HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)

K023530 · Westcon Contact Lens Co., Inc. · LPL · Nov 26, 2002 · Ophthalmic

Device Facts

• Record ID: K023530
• Device Name: HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED)
• Applicant: Westcon Contact Lens Co., Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Horizon 38 (polymacon). Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes. The lens may be disinfected using either a heat or chemical system .

Device Story

Soft hydrophilic contact lenses manufactured from polymacon; lathe-cut into hemispherical shells. Designed to fit over corneal surface; base curves conform to corneal radius; center over apex to correct ametropia. Features primary, secondary, and beveled edge configurations for centration and comfort. Used by patients for daily wear; prescribed by eye care professionals. Lenses provide refractive power corresponding to patient needs. Disinfection via heat or chemical systems.

Clinical Evidence

Bench testing only. Studies included leachability (no pigment leaching), toxicology (cytotoxicity, systemic toxicity, ocular irritation), physical/optical characterization (transmittance, refractive index, water content, expansion, tensile strength), and compatibility (spectra measurement after cleaning/disinfection).

Technological Characteristics

Material: Polymacon. Form: Lathe-cut hemispherical soft hydrophilic contact lens. Optical: Central optical zone >6mm. Sterilization/Maintenance: Compatible with heat or chemical disinfection systems. Shelf life: 3 years.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons with nondiseased eyes.

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

• K963837

Reference Devices

• K954524

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text 'K023530' in a bold, sans-serif font. The numbers and letters are closely spaced together. Below this text is the phrase '510 (k) Summary' in a smaller font size.

| 1.0 | Name and<br>address of<br>submitter | Westcon Contact Lens Company, Inc.<br>611 Eisenhauer Street<br>Grand Junction, CO. 81503 |
|--------------|-------------------------------------|------------------------------------------------------------------------------------------|
| | Contact Person | Carol Noble<br>970-245-3845 |
| | Fax | 970-245-4516 |
| | Date Prepared | 10/14/02 |
| NOV 2 6 2002 | | |

### 2.0 Name of Device

- ♦ Trade Name:
Spherical: Horizon 38 (polymacon) and Horizon 38 Westint (polymacon)

### Toric:

Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)

- Common Name: Daily Wear Soft Contact Lens �
- � Generic (USAN) Name: Polymacon
- Classification Name: Soft Hydrophilic Contact Lens �

### 3.0 Indications

The Horizon 38 (polymacon). Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.

The lens may be disinfected using either a heat or chemical system .

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Traditional 510(k)-Submission

### 8.0 510 (k) Summary

### Device Description 4.0

The soft contact lenses that are manufactured from W-38 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of ametropia (myopia, hyperopic and astigmatism). Each lens provides corrective power, which corresponds to the refractive power of the eye to which it is being treated.

Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary, as well as, beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.

### 5.0 Substantially Equivalent To:

Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K963837.

### Summary of Safety and Effectiveness 6.0

W-38 (polymacon) lens blanks were subjected to leachability studies and showed no identifiable evidence of tint pigment leaching.

### 7.0 Technical Summaries

### 7.1 Toxicology:

Cytotoxicity, systemic toxicity and ocular irritation studies were. Test results showed no evidence of cellular or systemic toxicity, or ocular irritation.

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- Physical/Optical Characteristics 7.2
Light transmittance, refractive index, water content, linear expansion, radial expansion and tensile strength were determined. A comparison of data from these studies showed that the W-38 polymacon is equivalent in physical and optical characteristics as 510(k) K963837

- 7.3 Microbiology
There will be no changes to the validated process in 510(k) K954524

- 7.4 Compatibility
The spectra measurement after the numerous cleaning and disinfecting cycles remained the same as the before measurement.

- 7.5 Shelf Life
The three year shelf life study has been started on the lenses manufactured from W-38 and will be completed later this year. The packaging remains the same as 510(k) K954524 and 510(k) K963837.

#### 8.0 Conclusion

In conclusion, it is Westcons' conviction that the data submitted shows that manufacturing with W-38 polymacon instead of Benz's polymacon material does not raise different questions of safety and effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Westcon Contact Lens Co., Inc. c/o Ms. Carol Noble Management Representative 611 Eisenhauer Street Grand Junction, CO 81505

Re: K023530

Trade/Device Name: The Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 14, 2002 Received: October 21, 2002

Dear Ms. Noble:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters and is evenly spaced around the circle.

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Page 2 – Ms. Carol Noble

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. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. 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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# INDICATIONS FOR USE STATEMENT

## Device Name:

Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)

:

## Indication of Use:

The Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.

The lenses may be disinfected using either a heat or chemical system .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off | <div></div> |
|-----------------------------------------------------|----------------------|
| Division of Ophthalmic Ear, Nose and Throat Devices | |
| 510(k) Number | K023530 |
| Prescription Use | X |
| | OR |
| | Over-The-Counter Use |
| (Per 21 CFR 801.109 | |
| (Optional Format 1-2-96) | |