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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.

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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.

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