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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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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.

Not Found

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.

Ask a specific question about this device