COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT

{0}------------------------------------------------ ## 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. FEB 1 2 2003 The assigned 510(k) number is: KD24164 Applicant information: Date Prepared: February 4, 2003 Name: Address Metro Optics, Inc. 15802 Vision Drive Pflugerville, TX 78660 Contact Person: Phone Number: . Fax: Mr. Steve Webb Vice President (512) 251-2382 (512) 251-6554 | Official Correspondent: | Med-Vice Consulting, Inc. | |-------------------------|---------------------------| | Regulatory Consultant: | Ms. Deanna Werber | | | 623 Glacier Drive | | | Grand Junction, CO 81503 | | Phone Number: | (970) 243-5490 | | Fax Number: | (970) 243-5501 | ### Device Information: Regulatory Classification: Class II Product Code: HOD Trade Name: ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pernufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) Purpose for 510(k) Addition of three RGP materials to a previously cleared design and indication for use. (K990264) Classification Name: Lenses, Contact (other material), Daily Wear {1}------------------------------------------------ ### Equivalent Devices: The Comfort Keratoconus Aspheric (hybufocon A. filofocon A. pernufocon A) 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 manufacturer: Metro Optics of Austin, Inc. 1.) 15802 Vision Drive Pflugerville, TX 78660 510(k) 990264 Device name: ComfortKone™, Keratoconus, Daily Wear 510(k) #: K990264 Device Description: The ComfortKone" Keratoconus Aspheric Contact Lens is fabricated from the hydrophobic contact lens materials (hybufocon A, filotocon A, pemufocon A). When placed on the human cornea, the Comfort Keratoconus Aspheric rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina. The Comfort Kone" is a aspheric contact lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The ComfortKone™ lens design begins with a spherical 4.0 mm ontic zone that fits the peak of the cone and provides for good visual acuity. The lens then thattens into 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. design finishes with two junctioniess peripheral aspheric curves to maintain alignment. Metro Optics of Austin, Inc., has been granted referencing rights from the button manufacturers. The physical properties of the lenses can be referenced in the corresponding 510(k)'s. > Contamac HyBrid FS (hybufocon A) reference 510(k) K021977 Innovision Hydro2 (filofocon A) reference 510(k) K000485 Innovision Accucon (pemufocon A) reference 510(k) K944223 {2}------------------------------------------------ ### Intended Use: The Comfort Kone™ Keratoconus Aspheric (hybufocon A, filofocon A, persufocon A) Rigid Gas The Connortone - Romact Lens (Clear and Tinted, Lathe-cut from Lens Blank) is indicated for daily wear for persons requiring Keratocomus management with otherwise non-diseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in appakic and not-arbakic 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 OSR guidelines. The new device will undergo manufacturing, packaging and other bysich berther to QGP 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 Metro Optics, Inc. ComfortKone™, Keratoconus, Daily Wear SION #K990264. 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 Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens are substantially equivalent to the predicate device. In addition, the indication, intended use, production method, water content, polymer, Dk value, specific gravity, are as well substantially equivalent to the predicate device. {3}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS Substantial Equivalence Matrix . : 上一 . . 1. 1. 1. : : 上 11. 1 : 1 1 : 1 : 1 : : : . and the comments of : | | Characteristic | New Device<br>ComfortKone<br>Keratoconus Aspheric<br>(hybufocon A, filofocon A,<br>pemufocon A) | Predicate Device<br>ComfortKone<br>Keratoconus Aspheric<br>(paflufocon C) | |-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1.) | INDICATION | Daily wear, Rigid Gas Permeable<br>(RGP) contact lens | Daily wear, Rigid Gas Permeable<br>(RGP) contact lens | | 2.) | INTENDED USE | Daily wear for persons requiring<br>Keratoconus management. The lens<br>may be prescribed for the correction of<br>refractive ametropia (myopia, hyperopia,<br>and astigmatism) in aphakic and not<br>aphakic persons with non-diseased<br>eyes. | Daily wear for persons requiring<br>Keratoconus management. The lens<br>may be prescribed for the correction of<br>refractive ametropia (myopia, hyperopia,<br>and astigmatism) in aphakic and not<br>aphakic persons with non-diseased<br>eyes. | | 3.) | PRODUCTION<br>METHOD | Lathe-Cut | Lathe-Cut | | 4.) | RGP MATERIAL<br>common name | HyBrid FS<br>Hydro2<br>Accucon | Fluroperm 30 | | a. | Water Content | (hybufocon A) <1%<br>(filofocon A) < 1%<br>(pemufocon A) < 1% | < 1% | | b. | Polymer/USAN | HyBrid FS (hybufocon A)<br>Hydro2 (filofocon A)<br>Accucon (pemufocon A) | Fluroperm 30 (paflufocon C) | | c. | Specific Gravity | (hybufocon A) 1.18<br>(filofocon A) 1.14<br>(pemufocon A) 1.16 | (paflufocon C) 1.14 | | d. | Oxygen Permeability | (hybufocon A) = 23<br>(filofocon A) = 50<br>(pemufocon A) = 25 | 30 | | e. | Wetting Angle | (hybufocon A) = immeasurable *<br>(filofocon A) = <5 **<br>(pemufocon A) = <25 ** | 12.8 | | f. | Light Transmittance | (hybufocon A) = >93%<br>(filofocon A) = >93%<br>(pemufocon A) = >93% | >93% | | g. | Refractive Index | (hybufocon A) = 1.44<br>(filofocon A) = 1.45<br>(pemufocon A) = 1.45 | 1.47 | ** receding angle mathod in the course igle medioxi 11:11:11:1 : | . . . . . . . . . . . . . {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## FEB 1 2 2003 Metro Optics, Inc. c/o Ms. Deanna Werber MedVice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503 Re: K024164 ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Tinted, Lathe-cut from Lens Blank) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: December 9, 2002 Received: December 17, 2002 Dear Ms. Werber: 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. {5}------------------------------------------------ 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, A. halyi 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 {6}------------------------------------------------ # INDICATIONS FOR USE STATEMENT **Device Name:** Comfort Kone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (Clear and Timed, Lathe-cut from Lens Blank) ### INDICATIONS FOR USE: The ComfortKone™ Keratoconus Aspheric (hybufocon A, filofocon A, pemufocon A) 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 Prescription Use (Per 21 CFR 801.109) Concurrence of CDRH, Office of Device Evaluation (ODE) Of Over-The-Counter Use (Optional Format 1-2-96) Myra Smith (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number KO24169