SPECTRA Wearable 2

The SPECTRA Wearable 2 is a powered breast pump designed for lactating women to stimulate, express, and collect milk from their breasts. It is a single-user, wearable, battery-operated device intended for home use that can pump from a single breast without external power cords.

The device uses a diaphragm pump mechanism with two preprogrammed suction patterns (massage and expression modes) offering adjustable vacuum levels. Expression mode ranges from 100–270 mmHg at 5 levels; massage mode ranges from 50–130 mmHg at 5 levels. Cycle speeds are 12–53 CPM for pumping and 60–100 CPM for massage. It is powered by a rechargeable Li-polymer battery (3.7 V, 1500 mAh) and includes backflow protection.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (sensitization), ISO 10993-23:2021 (irritation), IEC 60601-1:2005+A1:2012+A2:2020 (medical electrical equipment general safety), IEC 60601-1-11:2015+A1:2020 (home healthcare environments), IEC 62133-2 (lithium battery safety), IEC 60601-1-2:2014+AMD 1:2020 (electromagnetic compatibility), and IEC TR 60601-4-2:2016 (electromagnetic immunity).

The subject device is substantially equivalent to the predicate SPECTRA Wearable (K220926) because both have identical indications for use, same regulatory classification (Class II), identical pump type and specifications (suction strength, cycle speed, power source, backflow protection), and the same intended user population. Differences in accessories and design do not raise different safety or effectiveness questions. Non-clinical testing demonstrates the device meets all design specifications and is as safe and effective as the predicate.