SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR

K991323 · Smith & Nephew, Inc. · FFS · Jul 6, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991323
• Device Name: SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
• Applicant: Smith & Nephew, Inc.
• Product Code: FFS · Gastroenterology, Urology
• Decision Date: Jul 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Subcutaneous Illuminator is intended to be used for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

Device Story

Device is a handpiece containing glass fiber optics and an irrigation channel. Used during endoscopic resection of superficial varicosities of lower extremities. Surgeon inserts device into surgically created pockets in subcutaneous tissue. Fiber optics transfer light to surgical site for transillumination; irrigation channel provides fluid to site. Device aids visualization and irrigation during procedure. Benefits include improved surgical site visibility and management during vein resection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Handpiece with glass fiber optics for light transmission and an integrated irrigation channel. Designed for insertion into subcutaneous tissues. Non-powered optical/mechanical device.

Indications for Use

Indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

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

• Dyonics Endoscope for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities
• Strykeflow Suction Irrigator Gravity Flow (K963646)
• Endolumina Transillumination System II (K964561)
• AMD Fiberoptic End Irrigating Endo-Illuminator (K970882)

Submission Summary (Full Text)

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K99/323

April 15, 1999 510(k) Summary Subcutaneous Illuminator

#### Substantial Equivalence:

The Smith & Nephew Subcutaneous Illuminator is substantially equivalent in design, materials, function, and intended use to the Dyonics Endoscope for Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities, the Strykeflow Suction Irrigator Gravity Flow marketed by Stryker Endoscopy(K963646), the Endolumina Transillumination System II marketed by BioEnterics (K964561) and the AMD Fiberoptic End Irrigating Endo-Illuminator (K970882).

## Predicate Devices:

The predicate devices for this submission are the Dyonics Endoscopic Surgery of Superficial Veins and Fascia of the Lower Extremities, the Strykeflow Suction Irrigator Gravity Flow, the Endolumina Transillumination System II marketed by and the AMD Fiberoptic End Irrigating Endo-Illuminator.

#### Summary of Device Function:

The Smith & Nephew Subcutaneous Illuminator transfers light to the surgical site via glass fiber optics and includes irrigation via an irrigation channel. The Subcutaneous Illuminator allows it to gain access to the surgical site.

#### Intended Use of Device:

The Subcutaneous Illuminator is indicated for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

### Comparison of Technological Characteristics of Predicate Device:

The basic technologies, design and function of the Smith & Nephew Subcutaneous Illuminator is substantially equivalent in materials, design and function with the exception of optical transmission capabilities, to the Dyonics Endoscopes, for use in endoscopic surgery of superficial vessels of the lower extremities and raises of safety and effectiveness. The Subcutaneous Illuminator and the EndoIllumina II Transillumination System are both intended to be inserted into the subcutaneous tissues through surgically created pockets. The Subcutaneous Illuminator and the Dyonics Endoscope are both indicated for use in endoscopic surgery of superficial vessels of the lower extremities. The Subcutaneous Illuminator, and the Strykeflow Suction Irrigator Gravity Flow are all indicated for irrigation during laparoscopic surgery. Although the AMD Fiberoptic End Irrigating Endo-Illuminator is indicated for ophthalmic use, the technology of the device is identical to the Subcutaneous Illuminator in that they are both consist of a handpiece with fiberoptic fibers and irrigation channel for illumination and irrigation of the surgical site.

Debark f. Conns

Deborah J. Connors Principal Regulatory Affairs Specialist

# Endoscopy Division

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

# Smith - Nephew

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 1999

Ms. Deborah J. Connors Principal Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01801

Re: K991323 Subcutaneous Illuminator Dated: April 15, 1999 Received: April 19, 1999 -Regulatory Class: II 21 CFR §876.1500 and §880.6960 Product Code: 78 FFS and 80 GCJ

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 legally marketed predicate devices marketed in interstate commerce proor 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 (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 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.

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 Compiance 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 :is internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/1/Picture/14 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

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510(k) Number : K 991323

Device Name : Smith & Nephew, Inc., Endoscopy Division Subcutaneous Illuminator

Indications for Use :

The Subcutaneous Illuminator is intended to be used for transillumination and irrigation during endoscopic resection of superficial varicosities of the lower extremities.

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David G. Flynn

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number