BpTru BPM-300
Device Model:
BPM-300
Manufacturer:

OBL: BpTru (Appears to be Suspended), Unit 1, 1850 Hartley Avenue Coquitlam, BC Canada V3K 7, CANADA.

OEM: VSM MedTech Ltd. (Appears to be Suspended), 9 Burbidge Street, Coquitlam, British Columbia V3K 7B2, CANADA.

Measuring functions:
Blood pressure, Temperature
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single and repeated measurements
Availability:
Obsolete
Description:
The BpTru BPM-300 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 professional use. This device is now obsolete.
Assessment:
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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP BIHS (UK and IRL) Previous recommendation, now archived (Archived) Manufacturer declaration of equivalence to the BpTRU BPM-100
BP ESH (Europe) Professional use for adults and children The BIHS recommendation, despite the absence, at the time, of the scientific evidence required by the same authors' criteria.
BP FDA (US) 510(k) 510(k) K023078
Device Family:
BpTru BPM-100B, BpTru BPM-200B, BpTru BPM-300B
Legend: B BIHS Derivative
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.

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, aged 3 to 18 years (n=162/36)

BHS:1993 - Pass (B/B) Children, aged 3 to 18 years (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 - Fail Normotensive pregnancy (n=15), Hypertensive pregnancy (n=15), Pre-eclampsia (n=15) (Note: Overall results. Results for subgroups are provided for bands only.)

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