EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR

K992787 · Specialty Ultravision, Inc. · HQD · Feb 2, 2000 · Ophthalmic

Device Facts

• Record ID: K992787
• Device Name: EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
• Applicant: Specialty Ultravision, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Feb 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic or not-aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.

Device Story

EpiCon K is a rigid gas permeable (RGP) contact lens designed for daily wear in patients with keratoconus or refractive ametropia. The lens is a hemispherical shell manufactured from carbosilfocon A (polymethyl methacrylate combined with a silicone-containing copolymer) using a gel flow molding process. It features a blue handling tint (D&C Green No. 6). The device is prescribed by eye care professionals to correct vision and manage irregular corneal surfaces. It functions by providing a stable refractive surface over the irregular cornea. Patients use the lens daily and maintain it using chemical disinfection systems. The device benefits patients by improving visual acuity and managing keratoconus-related corneal irregularities.

Clinical Evidence

Four-week prospective clinical evaluation at five sites with 38 keratoconic subjects. 18 subjects (47.4%) completed the study; 20 (52.6%) discontinued. Primary endpoints included slit lamp findings, subject symptoms, keratometry, refractive changes, visual acuity, and lens comfort. Results indicated performance within expected ranges for RGP lenses in keratoconic eyes. Two adverse reactions occurred, both resolving without sequelae. Clinical performance was determined to be substantially equivalent to the predicate.

Technological Characteristics

Material: carbosilfocon A (PMMA/silicone copolymer); Hydrophobic Lens Group 2. Dimensions: 10.5-14.0 mm chord diameter, 0.10-0.35 mm center thickness, 6.0-8.5 mm base curve. Power: Plano to -20.00 D. Dk (35°C): 52 x 10^-11. Refractive index: 1.49 at 20°C. Specific gravity: 1.105. Wetting angle: < 19°. Manufacturing: Gel Flow Molding. Sterilization: Chemical disinfection system.

Indications for Use

Indicated for daily wear in aphakic or non-aphakic persons with irregular corneal surfaces due to keratoconus or requiring keratoconus management in otherwise nondiseased eyes; also for correction of myopia, hyperopia, and astigmatism.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear (K980197)

Submission Summary (Full Text)

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510(k) Summary

| Company: | Specialty UltraVision, Inc.<br>307 Orchard City Drive, Suite 100<br>Campbell, CA 95008 |
|----------|----------------------------------------------------------------------------------------|
| Contact: | Garold L. Edwards, O.D., F.A.A.O.<br>Vice President. Technical Affairs |

Telephone: [phone] Fax: [phone]

Date Prepared: December 6, 1999

#### Device Name:

| Common Name: | Rigid Gas Permeable Contact Lens |
|--------------------------|-------------------------------------------------------------------------------|
| Trade/Proprietary Names: | EpiCon K (carbosilfocon A) Rigid Gas<br>Permeable Contact Lens for Daily Wear |

Classification Name: Rigid Gas Permeable Contact Lens

Device Classification: Class II (21 CFR 886.5916)

# Predicate Device:

The predicate device is the UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear, which was cleared under 510(k) K980197. This device was selected as the predicate device because it is manufactured from the same polymer, using similar lens designs, at the same manufacturing facility, under the same Quality System and using the same manufacturing equipment.

#### Description of Device:

.

The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is available as a hybrid lens design with spherical and aspherical curves on its surfaces. The lens material (carbosilfocon A) is composed of polymethyl methacrylate (PMMA) combined with a proprietary copolymer that contains silicone. D&C Green No. 6 is incorporated into the polymer, resulting in a blue handling tint. The EpiCon K Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:

- . Chord Diameter: 10.5 mm to 14.0 mm
- Center Thickness: 0.10 mm to 0.35 mm
- Base Curve:

6.0 to 8.5 mm

- Plano to-20.00 D
- Powers: . . Peripheral Curves: A. B. C. D. E. F and G

1323 44™ AVENUE N.E. CALGARY, ALBERTA CANADA T2E 6L5 TEL: [phone] FAX: [phone]

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# Comparison to Predicate Device

| PARAMETER | EpiCon K Rigid Gas<br>Permeable Contact Lens for<br>Daily Wear | UltraCon S Rigid Gas<br>Permeable Contact Lens for<br>Daily Wear |
|----------------------------|----------------------------------------------------------------|------------------------------------------------------------------|
| material | carbosilfocon A | carbosilfocon A |
| material<br>classification | Hydrophobic Lens Group 2 | Hydrophobic Lens Group 2 |
| indication for use | myopia, hyperopia and<br>astigmatism | myopia, hyperopia and<br>astigmatism |
| water content | 0.5% | 0.5% |
| light transmittance | 96.5% | 96.5% |
| Dk (35° C) | 52 x 10-11 | 52 x 10-11 |
| powers | Plano to -20.00 Diopters | +20.00 to -20.00 Diopters |
| color | blue visibility | blue visibility |
| specific gravity | 1.105 | 1.105 |
| refractive index | 1.49 at 20° | 1.49 at 20° |
| wetting angle | < 19° | < 19° |
| Method of<br>manufacture | Gel Flow Molding | Gel Flow Molding |

### Indications for Use:

The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.

# Description of Safety and Substantial Equivalence:

Biocompatibility, toxicology, physicochemical and leachability studies were previously performed on the carbosilfocon A polymer and cleared under K980197. Results of that testing indicate that the lens material is non-toxic and biocompatible.

# Clinical Testing:

A four week clinical evaluation of the EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear was performed at five investigational sites in accordance with current Good Clinical Practices and established regulations. The study assessed the clinical performance of the EpiCon K lens in subjects with bilateral keratoconus. Subjects were seen at an Initial Visit. which was a diagnostic fitting visit. Subjects were seen at a Dispensing Visit, and after 1, 2 and 4 weeks of lens wear. The EpiCon K lens was dispensed to 38 keratoconic subjects, and 18 subjects (47.4%) completed the 4 weeks of the study period while 20 subjects (52.6%) discontinued. Two adverse reactions were reported during the study period, both of which resolved without sequelae upon discontinuation of lens wear.

Based on the clinical data analysis, it was determined that the incidence of positive slit lamp findings, subject symptoms, problems and complaints, keratometry and refractive changes, visual acuity with the lens, lens wearing time and lens comfort were within the expected range for keratoconic eyes wearing RGP lenses.

Clinical performance of the EpiCon K lens was substantially equivalent to the clinical performance of the predicate lens.

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized human figure with three lines representing the head, body, and legs. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 2 2000 FEB

Gerald L. Edwards, O.D., F.A.A.O. Vice President, Technical Affairs Specialty UltraVision, Inc. 307 Orchard City Drive, Suite 100 Campbell, California 95008

Re: K992787

Trade Name: EpiCon K (Carbosilifocon A) Rigid Gas Permeable Contact Lens for Daily Wear (Keratoconus Design) Regulatory Class: Class II Product Code: 86HQD Dated: December 6, 1999 Received: December 7, 1999

Dear Dr. Edwards:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 verity such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Gerald L. Edwards, O.D., F.A.A.O.

· This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

・

ARalph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS STATEMENT

### Device Name:

EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear

### Indications for Use:

The EpiCon K (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear in aphakic or not-aphakic persons exhibiting the irregular corneal surface associated with keratoconus and/or requiring keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be disinfected using a chemical disinfecting system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use OR

Linda Dee Cohn, MD

510(k) Nur