(195 days)
Northgate Technologies Inc. Resectoscope Electrodes are intended to be used in urological procedures.
Northgate's Cutting Loops and Knife Resectoscope Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures. The Vapor-Tech Series Electrodes are designed with several tip configurations: roller, grooved roller, ball, and scoop.
This document is a K954710 510(k) premarket notification for Resectoscope Electrodes, submitted by Northgate Technologies Inc. in 1996. It describes the device, its materials, and intended use, and claims substantial equivalence to other marketed devices.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a premarket notification, which focuses on demonstrating substantial equivalence to predicate devices, not on detailed performance studies with acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of detailed performance data is typically found in clinical trial reports or validation studies, which are not part of this 510(k) summary.
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EXHIBIT
SUMMARY OF SAFETY AND EFFECTIVENES
VENESS
K954710
Resectoscope Electrodes Common/Usual Name: APR 2 4 1996 Vapor-Tech Roller, Vapor-Tech Grooved Roller, Proprietary Name: Vapor-Tech Ball, Vapor-Tech Scoop CLASS II Classification:
Materials:
All materials used to manufacture the Northgate Technologies Inc. Electrodes are non-toxic and have been previously used to manufacture other medical devices.
Description:
Northgate's Cutting Loops and Knife Resectoscope Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.
The Vapor-Tech Series Electrodes are designed with several tip configurations: roller, grooved roller, ball, and scoop.
Substantial Equivalence:
Northgate's Resectoscope Electrodes are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Circon/ACMI, Olympus, Storz Products, Inc., and Richard Wolf.
Intended Use:
Northgate Technologies Inc. Resectoscope Electrodes are intended to be used in urological procedures.
§ 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).