(62 days)
This instrument has been designed for use in a medical facility under the supervision of a trained physician. It has been designed for general(open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes(fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery(cutting and coagulation), light sources and other ancillary equipment.
The Electrosurgical Unit XUES-41 produces the high frequency current waveform delivered to tissue via the electrosurgical accessories and electrodes. When the high frequency current is fed through tissue, it generates heat rises, causing changes from protein degeneration to desiccation and vaporization.
The provided text is a 510(k) summary for the OLYMPUS XUES-41 Electrosurgical Unit. It describes the device and its intended use, and importantly, it states that no clinical data was required or submitted to demonstrate the device meets acceptance criteria.
The basis for market clearance is that the XUES-41 is substantially equivalent to existing predicate devices (OLYMPUS UES-30 Electrosurgical UNIT and GYRUS Endourology System) and does not incorporate any significant changes that would affect safety and effectiveness.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study cannot be provided from this document as no such study was conducted or deemed necessary for this 510(k) submission.
Reason for Not Requiring Clinical Data:
The document explicitly states: "The subject XUES-41 is similar to the OLYMPUS UES-30 Electrosurgical UNIT cleared in the previous 510(k) #K023767, Gyrus cleared in the previous 510(k) #990628. And when compared to the predicated devices listed above, the Olympus XUES-41 Electrosurgical UNIT does not incorporate any significant change in intended use, method of operation, material, or design that could affect safety and effectiveness. Therefore the clinical data is not necessary for its evaluation of safety and efficacy."
§ 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).