Smith & Nephew Images Endoscopic Video System and components are indicated for use in diagnostic and operative arthroscopic, laparoscopic and ENT endoscopic procedures to provide illumination and allow visualization of the surgical site.

Smith & Nephew Manual Surgical Instruments for Sinus Surgery are indicated for the endoscopic examination and treatment of the nasal cavity and nasal pharynx.

Device Description

The Smith & Nephew Images Video System offered by Smith & Nephew, Inc., Endoscopy Division includes the following components:

Smith & Nephew Images Arthroscopes/ENT Endoscopes, Surgical Cameras and various video monitors, video recording devices, image enhancement devices, disk recorders and accessories. The surgical cameras and accessories mate to the endoscope by means of various camera couplers, beamsplitters, and video adapters to allow for visualization during the surgical procedure.

Smith & Nephew Images Xenon Light Sources, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.

Smith & Nephew manual surgical instruments for sinus surgery are utilized to examine and treat tissues in the nasal cavity and nasal pharynx.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Smith & Nephew Images Video System and Hand Instruments). This type of document is for regulatory clearance and focuses on establishing substantial equivalence to existing devices, rather than presenting a detailed study with acceptance criteria and performance data in the manner a diagnostic AI study would.

Therefore, the requested information elements related to a study's acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable and cannot be extracted from this document.

The document does describe the intended use and technological characteristics, but it does not provide the kind of performance study data requested.

Summary

{0}------------------------------------------------

510(k) Summary Smith & Nephew, Inc., Endoscopy Division, Images Video System and Hand Instruments

970247

Substantial Equivalence

The Smith & Nephew Images Video System components and manual surgical instruments for sinus surgery offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent in both design and intended use to sinuscopes, surgical cameras, video components, illumination products and ENT hand instruments offered by Smith & Nephew, Inc., ENT Division.

The Video Components, Surgical Cameras, Illuminators and accessories offered by the above referenced manufacturers mate with the endoscope to allow for visualization during the surgical procedure. The Illuminators, Light Guides and accessories mate to the light post of the endoscope and deliver light to the surgical site.

Manual Surgical Instruments for Sinus Surgery offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent in materials, design and intended use to ENT hand instruments offered by Smith & Nephew, Inc., ENT Division.

Predicate Device:

The predicate devices for this submission are the sinuscopes, video components, surgical cameras, illuminators and accessories and ENT surgical hand instruments manufactured and distributed by Smith & Nephew, Inc., ENT Division.

Summary of Device Function:

The Smith & Nephew Images Video System offered by Smith & Nephew, Inc., Endoscopy Division includes the following components:

MAR 2 | 1997

er. MA 01810 U.S.A.

Smith+Nephew

dosconv Division

{1}------------------------------------------------

Smith & Nephew manual surgical instruments for sinus surgery are utilized to examine and treat tissues in the nasal cavity and nasal pharynx.

Intended Use of Device:

Smith & Nephew Manual Surgical Instruments for Sinus Surgery are indicated for the endoscopic examination and treatment of the nasal cavity and nasal pharynx.

Comparison of Technological Characteristics of Predicate Devices:

Smith & Nephew Images Arthroscopes/ENT Endoscopes and Manual Surgical Instruments for Sinus Surgery offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent to sinuscopes and ENT surgical hand instruments offered by Smith & Nephew, Inc., ENT Division in intended use, materials and technology.

Smith & Nephew Images Surgical Cameras, Video Components, Light Sources and accessories offered by Smith & Nephew, Inc., Endoscopy Division are substantially equivalent in design, materials and function to Smith & Nephew Images devices described in previous premarket notification submissions. All electro-mechanical equipment complies with UL544 and IEC 601-1 requirements for electrical safety of medical devices. The components of the Smith & Nephew Images Video System are substantially equivalent in both design and intended use to surgical cameras, video components, illumination products and accessories offered by Smith & Nephew, Inc. ENT Division.

Dubrah Connors
Deborah Connors

Deborah Connors Regulatory Affairs Department

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.