BB-613-BPM

The Biobeat BB-613-BPM is a noninvasive blood pressure monitor worn as a chest patch that measures systolic and diastolic blood pressure and pulse rate in adults. It provides notifications every 15 minutes over 24 hours for user-initiated measurements and requires calibration with an FDA-cleared oscillometric blood pressure monitor. Data is transmitted via Bluetooth to a mobile app and cloud platform for healthcare professional review. The device is intended for use in hospitals, clinics, long-term care, and home settings, but not for critical care patients.

The subject device uses identical pulse reflectance technology (four LEDs at 880nm IR and 650nm red wavelengths with a photodiode) and the same sensor hardware and algorithms as predicate devices K190792 and K222010. The primary difference is added software for 24-hour patient-initiated monitoring with notifications, replacing the spot-check measurement design. Measurement ranges, accuracy (±5 mmHg for BP, ±3% for pulse rate), wireless BLE connectivity, and contact materials are identical to predicates. Operation time is 24 hours versus 120 hours for predicates.

Not stated in this summary.

The BB-613-BPM uses identical hardware components and the same physiological measurement algorithms as the cleared predicate devices K190792 and K222010, so their prior evaluation testing for pulse rate and blood pressure accuracy remains applicable. The only technological difference is updated software for scheduling 24-hour user-initiated measurements instead of spot checks, which does not raise new safety or effectiveness concerns because the underlying sensing, calibration, and data analysis methods are unchanged. Additional software validation was performed per FDA guidance on General Principles of Software Validation, and performance data confirm the device maintains equivalent accuracy and safety profiles as the predicates.