SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE

K970247 · Smith & Nephew, Inc. · EOB · Mar 21, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K970247
• Device Name: SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
• Applicant: Smith & Nephew, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

System comprises endoscopes, surgical cameras, video monitors, recording devices, image enhancement units, and xenon light sources. Components connect via couplers, beamsplitters, and adapters to provide illumination and visualization of surgical sites. Manual instruments facilitate tissue examination and treatment in nasal cavity/nasopharynx. Used in OR/clinical settings by surgeons. System provides real-time visual feedback to assist in surgical navigation and decision-making.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

System includes endoscopes, xenon light sources, cameras, and manual surgical instruments. Electro-mechanical components comply with UL544 and IEC 601-1 electrical safety standards. Connectivity via standard optical and video coupling interfaces.

Indications for Use

Indicated for patients undergoing diagnostic or operative arthroscopic, laparoscopic, or ENT endoscopic procedures, and for patients requiring examination or treatment of the nasal cavity and nasal pharynx.

Regulatory Classification

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.

Predicate Devices

• Smith & Nephew ENT Division sinuscopes, surgical cameras, video components, illumination products, and ENT hand instruments

Submission Summary (Full Text)

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

MAR 21 1997

Endoscopy Division
Smith & Nephew, Inc.
160 Dascomb Road, Andover, MA 01810 U.S.A.
Telephone: [phone]
Telefax: 508-749-1599

Smith & Nephew

K970247

## 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:

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.

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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 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.

## 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 sinoscopes 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.

Deborah Connors
Regulatory Affairs Department