DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

K030054 · Fci Ophthalmics, Inc. · HJK · Feb 26, 2003 · Ophthalmic

Device Facts

• Record ID: K030054
• Device Name: DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
• Applicant: Fci Ophthalmics, Inc.
• Product Code: HJK · Ophthalmic
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1385
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.

Device Story

Disposable Vitrectomy Set comprises infusion cannula, surgical knife, and vitrectomy lenses. Infusion cannula with tubing delivers saline/balanced saline solution to maintain ocular tonicity during vitrectomy; self-blocking design eliminates need for sutures. Surgical knife creates calibrated, non-leaking incisions for cannula insertion. Vitrectomy lenses, used with surgical microscope, cancel corneal diopter to enable retinal visualization; feature frosted ring to minimize edge glare; designed for manipulation on cornea via forceps. Used in clinical surgical settings by ophthalmologists. Benefits include simplified surgical workflow, reduced procedural time, and improved visualization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Components: PMMA diagnostic contact lens, infusion cannula, surgical knife. Principle: Mechanical infusion and optical visualization. Form factor: Disposable, sterile, single-use. No software or electronic components.

Indications for Use

Indicated for use during vitrectomy procedures to maintain ocular tonicity via infusion, facilitate retinal visualization via corneal diopter cancellation, and create surgical incisions.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2003

FCI Ophthalmics, Inc. c/o Hillard W. Welch U.S. Representative for FCI 344 Annabelle Point Road Centerville, MA 02632-2402

Re: K030054

Trade/Device Name: Disposable Vitrectomy Lenses Disposable Infusion Cannula Surgical Knife Regulation Number: 21 CFR 886.1385; 21 CFR 886.4350 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II; Class I; Class I Product Code: HJK; HMX; HMX; HNN Dated: December 31, 2002 Received: January 6, 2003

Dear Mr. Welch:

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 - Hillard W. Welch

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/dsma/dsmamain.html

Sincerely yours,

A Kalgi korenthal

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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K030054 510(k) Number (if known):

> Disposable Vitrectomy Set Disposable Vitrectomy Lenses

Device Name:

Indications for Use:

The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jake W. Brown, Ph.D.

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

510(k) Number K030054

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)