(18 days)
Like the predicate devices, the proposed unit together with the same already marketed related predicate accessories is used for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.
System 7500 Electrosurgical Unit
This document is an FDA 510(k) clearance letter for the "System 7500 Electrosurgical Unit". It states that the device is substantially equivalent to legally marketed predicate devices for the controlled destruction of human tissue in surgical procedures to provide a therapeutic benefit.
However, the provided text does not contain any information regarding acceptance criteria, device performance metrics, study details, sample sizes, ground truth establishment, or expert qualifications. The letter is purely regulatory in nature, indicating approval for marketing based on substantial equivalence.
Therefore, I cannot fulfill your request for the detailed table and study information.
§ 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.