(48 days)
Replacement battery for IVAC Corp. 123233 230, 600 Infusion Controller, 510(k) Number K884307.
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.
Not Found
I apologize, but the provided text is a 510(k) Pre-Market Notification letter from the FDA regarding a medical device, specifically a replacement battery for an infusion pump. This document does not contain information about acceptance criteria for a study, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
This means the FDA determined the device is substantially equivalent to a product already on the market, which is a different process than evaluating a study that proves a device meets specific acceptance criteria. The letter and its enclosure (Indications for Use) focus on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.
Therefore, I cannot fulfill your request as the necessary information is not present in 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).