Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)

The Wearable Electric Breast Pump is a battery-powered device intended for lactating women to express and collect milk from their breasts for single-user use. It features four models (RH 668, RH 708, RH 718, RH 728) with three modes (stimulate, mixed, and expression) and variable suction levels controlled by a microprocessor-driven diaphragm pump.

The subject device is wearable (versus hand-held predicate), uses a rechargeable 3.7V Li-ion battery (versus 5VDC or smaller battery), offers different suction strength ranges across models, varies in cycle speeds and available modes/levels, includes LED display (versus predicate's LED or LCD), and has a 2-year use-life (versus predicate's 18 months).

IEC 60601-1:2005+A1:2012 (medical electrical safety), IEC 60601-1-11:2015 (home healthcare), IEC 60601-1-2:2014/A1:2021 (EMC), IEC 62133-2:2017 (lithium battery safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (irritation), and FDA 2023 guidance on device software.

The subject device has the same intended use and similar indications as the predicate (expressing milk for single users). Although technological differences exist (form factor, power source, specifications), these do not raise different safety or effectiveness questions. Performance testing demonstrates the device meets acceptance criteria for vacuum, cycle speed, backflow protection, battery, use-life, biocompatibility, electrical safety, and software validation.