(28 days)
The TUNA Office System is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
Precision™ TUNA® Office System with Model 6800 Cartridge, Model 6198 Handle, Model 7800 RF Generator (with no rectal temperature monitoring tape)
This document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device. It does not contain information about acceptance criteria, study details, or device performance metrics typically found in a clinical study report or a detailed pre-market submission.
Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on regulatory approval and classification for the "Precision™ TUNA® Office System."
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).