(424 days)
The BASEN™ Wearable Breast Pump (Model: YM-801, YM-805, YM-805, YM-806, YM-808) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The BASEN™ Wearable Breast Pump is an electrically powered wearable breast pump consisting of the following key components: pump, pump diaphragm, container valve, 5-ounce (150 milliliter) container bowl, flange, seal ring, joint pipe, and USB charging cable. It is designed to work in the user's bra and has a rechargeable battery so it can be used hands-free without any external power cords. The motor unit includes a press-button user interface, pump body, and LED display. Pumping can be performed on one breast (single pumping). The user interface allows the user to switch from stimulation, massage mode, and expression mode and control the vacuum levels within those modes.
Both stimulation and expression mode consist of 9 vacuum levels. The pump can provide vacuum levels from -40 to -105 mmHg with cycling rates from 70 to 114 cycles per minute in stimulation and massage mode. Expression mode had vacuum levels from -40 to -245 mmHg with cycling rates from 23 to 90 cycles per minute.
The motor unit operates on embedded software. Software updates by end-users are not supported. The subject device is for repeated use by a single user in a home environment. The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the nipple. The milk is collection container bowl. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. The device is provided not sterile.
The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.
The subject device components are made of the following materials:
- . Motor unit: Acrylonitrile Butadiene Styrene (ABS) plastic
- . Flange, tube, valve, diaphragm: Silicone
- Linker, milk collection container: Polypropylene
All milk contacting components are compliant with 21 CFR 174-179.
It seems there's a misunderstanding based on the provided document. The document describes a 510(k) premarket notification for a medical device (a breast pump), and it focuses on demonstrating substantial equivalence to a predicate device.
Crucially, this document does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study specifically proving that an AI/powered device meets such criteria.
The "Software" section on page 9 states: "Software was evaluated at a basic documentation level as recommended in the 2023 FDA guidance document 'Guidance for the Content of Premarket Submissions for device software function.'" This indicates that the software in this breast pump is likely embedded software controlling its basic mechanical functions (like motor control, vacuum levels, and modes), rather than an AI/ML algorithm performing diagnostic or predictive tasks that would require the kind of extensive clinical validation, ground truth establishment, and MRMC studies you're asking about.
Therefore, I cannot extract the information requested about acceptance criteria and a study proving an AI/ML device meets them from this document.
If you have a document pertaining to an AI/ML medical device, please provide that, and I would be happy to help answer your questions.
§ 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).