XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII

K062895 · Dutch Ophthalmic Research Center International BV · MPA · Oct 13, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062895
• Device Name: XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII
• Applicant: Dutch Ophthalmic Research Center International BV
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

Device Story

Xenon BrightStar Illumination System provides intraocular illumination for vitreoretinal surgery. Device comprises illumination unit and accessories (fiber optic probes, micro instruments). Unit utilizes 75W Xenon Short Arc lamp; internal focusing systems direct light into two individually controlled ports. Features include selectable UV cut-off filters and variable light intensity settings with digital display. Used in surgical settings by ophthalmologists. Provides illumination via fiber optic probes to assist visualization during vitreoretinal procedures. Benefits include enhanced surgical field visibility through adjustable intensity and spectral filtering.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Illumination unit with 75W Xenon Short Arc lamp. Two-port output with individual intensity control. Spectral range 410-700 nm. Includes UV filtration (420, 435, 475, 515 nm) and infrared filtration. Dimensions 350 x 250 x 300 mm; weight 15 kg. Accessories include sterile single-use and reusable fiber optic probes. Sterilizable control knobs.

Indications for Use

Indicated for patients undergoing vitreoretinal surgery requiring intraocular illumination.

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

• D.O.R.C. HEXON ILLUMINATION SYSTEM (K973229)

Submission Summary (Full Text)

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# 510(k) Summary

0C1 1 3 2006

### 1. COMPANY NAME AND ADDRESS

Dutch Ophthalmic Research Center International by Scheijdelveweg 2 3214 VN Zuidland The Netherlands

Contact: Mr. Ger Vijfvinkel, President Phone Fax : [phone] Date of summary: September 15, 2006

### 2. DEVICE NAME

| Trade Name | : Xenon BrightStar Illumination System |
|---------------------|---------------------------------------------------------------|
| Common Name | : Ophthalmic Light Source |
| Classification Name | : Endoilluminator (21 CFR 876.1500,<br>Product Code MPA, GCT) |

#### 3. PREDICATE DEVICE

D.O.R.C. HEXON ILLUMINATION SYSTEM (K973229)

#### 4. DEVICE DESCRIPTION

The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.

#### 5. INTENDED USE

The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

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## 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The following table summarizes the technological characteristics of the Xenon BrightStar Illumination System in comparison to the predicate D.O.R.C. Hexon Illumination System.

| Comparison of Xenon BrightStar Illumination System to Predicate Device | | | |
|------------------------------------------------------------------------|-----|------------------------------------------------|---------------------------------------------|
| Characteristic | | Xenon BrightStar<br>Illum. System<br>1266.XIII | D.O.R.C. Hexon<br>Illum. System<br>1266.XII |
| Indication: Endoillumination for<br>vitreoretinal surgery | | YES | YES |
| Lamp Type | | Xenon Short Arc | Metal Halide |
| Lamp rating (Watts) | | 75 | 24 |
| Light Output (lumens) | | Min. 850 | 1850 |
| Color Temperature (degrees K) | | Approx. 6000 | 4700 |
| Variable intensity | | YES | YES |
| Intensity displayed | | YES | NO |
| Wavelength Range (nm) | | 410-700 | 400-800 |
| UV filtration (nm) | 420 | YES | NO |
| | 435 | YES | YES |
| | 475 | YES | YES |
| | 515 | YES | NO |
| Infrared filtration | | YES | YES |
| Additional color filtration | | NO | YES |
| Sterilizable knobs | | YES | NO |
| Multiple probe diameters | | YES | YES |
| Panoramic light probes | | YES | YES |
| Straight Probes | | YES | YES |
| Illuminated accessories | | YES | YES |
| Illumination ports | | 2 | 1 |
| Dimensions of unit (mm) | | 350 x 250 x 300 | 150 x 257 x 256 |
| Weight of unit (kgs) | | 15 | 6 |

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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dutch Ophthalmic Research Center International c/o Ms. Fran Carleton One Little River Rd. Kingston, NH 03848

OCT 1 3 2006

Re: K062895

Trade/Device Name: Xenon BrightStar Illumination System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoilluminator Regulatory Class: Class II Product Code: MPA Dated: September 25, 2006 Received: September 27, 2006

Dear Ms. Carleton:

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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w you to obgan mating of substantial equivalence of your device to a legally prematicated 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 If you desire sportio acrite 10. Jour 240) 276-0115. Also, please note the regulation entitled, eonialor the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

MB. EgclehmisiwD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX 1

# Indications for Use

510(k) Number (if known): K062895

Device Name: _XENON BRIGHTSTAR ILLUMINATION SYSTEM

Indications for Use:

The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dennis L. McCarthy

Division of Ophthalmic Ear,
Nose and Throat Devices

510(k) Number K062845