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

{0}------------------------------------------------ ## 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. ## K013220 The assigned 510(k) number is: Applicant information: Date Prepared: September 19th, 2000 Name: Address Poly Vue Technologies, Inc. Seven Hazel Avenue Larkspur, CA 94939 Contact Person: Mr. Harold E. Johnson President/CEO (415) 945-9043 Phone number: USA Consultant: Phone number: Fax number: Email address: Med-Vice Consulting, Inc. Mr. Martin Dalsing (970) 243-5490 (970) 243-5501 mdalsing@FDApproval.com #### Device Information: Device Classification: Class II Classification Number: LPL Classification Name: Lenses, Soft Contact, Daily Wear Trade Name: #### HD/HDT, PV/PVT (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, fully cast-molded lens) {1}------------------------------------------------ # Poly Vue Technologies, Inc. 510(k) Premarket Notification #### Purpose of 510(k) Submission: #### NEW DEVICE ~ PolyVue Technologies, Inc. proposes to market and sell in United States interstate commerce, a fully Poly vie Technologies, Inc. proposes will and contact lens material. The device will be made cast-mondoe both vonuct configurations; 1) the High Definition (HD) aspheric lens, 2) the High available in Toric (HDT) aspheric toric lens, 3) the PolyVue (PV) multi-aspheric multifocal lens, and 4) the PolyVue Toric (PVT) multi-aspheric toric multifocal lens. Data supporting substantial equivalency the Poly de Toric (1 v 1 ) mail appliered safety & efficacy of the (polymacon) polymason) polymas is authorized through a letter granting Poly Vue Technologies, Inc. complete referencing rights to 510(k) K002099 from Bescon Co. Ltd. and is contained in this submission. #### Equivalent Devices: The HD/HDT, PV/PVT (polymacon) Soft Contact Lenses are substantially equivalent to the following predicate devices: #### Predicate devices: - "PolyVue" (polymacon) K982110, approval by Optech, Inc. . - "Poly Vue Silver Chord, Unisoft (methafilcon A) K980818, approval by Steven A. Dunn, Inc. ● - "Hydron Biomedics" (polymacon) P780007, approval by Ocular Sciences, Inc. . #### Device Description: The HD/HDT, PV/PVT (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 co-I his 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 timing pattern are subsequently processed to incorporate the 'listed' color additives and contain only the amount of color subsequently processed to morporate and noloring 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 sugary ocyone the minous coming a ace. 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 mannualios in a rany arguited warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. {2}------------------------------------------------ 510(k) Premarket Notification 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: | Refractive Index | 1.43 (hydrated) | |-----------------------------|-------------------------------------------------------------------------| | Light Transmission (clear) | greater than 90% | | Light Transmission (tinted) | greater than 90% | | Water Content | 38% ± 2% | | Oxygen Permeability | 8.4 X 10-11 (cm2/sec) (ml O2/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 visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn 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 correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The PV (polymacon) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyonic. The lens may be worn 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 PVT (polymacon) Multi-Aspheric Toric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted 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 cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. {3}------------------------------------------------ 510(k) Premarket Notification #### Pre-Clinical Performance Data: Poly Vue Technologies, Inc. has complete reference and privilege rights to K002099. Pre-clinical Poly vie Technologies, inc. has comprete the stremic injection test, and ocular eye intitation test performatice data addressing the Official of the spiron data for all relevant manufacturing information, including verification data can be referenced in the 510(k) # K002099. Concerning compatibility testing, the recommended lens care products (cleaning, insing and Concerning companibility testing, the recommended teas group. Therefore, no additional compatibility testing is included. With regard to preservative uptake and release studies, since the subject contact lens material With regard to preservative updake and release naturial, no additional studies need be conducted. #### Substantial Equivalence: The HD/HDT, PV/PVT Soft Contact Lens will be manufactured according to specified process controls The HD/HDT, FV/F V I SOIL Collact Lons will of mace and referenced in 510(k) K002099. The final all a CCIMI' quality assuration program can will be carried out in accordance with referenced PMA's & 100 passeguir 34, K983021, K973597, K970312, P830012 and P820051. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the I he established salety produced to the predicate devices identified previously. Being similar with respect to indications for use, target population, hydrophilic materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act the salety & Enectiveless to the productions and different questions of safety and effectiveness than the predicate device identified above. The following matrix illustrates the equivalencies between the HD/HDT, PV/PVT Soft Contact Lens and the substantial equivalent predicate devices. {4}------------------------------------------------ ## PolyVue Technologies, Inc. 510(k) Premarket Notification ### Substantial Equivalence Matrix | Substantial<br>Equivalency | HD/HDT, PV/PVT<br>'Subject Device' | Hydron Biomedics 38<br>'Predicate Device' | PolyVue<br>'Predicate Device' | PolyVue Silver Chord<br>'Predicate Device' | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacture | PolyVue Technologies | Ocular Sciences, Inc. | 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/or are presbyopic. | Soft Contact lenses for daily<br>wear are indicated for the<br>correction of refractive<br>ametropia (myopia, hyperopia<br>and astigmatism) in aphakic<br>and not aphakic persons with<br>non-diseased eyes that may<br>exhibit refractive and/or corneal<br>astigmatism up to 2.50 diopters | Soft Contact lenses for daily<br>wear are indicated for the<br>correction of refractive<br>ametropia (myopia and<br>hyperopia), presbyopia and<br>astigmatism 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 astigmatism 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 | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wings and body. The eagle is enclosed within a circular border, and the text "HEALTH & HUMAN SERVICES - USA" is written around the border of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 0 2001 Poly Vue Technologies, Inc. c/o Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503 Re: K013220 Trade/Device Name: HD/HDT, PV/PVT (polymacon) Soft Contact Lens for Daily Wear (clear and tinted, fully cast-molded lens) Regulation Number: 21 CFR 886.5925 Regulation Name: Lenses, Soft Contact, Daily Wear Regulatory Class: Class II Product Code: LPL Dated: September 19, 2001 Received: September 26, 2001 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. {6}------------------------------------------------ #### Page 2 - Martin Dalsing 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. 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 {7}------------------------------------------------ KD13220 NOV 2 0 2001 Poly Vue Technologies, Inc. 510(k) Premarket Notification ## INDICATIONS FOR USE STATEMENT #### HD/HDT, PV/PVT (polymacon) Soft Contact Lens for Daily Wear (clear Device Name: and tinted, fully cast-molded lens) #### INDICATIONS FOR USE: The HD (polymacon) Aspheric Soft Contact Lenses for daily wear are indicated for the correction of I he too (porymacon) / rsplace to bakic persons with non-diseased eyes with myopia or hyperopia. The visual actury in updated and not appearly 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 (polymatore) In not aplakic persons with non-diseased eyes with myopia or hyperopia contection of visual douty in not apians persoeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. The PV (polymacon) Multi-Aspheric Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn 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 PVT (polymacon) Multi-Aspheric Toric Multifocal Soft Contact Lenses for daily wear are THE I T I (poryancour) in and acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive astigmatism not exceeding 5.00 diopters and are presbyopic. The lens or arpections possesses a 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 cleaning disinfection and scheduled replacement. When prescribed 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) | | <i>Vanul W. C. Brown, Ph.D.</i> | |--------------------------------|---------------------------------| | (Division Sign-Off) | | | Division of Ophthalmic Devices | | | 510(k) Number | K013220 | | Prescription Use | x | or | Over-The-Counter Use __ | |----------------------|---|----|-------------------------| | (Per 21 CFR 801.109) | | | | (Optional Format 1-2-96)