Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)

The AOV Wearable Breast Pump is an over-the-counter, battery-powered breast pump designed for lactating women to express and collect milk at home. It features four models (AOV6853, AOV6860, AOV6861, AOV6862) with a diaphragm-type vacuum pump, rechargeable lithium-ion battery, and software-controlled vacuum pressure and cycle speed across three operating modes: stimulation, expression, and mixed.

The subject device differs from the predicate device in suction levels (5 levels in stimulation mode vs. 9 overall in predicate), vacuum ranges (e.g., stimulation -80 to -160 mmHg vs. predicate 36–242 mmHg), cycle speeds (55–110 cycle/min stimulation vs. predicate 37.5–150 cycle/min), and power source specifications (3.7V Li-ion battery only vs. predicate with dual internal/external power options). Both devices use diaphragm pumps with backflow protection, operate in single-pump mode, and share similar materials (silicone flanges, ABS housing).

Testing conducted per ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ANSI AAMI ES60601-1:2005 (medical electrical safety), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), ANSI AAMI HA60601-1-11:2015 (home healthcare environment), IEC 62133-2:2017 (lithium battery safety), and FDA Guidance for Device Software Functions (Basic documentation level). Vacuum, cycle, backflow, use-life, battery performance, and battery indicator testing were also conducted.

The subject device is substantially equivalent because it shares the same intended use (expressing milk from lactating women), regulatory classification (Class II, 21 CFR 884.5160, product code HGX), technological design approach (diaphragm pump with backflow protection, single-pump operation), and patient population as the predicate device. Although technological parameters differ (vacuum ranges, cycle speeds, suction levels), these differences do not raise different safety or effectiveness questions. All performance testing, biocompatibility, electrical safety, and software validation demonstrated compliance with applicable standards and design specifications comparable to the predicate.