(55 days)
Replacement battery for IVAC Corp. 0810-0008 560/560 Plus/565/570 Models Variable Pressure Pump, 510(k) Number K811238.
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 GL8108
The provided document is a 510(k) premarket notification letter from the FDA regarding a rechargeable battery (Part Number GL8108). This document is a regulatory communication and does not contain information about acceptance criteria for device performance, clinical study details, or ground truth establishment.
Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence of the battery to a predicate device for its intended use as a replacement battery for specific IVAC Corp. pump models.
§ 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).