(88 days)
To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the Thomas Medical Electrodes. It is a regulatory document and does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth information, etc.) because these types of studies are not typically required for a 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the given text. The prompt asks for details about a study that proves the device meets acceptance criteria, but this document only states that the device is substantially equivalent to a predicate device and can proceed to market.
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).