D.O.R.C. HEXON ILLUMINATION SYSTEM

K973229 · Dutch Ophthalmic USA, Inc. · MPA · Nov 25, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973229
• Device Name: D.O.R.C. HEXON ILLUMINATION SYSTEM
• Applicant: Dutch Ophthalmic USA, Inc.
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Nov 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The D.O.R.C. HEXON Illumination System is indicated for intraocular illumination in vitreoretinal surgery.

Device Story

HEXON Illumination System provides intraocular light for vitreoretinal surgery. System comprises illumination unit, fiberoptic probes, and accessories. Unit utilizes metal halide discharge lamp; internal focusing system directs light into optical fiber. Features include variable intensity, UV/infrared filtration, and multiple color filters (green, yellow, red, blue, daylight). Used in clinical settings by surgeons; light delivered via fiberoptic probes to surgical site. Provides illumination to assist visualization during procedures; benefits patient by enabling surgeon to perform complex vitreoretinal surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metal halide discharge lamp (24 watts); 1850 lumens output; 4700K color temperature; 400-800 nm wavelength range. Includes UV and infrared filtration. Features variable intensity control and interchangeable color filters. System utilizes fiberoptic probes and microinstruments. No software or electronic algorithm components described.

Indications for Use

Indicated for intraocular illumination during vitreoretinal surgery.

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

• Grieshaber Light Source
• Escalon VitLite I (K963417)

Submission Summary (Full Text)

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K973229

e 2

510(k) Summary Dutch Ophthalmic, USA D.O.R.C. HEXON Illumination System (per 21 CFR 807.92)

NOV 2 5 1997

## SUBMITTER NAME AND ADDRESS 1.

Dutch Ophthalmic, USA One Little River Roud P.O. Box 968 Kingston, NH 03848

Mark W. Furlong, President Contact Person: Telephone: [phone]

August 26, 1997 Date Prepared: Date Amended: November 24, 1997

### 2. DEVICE NAME

Proprietary Name: HEXON Illumination System Common/Usual Name: Endoillumination System Ophthalmic Light Source Classification Name:

### PREDICATE DEVICE/S 3.

Grieshaber Light Source Escalon VitLite I (K963417)

### DEVICE DESCRIPTION 4.

The D.O.R.C. HEXON Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a metal halide discharge lamp and utilizes an internal focusing system to focus the light into the end of the optical fiber. Accessories to the Illumination Unit include adapters and color filters. Accessories to the system include single use and reusable fiberoptic probes, fibers, and microinstruments which require storilization prior to use.

### INTENDED USE ડ.

The D.O.R.C. HEXON Illumination System is indicated for intraocular illumination in vitreoretinal surgery.

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# 1973220

# BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Operational and technological cliaracteristics for the determination of aubstantial Operational and technological clisition with hegally marketed predicate
equivalence of the D.O.R.C. HEXON Illumination System with hegally marketed predicate equivalence of the D.O.R.C. HEXON Inumilation includes desoriptive information
devices. Information supplied in this prematical obserciptive information devices. Information supplied in this president includes . The following table about the intended use, operation and technological characteristics - HEXON Illumination System in
summarizes the toch of the D.O.R.C. HEXON Illumination System in comparison to the prodicate devices.

| Comparison of HEXON Illumination System to Predicate Devices | | | | |
|--------------------------------------------------------------|----------|------------------------|----------------------------|--------------------|
| | | HEXON<br>Illum. System | Grieshaber<br>Light Source | Escalon<br>VitLite |
| Characteristic | | | | |
| Indication: Endollumination for<br>vitreoretinal surgery | | YES | YES | YES |
| Lamp Type | | Metal Halide | Halogen | Metal Halide |
| Lamp Rating | | 24 watts | not specified | not specified |
| Light Output (lumens) | | 1850 | not specified | not specified |
| Color Temperature (degrees K) | | 4700 | not specified | 5300 |
| Variable Intensity | | Yes | Yes | Yes |
| Wavelength Range (nm) | | 400-800 | not specified | 450-700 |
| UV filtration | | Yes | Yes | Yes |
| Infrared filtration | | Yes | Yes | Yes |
| Additional color filtration | Green | Yes | Yes | not specified |
| | Yellow | Yes | Yes | not specified |
| | Red | Yes | Yes | not specified |
| | Blue | Yes | Yes | not specified |
| | Daylight | Yes | not specified | not specified |
| Multiple probe diameters | | Yes | Yes | Yes |
| Panoramic light probe | | Yes | not specified | Yes |
| Straight probe | | Yes | Yes | Yes |
| Illuminated accessories | | Yes | Yes | Yes |

D.O.R.C. HEXON Illumination System 510(k) 8/26/97

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 5 1997 NOV

Mr. Mark W. Furlong Dutch Ophthalmic, U.S.A., Inc. One Little River Road P.O. Box 968 Kingston, NH 03848

Re: K973229

Trade Name: D.O.R.C. Hexon Illumination System Regulatory Class: II Product Code: 86 MPA Dated: August 25, 1997 Received: August 27, 1997

Dear Mr. Furlong:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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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 yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973229 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

D.Q.R.C. Hexon Illumination System Device Name:

Indications For Use:

The D.O.R.C. Hexon Illumination System is indicated for intraocular illumination in vitreoretinal surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bruce Drum

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K973229

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use ------------