(273 days)
The primary indications for use are abnormal uterine bleeding with or without pain, and infertility. Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Müllerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.
VaporTrode™ Vaporization Electrodes in Gynecology
This document is a 510(k) clearance letter from the FDA, and it does not contain the detailed information about acceptance criteria or a study proving device performance as requested. The letter confirms that Circon Corporation's VaporTrode™ Vaporization Electrodes in Gynecology are "substantially equivalent" to legally marketed predicate devices, allowing them to be marketed.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from the provided text. The document is primarily a regulatory approval notification and does not delve into the technical study details.
§ 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).