Wearable Breast Pump (Model W12)

The Wearable Breast Pump (Model W12) is a powered breast pump intended for use by lactating women to express and collect milk from their breasts for a single user. It is a wearable device powered by a rechargeable lithium-ion battery with multiple suction modes (stimulation, expression, auto, massage, and hot compress) and adjustable vacuum levels.

The W12 has 12 vacuum levels (vs. 15 in predicate), includes a heating element (≤42°C) not present in the predicate, and provides different vacuum/cycle specifications across modes. Both devices are wearable, single-user, microcontroller-based pumps with backflow protection and similar materials (polypropylene, silicone, ABS), but the W12 adds a hot compress mode.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (skin sensitization and irritation), ANSI/AAMI ES60601-1:2005/A2:2010 (electrical safety), IEC 62133-2:2017 (lithium battery safety), IEC 60601-1-11:2015 (home healthcare equipment), and IEC 60601-1-2:2020 (electromagnetic compatibility).

The subject device has identical indications for use and the same intended user population as the predicate (W8). Although technological differences exist in vacuum/cycle specifications and the addition of a heating element and hot compress mode, these differences do not raise different safety or effectiveness questions. Biocompatibility, electrical safety, EMC, and performance testing all demonstrate the W12 is as safe and effective as the predicate device.