HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS)

{0}------------------------------------------------ ## MAY 1 6 2002 # 510 (k) 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: K020608 Applicant information: | Date Prepared: | February 19, 2002 | |-----------------|------------------------------------------------| | Name: | PolyVue Technologies, Inc. | | Address | Seven Hazel Avenue<br>Larkspur, CA 94939 | | Contact Person: | Mr. Harold E. Johnson<br>President/CEO | | Phone number: | (415) 945-9043 | | USA Consultant: | Med-Vice Consulting, Inc.<br>Ms. Deanna Werber | | Phone number: | (970) 243-5490 | | Fax number: | (970) 243-5501 | | Email address: | dwerber@FDApproval.com | Device Information: | Device Classification: | Class II | |------------------------|----------------------------------------------------------------------------------------------------| | Classification Number: | LPL | | Classification Name: | Lenses, Soft Contact, Daily Wear | | Trade Name: | HD/HDT, (polymacon) Soft Contact Lens for Daily Wear<br>(clear and tinted, fully cast-molded lens) | {1}------------------------------------------------ ### Purpose of 510(k) Submission: ### NEW INDICATION ~ A new indication of "early presbyopia" up to 1.25 diopters is being added to the previously cleared HD/HDT, (polymacon) Soft Contact Lens for Daily Wear reference K013220. ### Equivalent Devices: The HD/HDT, (polymacon) Soft Contact Lenses are substantially equivalent to the following predicate devices: #### Predicate devices: - "HD/HDT" (polymacon) K013220, approval by Poly Vue Technologies, Inc. . - "PolyVue" (polymacon) K982110, approval by Optech, Inc. . - "PolyVue" Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. . ### Device Description: The HD/HDT, (polymacon) Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution. The lenses are available clear or tinted. Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color additive needed to accomplish the intended coloring effect. Lenses are tinted with one or a combination of one or more of the following pigments, 'listed' color additives. Phthalocyanine blue (21 CFR § 74.3045), Phthalocyanine green (21 CFR § 73.3124) and Titanium dioxide (21 CFR § 73.3126) In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are: 1.445 (hydrated) Refractive Index greater than 90% Light Transmission (clear) Light Transmission (tinted) greater than 90% {2}------------------------------------------------ Water Content Oxygen Permeability 38 % ± 2% 8.4 X 10-1 (cm /sec) (ml O /ml x mm Hg @ 35 C), (revised Fatt method). ### Intended Use: The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of ITIC \porymated.h} I spiritorio is with non-diseased eyes with myopia or hyperopia and early visual actiry in not apinatio persons who new by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the The IID I (polymaton) Issphoric roskic persons with non-diseased eyes with myopia or hyperopia, contection of visual would in not exceeding 5.00 diopters and early presbyopia up to 1.25 diopters. The lens is available clear or timed and may be used to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with Dyour prociment may prescribed replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. #### Pre-Clinical Performance Data: Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test can be referenced in the 510(k) # K013220. In addition, data for all relevant manufacturing information, including verification data can be referenced in the 510(k) # K013220. Concerning compatibility testing, the recommended lens care products (cleaning, rinsing and disinfection) have been approved for use with lens of the same lens group. Therefore, no additional compatibility testing is included. With regard to preservative uptake and release studies, since the subject contact lens material (polymacon) is not a new and/or modified lens material, no additional studies need be conducted. {3}------------------------------------------------ ### Substantial Equivalence: The HD/HDT, Soft Contact Lens will be manufactured according to specified process controls and a The more box , box of arogram currently in place and referenced in 510(k) K002099. Reference K013220 for he final lens packaging and sterilization of the lenses. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the THE ESTADISICU Salery promo (pro onlined to the previously. Being similar with respect to indications for use, target population, hydrophilic materials, physical construction and safety & to mucations for use, target population, areas 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 the equivalencies between the HD/HDT, Soft Contact Lens and the substantial equivalent predicate devices. | Substantial<br>Equivalency | HD/HDT<br>'Subject Device' | HD/HDT,<br>'Predicate Device' | Poly Vue<br>'Predicate Device' | Poly Vue Silver Chord<br>'Predicate Device' | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacture | Poly Vue Technologies | Poly Vue Technologies | Optech, Inc. | Steven A. Dunn, Inc. | | INDICATION | Soft Contact Lenses for daily<br>wear are indicated for the<br>correction of visual acuity in<br>aphakic and not aphakic<br>persons with non-diseased eyes<br>with myopia or hyperopia<br>and/or possesses refractive<br>astigmatism not exceeding 5.00<br>diopters, and early presbyopia<br>up to 1.25 diopters. | Soft Contact Lenses for daily<br>wear are indicated for the<br>correction of visual acuity in<br>aphakic and not aphakic<br>persons with non-diseased eyes<br>with myopia or hyperopia<br>and/or possesses refractive<br>astigmatism not exceeding 5.00<br>diopters, and/or are presbyopic. | Soft Contact lenses for daily<br>wear are indicated for the<br>correction of refractive<br>ametropia (myopia and<br>hyperopia), presbyopia and<br>astisgmatism in aphakic and not<br>aphakic persons with non-<br>diseased eyes. | Soft Contact lenses for daily<br>wear are indicated for the<br>correction of refractive<br>ametropia (myopia and<br>hyperopia), and astisgmatism in<br>aphakic and not aphakic<br>persons with non-diseased eyes. | | INTENDED<br>USE | Daily Wear, Soft<br>(hydrophilic) Contact<br>Lens | Daily Wear, Soft<br>(hydrophilic) Contact<br>Lens | Daily Wear, Soft<br>(hydrophilic) Contact<br>Lens | Daily Wear, Soft<br>(hydrophilic) Contact<br>Lens | | Manufacturing<br>Method | Fully-molded | Fully-molded | Lathe-cut<br>(Semi-Mold) | Lathe-cut<br>(Semi-Mold) | | USAN name<br>Material name | polymacon | polymacon | polymacon | methafilcon A | | Water Content<br>(%) | 38.0% | 38.0% | 38.0% | 55.0% | | Toxicity<br>(safety) | Non-Toxic | Non-Toxic | Non-Toxic | Non-Toxic | ### Substantial Equivalence Matrix {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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a body. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY 1 6 2002 Poly Vue Technologies, Inc. c/o Deanna Werber Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503 Re: K020608 Trade/Device Name: HD/HDT, (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, fully cast-molded lens) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: February 19, 2002 Received: February 25, 2002 #### Dear Ms. Werber: 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}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to oegill inding of substantial equivalence of your device to a legally promatication. "The PDF interior 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF F F ar 3613. Additionally, for questions on the promotion and advertising of Compliance at (301) 591 - 1010 - 12 - 101 - 12 - 101 - 10 - 4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general 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. Ralph 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 {6}------------------------------------------------ # INDICATIONS FOR USE STATEMENT HD/HDT, (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, Device Name: fully cast-molded lens) ### INDICATIONS FOR USE: The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of The IID (porymacon) I sopherrous with non-diseased eyes with myopia or hyperopia and early visual active in not apliance persons who note by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The HDT (polymacon) Aspheric Toric Soft Contact Lenses for daily wear are indicated for the The MD I (porymacom) in not aphakic persons with non-diseased eyes with myopia or hyperopia, Concellon of visual actity in hot uphane peing 5.00 diopters and early presbyopia up to 1.25 diopters. possesses it cractive astiginatism not oneoouhs very to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with Eyecan oplaintoners may problish raily of any of except bed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. (PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel W. C. Brown, PHD (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number K020608 Prescription Use ✗ (Per 21 CFR 801.109) or (Optional Format 1-2-96) Over-The-Counter Use *_*_