Wearable Breast Pump (Model S33)

The Wearable Breast Pump (Model S33) is a powered, wearable breast pump designed for lactating women to express and collect milk. It is electrically powered by a rechargeable lithium-ion battery, software-controlled, and intended for single-user home use. The device features four operating modes (Stimulation, Expression, Massage, and Auto) with nine suction levels and provides vacuum levels ranging from 40–245 mmHg depending on mode.

Compared to the predicate device (Model W8, K242850), the S33 has a slightly smaller battery (1000 mAh vs. 1200 mAh), reduced suction strength in some modes (e.g., Stimulation 40–160 mmHg vs. 40–170 mmHg), different cycle speed ranges across modes, and nine suction levels instead of fifteen. Both are wearable diaphragm pumps with microprocessor control, media separation, and similar user interfaces; the differences do not raise new safety or effectiveness questions.

IEC 60601-1:2005+A1:2012 (electrical safety), IEC 60601-1-11:2015 (home healthcare environment requirements), IEC 60601-1-2:2014/A1:2021 (electromagnetic compatibility), IEC 62133-2:2017 (lithium battery safety), and ISO 10993-1 (biocompatibility). Software validation followed the 2023 FDA guidance on device software functions at a Basic Documentation Level.

The subject device has the same intended use (milk expression for lactating women), same regulatory classification and product code, substantially similar technological design (wearable, microprocessor-controlled diaphragm pump with backflow protection), and equivalent user controls as the predicate. Although vacuum and cycle specifications differ, these variations remain within ranges typical for breast pump design and do not introduce new safety or effectiveness concerns, as demonstrated by comprehensive bench testing, electrical/EMC compliance, biocompatibility assessment, and software validation.