Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)

The Momcozy Wearable Breast Pump is an electrically powered device designed for lactating women to express and collect milk from their breasts. It operates in stimulation, expression, and mixed modes using a microprocessor-controlled diaphragm-type vacuum pump. The BP380 series includes Bluetooth wireless operation via mobile app, while the M5 series disables Bluetooth functionality. Both are single-user, over-the-counter devices.

The subject device differs from the predicate (BP223) in suction levels (9 vs 15), vacuum range specifications (stimulation mode -75~-145 vs -65~-174 mmHg), and cycle speeds (stimulation 50–120 vs 54–90 cycles/min). Both devices share the same power supply (3.7V Li-ion battery), microcontroller cycling, backflow protection, three suction modes, adjustable levels, LED indicators, and OTC classification. The subject device adds Bluetooth mobile app capability (BP380 series only).

Biocompatibility per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (skin irritation). Electrical safety and EMC per ANSI AAMI ES60601-1, IEC 60601-1-11, ANSI AAMI ES 60601-1-2, IEC 60601-1-6, and IEC 62133-2 (battery safety). Software verification and validation per FDA guidance (June 2023). Additional non-clinical testing included suction strength, cycle speed, backflow, battery capacity, and device life testing.

The subject and predicate devices have identical indications for use, intended patient population, and environment of use. Both are Class II powered breast pumps with the same product code and similar technological features including wearable design, battery power, and microcontroller cycling. Minor differences in vacuum range, cycle speed, and suction levels do not raise different safety or effectiveness questions. Performance testing demonstrates the subject device is as safe and effective as the predicate device.