Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)

The Electric Breast Pump (models YM-8807, YM-8805, YM-8806, YM-8810) is a powered device intended to express milk from lactating women's breasts for collection. It is a reusable, single-user device for home healthcare use that stimulates lactation by creating a seal around the nipple and applying/releasing suction via a microprocessor-controlled diaphragm pump.

The subject device differs from the predicate (K211024) in suction strength ranges (subject: -80 to -280 mmHg vs. predicate: -60 to -285 mmHg), cycle speed ranges (subject: 5–120 cycles/min vs. predicate: 14–123 cycles/min), number of suction levels (subject: 9 levels for all modes vs. predicate: 5–7 levels depending on mode), and user interface design (subject: four buttons and LED display vs. predicate: controls on pump with LED/LCD). Both use 3.7V lithium-ion batteries, diaphragm pumps, microcontrollers, and support single/double pumping with backflow protection.

IEC 60601-1:2005/AMD2:2020 (electrical safety); IEC 60601-1-2:2020 (electromagnetic compatibility); IEC 60601-1-11:2020 (home healthcare environment); IEC 62133-2:2017 (lithium battery safety); ISO 10993-5:2009 (cytotoxicity); ISO 10993-23:2021 (skin irritation); ISO 10993-10:2021 (skin sensitization); 2023 FDA guidance on device software functions.

The subject and predicate devices share identical indications for use, regulatory classification (Class II, 21 CFR 884.5160), and fundamental operating principles (diaphragm pump, microcontroller, single user, lactation expression). Although suction modes, strength ranges, cycle speeds, suction levels, and user interface differ, these differences do not raise different questions of safety and effectiveness. Non-clinical testing demonstrates the subject device meets all design specifications and performance acceptance criteria, supporting substantial equivalence.