SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)

{0}------------------------------------------------ JUL - 7 1999 K984090 Image /page/0/Picture/2 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 logo. Below the rectangle, the word "ULTRAVISION" is written in large, bold, black letters. The letters "INC." are written in smaller, black letters in the bottom right corner of the logo. 510(k) Summarv # Submitter Information: Specialty UltraVision, Inc. 307 Orchard City Drive, Suite 100 Campbell, CA 95008 | Contact Person: | Ivalee Cohen | |-----------------|-------------------------------------------| | | Director, Regulatory and Clinical Affairs | | Telephone: | (408) 341-0700 | |------------|----------------| | Fax: | (408) 341-0717 | May 24, 1999 Date Prepared: ## Device Name: | Common Name: | Soft (Hydrophilic) Contact Lens | |--------------------------|----------------------------------------------------------------------------------------------| | Trade/Proprietary Names: | Specialty 55 Multifocal (methafilcon A) Soft<br>(Hydrophilic) Contact Lens for Daily Wear | | | Specialty 55 (methafilcon A) Soft (Hydrophilic) Single<br>Vision Contact Lens for Daily Wear | | Classification Name: | Soft (Hydrophilic) Contact Lens | | Device Classification: | Class II (21 CFR 886.5925) | ## Description of Devices: The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is available as a single vision lens. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethy) methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and the Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear are tinted using Vat Blue #6 in an entrapment tinting process during polymerization of the lens. 307 ORCHARD CITY DRIV CAMPBELL, CA 95008 TEL: 888-29-ULTRA 408-341-0700 FAX: 408-341-0717 323 44™ AVENUE N.E. LGARY, ALBERTA ANADA T2E 6LS TEL: 800-668-9251 403-291-1919 403-291-6477 {1}------------------------------------------------ #### Predicate Devices: The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens and the Specialty Choice AB (methafilcon A) Soft Single Vision Contact Lens, and the IGEL 56 (hefilcon C) Soft (hydrophilic) Contact Lens were selected as the predicate devices. The Specialty Choice AB and Specialty Progressive lenses were cleared under 510(k) K963488, and are manufactured by a molding process that uses the methafilcon A polymer and the same lens designs as the Specialty 55 lenses. The dye tinting process is different, the lenses are tinted with Reactive Blue #4 after lens hydration using a wet lens tinting process, where the Specialty 55 lenses are in-monomer tinted. The IGEL 56 lenses were cleared under 510(k) K974837, and were selected as predicate devices because, although they are molded from a different polymer, and tinted with a different dye, they are produced in the same facility, under the same quality system, using the same molding, in-monomer tinting, packaging and sterilization processes as the Specialty 55 lenses. | PARAMETER | Specialty 55<br>Multifocal and<br>Specialty 55 Soft<br>(Hydrophilic)<br>Contact Lenses for<br>Daily Wear | Progressive<br>Multifocal and<br>Choice AB Soft<br>(Hydrophilic)<br>Contact Lenses for<br>Daily Wear | IGEL 56 Soft<br>(hydrophilic) Contact<br>Lenses for Daily<br>Wear | |----------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | material | methafilcon A | methafilcon A | hefilcon C | | material<br>classification | Hydrophilic Lens<br>Group 4 | Hydrophilic Lens<br>Group 4 | Hydrophilic Lens<br>Group 2 | | indication for<br>use | myopia, hyperopia,<br>and presbyopia | myopia, hyperopia,<br>and presbyopia | myopia, hyperopia and<br>astigmatism | | water content | 55% | 55% | 56% | | light<br>transmittance | 98% | 90 to 97%,<br>dependent upon tint | 90 to 94% | | | Dk (35° C) | $18.8 x 10^{-11}$ | $19.7 x 10^{-11}$ | | powers | +20.00 to -20.00<br>Diopters | +20.00 to -20.00<br>Diopters | +6.00 to -12.00<br>Diopters | | | color | blue visibility | blue visibility | | refractive index | 1.42 | 1.41 | 1.41 | | specific gravity | 1.06 | 1.09 | 1.16 | | Method of<br>manufacture | Molded | Molded | Molded | | | Tint | Vat Blue #6 | Reactive Blue #4 | | Tint process | Entrapment process<br>during polymerization | Wet lens tinting<br>process | Entrapment process<br>during polymerization | ## Comparison to Predicate Device {2}------------------------------------------------ ## Indications for Use: The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual i acuity. The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Evecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems. ### Description of Safety and Substantial Equivalence: A series of preclinical tests were performed to demonstrate the safety and effectiveness of the Specialty 55 Multifocal and Specialty 55 (methafilcon A) Single Vision Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices. Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. A Solution Compatibility test, using chemical and hydrogen peroxide regimens showed Specialty 55 lenses to be compatible with both regimens. Specialty 55 lenses were extracted and evaluated for presence of the Vat Blue #6 dye. Results show no detectable leachability of the dye. Physicochemical testing of the Specialty 55 lenses determined equivalency to the predicate devices. #### Conclusion: Information submitted in the 510(k) establishes that the Specialty 55 Multifocal and Specialty 55 Single Vision Contact Lenses (methafilcon A) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Therefore, the devices are substantially equivalent to the predicate devices. {3}------------------------------------------------ Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three wavy lines extending from the head, resembling hair or a flowing garment. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 7 1999 Ms. Ivalee I. Cohen Director, Regulatory and Clinical Affairs Specialty UltraVision, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008 Re: K984090 Trade Name: Specialty 55 Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (blue visibility tinted); Specialty 55 (methalfilcon A) Soft (hydrophilic) Single Vision Contact Lens for Daily Wear (blue visibility tinted) Regulatory Class: II Product Code: 86 LPL Dated: May 25, 1999 Received: May 27, 1999 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 . {4}------------------------------------------------ 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 (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {5}------------------------------------------------ #### INDICATIONS STATEMENT #### Device Names: Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear and Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear #### Indications for Use: The Specialty 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Specialty 55 (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The lenses may be disinfected using a chemical or hydrogen peroxide disinfection system. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfection systems. Myra Smith (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K984090 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use