(87 days)
Replacement battery for Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump, 510(k) Number K821661. 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 GL625
This document is solely a 510(k) clearance letter for a replacement battery, indicating its substantial equivalence to a previously marketed device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details that would allow for a discussion of AI performance or comparative effectiveness.
Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving device performance based on the provided 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).