Wearable Breast Pump (Model W2)

The Wearable Breast Pump (Model W2) 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 an embedded control program managing pump functions, featuring expression mode, massage mode, and a hot compress heating mode.

The subject device offers 9 adjustable suction levels (versus 15 in the predicate), expression mode vacuum of 120-245 mmHg with 34-111 cycles per minute, massage mode vacuum of 40-120 mmHg with 107-143 cycles per minute, and includes a heating element (≤42°C) not present in the predicate. Both devices use microcontroller cycling, Li-Ion batteries, wearable design with combined milk collector and flange, and have backflow protection with silicone flanges and polypropylene collectors.

ANSI/AAMI ES60601-1:2005/A2:2010 (electrical safety), IEC 62133-2:2017 (lithium battery safety), IEC 60601-1-11:2015 (home healthcare electrical equipment), IEC 60601-1-2:2020 (electromagnetic compatibility), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (skin sensitization and irritation), and 2023 FDA guidance on device software.

The subject device is substantially equivalent because it has identical indications for use, similar technological features including wearable operation and power supply, and the technological differences (fewer suction levels, inclusion of heating element, and limited modes) do not raise different questions of safety and effectiveness as demonstrated by comprehensive performance testing including vacuum verification, backflow protection, heating element performance, use life, and battery testing.