COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS

K990264 · Metro Optics of Austin, Inc. · HQD · Mar 31, 1999 · Ophthalmic

Device Facts

• Record ID: K990264
• Device Name: COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS
• Applicant: Metro Optics of Austin, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Mar 31, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ComfortKone™ Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.

Device Story

ComfortKone is a lathe-cut, rigid gas permeable (RGP) contact lens fabricated from paflufocon C (fluorosilicone acrylate thermoset copolymer). Device functions as a refractive medium to focus light on the retina; design features a 4.0 mm spherical optic zone for the cone peak, transitioning to an aspheric fitting curve, and two junctionless peripheral aspheric curves for corneal alignment. Used by patients for daily wear to manage keratoconus and correct refractive errors. Prescribed by eye care professionals. Lens provides visual acuity and comfort through corneal alignment. Benefits include management of keratoconus-related refractive conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on material chemistry, physical property comparisons, and established safety profiles of similar RGP contact lenses.

Technological Characteristics

Material: paflufocon C (fluorosilicone acrylate). Form: Lathe-cut RGP contact lens. Oxygen permeability: 30 x 10^-11 (cm2/sec)(ml O2/ml x mmHg @ 35°C). Refractive index: 1.475. Hardness: 84 Shore D. Water content: <1%. Specific gravity: 1.14. Wetting angle: 12.8°. Pigments: D&C Green No. 6, Perox Yellow No. 9, D&C Violet No. 2 (per 21 CFR 74.3206, 73.3122, 74.3602).

Indications for Use

Indicated for daily wear in patients requiring keratoconus management with otherwise non-diseased eyes. Used for correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and non-aphakic persons.

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

• Rose K Lens (K945955)

Submission Summary (Full Text)

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3/31/99

# 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: | K990264 |
|--------------------------------|---------------------------|
| Applicant information: | |
| Date Prepared: | January 25th, 1999 |
| Name: | Metro Optics, Inc. |
| Address | 15802 Vision Drive |
| | Pflugerville, TX 78660 |
| | P.O. Box 14847 |
| | Austin, Texas 78761 |
| Contact Person: | Mr. Steve Webb |
| | Vice President |
| Phone Number: | [phone] |
| Fax: | [phone] |
| Official Correspondent: | Med-Vice Consulting, Inc. |
| Regulatory Consultant: | Mr. Martin Dalsing |
| | 623 Glacier Drive |
| | Grand Junction, CO 81503 |
| Phone Number: | [phone] |
| Fax Number: | (970) 243 -5501 |
| Device Information: | |

| Regulatory Classification: | Class II |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | HQD |
| Trade Name: | ComfortKone ^TM Keratoconus Aspheric (paflufocon C)<br>Rigid Gas Permeable (RGP) Daily Wear Contact Lens<br>(Clear and Tinted, Lathe-cut from Lens Blank) |
| Classification Name: | Lenses, Contact (other material), Daily Wear |

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## Equivalent Devices:

The Comfort Kone™ Keratoconus Aspheric (patiufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device:

Rose K Lens ર ! 0(k) # K945955 Manufactured under license by: 510(k) Author:

Lens Dynamics, Inc. Rose K International Limited

#### Device Description:

The Comfort Kone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens material (patfufocon C). The material is a thermoset copolymer derived from fluorosilicone acrylate When placed on the human cornea, the ComfortKone" Keratoconus Aspheric rigid gas monomer. permeable contact lenses act as a refracting medium to focus light rays upon the retina.

The ComfortKone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acury to the keratoconus patient. The ComfortKone" lens design begins with a spherical 4,0 mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then the aspheric curve, which is considered the fitting curve of the lens. The aspheric curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with two junctionless peripheral aspheric curves to maintain alignment.

The physical properties of the lens are

| Refractive Index | 1.475 (Nd at 25°C) |
|--------------------------------|-----------------------------------------------------------|
| Light Transmission (clear) | 93 % |
| Light Transmission (blue) | 91 % |
| Light Transmission (gray) | 91 % |
| Light Transmission (green) | 92 % |
| Wetting Angle (receding angle) | 12.8° |
| Specific Gravity | 1.14 |
| Hardness (shore D) | 84 |
| Water Content | < 1% |
| Color Pigment Names | D & C Green No. 6, Perox Yellow No. 9, D & C Violet No. 2 |
| | 21 CFR § 74.3206, § 73.3122, § 74.3602 |
| Oxygen Permeability | 30 X 10-11 (cm2/sec) (ml O 2/ml x mm Hg @ 35°C), |
| | revised Irving Fatt method. |

The Comfort Keratoconus Aspheric (patlufocon C) Rigid Gas Permesble (RGP) Daily Wear Contact Leas

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### Intended Use:

The Comforthone™ Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Leas Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.

### Substantial Equivalence:

The new device will be manufactured according to specified process controls and a Quality Management System certified to CGMP guidelines. The new device will undergo manufacturing, packaging and other process procedures similar to RGP devices currently marketed and distributed by Metro Optics, Inc. in the USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Rose K Lens (RGP), 510(k) #K945955. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, this 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.

The following matrix illustrates that the production method, lens function and material of the Comfort Kone™ Keratoconus Aspheric (patlufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens are substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, wetting angle and light transmission are as well substantially equivalent to the predicate device.

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# Metro Optics 510(k) Premarket Notification

# SUMMARY OF SAFETY AND EFFECTIVENESS Substantial Equivalence Matrix

,

:

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. T

1 - 1 - 1 - 1 - 1 -

| | Characteristic | ComfortKone<br>Keratoconus Aspheric | Predicate Device:<br>ROSE K LENS<br>Keratoconus Aspheric |
|-----|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION<br>METHOD | Lathe-Cut | Lathe-Cut |
| 2.) | LENS FUNCTION | Keratoconus management.<br>Refractive medium that focuses<br>light rays from near and distant<br>objects on the retina, while<br>compensating for refractive error,<br>including (astigmatism) | Keratoconus management.<br>Refractive medium that focuses<br>light rays from near and distant<br>objects on the retina, while<br>compensating for refractive error,<br>including (astigmatism) |
| 3.) | RGP MATERIAL | Rigid Gas Permeable (RGP)<br>Fluroperm 30 | Rigid Gas Permeable (RGP)<br>Boston ES |
| a. | Water Content | < 1% | < 1% |
| b. | Polymer | (paflufocon C) | (enflufocon A) |
| c. | Oxygen Permeability | 30 | 31 |
| d. | Refractive Index | 1.475 | 1.443 |
| e. | Specific Gravity | 1.14 | 1.22 |
| f. | Wetting Angle | 12.8 deg. | 52.0 deg. |
| g. | Light Transmission<br>(clear lens) | > 93 % | > 84 % |

The ComfortKone™ Keratocoms Aspheric (paflufocon C) Rigid Gas Permeable (RGP) Daily Wear Costact Lens

:

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are drawn with thick, curved lines. The image is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 1999

Mr. Martin Dalsing Official FDA Correspondent for Metro Optics, Inc. Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K990264

Trade Name: ComfortKone™, Keratoconus Aspheric (paflufocon C) Rigid Gas Permeable Contact Lens for Daily Wear (Clear and Tinted)

Regulatory Class: II Product Code: 86 HQD Dated: March 23, 1999 Received: March 26, 1999

Dear Mr. Dalsing:

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 -- Mr. Martin Dalsing

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,

. '

A Ralph 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 FOR USE STATEMENT

્રોંક

#### Device Name:

## Comforthonem Keratoconus Aspheric, (paflufocon C) Rigid Gas Permeable (RGP), Daily Wear Contact Leus (Clear and Tinted, Lathe-cut from Lens Blank)

# INDICATIONS FOR USE:

The Comforthone™ Keratoconus Aspheric (patlufocon C) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical disinfection system.

## (PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Or

Over-The-Counter Use

(Optional Format 1-2-96)

Smteeto

(Division Sign-Off) Division of Ophthalmic Devices

510(k) Number k 990264