A Clinical Study to Validate the Accuracy of BTL-001-2 ABPM (Ambulatory Non-Invasive Blood Pressure Sphygmomanometer) in Conformance with ISO 81060 – 2: 2018 + A1:2020 and A2:2024

The BTL-001-2 ABPM blood pressure monitoring device is planned to be evaluated in a minimum of 200 subjects throughout all study phases that will approximate the distribution of blood pressures as outlined in ISO 81060-2:2018 + A1: 2020 and A2:2024. Two trained observers who are medical professionals will observe (listen to) the Korotkoff sounds at the brachial artery of the arm. The reference blood pressure measurements by the medical professionals will be performed sequentially with the device under test. The medical professionals will complete initial baseline auscultatory reference blood pressure measurements and device under test (BTL-001-2 ABPM) measurements. This is followed by minimum 3 and a maximum of 8 valid paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements. Once the BTL-001-2 ABPM (Ambulatory Non-Invasive Blood Pressure Sphygmomanometer) passes the clinical investigation as per the requirements ISO 81060 – 2: 2018 + A1:2020 and A2:2024 given in sections 5.1 and 5.2 (Phase 1) then it shall undergo investigation in at least 35 adult subjects according to 5.2.6 (Phase 2, ambulatory monitoring) and 5.2 in at least an additional 45 adult pregnant women (Phase 3) and 35 children of age 3-12 years (Phase 4). The prerequisite to initiate Phases 2-4 is a successful result of the Phase 1. It is expected that the data collection will take up to approximately 1 hour per subject. There is no additional follow-up required for the study. For accuracy claims, the test device measurements will be compared to those made by the reference device. The data for the final analysis will contain no fewer than 85 subjects with a minimum of 255 valid paired observations (Phase 1). Further no fewer than 35 subjects with a minimum of 11 subjects with a BP >140 mmHg will be analyzed with a minimum of 3 valid pairs in Phase 2. Also, no fewer than 45 pregnant subjects who are normotensive, hypertensive and pre-eclampsia with a minimum of 3 valid pairs will be analyzed in Phase 3. Lastly, no fewer than 35 children of age 3-12 years minimum of 3 valid pairs will be analyzed in Phase 4. At least 90% of the subjects will contribute 3 valid paired observations.