(44 days)
Replacement battery for IVAC Corp. 123233, 41B905KD10-1 230 Infusion Controller, 510(k) Number KR84307 K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitions only contrience with the replacement battley of to pancellar device of to intended use is a replacement hattery. The biomedical equipment technician t intended use is as a replacement battery.
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This document is a 510(k) substantial equivalence letter for a replacement battery for an infusion pump. It does not contain any information regarding acceptance criteria or a study proving device performance related to a diagnostic or AI-driven medical device.
Therefore, I cannot provide the requested information in the structured format because the input document does not pertain to the type of device or study described in the prompt's requirements.
The document is a regulatory communication from the FDA to a manufacturer regarding a "Rechargeable Battery Part Number M12/500-3P" for an "Infusion Pump." It confirms the device's substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market it. This type of regulatory approval does not typically include detailed performance studies with acceptance criteria as would be required for a diagnostic or AI-powered medical device.
§ 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).