DORC VITRECTOMY LENSES, MODEL 1284 SERIES

K033950 · Dutch Ophthalmic Research Center (D.O.R.C.) · HJK · Feb 20, 2004 · Ophthalmic

Device Facts

• Record ID: K033950
• Device Name: DORC VITRECTOMY LENSES, MODEL 1284 SERIES
• Applicant: Dutch Ophthalmic Research Center (D.O.R.C.)
• Product Code: HJK · Ophthalmic
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1385
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.

Device Story

D.O.R.C. Vitrectomy Lens is a surgical optic used with an operating microscope; improves visualization of ocular fundus, vitreous, and retinal structures during vitreoretinal surgery. Device includes various designs: bioconcave, wideview field, flat lens, 20° and 30° prism lenses; some models utilize handles or sutured scleral rings. Available as sterile single-use disposable or non-sterile reusable versions. Operated by surgeons in clinical/OR settings. Provides direct optical magnification/field-of-view enhancement to assist in surgical navigation and tissue manipulation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Silicone, glass, quartz. Design: Various optical configurations including bioconcave, wideview, flat, and prism (20°/30°). Form factor: Handheld or sutured scleral ring mount. Sterilization: Sterile disposable or non-sterile reusable. No software or electronic components.

Indications for Use

Indicated for use during vitreoretinal surgical procedures to improve visualization of the ocular fundus, vitreous, and retinal structures.

Regulatory Classification

Identification

A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

Predicate Devices

• Ocular Instruments Inc. Vitrectomy Lens (K012096)

Submission Summary (Full Text)

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### Date Prepared 1.0 December 1, 2003

HIGH

#### Submitter 2.0

L.W.M. Heller D.O.R.C. International b.v. Scheijdelveweg 2 3214 VN Zuidland The Netherlands

#### 3.0 Device Name

D.O.R.C. Vitrectomy Lens Proprietary Name: Vitrectomy Lens Common Name(s): Classification Name: Polymethylmethacrylate Diagnostic Contact Lens

#### Device Classification 4.0

HJK, Class II, 21 CFR 886.1385

#### Device Description 5.0

D.O.R.C. Vitrectomy Lens includes a variety of designs both sterile, single use, disposable vitrectomy lenses, as well as vitrectomy lenses intended to be reused which are sold non-sterile.

#### 6.0 Intended Use

The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.

#### 7.0 Substantial Equivalence

The D.O.R.C. Vitrectomy Lenses are equivalent in design, materials, classification, intended use and indications to vitrectomy lenses marketed by Ocular Instruments Inc. cleared via 510(k) number K012096, 8/24/01.

| | D.O.R.C. Vitrectomy Lens | Ocular Instruments Inc. Vitrectomy<br>Lens |
|-----------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Silicone, glass, quartz | Silicone, glass, quartz |
| Design | Various designs including bioconcave,<br>wideview field, flat lens, 20° and 30°<br>prism lenses. Some designs may be<br>used with a handle or sutured scleral<br>ring. | Various designs including bioconcave,<br>wideview field, flat lens, 20° and 30°<br>prism lenses. Some designs may be used<br>with a handle or sutured scleral ring. |
| Sterility | Sterile Disposable and Non-Sterile<br>Reusable | Sterile Disposable and Non-Sterile<br>Reusable |

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Dutch Ophthalmic Research Center c/o Fran Carleton Dutch Ophthalmic USA One Little River Road Kingston, NH 03848

Re: K033950

Trade/Device Name: D.O.R.C. Vitrectomy Lenses Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate Diagnostic Contact Lens Regulatory Class: Class II Product Code: HJK Dated: December 11, 2003 Received: December 29, 2003

Dear Mr. Carleton:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premainted is substantially equivalent (for the indications for used and nave decembred the article the articate devices marketed in interstate for use stated in the encrosule) to regary mancede possible increased the Federal Food Drug commerce prior to May 28, 1970, the endemner with the provisions of the Federal Food, Drug, devices that have been reclassince in accordance while a premarket approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a pressions of the Act and Cosment Act (Act) that do not require applierte of the general controls provisions of the Act. The You may, therefore, market the device, belgies of the more of registration, listing of general controls provisions of the Hereland, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (See above) mlo cities in the pegulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA m may be subject to such additional controls. Extentify - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of I casian Regeraing your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I'DA's issumes of a basedian and other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA nas made a decermination administered by other l'ederal agencies. You must or any Pederal statutes and regulations administed to: registration and listing and listing comply with all the Act stequirences includes and monufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requir (21 CFR Part 807); labeling (21 CFR Pair 800); good art 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CVR Part 200); and if applica forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

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### Page 2 -- Fran Carleton

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wating of substantial equivalence of your device of your device to a legally promated 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

Sincercly yours,

A Kalph Rosenthal

A. Ralph Rosenthal, 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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## Intended Use Statement

510(k) Number (if known): K033950

Device Name: D.O.R.C. Vitrectomy Lens

Indications for Use:

The Vitrectomy Lenses are intended to be used in conjunction with an operating The Viroscope as a surgical optic to improve visualization of the ocular fundus, vitreous metoseopo us a surgrour specifical spatisms lenses are indicated for use during vitreoretinal surgical procedures.

> (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use *X*

Or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Daniel W. C. Broyn, (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

коззяво 510(k) Number _