(76 days)
The KSEA Thermocoagulator is intended to be used for the laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels and separation of adhesions.
The KSEA Thermocoagulator is composed of a generator unit, a footswitch, a cord to connect the unit to a power supply, and a cord to connect the unit to the thermocoagulation probes. The Thermocoagulator contains no are no patient contact materials. Coagulation time can be set by the end user for 10-70 seconds, and the instrument temperature can be set by the end user for 70-130°C. The
This document is a 510(k) summary for the KSEA Thermocoagulator (model 265100 20), a gynecologic electrocautery generator. It outlines the device's identification, indication, description, and claims of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert reviews as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document focuses on regulatory submission information rather than detailed performance study results.
§ 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).