(50 days)
The subject device of this premarket notification submission is indicated for use to cut and or coagulate during laparoscopic surgical procedures.
Resistick Solid Laparoscopic Electrodes
This document is a 510(k) clearance letter from the FDA for a medical device (Resistick Solid Laparoscopic Electrodes) that was issued in 1997. It explicitly states that the device is substantially equivalent to devices marketed prior to 1976.
Therefore, this document does not contain any information about acceptance criteria, study performance, or AI/software validation studies. These types of studies and the regulatory framework around them, especially for AI/ML devices, did not exist at the time this clearance was issued.
The document only confirms that the FDA reviewed the submission and determined that the device is "substantially equivalent" to predicate devices, allowing it to be marketed.
To answer your request, I would need a different type of document, specifically a more recent regulatory submission or clinical study report for an AI-powered medical device.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).