Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle is used in coniunction with an electrical generator to excise tissue and coagulate bleeding.

AI/ML Overview

This document, K963901, is a 510(k) summary for a medical device: "Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle." It primarily addresses substantial equivalence to a pre-amendment device (K901505) and discusses minor changes related to labeling and user convenience.

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No acceptance criteria or device performance data: The document doesn't present any specific performance metrics (e.g., sensitivity, specificity, accuracy, surgical success rates) or associated acceptance criteria. It merely states the device's function and intended use.
No study details: There is no mention of any clinical or performance studies, sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods. The document is strictly a regulatory submission focused on demonstrating substantial equivalence based on prior approvals and minor, non-functional changes.
Not an AI/algorithm-driven device: This device is an electrosurgical probe and handle, a physical instrument for surgery. It is not an AI or algorithm-based diagnostic or assistive technology, which are the types of devices typically associated with the detailed performance evaluation criteria you've listed (e.g., standalone performance, MRMC studies, training/test sets for algorithms).

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Summary

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K963901

Smith & Nephew Endoscopy, Inc.

160 Dascomb Road Andover, MA 01810 U.S.A. Telephone (508) 470-2800 Fax (508) 470-2227

Smith - Nephew

NOV - 4 1996

510(k) Summary Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle

Substantial Equivalence :

The Smith & Nephew Endoscopy Disposable Endoscopic Elecrosurgical Probe and Handle were originaly determined to be substantially equivalent to pre-amendment devices under 510(k) K901505..

Predicate Device :

The change discussed in this 510(k) does not affect the method of use, or intended use, of the device. The additonal labeling of a voltage limit is a European requirement for CE marking. Other changes to this device are user convenience features only.

Summary of Device Function :

Smith & Nephew Endoscopy Endoscopic Electrosurgical Probe and Handle is used in coniunction with an electrical generator to excise tissue and coagulate bleeding.

Intended Use of Device :

Excise tissue and coagulate tissue.

Comparison of Technological Characteristics of Predicate Device :

The design technologies and function of the items refered to in this 510(k) notification are identical to those listed in the previous Electrosurgery Probe 510(k) submitted by Smith & Nephew Endoscopy, Inc.

Elizabeth A. Ryan

Elizabeth A. Rvan Regulatory Affairs

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.