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The Harwill Medical U-Klip Umbilical Clamp is a device used to compress the umbilical cord.

Harwill Medical U-Klip Umbilical Clamp

The provided text is a response letter from the FDA regarding a 510(k) premarket notification for the Harwill Medical U-Klip Umbilical Clamp. This type of document does not contain information about acceptance criteria or a study proving device performance in the typical sense of a clinical or performance study report.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce..."

This means the device's acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices, not on a new study proving specific performance metrics against pre-defined acceptance criteria as would be found in a clinical trial or performance verification study for a new, novel technology.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) cannot be extracted from the provided text. The letter confirms the device's clearance for marketing based on substantial equivalence to a predicate device.

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