BpTru BPM-300
While the technology used in the BpTru BPM-300, 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| BIHS (UK and IRL) | Professional use | Manufacturer declaration of equivalence | ||
| ESH (Europe) | Professional use for adults and children | The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria. | ||
| AMA VDL Criteria | Satisfies stated criteria | 510(k) K023078 plus | ||
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.
BpTru BPM-100
Mattu GS, Perry TL Jr, Wright JM. Comparison of the oscillometric blood pressure monitor (BPM-100(Beta)) with the auscultatory mercury sphygmomanometer. Blood Press Monit. 2001 Jun;6(3):153-9. PMID: 11518839.
SP10:1996 - Pass General population
BHS:1993 - Pass (A/A) General population
Wright JM, Mattu GS, Perry Jr TL, Gelferc ME, Strange KD, Zorn A, Chen Y. Validation of a new algorithm for the BPM-100 electronic oscillometric office blood pressure monitor. Blood Press Monit. 2001 Jun;6(3):161-5. PMID: 11518840.
SP10:1996 - Pass General population
BHS:1993 - Pass (A/A) General population
Mattu GS, Heran BS, Wright JM. Comparison of the automated non-invasive oscillometric blood pressure monitor (BpTRU) with the auscultatory mercury sphygmomanometer in a paediatric population. Blood Press Monit. 2004 Feb;9(1):39-45. PMID: 15021077.
SP10:1992 - Pass Children 3y to 18y (n=162/36)
BHS:1993 - Pass (B/B) Children 3y to 18y (n=162/36)
Mattu GS, Heran BS, Wright JM. Overall accuracy of the BpTRU--an automated electronic blood pressure device. Blood Press Monit. 2004 Feb;9(1):47-52. PMID: 15021078.
BHS:1993 - Pass (A/A) General population
SP10:2002 - Pass General population
Tran K, Potts J, Purkiss S, Robertson J, Khan N, Padwal R, Chan WS. Validation of an Automated Office Blood Pressure Machine in Pregnant Women According to the AAMI 2013/ISO Protocol. Hypertension. 2018 Dec;72(6):e91-e94. Epub: 2018 Oct 22. doi: 10.1161/HYPERTENSIONAHA.118.12085. PMID: 30571239. Research Letter.
81060-2:2013 General Pregnancy
The actual device and results are unclear from the section available publicly.
