Ameda GLO Wearable Breast Pump (Model W8S)

The Ameda GLO Wearable Breast Pump (Model W8S) is a powered, wearable breast pump designed for lactating women to express and collect breast milk. It is electrically powered, software-controlled, and operates as a single-user device with four operating modes: Expression, Massage, Auto, and Stimulation. The pump can function as a single or double pumping system and is powered by a rechargeable lithium-ion battery.

The W8S has identical functional specifications to the predicate device (Model W8), including the same suction strength ranges (40–170 mmHg stimulation, 120–245 mmHg expression, 40–140 mmHg massage), cycle speeds, 15 suction levels, milk collector capacity (180 ml), flange sizes (24 mm and 27 mm), and material composition (polypropylene, silicone, ABS). The only difference is the user interface: the W8S adds an LED status display with working mode and battery indicator, plus a long-press mode selection feature instead of simple mode selection on the W8.

IEC 60601-1:2005+amendments (medical electrical equipment general requirements), IEC 60601-1-11:2015 (home healthcare environment), IEC 60601-1-2:2014/A1:2021 (electromagnetic compatibility), IEC 62133-2:2017 (lithium battery safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization and irritation), and 21 CFR 177 (milk-contacting materials).

The W8S is substantially equivalent to the predicate W8 because both share identical indications for use, patient population, anatomical site, and all critical performance specifications (suction pressures, cycle speeds, materials, capacity). The user-contacting materials are identical and biocompatibility was demonstrated. Although the W8S adds an LED display and long-press control feature, these are minor user interface enhancements that do not raise different questions of safety or effectiveness. Performance and electrical safety testing leveraged from the predicate device confirmed the W8S meets all device specifications and relevant standards.