(331 days)
Hi bebe super (Models BT-150S and BT-150L) is intended to be used by lactating women for expressing and collecting breast milk. It is intended for a single user.
Hi bebe wer are powered breast pumps that are modified versions of the predicate device, K160274. The pumps are intended to express and collect milk from the breast of lactating women and are only to be used by a single user. The user has the option to pump breast milk from a single breast (single pumping) or from both breasts (double pumping). All patient-contacting and breast milk-contacting materials are identical to the predicate device.
Hi bebesting includes two models, BT-150L and BT-150L includes a nursing lamp option, which is not available for BT-150S. Both models are comprised of a motor unit and accessories. The pumps are powered by rechargeable lithium ion batteries (7.4 V Li-ion polymer, 2200 mA) and are software-controlled. The Hi bebe®™ breast pumps have two operating modes: massage mode and expression mode. The subject device also includes backflow protection feature to prevent milk from contacting the pump during use. For accessories, a 32 mm size funnel is added in addition to 21/24/27 mm.
The provided text describes a 510(k) premarket notification for a breast pump, the "Hi bebe super" (Models BT-150S and BT-150L). However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document is a typical FDA 510(k) submission summary for a physical medical device (a breast pump), demonstrating substantial equivalence to a predicate device. The "Software" section mentions verification and validation testing, and that the software was considered a "Moderate level of concern," but it does not describe a study to prove performance against specific clinical acceptance criteria, especially not in the way an AI/algorithm device would.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text relates to a breast pump and not an AI/algorithm. The information you are asking for (e.g., sample sizes for test sets, expert consensus, MRMC studies, standalone performance) is relevant to the evaluation of AI/algorithm-based medical devices, which this document does not cover. If you have a document about an AI/algorithm device, please provide that.
§ 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).