ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR

K980197 · Specialty Ultravision, Inc. · HQD · Aug 4, 1998 · Ophthalmic

Device Facts

• Record ID: K980197
• Device Name: ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
• Applicant: Specialty Ultravision, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Aug 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lenses may be disinfected using a chemical disinfection system.

Device Story

UltraCon and UltraCon S are rigid gas permeable (RGP) contact lenses; hemispherical shells composed of carbosilfocon A (PMMA and silicone-containing copolymer). Lenses correct refractive ametropia (myopia, hyperopia, astigmatism). UltraCon S features larger diameter for limbal coverage. Lenses are worn daily; disinfected via chemical systems. Prescribed by eye care professionals for patients with non-diseased eyes. Material provides oxygen permeability (Dk 44) and blue handling tint (D&C Green No. 6). Clinical benefit includes vision correction with gas-permeable material properties.

Clinical Evidence

Three-month clinical evaluation conducted at six sites. Study assessed safety and effectiveness of UltraCon S compared to the predicate lens. Results demonstrated substantial equivalence in safety and efficacy. Non-clinical testing included in vitro and in vivo toxicology, biocompatibility, and physicochemical/leachability testing per 21 CFR Part 58 GLP regulations, confirming non-toxic, non-irritating material properties.

Technological Characteristics

Material: carbosilfocon A (PMMA/silicone copolymer). Hydrophobic Group 2. Dk: 44 x 10^-11 (cm²/sec)(ml O₂/ml x mmHg) at 35°C. Refractive index: 1.57. Water content: 0.5%. Manufacturing: Gel flow molding. Dimensions: Chord diameter 8.5-14.0 mm; center thickness 0.10-0.28 mm; base curve 7.0-8.5 mm. Powers: +12.00 D to -20.00 D. Tint: D&C Green No. 6.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism (up to 4.00 diopters) in non-aphakic patients with non-diseased eyes.

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

• LifeStyle GP (telefocon B) Rigid Gas Permeable Contact Lens for Daily Wear (K963010)

Submission Summary (Full Text)

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AUG 4 1998

Image /page/0/Picture/1 description: The image shows the logo for Ultravision Inc. The word "SPECIALTY" is written in white letters on a black rectangle at the top of the image. Below that, the word "ULTRAVISION" is written in large, bold, black letters, with the letters "INC." in smaller letters below and to the right.

D

K980197

# 510(k) Summary

### Submitter Information:

| Company: | Specialty UltraVision, Inc.<br>307 Orchard City Drive, Suite 100<br>Campbell, CA 95008 | | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Ivalee Cohen<br>Director, Regulatory and Clinical Affairs | | |
| Telephone: | [phone] | | |
| Fax: | [phone] | | |
| Date Prepared: | January 16, 1998 | | |
| Device Name: | | | |
| Common Name: | Rigid Gas Permeable Contact Lens | | |
| Trade/Proprietary Names: | UltraCon (carbosilfocon A) Rigid Gas<br>Permeable Contact Lens for Daily Wear<br>and<br>UltraCon S (carbosilfocon A) Rigid Gas<br>Permeable Contact Lens for Daily Wear | | |
| Classification Name: | Rigid Gas Permeable Contact Lens | | |

Device Classification:

## Predicate Device:

The predicate device is the LifeStyle GP (telefocon B) Rigid Gas Permeable Contact Lens for Daily Wear, which was cleared under 510(k) K963010. This device was selected as the predicate device because of its similarities in intended use (daily wear), Dk value, and material type (FDA Group II: containing silicone but not fluorine).

Class II (21 CFR 886.5916)

## Description of Devices:

# 1. UltraCon (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear

The UltraCon (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

FEL: 888-29-ULTR. 408-341-0717

800-668-925 403-291-1919 403-291-547

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The UltraCon Rigid Gas Permeable Contact Lens for Daily handling tint. Wear is a hemispherical shell of the following dimensions:

- Chord Diameter: 8.5 to 10,5 mm .
- 0.10 mm to 0.28 mm Center Thickness: .
- 7.0 to 8.5 mm Base Curve: .
- +12.00 D to-20.00 D Powers: .

The physical/optical properties of the lens are:

- Specific Gravity 1.105 .
- 1.57 at 20°C Refractive Index: .
- 98.5% Light Transmittance: .
- Hydrophobic Surface Character: .
- 0.5% Water Content: .
- 19° (CLMA method) Wetting Angle: .
- Oxygen Permeability (Dk) :: 44 x 10-11 (cm2/sec) (ml O2 /ml x mm Hg) .

at 35°C

*[Fatt method used for determination of oxygen permeability]

## 2. UltraCon S (carbosifiocon A) Rigid Gas Permeable Contact Lens for Daily Wear

The UltraCon S (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 diameter of the lens is larger than conventional rigid gas permeable lenses, and the UltraCon S lens extends beyond the cornea and onto the limbal region. 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 UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear is a hemispherical shell of the following dimensions:

| • | Chord Diameter: | 12.0 mm to 14.0 mm |
|---|--------------------|---------------------|
| • | Center Thickness: | 0.10 mm to 0.28 mm |
| • | Base Curve: | 7.0 to 8.5 mm |
| • | Powers: | +12.00 D to-20.00 D |
| • | Peripheral Curves: | C, D, and E |

The physical/optical properties of the lens are:

| • Specific Gravity | 1.105 |
|------------------------------|-----------------------------------------------------|
| • Refractive Index: | 1.57 at 20°C |
| • Light Transmittance: | 96.5% |
| • Surface Character: | Hydrophobic |
| • Water Content: | 0.5% |
| • Wetting Angle: | 19° (CLMA method) |
| • Oxygen Permeability (Dk)*: | 44 x 10-11 (cm²/sec) (ml O₂ /ml x mm Hg)<br>at 35°C |

*[Fatt method used for determination of oxygen permeability]

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## Comparison to Predicate Device

| PARAMETER | UltraCon and UltraCon S<br>Rigid Gas Permeable<br>Contact Lens for Daily<br>Wear | LifeStyle Gp Rigid Gas<br>Permeable Contact Lens<br>for Daily Wear (K963010) |
|----------------------------|----------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| material | carbosilfocon A | telefocon B |
| 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% | less than 0.5% |
| light transmittance | 96.5% | 96% |
| Dk (35° C) | 44 x 10-11 | 43.5 x 10-11 |
| powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| color | blue visibility | blue, green, brown and gray |
| specific gravity | 1.105 | 1.126 |
| refractive index | 1.57 at 20° | 1.480 at 20° C |
| wetting angle | < 19° | < 30° |
| Method of<br>manufacture | Gel Flow Molding | Lathe cut |

## Indications for Use:

The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lens may be disinfected using a chemical disinfection system.

### Description of Safety and Substantial Equivalence:

A series of non-clinical tests and a clinical study were performed to demoristrate the safety and effectiveness of the UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear, and to establish substantial equivalence to the predicate lens. All testing was conducted in accordance with the May, 1994 FDA quideline titled Premarket Notification 510(k) Guidance Document for Class II Contact Lenses and in conformance to applicable device regulations. Results demonstrate the lens is non-toxic and biocompatible, and has material characteristics comparable to or better than other currently marketed RGP lenses. Clinically, the lens has performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the substantial equivalence to the predicate lens.

#### Non-Clinical Testing:

In vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety of the device. All tests were conducted in accordance with 21 CFR Part 58. GLP requlations. Physicochemical and leachability testing was performed to establish device characteristics.

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Results of the testing demonstrate that the lens material and extracts are not toxic and non irritating, and that the lens physical and material properties are consistent with marketed contact lenses.

## Clinical Testing:

A three month clinical evaluation of the UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear was performed at six investigational sites in accordance with current Good Clinical Practices and established regulations. The study assessed the safety and effectiveness of the lens, and compared its clinical performance to the predicate lens.

Performance of the UltraCon S lens was substantially equivalent to performance of the predicate lens with respect to safety and efficacy.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 1998

Ms. Ivalee I. Cohen Director, Regulatory and Clinical Affairs Specialty ULTRAVISION, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008

Re: K980197

Trade Name: UltraCon and UltraCon S (Carbosilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear (Sperical and Aspheric) Visibility tinted with D & C Green No. 6 Regulatory Class: II Product Code: 86 HQD Dated: June 5, 1998 Received: June 8, 1998

Dear Ms. Cohen:

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 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 verify 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 - Ms. Ivalee I. Cohen

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:

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

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

#### Indications for Use:

The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lenses 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 | <span style="text-decoration: overline;">✓</span> | OR | Over-the-Counter Use | |
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| | <div style="text-decoration: overline;">E.Y.C.</div> <div>(Division Sign-Off)</div> <div>Division of Ophthalmic Devices</div> | |
|---------------|-------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Number | K980197 | |

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