Thrive 2-in-1 Breast Pump (Model P3)

The Thrive 2-in-1 Breast Pump (Model P3) is a wearable, battery-powered breast pump designed for lactating women to express and collect milk from their breasts. It features microprocessor control, two operating modes (Expression and Massage), nine suction levels per mode, and is intended for single-user, double-pumping use only.

The subject device differs from the predicate Lucy Breast Pump in several specifications: maximum vacuum of -250 mmHg (vs. -295), vacuum ranges of 60-245 mmHg in Expression mode and 60-130 mmHg in Massage mode (vs. -75 to -280), cycle speeds of 15-52 cycles/minute depending on mode and frequency setting (vs. 30-100), dual operating modes with frequency selection, and an enhanced user interface including mode/frequency and pause buttons. Both use rechargeable lithium-ion batteries and diaphragm-type wearable pumps with backflow protection.

Biocompatibility per ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation); electrical safety and EMC per IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133-2; software verification and validation per 2023 FDA guidance. Milk-contacting materials comply with 21 CFR 177.

Although the subject device has technological differences in vacuum range, cycle speed specifications, operating modes, and user interface compared to the predicate, these differences do not raise different questions of safety or effectiveness because both devices accomplish the same intended use—milk collection from lactating women—using the same general mechanism (diaphragm-type wearable pump with microprocessor control). Performance testing demonstrates the subject device meets its design specifications and maintains safety margins comparable to the predicate through rigorous biocompatibility, electrical safety, EMC, and use-life verification testing.