Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

The WBP-02A is a wearable ambulatory blood pressure monitor that non-invasively measures systolic and diastolic blood pressure using the oscillometric method. It is intended for individuals aged 12 years and older and stores up to 300 measurements in internal memory. Data is transmitted via USB to a PC for analysis by healthcare professionals; the device is for prescription use only and is contraindicated in diabetic patients, pregnant women, patients with arrhythmia, and certain vascular or surgical conditions.

The subject device uses a rechargeable lithium battery (versus alkaline batteries in the predicate), has a tubeless design, employs encrypted canvas cuff material (versus nylon), stores 300 readings (versus 250), uses USB-only data transmission (versus optional Bluetooth), and includes an alarm function not present in the predicate. Minor differences exist in over-pressure protection thresholds (290 mmHg versus 300 mmHg), measurement period protection (150s versus 140s), and operating environment specifications.

IEC 60601-1, IEC 60601-1-8, IEC 60601-1-2, IEC 80601-2-30, IEC 62133-2, ISO 10993-5, ISO 10993-10, ISO 10993-23, IEC 60601-1-11, ISO 81060-2, and ISO TS 60601-4-2. Clinical validation was performed per ISO 81060-2:2018+A1:2020 in two studies: a general study with 95 subjects and an ambulatory supplementary study with 36 subjects.

The subject device is substantially equivalent because both it and the predicate (SunTech Oscar 2) are non-invasive oscillometric ambulatory blood pressure monitors intended for 24-hour monitoring with similar measurement methods and accuracy (±5 mmHg mean error, ±8 mmHg standard deviation). Differences in battery type, cuff material, data storage capacity, and transmission method do not raise new safety or effectiveness concerns, as they have been validated per applicable standards. The narrower intended population (age 12+) and additional contraindications (diabetics, pregnant women) are supported by clinical validation and do not affect substantial equivalence.