Accurate Mini Non-invasive blood pressure monitor (AMB-001)

The Accurate Mini Non-invasive blood pressure monitor (AMB-001) is a wrist-worn digital device that measures systolic and diastolic blood pressure and pulse rate in adults aged 20-70 with wrist circumference 13.5-21.5 cm and BMI<40. It is intended for spot-checking in hospitals, clinics, long-term care, and home settings, using pulse wave transit time technology with dual piezo sensors and near-infrared spectroscopy optic sensors to obtain measurements.

The Accurate Mini BPM differs from its predicate (Accurate 24 BPM) in three minor ways: (1) optical sensors reduced from 2 to 1 NIRS sensor while maintaining the same function; (2) pressure sensors for wrist tightness sensing were eliminated; (3) the display changed from PMOLED to TFT LCD and the physical dimensions were reduced (38×68.8×14.4mm vs 70×60×14mm). Both devices use the same Moens-Korteweg equation, dual piezo sensors for pulse wave velocity, and achieve identical measurement ranges and accuracy specifications (±5 mmHg for blood pressure).

ISO 81060-2 Third edition 2018-11/Amendment 1 (2020), IEEE Std 1708-2014/IEEE Std 1708a-2019 for clinical validation; IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30 for electrical safety and EMC; ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility; and IEC 62366-1 for usability.

The Accurate Mini BPM is substantially equivalent because it has identical indications for use, identical measurement principles (pulse wave transit time with hemodynamic method), identical performance specifications (±5 mmHg accuracy, 40-250 bpm pulse rate), and identical regulatory classification and standards as the predicate. Clinical testing on 367 subjects met ISO 81060-2 accuracy requirements with mean biases of -0.24 mmHg (systolic) and 0.35 mmHg (diastolic), and the minor hardware changes (reduced optics, eliminated pressure sensors, smaller form factor) do not raise new safety or effectiveness issues as demonstrated by the clinical data.