(55 days)
Replacement battery for Abbott Medical Electronics 0810-0077, 140050-080 Enteral Pump Model #076 FlexiFlow II, 510(k) Number K821661.
This battery is shipped only to customers who request a replacement battery for a particular device or This battery is shipped only to ouslomers with Teques a replacemician therefore knows the intended use is as a replacement battery.
Rechargeable Battery Part Number GL4018
This document is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company regarding their rechargeable battery, part number GL4018. It states that the device is substantially equivalent to legally marketed predicate devices.
Based on the provided text, the document focuses on the FDA's clearance of a replacement battery and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with medical device efficacy studies (e.g., clinical trials or performance testing with specific metrics like sensitivity, specificity, accuracy).
The "Indications for Use" section simply states: "Replacement battery for Abbott Medical Electronics 0810-0077, 140050-080 Enteral Pump Model #076 FlexiFlow II, 510(k) Number K821661." This indicates that its primary function is to serve as a power source for an existing, cleared medical device.
Therefore, I cannot provide the requested information because the provided text does not contain details about acceptance criteria or a study that proves the device meets those criteria for performance as a medical diagnostic or therapeutic device. The regulatory approval here is for a component (a battery) based on substantial equivalence, implying it performs functionally similarly to existing cleared batteries for that specific pump.
If this were a different type of medical device (e.g., an AI-powered diagnostic tool), the document would typically include performance data, study designs, and detailed acceptance criteria for metrics like sensitivity, specificity, accuracy, etc.
§ 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).