))