(94 days)
The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "Omnitech Fulgurating Electrode." It certifies that the device is substantially equivalent to legally marketed predicate devices.
The provided text does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.
This document is a regulatory approval, not a performance study report. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document only states the device's indications for use:
"The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field."
§ 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).