(160 days)
The Wearable Breast Pump (Model S12A) is a powered breast pump intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
The Wearable Breast Pump (Model S12A) is an electrically powered, software-controlled, single user pump designed for lactating women to express and collect milk from the breast.
The device has three modes of operation - Expression mode, Stimulation mode, and Auto mode, with multiple suction levels for each mode. Stimulation mode consists of pressures ranging from 30/160-120/160 mmHg and cycle speeds of 74-134 cycles/min, expression mode consists of pressure ranges from 120-245 mmHg and cycle speeds of 29-92 cycles/min, and auto mode consists of pressure ranges from 30-245 mmHg and cycle speeds of 29-128 cycles per minute. There is an LED status display for S12A, and the working mode and battery indicator are shown on the pump body.
S12A may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, they would need to use two S12A devices at the same time, one on each breast. The pump is provided non-sterile and can be re-used by a single user. The device is powered by a Li-ion battery and charged using a 5V DC adaptor. The device is designed not to be used during charging.
The breast pump does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product. All milk contacting components of the device are compliant with 21 CFR 177.
This document is a 510(k) clearance letter for a Wearable Breast Pump. It does not contain details about acceptance criteria for an AI/ML device or a study proving an AI/ML device meets acceptance criteria.
The document discusses the regulatory clearance of a medical device (a breast pump) and its comparison to a predicate device, focusing on:
- Device Description: A powered breast pump with different modes, suction levels, and an LED display.
- Indications for Use: For lactating women to express and collect milk.
- Technological Characteristics: Comparison of classification, regulation, product code, intended use, single/double pump capability, user interface, materials, power source, control mechanism, maximum vacuum, vacuum range, cycle speed range, and backflow/overflow protection between the subject device (Wearable Breast Pump Model S12A) and the predicate device (Lucy Breast Pump).
- Performance Testing:
- Biocompatibility testing: Cytotoxicity, skin irritation, and skin sensitization for patient-contacting components.
- Electrical safety and electromagnetic compatibility (EMC) testing: Adherence to IEC standards.
- Software Verification and Validation Testing: Evaluated at a basic documentation level.
- Performance and Use Life Verification: Vacuum level verification, backflow protection, use life testing (device maintaining specifications), battery performance, and battery status indicator testing.
The document concludes that the Wearable Breast Pump (Model S12A) is as safe and effective as the predicate device, supporting a determination of substantial equivalence.
Therefore, I cannot provide the requested information about AI/ML device acceptance criteria or studies from this document, as it pertains to a mechanical/electronic medical device without AI/ML components.
§ 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).