HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS

{0}------------------------------------------------ # JUL 1 8 2003 510(K) PREMARKET NOTIFICATION SUMMARY | Reference | OSLA60 | |-----------|--------| | Section | 3 | | Version | 1 | | Page | 1 / 5 | (ocufilcon F) soft (hydrophilic) contact lens SECTION 3: ## 510(K) SUMMARY ## APPLICANT'S NAME AND ADDRESS Ocular Sciences Inc. 1855 Gateway Blvd. Suite 700 Concord, CA 94520 USA Richard Lippman, OD FAAO Vice President Ophthalmic Regulatory Medical Products R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road Suite 30 Rockville, Maryland 20850 Telephone: (240) 683-3738 (240)683-9236 Fax: ## 1. IDENTIFICATION OF DEVICE Common Name: Trade Name: Contact Person Classification: Device classification: Hydrophilic Soft Contact Lens HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens Daily Wear Soft (hydrophilic) Contact Lens Class II (21 CFR 886.5925) #### 2. DESCRIPTION OF DEVICE HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based): - +10.00 D to -10.00 D Asphere - with center thickness from 0.025mm to 0.40mm - . with base curves of 8.00mm to 9.20mm - . with diameter of 12.00mm to 18.00mm The lens material for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same as the Biomedics® 60 UV (ocufileon F) lens in spherical design as described in submission K992264 cleared on November 24, 1999. The aspheric lens design for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same design construct as the BIOMEDICS® UV ASPHERE (ocufilcon D) as cleared in K020193 on February 28, 2002. The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This front optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range. {1}------------------------------------------------ | <b>Ocular Sciences</b> | <b>510(K) PREMARKET NOTIFICATION</b> | Reference : OSLA60 | | | | | | | |-----------------------------------------------|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|-----|---------|-----|------|---------| | (ocufilcon F) soft (hydrophilic) contact lens | SUMMARY | <table><tr><td>Section</td><td>: 3</td></tr><tr><td>Version</td><td>: 1</td></tr><tr><td>Page</td><td>: 2 / 5</td></tr></table> | Section | : 3 | Version | : 1 | Page | : 2 / 5 | | Section | : 3 | | | | | | | | | Version | : 1 | | | | | | | | | Page | : 2 / 5 | | | | | | | | #### 3. INTENDED USE HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The HYDROGENIC® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. #### 4. PREDICATE DEVICES The following predicate lenses were selected to address material (FDA Group IV: high water, ionic polymer), intended use (daily wear) and lens designs (Asphere). #### Lens material, spherical lens design and intended use: BIOMEDICS® UV 60 (ocufilcon F) Hydrophilic Contact Lenses for Daily Wear, FDA Group IV, high water content, ionic soft contact lenses are marketed nationally by OCULAR SCIENCES Inc. under PMA K992264 cleared for marketing on November 24, 1999. #### Asphere lens design: BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, FDA Group IV, high water content, ionic soft contact lenses are marketed nationally and internationally by OCULAR SCIENCES Inc. under K020193 cleared for marketing on February 28, 2002. {2}------------------------------------------------ | Ocular Sciences | 510(K) PREMARKET NOTIFICATION | Reference : OSLA60 | |-----------------------------------------------|-------------------------------|--------------------| | | SUMMARY | Section : 3 | | (ocufilcon F) soft (hydrophilic) contact lens | | Version : 1 | | | | Page : 3 / 5 | ## 5. CHARACTERISTICS The characteristics of the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are compared to the characteristics of the predicate device HYDROGENICS 60 UV Sphere in the following table. #### TABLE I | Material Comparison | | | |-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------| | | Predicate Device<br>HYDROGENICS® 60<br>UV Sphere and Toric<br>(K992264) | Subject device<br>HYDROGENICS® 2.0 60<br>UV Asphere | | PRODUCTION METHOD | Cast molded process | Cast molded process | | INTENDED USE | Daily wear<br>Correction of ametropia | Daily wear<br>Correction of ametropia | | MATERIAL | ocufilcon F<br>60% | ocufilcon F<br>60% | | Type | Group IV | Group IV | | Color additive | Vat Blue 6 Dye<br>CFR 130-20-1 | Vat Blue 6 Dye<br>CFR 130-20-1 | | UV additive | Yes | Yes | | Dk permeability, ISO 9913-1 Polarimetric method<br>with edge correction @ 35°C<br>x $10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg) | $25.3 x 10^{-11}$ | $25.3 x 10^{-11}$ | | Light transmittance | Tv, % @ 20°C<br>Illuminant A<br>with a 2°<br>observer<br>(between 380<br>and 780 nm)<br>97.7% | (between 400 and<br>800 nm)<br>>95% | | | Tv, % @ 20°C<br>Illuminant A<br>with a 2°<br>observer<br>(between 380<br>and 780 nm)<br>97.7% | (between 400 and<br>800 nm)<br>>95% | {3}------------------------------------------------ ## 510(K) PREMARKET NOTIFICATION ## SUMMARY (ocufilcon F) soft (hydrophilic) contact lens ## TABLE 2 | | Lenses design comparison | | | | |----------------------------------------|-------------------------------------------------------------------|---------|--------------------------------------------------------------------------|---------| | | Subject Device<br>HYDROGENICS® 2.0 60 UV ASPHERE<br>(ocufilcon F) | | Predicate Device<br>BIOMEDICS® 55 UV Asphere<br>(ocufilcon D)<br>K020193 | | | Characteristics comparison,<br>-2.00 D | Measured | Labeled | Measured | Labeled | | Base Curve, mm | 8.5 | 8.5 | 8.4 | 8.6 | | Diameter, mm | 14.08 | 14.1 | 14.1 | 14.2 | | Power, D | -1.97 | -2.00 | 2.13 | -2.00 | ## 6. NON CLINICAL STUDIES In support to this application we are providing - Additional Manufacturing information . - Finished Lens Parameters comparison with the predicate device ● - Labeling Information ● By reference: K992264, K020193 and K984046 data can be found concerning: - Predicate Device ● - . Chemistry - Manufacturing process . - Toxicology: lens and packaging materials - Residual (leachables) Monomer - Shelf life data - Microbiology . - . Packaging ## 7. CLINICAL DATA It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the HYDROGENICS®2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses, This determination was based on the following: - The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses were . demonstrated to be substantial equivalent to the predicate BIOMEDICS/HYDROGENICS® UV Sphere lenses (K99264 and K984046). All demonstrated substantial equivalence in parameters. - . The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens design was demonstrated to be equivalent to the predicate Asphere lenses: BIOMEDICS® UV Asphere (ocuffilcon D) approved under K020193. {4}------------------------------------------------ | Ocular | Sciences | |--------|----------| |--------|----------| ## 510(K) PREMARKET NOTIFICATION (ocufilcon F) soft (hydrophilic) contact lens ## 8. CONCLUSIONS DRAWN FROM STUDIES #### Substantial Equivalence: The information provided in this 510(k) establishes that the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are equivalent in optical, chemical and physical properties of the predicate devices and do not raise any questions of safety and effectiveness. Therefore the device is substantially equivalent to the predicate device. #### Risk and Benefits: The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear base. The patient are the same as those for other soft (hydrophilic) contact lenses. ## 9. ROUTE CHOSEN IN THE FLOW CHART FOR 510 (K) DAILY WEAR CONTACT LENS #### FIGURE 1 ## HYDROGENICS® 2.0 60 UV ASPHERE Image /page/4/Figure/13 description: This image is a flowchart that outlines a decision-making process. It starts with "510(k)" and branches out based on questions like "Clear?" and "FDA Approved Care Regimen?". The flowchart then leads to different categories such as "Same USAN with Same Suffix", "Same USAN with Different Suffix", and "New USAN", each requiring specific data like Physicochemical Properties, Toxicology, Microbiology, and Clinical Performance Data to determine if it is SE or NSE. {5}------------------------------------------------ Image /page/5/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" around the perimeter. Inside the circle is a stylized symbol resembling three abstract human figures or birds in flight, arranged in a layered, overlapping manner. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ocular Sciences, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road, Suite 30 Rockville, MD 20850 Re: K031477 Trade/Device Name: Hydrogenics® 2.0 60 UV Asphere (ocufilcon F) Soft (hydrophilic) Contact Lenses indicated for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL; MVN Dated: May 9, 2003 Received: May 9, 2003 JUL 1 8 2003 Dear Dr. Lippman: 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. {6}------------------------------------------------ ## Page 2 - Richard E. Lippman, O.D., F.A.A.O. 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. Reipi 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 {7}------------------------------------------------ #### INDICATION FOR USE STATEMENT # SECTION 2: INDICATION FOR USE STATEMENT KC31477 510(k) Number (if known) HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses Device Name: #### Indications for Use: HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism 2.00 diopters or less that does not interfere with visual acuity. The HYDROGENIC® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. #### (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 (Division Sign-off) Division of Ophthalmic Devices 510(k) Number K031477