Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

The Wearable Breast Pump (Models FS12A and FS12B) are powered breast pumps intended for lactating women to express and collect milk from their breasts. Both models are single-user, wearable devices powered by rechargeable lithium-ion batteries with embedded microcontroller software managing all device functions through stimulation, expression, and auto modes.

The subject devices differ from the predicate (Model S12) in several performance specifications: they offer 12 vacuum levels instead of 9, include an additional auto mode not present in the predicate, feature different vacuum ranges across all modes (stimulation -40 to -160 mmHg vs. predicate -40 to -105 mmHg), and have different cycling rates. Both devices share similar fundamental design with wearable operation, lithium-ion battery power, microcontroller cycling control, backflow protection, and combined milk collector/flange design.

Testing was conducted per IEC 60601-1 Edition 3.2 (medical electrical equipment general safety), IEC 62133-2:2017 (lithium battery safety), IEC 60601-1-11 Edition 3.1 (home healthcare equipment), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), and ISO 10993-1 (biocompatibility evaluation). Software was evaluated at the Basic Documentation level per FDA 2023 guidance.

The subject devices have the same intended use as the predicate—milk expression and collection from lactating women. Although the subject devices feature enhanced vacuum/cycle specifications and an additional auto mode, these technological differences do not raise different safety or effectiveness questions because the expanded performance envelope remains within clinically appropriate parameters for breast milk expression and maintains identical design principles including backflow protection, wearable architecture, and biocompatible milk-contacting components. Performance testing demonstrates the devices meet their specifications and maintain functionality throughout their use life.