(65 days)
The UM-150A unit is to be used in order to cut and coagulate (burn) the skin in surgical procedures.
Electrosurgical Units, Device Model: UM-150A
This document is an FDA 510(k) clearance letter for an electrosurgical unit (UM-150A). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its efficacy or performance against specific acceptance criteria. Therefore, most of the requested information is not available in these documents.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.