Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

The Wrist Digital Blood Pressure Monitor (models BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) is a battery-operated, non-invasive digital monitor that measures systolic and diastolic blood pressure and pulse rate in adults using an inflatable wrist cuff with circumference ranging from 13.5 to 19.5 cm. It is intended for both clinical and home use.

Both the proposed device and predicate employ the oscillometric method with automatic inflation/deflation, piezoelectric pressure sensors, LCD displays, and two AAA batteries. Both achieve ±3 mmHg accuracy for blood pressure and ±5% for pulse rate (40–180 beats/min). Minor differences include the proposed device's slightly narrower wrist circumference range (13.5–19.5 cm vs. 13.5–21.5 cm), marginally lower cuff pressure range (0–295 mmHg vs. 0–299 mmHg), slightly broader operating temperature range (5–40°C vs. 10–40°C), and different dimensions/weight due to design updates.

IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30 (electrical safety and sphygmomanometer standards); IEC 60601-1-2 (electromagnetic compatibility); AAMI/ANSI/ISO 81060-2 (performance validation); ISO 10993-5 and ISO 10993-10 (biocompatibility); ISO 81060-2:2018 (clinical validation). One model (BSX335) was tested in a clinical study with 85 subjects meeting inclusion criteria.

The proposed device uses the same measurement technology, accuracy specifications, patient population, and operational principles as the predicate. Both achieve identical measurement accuracy (±3 mmHg blood pressure, ±5% pulse rate) and employ identical inflation/deflation and sensing mechanisms. The narrower wrist circumference range and slightly lower cuff pressure ceiling do not raise new safety or effectiveness questions because the device passed the same IEC 80601-2-30 standard and showed equivalent performance in pulse wave generator testing. Minor dimensional and environmental differences relate to routine design updates and convenience, not to fundamental safety or performance.