VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

K050623 · Volk Optical, Inc. · HJK · Mar 28, 2005 · Ophthalmic

Device Facts

• Record ID: K050623
• Device Name: VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
• Applicant: Volk Optical, Inc.
• Product Code: HJK · Ophthalmic
• Decision Date: Mar 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.1385
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.

Device Story

Volk Disposable Vitrectomy Lenses are sterile, single-use contact lenses used by ophthalmologists during eye fundus examinations and intraocular surgeries. The lenses are constructed from PMMA and are designed to provide visualization of the ocular fundus, vitreous, and retinal structures. The device is placed on the patient's eye by the clinician to facilitate the examination or therapeutic procedure. By providing a clear view of internal eye structures, the lens assists the physician in diagnosing and treating intraocular abnormalities. The disposable nature of the device eliminates the need for reprocessing between patients.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Polymethylmethacrylate (PMMA). Form factor: Various designs including flat, wide field, and 30° prism. Sterilization: Ethylene Oxide (EO). Connectivity: None (standalone).

Indications for Use

Indicated for use as diagnostic contact lenses for eye fundus examinations and therapy of intraocular abnormalities in patients requiring such procedures.

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 Disposable Vitrectomy Lenses (K012096)
• Volk Quadraspheric Fundus Lens (K943125)

Submission Summary (Full Text)

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## Volk Optical, Inc.

## 510(k) SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

11:10 PM

March 7, 2005 Date:

Volk Optical, Inc. Submitter: 7893 Enterprise Drive Mentor, Ohio 44060 [phone]

#### Contact Person:

Michaeleen Dom

:

### Official Correspondent:

Richard E. Lippman, O.D., F.A.A.O. Vice President Ophthalmic Product Regulatory Affairs R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road Suite 30 Rockville, Maryland 20850 [phone]

#### Device Name:

| Trade Name: | Volk Disposable Vitrectomy Lenses |
|------------------------|-----------------------------------|
| Common Name: | Vitrectomy contact lens |
| Classification Name: | Lens, Contact- Diagnostic |
| Device Classification: | 21 CFR 886.1385<br>Class II |
| Product Code: | HJK |

#### Device Description:

The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.

#### Intended Use:

The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.

#### Substantial Equivalence:

The Volk Disposable Vitrectomy Lenses are substantially equivalent in design, material, classification, and intended use to vitrectomy lenses cleared for marketing by Ocular Instruments, Inc. (K012096), and Volk Optical, Inc. (K943125). See chart below.

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## Volk Optical, Inc.

| Comparison | Volk Contact &<br>Laser Diagnostic<br>Lenses (current<br>application) | Volk Quadraspheric<br>Fundus Lens<br>(K943125) | Ocular Disposable<br>Vitrectomy Lenses<br>(K012096) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | Diagnostic contact<br>lens for eye fundus<br>examinations and<br>use in the therapy of<br>intraocular<br>abnormalities | Diagnostic contact<br>lens for eye fundus<br>examinations and<br>use in the therapy of<br>intraocular<br>abnormalities | Visualizastion of the<br>ocular fundus, vitreous<br>and retinal structures<br>during vitrectomy<br>surgeries. |
| Design | Various designs<br>include the flat, wide<br>field and 30° prism. | Various designs<br>include the flat, wide<br>field and 30° prism | Various designs include<br>the flat, wide field and<br>30° prism. |
| Materials | PMMA | PMMA | PMMA |
| Sterility | EO Sterilized | Non-sterile | EO Sterilized |

:

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle.

Public Health Service

MAR 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Volk Optical, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. Official Correspondent for Volk Optical, Inc. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Rd., Suite 30 Rockville, MD 20850

Re: K050623

Trade/Device Name: Volk Disposable Vitrectomy lenses Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: March 9, 2005 Received: March 10, 2005

Dear Dr. Lippman:

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 - Richard E. Lippman, O.D., F.A.A.O.

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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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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# INDICATION FOR USE STATEMENT

510(k) Number (if known)

K050623

.

11. Sales and the same

. . .

Device Name:

Volk Disposable Vitrectomy Lenses

Indications for Use:

The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.

X Prescription Use (Part 21 CFR 801 Subpart D)

> : 2 .

AND/OR

11. 43. 15.

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)

Daniel W.C. Brown, Ph.D.

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

K050623 510(k) Number.