Wearable breast pump (model S12A)

The Wearable Breast Pump (Model S12A) is an electrically powered, software-controlled breast pump designed for lactating women to express and collect milk from their breasts. It is intended for single-user operation and can function as a single or double pump system (requiring two devices for simultaneous bilateral pumping).

The S12A features three operational modes (Stimulation, Expression, and Auto) with adjustable suction levels, a microprocessor control mechanism, internal rechargeable Li-ion battery, and backflow protection via diaphragm. Technological differences from the predicate (Lucy Breast Pump) include lower maximum vacuum (-250 vs -295 mmHg), narrower vacuum ranges, different cycle speed ranges, different materials (polypropylene milk collector, silicone valve/diaphragm vs all-polypropylene), and an LED display instead of LED light.

Biocompatibility testing per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (skin irritation). Electrical safety and EMC testing per IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-11:2015, IEC 60601-1-2:2014, and IEC 62133-2:2017. Software evaluated per 2023 FDA Guidance on Device Software Functions. Additional testing included vacuum verification, backflow protection, and use-life validation.

Although the S12A differs from the Lucy Breast Pump in vacuum specifications, cycle speed ranges, user interface, and materials, these differences do not raise different questions of safety and effectiveness because both devices share identical indications for use (breast milk collection), the same regulatory classification and product code, the same control mechanism (microprocessor), equivalent backflow protection, and comparable power sources. Performance testing demonstrates the S12A meets its design requirements and maintains safety through biocompatibility and electrical safety compliance, supporting the conclusion that differences in specifications are design variations within the same device category rather than functionally significant distinctions.