(26 days)
The electrosurgical probes and devices are to be used with commercially available R.F. generators, endoscopes including hysteroscopes, resectoscopes, cystoscopes and laparoscopes, suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy.
Electrodes/Probes/Devices
This is a 510(k) premarket notification letter from the FDA to Ximed Medical/ProSurg, Inc. regarding their "Electrodes/Probes/Devices."
The document states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to predicate devices. This letter approves the device for marketing.
However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
The information provided (K974637) is a regulatory approval document, not a clinical study report or a performance specification document. Therefore, I cannot extract the requested information from the provided text.
§ 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).