SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES

K971850 · Smith & Nephew, Inc. · GCJ · Aug 12, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971850
• Device Name: SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 5mm x 300mm Images Endoscope (REF. 7205XXX) is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

Device Story

The Smith & Nephew Images 5mm x 300mm Endoscope is a rigid optical instrument used in endoscopic surgery. It functions by transferring light to the surgical site via internal glass fiber optics and providing visualization of the site through a series of optical lenses and prisms. The device is used by surgeons in a clinical or operating room setting to facilitate access to the surgical site, allowing for the decission, ligation, and harvesting of superficial vessels and fascia in the lower extremities. The output is a direct visual image of the surgical field, which assists the clinician in performing minimally invasive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscope, 5mm diameter x 300mm length. Materials include glass fiber optics, optical lenses, and prisms. Operates via external light source connection. Non-powered, mechanical optical device.

Indications for Use

Indicated for patients undergoing endoscopic surgery of superficial vessels and fascia of the lower extremities for vessel decission, ligation, and harvesting.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Karl Storz Endoscopy Telescope for use in endoscopic surgery of superficial veins and fascia of the lower extremities

Submission Summary (Full Text)

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AUG 1 2 1997

11850

## 510(k) Summary

Smith & Nephew, Inc., Endoscopy Division Images 5mm x 300mm Endoscope

#### Substantial Equivalence:

The Smith & Nephew Images 5mm x 300mm Endoscope is substantially equivalent in design, materials, function, and intended use to the 5mm x 300mm telescope offered by Karl Storz Endoscopy as part of the KSEA Instrument Set for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities.

#### Predicate Device:

The predicate device for this submission is the Karl Storz Endoscopy Telescope for use in endoscopic surgery of superficial veins and fascia of the lower extremities.

#### Summary of Device Function:

The Smith & Nephew Images 5mm x 300mm Endoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a series of optical lenses and prisms. The endoscope allows it to gain access to the surgical site.

#### Intended Use of Device:

The 5mm x 300mm Images Endoscope is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

#### Comparison of Technological Characteristics of Predicate Device:

The basic technologies, design and function of the Smith & Nephew Images 5mm x 300mm Endoscope is substantially equivalent in materials, design and function to the Karl Storz Endoscopy 5mm x 300mm Telescope for use in endoscopic surgery of superficial veins and fascia of the lower extremities and raises of safety and effectiveness.

Delores J. Conners

Deborah J. Connors Regulatory Affairs Specialist

### Endoscopy Division

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

# Smith - Nephew

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Deborah J. Connors Regulatory Affairs Specialist Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810

AUG 1 2 1997

Re: K971850

> Trade Name: Images Endoscopes and Accessories Regulatory Class: II Product Code: GCJ Dated: May 19, 1997 Received: May 20, 1997

Dear Ms. Connors:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Ms. Deborah J. Connors

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number :

Device Name : Smith & Nephew, Inc., Endoscopy Division Images Endoscopes

Indications for Use :

The 5mm x 300mm Images Endoscope (REF. 7205XXX) is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109)

OR

Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Division or General Restorative Devices
510(k) Number K971850