SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES

K980604 · Smith & Nephew, Inc. · GCJ · May 19, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980604
• Device Name: SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Dyonics endoscopes are indicated for use in laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals.

Device Story

Dyonics Endoscopes are rigid surgical instruments used to facilitate visualization during laparoscopic and thoracic procedures. The device functions by transferring light to the surgical site via integrated glass fiber optics and providing a direct view of the anatomy through a rod lens optical system. Certain models include working channels to allow for the passage of instruments for tissue manipulation. The device is intended for use by surgeons in an operating room environment. By providing illumination and a clear optical path, the endoscope enables the surgeon to perform minimally invasive procedures, potentially reducing patient trauma compared to open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscope design; glass fiber optics for illumination; rod lens optical system for visualization; optional working channels for instrument passage. Materials and construction are equivalent to predicate devices.

Indications for Use

Indicated for patients undergoing laparoscopic and thoracic surgical procedures requiring access, illumination, and visualization or manipulation of body cavities, hollow organs, and canals.

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 Laparoscopes/Thoracoscopes

Submission Summary (Full Text)

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MAY 1 8 1998

510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics Endoscopes

#### Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: [phone] lefax: 978-749-1599

## Smith == Nephew

K980604

### Substantial Equivalence:

The Smith & Nephew Dyonics Endoscopes are substantially equivalent in design, materials, function, and intended use to the line of Laparoscopes/Thoracoscopes offered by Karl Storz Endoscopy.

#### Predicate Device:

The predicate device for this submission is the line of Laparoscopes/Thoracoscopes offered Karl Storz Endoscopy Telescope for use in thoracic surgical procedures.

#### Summary of Device Function:

The Smith & Nephew Dyonics Endoscopes transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a rod lens optical system. Selected endoscopes have working channels to accommodate surgeon preference.

#### Intended Use of Device:

Dyonics endoscopes are indicated for use in laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals.

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

The basic technologies, design and function of the Smith & Nephew Dyonics line of endoscopes is substantially equivalent in materials, design and function to Laparoscopes/Thoracoscopes offered by Karl Storz Endoscopy. The minor differences in product specifications raise no new issues of safety and effectiveness.

Debnah L. Conner

Deborah J. Connors Sr. Regulatory Affairs Specialist

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 1998

Ms. Deborah Connors Senior Regulatory Affairs Specialist Smith & Nephew, Incorporated 160 Dascomb Road Andover, Massachusetts 01810

Re: K980604 Trade Name: Smith & Nephew Dyonics Endoscopes and Accessories Regulatory Class: II Product Code: GCJ February 13, 1998 Dated: Received: February 17, 1998

Dear Ms. Connors:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirement, as set forth in the Quality System Regulation (QS) 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 devices 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. Connors

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

If you desire specific advice for your devices 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 devices, 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 yours,

C. Colin M. Witten, Ph.D.

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

Enclosures

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# 510(k) Number : K 98060 4

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

Indications for Use :

Dyonics endoscopes are indicated for use in laparoscopic and thoracic surgical procedures to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals.

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______________________________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K980604 |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

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Over-the-Counter. ____________________________________________________________________________________________________________________________________________________________

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