(55 days)
Replacement battery for Baxter 64276002002 Flo-Guard 8000, 8100, 8200 Infusion Pumps (controller), 510(k) Number K813403.
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-P
I am sorry, but the provided text from the FDA document (K971213) is a 510(k) clearance letter for a rechargeable battery (GL825-P) used in infusion pumps. This document does not describe an AI/ML medical device or any study data related to its performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as none of that is present in this clearance letter for a simple medical device component like a battery.
§ 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).