Wearable Breast Pump (Model S21A)

The Wearable Breast Pump (Model S21A) is a powered breast pump intended for 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 microcontroller that manages stimulation, expression, and auto modes with adjustable vacuum levels and cycling rates.

The subject device has the same wearable design, 2-phase expression pattern, microcontroller-based cycling control, and li-ion battery as the predicate (Model S21), but differs in vacuum level ranges and cycling rates: stimulation 40-150 mmHg (vs 40-120), expression 100-245 mmHg (vs 120-245), and cycles per minute ranges of 67-109, 25-93, and 25-120 respectively (vs 62-104, 22-86, and 22-104). Both devices use identical materials (polypropylene, silicone, ABS) and have the same backflow protection, 12 suction levels per mode, and user interface.

Biocompatibility per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (skin sensitization and irritation); electrical safety per ANSI/AAMI ES60601-1:2005/A2:2010, IEC 62133-2:2017, and IEC 60601-1-11:2015; electromagnetic compatibility per IEC 60601-1-2:2014; software evaluated at Basic Documentation level per 2023 FDA guidance.

The subject and predicate devices have identical indications for use, same intended use population, and similar technological features including wearable operation, power supply, materials, and user interface. Although the subject device has different vacuum and cycling rate specifications, these differences do not raise new questions of safety and effectiveness. Performance testing demonstrates the device meets design requirements, maintains backflow protection, and functions reliably throughout its use life, supporting substantial equivalence to the predicate.