Wearable Breast Pump (Model S21)

The Wearable Breast Pump (Model S21) is a battery-powered breast pump designed for lactating women to express and collect milk from their breasts. It is intended for single-user, repeated use in a home environment and features three suction modes (stimulation, expression, and auto) with 12 adjustable vacuum levels.

The subject device differs from its predicate (Model S12) in offering three suction modes versus two, 12 vacuum levels instead of 9, and revised vacuum ranges and cycle speeds across all modes. Both devices share the same wearable design, microcontroller-based cycling control, backflow protection, Li-Ion battery power supply, and combined milk collector/flange design.

ANSI/AAMI ES60601-1:2005/A2:2010 (electrical safety), IEC 62133-2:2017 (lithium battery safety), IEC 60601-1-11:2015 (home healthcare environment), IEC 60601-1-2:2014 (electromagnetic compatibility), and ISO 10993-1:2023 (biocompatibility).

Although the subject device has different vacuum specifications, cycle speeds, and adds an auto mode compared to the predicate, these technological differences do not raise different safety or effectiveness questions because they represent refinements within established parameter ranges. Both devices employ identical fundamental mechanisms (microcontroller-based cycling with backflow protection), serve the same intended use population and indication, use the same power supply approach, and undergo equivalent performance testing demonstrating vacuum specification compliance, backflow protection, use-life durability, and battery functionality.