POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR

{0}------------------------------------------------ NOV 6 1998 # 510 (K) Summary ## SUBMITTER: #### Submitted on behalf of: | Company Name: | Optech, Inc. | |---------------|----------------------------------------------------| | Address: | 6341 South Troy Circle<br>Englewood, CO 80111-6415 | Phone! Fox: 303 708-1390 303 708-1392 #### CONTACT PERSON: Jarnes A. Brooks #### DATE SUMMARY PREPARED: June 10, 1998 7 : 0 : 0 : 0000000 TRADE NAME: The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and - i ------------------------------------------------------------------------------------------------------------visibility tinted) ### COMMON NAME: contact lens ### SUBSTANTIALLY EQUIVALENT TO: -- ------ The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophlic Contact Lenses for Dally Wear (clear and visibility tinted) is equivalent to Specially UltraVision's Specialty T (ocufilcon A) Toric Hydrophlic Contact lens for daily wear as currently marketed in the U.S. The PolyVue 43™ (ocurilcon A) Spherical, Toric and Aspherical Multifocal l lydrophille Contact Lenses for Dally Wear (clear and visibility tinted) are substantlally equivalent to Specialty UltraVision's Specialty T (ocufilcon A) Toric lens. PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lens (clear and visibility tinted) is the same lens " material that received marketing clearance pursuant to K963764 for Specialty UltraVision, Inc. This lens conforms to and Is substantially equivalent to spherical, aspherical, presbyopic and astigmatic lens designs that are currently marketed in the United States. The intended use and target population are substantlally equivalent. This lens is in Group 'J lonic, low water content polymers as established by the FDA and located in the Guldance Document for Dally Wear Contact Lenses, {1}------------------------------------------------ Revised Edition May 1994. The physical, optical and chemical propertles of the PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and visibility tinted) and the Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Dally Wear are substantially equivalent. | PARAMETER | | PolyVue 43™ | Specialty T Toric | | |---------------------|--|--------------------------------------------------|-----------------------------------|--| | material | | ocufilcon A | ocufilcon A | | | indication for use | | myopia, hyperopia, presbyopia<br>and astigmatism | myopia, hyperopia and astigmatism | | | water content | | 43% | 44.1% | | | light transmittance | | 98.513 | 98.493 | | | Dk (35°C) | | $11.340 X 10^{-11}$ | $11.267 X 10^{-11}$ | | | modulus | | 36.50 g/mm² | 35.96 g/mm² | | | tensile strength | | 34.68 g/mm² | 33.98 g/mm² | | | elongation @ break | | 169.26 % | 165.27% | | | toughness | | 31.9668 g/mm² | 31.8488 g/mm² | | | color | | clear and visibility tinted | clear | | | refractive index | | 1.427 | 1.427 | | | Powers | | -20.00 TO +20.00 d | -20.00 to +20.00 D | | ## SIMILARITIES and DIFFERENCES: #### DESCRIPTION of the DEVICE: Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and methacrylic acid crosslinked with EGDMA, which yield the appearance of lenses, which are designed to fit over the corneal surface of the eyc. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refi action of functional conditions of the eye including myopla (nearsightedness), hyperopia (farsightedness), presbyopia and astigmatism (multiple foci). Each lens provides corrective power, which is to correspond to the refractive power of the eye to which It Is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Spherical and aspheric curves as well as beveled edge configurations are built into the lens for alding in lens centration and comfort as well as providing additional add power for near and blocking spherical aberration. #### PERFORMANCE Optech, Inc. has carried out a complete performance evaluation of the PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact {2}------------------------------------------------ Lenses for Daily Wear (clear and visibility tinted). This assessment addressed the following issues: - Cytotoxicity Tast 1. - SystemIc Injection I est 2. - 3. Eye Irritation Test - 4. Compatibility tasting - ഗ് Preservative Uptake and Release - Leachability of color additives and residual monomers 6. These studies demonstrate that the material Is non toxic, compatible with standard lens care regimens and that the residual monomers and color additive leachability is within acceptable limits. Concerning compatibility testing, the recommended lens care products (cleaning, rinsing and disinfection) have been approved for use with lenses of the same lens group. Therefore, no additional compatibility testing is Included. with regard to preservalive uptake and release studies, since the subject contact lens has the same surface electric charge as the predicate device (same material being used) no additional studies need be conducted. We have also included in this submission the results of 10 multifocal lenses, manufactured to variely of prescribed specifications to verify ablity of the manufacturer to make these lenses. ## INDICATIONS FOR USE: Device Name: PolyVue 43™ (ocufiicon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lous (clear and visibility tinted) The Polyvue 43m (ocutiicon A) Spherical, Toric and Aspherical Multifocal Hydrophlic Contact Lens (clear and visibility tinted) Is Indicated for dally wear for the correction of refractive ametropia (myopla and hyperopia), presbyopia and astigmatism In aphakic and non-aphakic persons with non-diseased eyes. Lyecare practitioners may prescribe the lens for dally wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems. {3}------------------------------------------------ ## PARAMETERS AVAILABLE: ## PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophlic Contact Lens (clear and visibility tinted) ・ ### Spherical and Aspherical Multifocal Powers: Center Thickness: Diameter: Bose Curve: Cylinder Powers: Axis: +20.00 to -20.00D 0.03 το 0.40mm 14.0, 14.5mm 8.3 to 8.6mm N/A N/A Toric +20.00 to -20.00D 0.101 to 0.520mm 14.0, 14.5, 15.0mm 8.0 to 9.3mm -0.50 to -16.00 in 0.25 D steps 10 to 1800 in 10 sleps #### For the Multifocal Design Add Powers: Continuous adds to 3.25 D {4}------------------------------------------------ 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 an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 1998 6 NOV James A. Brooks 6341 S. Troy Circle Unit E Englewood, CO 80111-6415 Re: K982110/S1 Trade Name: Poly Vue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Daily Wear (clear and visibility tinted, lathe cut from molded buttons) Regulatory Class: II Product Code: 86LPL Dated: August 25, 1998 Received: August 27, 1998 Dear Mr. Brooks: 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. {5}------------------------------------------------ Page 2 - Mr. James A. Brooks 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 {6}------------------------------------------------ # INDICATIONS STATEMENT #### Device Name: PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophilic Contact Lenses for Dally Wear (clear and visibility tinted) The PolyVue 43™ (ocufilcon A) Spherical, Toric and Aspherical Multifocal Hydrophlilic Contact Lens (clear and visibility tinted) is indicated for daily wear for the correctlon of refractive ametropia (myopia and hyperopia), presbyopla and astigmatism in aphakic and non-aphakic persons with non-diseased eyes. Eyecare practitioners may prescribe the lens for daily wear In a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | <u>Ming-chuen Shut</u><br>(Division Sign-Off)<br>Division of Ophthalmic Devices | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prescription Use | <div style="display:inline-block; vertical-align:middle;"> <img height="5" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/w+r8+KXEy8vLgYmJicEA4v8AAQ1OBN52kHQAAAAASUVORK5CYII=" width="5"/> </div> | | or Over-The-Counter Use | 510(k) Number <u>K982110</u> | (Optional Format 1-2-9G)