DISPOSABLE VITRECTOMY LENS

K012096 · Ocular Instruments, Inc. · HJK · Aug 24, 2001 · Ophthalmic

Device Facts

• Record ID: K012096
• Device Name: DISPOSABLE VITRECTOMY LENS
• Applicant: Ocular Instruments, Inc.
• Product Code: HJK · Ophthalmic
• Decision Date: Aug 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1385
• Device Class: Class 2

Intended Use

Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

Device Story

Disposable vitrectomy lens used during ophthalmic surgery. Device provides clear visualization of ocular fundus, vitreous, and retinal structures for surgeon. Used in operating room by ophthalmologists. Lens facilitates surgical navigation and tissue manipulation during vitrectomy procedures. Single-use design eliminates sterilization requirements between patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable lens for ophthalmic visualization. Form factor designed for vitrectomy surgery. Single-use, non-sterile or sterile (implied by disposable nature).

Indications for Use

Indicated for patients undergoing vitrectomy surgery to allow 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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2001

Ocular Instruments, Inc. c/o Mr. Raymond Graham Director of Engineering & Product Development 2255 116th Ave., N.E. Bellevue, WA 98004-3039

Re: 510(K) Number: K012096 Trade/Device Name: Disposable Vitrectomy Lens Regulation Number: 21 CFR 886.1385 Regulatory Class: Class II Product Code: HJK Dated: July 3, 2001 Received: July 5, 2001

Dear Mr. Graham:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becamed the device is substantially equivalent (for the indications for use above and we and oure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the enorthere) (Device Amendments, or to devices that have been reclassified in enacificant anie of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the device, subject to the general controls provisions of the Act. The general chercedes, mailier the device as lude 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 (1 remarited i Ipproval), it the Code of Federal Regulations, Title 21, Parts 800 to ancecing your don't lee can valent determination assumes compliance with the Current Good 099. It substantially of of a quirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moponesis) with the GMP regulation may result in regulatory action. In addition, FDA may collips " will one of comments concerning your device in the Federal Register. Please note: publication and caremarket notification submission does not affect any obligation you this response to your premation of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Raymond Graham

This letter will allow you to begin marketing your device as described in your 510(k) premarker notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The PDF mically of casswation 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 II you distre specific at not ro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please 571-6115. Italiaonal), roompliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information " Misoranonig by reletence to prematics nounceaver (2) virision of Small Manufacturers On your responsibilities and and and and are [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
A. Ralph 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

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510(k) Number KOJ 2096

DEVICE NAME Disposable Vitrectomy Lens

## INDICATIONS FOR USE

Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

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Prescription Use __ X

Over-The Counter-Use _ OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Daniel W.C. Brown, Ph.D.

ivision of Ophthalmic Devices K012096 510(k) Number