59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS

K040303 · Hydrogel Vision Corporation · LPL · Feb 2, 2005 · Ophthalmic

Device Facts

• Record ID: K040303
• Device Name: 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS
• Applicant: Hydrogel Vision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Device Story

59% Extreme H2O (hioxifilcon A) toric soft contact lens; hemispherical shell design; fabricated from non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (GMA), cross-linked with EGDMA; 59% water content; includes blue visibility handling tint (phthalocyanato (2) - (copper)). Prescribed by eye care practitioners for daily wear; frequent/planned replacement schedule; requires chemical disinfection. Corrects visual acuity in aphakic/not-aphakic patients with myopia, hyperopia, or astigmatism up to 10.00 Diopters. Benefits include vision correction for patients with higher astigmatism levels compared to previous spherical-only models.

Clinical Evidence

No clinical data provided; substantial equivalence based on design modification to a previously cleared predicate device.

Technological Characteristics

Material: hioxifilcon A (copolymer of 2-HEMA and GMA cross-linked with EGDMA); 59% water content; blue visibility tint (phthalocyanato (2) - (copper)); hemispherical shell form factor; daily wear; chemical disinfection.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic, including those with astigmatism up to 10.00 Diopters.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

Predicate Devices

• 59% Extreme H2O (hioxifilcon A) spherical lens (K992692)

Submission Summary (Full Text)

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# FEB ~ 2 2005

# HYDROGEL VISION CORPORATION 510(K) Premarket Notification - Supplement 2

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K040303 |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Applicant information:<br>Date Prepared: | January 27, 2005 |
| Name:<br>Address: | Hydrogel Vision Corporation<br>6447 Parkland Drive<br>Sarasota, FL 34243 |
| Contact Person: | Donna Hovanec<br>Quality System Coordinator<br>Hydrogel Vision Corporation |
| Phone number: | 941-739-1382 |
| Device information:<br>Device Classification: | Class II |
| Classification Number: | LPL |
| Classification Name: | Lens, Soft Contact, Daily Wear |
| Trade Name: | 59% Extreme H2O (hioxifilcon A) Soft Contact<br>Lens for Daily Wear (cast-molded, with a<br>visibility tint) |

#### Purpose of 510(k) Submission:

Hydrogel Vision Corporation is requesting clearance from the FDA to expand the Indications for Use for the 59% Extreme H2O soft contact lens. The lens was originally approved on October 18, 1999, under 510(k) K992692, for the indication of daily wear correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. We are submitting this 510(k) to expand the indication to include toric lenses. The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and

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## HYDROGEL VISION CORPORATION 510(K) Premarket Notification - Supplement 2

scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

## Equivalent Device:

The 59% Extreme H2O (hioxifilcon A) toric soft contact lens is substantially equivalent to our already cleared 59% Extreme H2O (hioxifilcon A) spherical lens under 510(k) K992692.

## Device Description:

59% Extreme H2O (hioxifilcon A) soft contact lenses are hemispherical shells and are available as spherical (G59 S-Thin and G59 S-Xtra) or toric (G59 Toric) lens designs. The 59% Extreme H2O (hioxifilcon A) soft contact lens is fabricated from hioxifilcon A, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium perforate. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).

## Intended Use (Indications):

The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

#### Substantial Equivalence:

The information provided in this 510(k) establishes that the 59% Extreme H2O (hioxifilcon A) toric soft contact lens differs only in design to the 59% Extreme H2O (hioxifilcon A) spherical soft contact lens and meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hydrogel Vision Corporation c/o Donna Hovanec Quality System Coordinator 6447 Parkland Drive

Re: K040303

Sarasota, FL 34243

Trade/Device Name: 59% Extreme H2O (hioxifilcon A) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: January 13, 2005 Received: January 14, 2005

Dear Ms. Hovanec:

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.

FEB - 2 2005

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Page 2 - Donna Hovanec

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,

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

Enclosure

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HYDROGEL VISION CORPORATION 510(K) Premarket Notification - Supplement 2

# INDICATIONS FOR USE STATEMENT

Device Name: 59% Extreme H2O® (hioxifilcon A) toric soft contact lens

INDICATIONS FOR USE:

The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Use (Per 21 CFR 801.109) or

Over-The-Counter

(Optional Format 1-2-96)

Smisler

sion of Ophthalmic

510(k) Number K040303