SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE

K032598 · Synergetics, Inc. · MPA · Nov 24, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K032598
• Device Name: SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
• Applicant: Synergetics, Inc.
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Nov 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.

Device Story

Synergetics Synerlight FiberOptic Lightsource provides illumination for anterior and posterior vitreoretinal surgery. Device functions as a light source for fiberoptic probes; also facilitates photocoagulation when integrated with compatible external laser light sources and probes. Used in clinical surgical settings by ophthalmologists/surgeons. Output is light delivered via fiberoptics to the surgical site, enabling visualization of ocular structures. Benefits include improved surgical field visibility and support for laser-based therapeutic procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Fiberoptic light source for ophthalmic surgery. Provides illumination and supports laser photocoagulation via external laser integration. Class II device (Product Codes: MPA, GEX).

Indications for Use

Indicated for illumination of the eye during anterior and posterior vitreoretinal surgery and for providing photocoagulation when used with compatible laser light sources and probes.

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

• K964005

Submission Summary (Full Text)

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NOV 2 4 2003

K032598

## Attachment 2

## 510(k) Summary

| Company: | Synergetics, Inc.<br>3845 Corporate Centre Drive<br>St. Charles, MO 63304 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dan Regan |
| Date: | October 21, 2003 |
| Trade Name: | Synergetics Synerlight FiberOptic Lightsource |
| Common Name: | Ophthalmic Fiberoptic Lightsource |
| Predicate Device: | K964005 |
| Description/Intended Use: | The intended use of the device is to illuminate the eye<br>during anterior and posterior vitreoretinal surgery and<br>to provide photocoagulation when used with the<br>appropriate commercially available laser light source<br>and probe. |
| Testing Summary: | Testing demonstrated that the subject device is<br>substantially equivalent to the predicate device. |

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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 caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2003

Mr. Dan Regan Quality Assurance/Regulatory Affairs Director Synergetics, Inc. 3845 Corporate Centre Drive St. Charles, Missouri 63304

Re: K032598

Trade/Device Name: Synergetics Synerlight FiberOptic Lightsource Regulation Number: 21 CFR 876.1500, 878.4810 Regulation Name: Endoscope and accessories, Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: MPA, GEX Dated: August 22, 2003 Received: August 26, 2003

Dear Mr. Regan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Dan Regan

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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## Attachment 2

## Indications for Use Statement

| 510(k) Number<br>(if known) | K032598 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Synergetics Synerlight FiberOptic Lightsource |
| Indications for Use | The intended use of the device is to illuminate the eye during<br>anterior and posterior vitreoretinal surgery and to provide<br>photocoagulation when used with the appropriate commercially<br>available laser light source and probe. |

PLEASE DO NOT 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 Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K032598