(266 days)
The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breasts, to alleviate engorgement of the breasts, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This electric breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
The Electric Breast Pump is a multi-user electric breast pump designed for lactating women to express and collect milk from the breast. It is intended for use in the hospital and home environments and can also be used by a single user. The device is an electrically powered pump consisting of the following key components: a flange, breast shield body, silicone diaphragm, tubing/tubing connector, pump motor, AC/DC adapter, and milk collector. The Electric Breast Pump contains two models, SMG and GEA. Both models can be operated in single and double pumping modes while connected to AC power and have an onboard rechargeable lithium-ion battery.
The SMG model has an LCD display, and the user can select between stimulation or expression mode. Stimulation mode has 5 vacuum levels and expression mode has 16 vacuum levels. For every vacuum level, the user can independently select among 9 cycle speed levels (for stimulation) and 16 cycle speeds (for expression up to vacuum level 11; higher vacuum levels have less available cycle speeds). The SMG model is wirelessly operable via Bluetooth connection to a smart device.
The GEA model also has an LCD display, and the user can select stimulation or expression mode. Stimulation mode and expression mode have 10 levels. Stimulation speed is set to 70 cycles per minute, whereas expression mode allows for cycling speed between 3 levels.
Both devices operate via an electric negative pressure module that runs discontinuously to generate periodic negative pressure suction and are controlled by a magnetic valve for negative pressure adjustment. Each vacuum pump operates with a DC motor and corresponding DC power supply. Both devices have a 40 min stimulation and expression duration. To prevent milk from flowing into the vacuum, a backflow protection mechanism physically separates the milk-contacting pathway from the vacuum system.
The provided text is an FDA 510(k) summary for an Electric Breast Pump (K212564). It details the device, its intended use, comparison to a predicate device, and non-clinical performance testing.
However, the document does not describe an AI/ML medical device, nor does it contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The document describes the testing performed for a standard medical device (an electric breast pump), primarily focusing on biocompatibility, electrical safety, electromagnetic compatibility, software evaluation (for embedded device software, not AI), and general performance tests like vacuum level verification and battery performance.
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).