(343 days)
The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.
The KSEA thermocoagulator accessories are manually operated, reusable surgical devices consisting of a point coagulator, crocodile forceps and a myoma enucleator. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to laparoscopes. The body contact materials are surgical grade stainless steel.
The provided document is a 510(k) Summary of Safety and Effectiveness for Karl Storz Endoscopy-America, Inc.'s Laparoscopic Thermocoagulator accessories, dated November 26, 1999.
This document does not contain information regarding acceptance criteria, device performance results from a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The summary focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices based on design and intended use, rather than presenting a performance study with specific criteria and results. Therefore, I cannot complete the requested information based on the provided text.
§ 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).