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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."

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The Olympus Integrated Endosurgery System EndoALPHA has been designed to be used with an Olympus endoscope ancillary equipment for central operation, central display, automatic initial setting and interlocking operation of the ancillary equipment.

Olympus EndoAlpha Integrated Endoscopy System is the remote control unit of Olympus legally marketed ancillary equipment. No new clinical functions are added to the above ancillary equipment by the proposed device. This subject device enables the remote control of the ancillary equipment, the display of their action status and the memory of the previous set-up values.

The provided text describes the Olympus Integrated Endoscopy System EndoALPHA, but it does not contain any information about acceptance criteria, device performance metrics, or a study conducted to prove that the device meets specific criteria.

The document is a 510(k) summary from 1998, which primarily focuses on:

• Identification of the device and manufacturer.
• Comparison to predicate devices: It states the device is a remote control unit for legally marketed ancillary equipment and adds no new clinical functions. This is the core of its argument for substantial equivalence.
• Intended Use.
• Technological Characteristics: Emphasizes that "no new clinical functions are added" and therefore "does not affect safety or effectiveness when compared to the predicate devices."
• Non-clinical Tests: Mentions compliance with voluntary safety standards (IEC 60601-1, IEC 60601-2, CISPR 11) and software validation.
• FDA's finding of substantial equivalence.

Because the device is a remote control unit that does not add new clinical functions, the validation appears to be centered around demonstrating electrical safety, material compatibility (no new patient-contacting materials), software validation for the remote control functionality, and adherence to relevant safety standards. There is no mention of clinical performance studies, diagnostic accuracy, or human factor studies in the context of specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document positions the device as substantially equivalent to existing predicate devices due to its lack of new clinical functionality, rather than presenting new performance data against specific clinical criteria.

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