(55 days)
Replacement battery for Abbott Medical Electronics 190706 Life Care Pump 4,5 (micro infusion pump), 510(k) Number K840263.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Rechargeable Battery Part Number GL825
The provided document is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company for a rechargeable battery (Part Number GL825). This document primarily establishes the FDA's finding of substantial equivalence for the device to a predicate device marketed before May 28, 1976.
As such, this document does not contain the acceptance criteria or the study details to prove the device meets acceptance criteria for an AI/ML medical device. It is a regulatory clearance letter for a standard medical device (a replacement battery), not an AI/ML product.
Therefore, I cannot provide the requested information from the given text.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).