(88 days)
Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device, the Baylis Pain Management Generator. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information from the provided text. The document is an FDA clearance and approval letter, not a device performance study report.
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).