BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

{0}------------------------------------------------ ## 510(K) PREMARKET NOTIFICATION ### SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE OCDC55 Reference Section : 3 Version : I Page : I / 6 ### 0. APPLICANT'S NAME AND ADDRESS Ocular Sciences Inc. 1855 Gateway Blvd. Suite 700 Concord, CA 94520 USA Contact Person Richard Lippman, OD FAAO Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852 Telephone: (301) 770-9590 (301) 770-9584 Fax: #### 1. IDENTIFICATION OF DEVICE Common Name: Trade Name: Classification: Device classification: Soft Contact Lens BIOMEDICS®UV Colors (ocufilcon D) Soft (Hydrophilic) Contact lens Daily Wear Soft (hydrophilic) Contact Lens Class II (21 CFR 886.5925 (b) (1)) #### 2. DESCRIPTION OF DEVICE The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with ultraviolet absorbing additive (benzophenone based) and marketed in four colors: - Blue, Green, Hazel and Grey ● - in the power range of -20.00 to +10.00 diopters for sphere, . - with center thickness from 0.025mm to.40mm . - with base curves of 8.00mm to 9.20mm . - with diameter of 12.00mm to 15.00mm . The lenses are made by affixing a color pigment on the front surface of the lens, which corresponds to the iris. The colored pigments consist of Iron Oxide (Black, Russet & Yellow), Titanium Dioxide (White), Cartozole The colored piginents consist of from Onle (Green), Chromium Oxide (Green). All colored additives used are listed in 21 CFR 73 subpart D and 74 subpart D. This lens material, packaging, manufacturing and sterilization process is equivalent to BIOMEDICS®UV (ocufilcon D) described in submission PMA890023/S4 and S7, 510(K) K984046. # K013377 DEC 2 0 2001 {1}------------------------------------------------ ### 510(K) PREMARKET NOTIFICATION ### SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE OCDC55 Reference Section : 3 : I Version :216 Page ### 3. INTENDED USE BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for daily wear to enhance or alter the apparent color of the eye. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The Biomedics® UV Colors Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. ### 4. PREDICATE DEVICES The predicate lenses were selected to address: material (FDA Group IV: high water, ionic polymer), intended use (daily wear) and lens designs (sphere, multifocal). #### Lens material, spherical lens design and intended use: BIOMEDICS® UV (ocufilcon D) Sphere Hydrophilic Contact Lenses, FDA Group IV, high water content, ionic soft contact lenses for daily wear marketed internationally by OCULAR SCIENCES Inc. under PMA 890023/57 and K984046. #### Opaque colored lens: FRESHLOOK Colorblends (phere (Hydrophilic) Contact lenses marketed internationally by Wesley Jessen under PMA 830037 S33/S39 and K954603. {2}------------------------------------------------ # 510(K) PREMARKET NOTIFICATION # SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE OCDC55 Reference : 3 Section Version : I : 3 / 6 Page ## 5. CHARACTERISTICS 5. CHARACTERISTICS Biomedics® UV sphere in the following table. ### TABLE 1 | Material comparison | | | | | |---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Predicate device | | Subject device | | | | BIOMEDICS® UV Sphere | | BIOMEDICS® UV Colors | | | | PRODUCTION METHOD | Cast molded process | | Cast molded process | | | INTENDED USE | Extended and daily wear<br>Correction of ametropia | | Daily wear<br>Correction of ametropia | | | MATERIAL | ocufilcon D | | ocufilcon D | | | Type | Group IV | | Group IV | | | Color additive | Vat Blue 6 Dye<br>21 CFR 73.3119<br>CAS #130-20-1 | | Iron Oxides | 21 CFR 73.3125 | | | | | Titanium Dioxide | 21 CFR 73.3126 | | | | | Carbazole Violet | 21 CFR 73.3107 | | | | | Copper Phthalocyanine Blue | 21 CFR 74.3045 | | | | | Copper Phthalocyanine Green | 21 CFR 73.3124 | | | | | Chrome Oxide | 21 CFR 73.3111 | | UV additive | Yes | | Yes | | | Characteristics comparison | Measured | Labeled | Measured | Labeled | | Water Content % @ 20°C | 54.1 | 55 | 53.8 | 55 | | Refractive Index @ 20°C | 1.405 | 1.41 | 1.405 | 1.41 | | Dk permeability, ISO 9913-1<br>Polarimetric method with edge<br>correction @ 35°C<br>x 10-11 (cm²/sec) (ml O₂/ml x mm Hg) | 17.4 | 19.6 | 17.4 | 19.6 | | Elongation at break, % @ 20°C | 80 | NA | 80 | NA | | Mechanical strength, Mpa @ 20°C | 0.52 | NA | 0.52 | NA | | Light transmittance | Tv, % @ 20°C<br>Illuminant A with a 2° observer<br>(between 380 and 780 nm) | (between 400 and 800 nm) | Tv, % @ 20°C<br>Illuminant A with a 2°<br>observer (between 380 and<br>780 nm) | Tv, % @ 20°C<br>Illuminant A with a 2°<br>observer (between 380<br>and 780 nm) | | | 97.4 | 97% | 97.8 | 97% | ### TABLE 2 | Parameter comparison | | | | | |--------------------------------------------------|-----------------------------------|-------------------|----------------------------------------|-------------------| | | Predicate device<br>BIOMEDICS® UV | | Subject device<br>BIOMEDICS® UV Colors | | | Characteristics comparison, -7.00 D<br>40 lenses | Labeled | Measured | Labeled | Measured | | Base Curve, mm | 8.60 | $8.55 \pm 0.021$ | 8.60 | $8.49 \pm 0.027$ | | Diameter, mm | 14.20 | $14.13 \pm 0.03$ | 14.20 | $14.20 \pm 0.008$ | | Power, D | -7.00 | $-7.48 \pm 0.087$ | -7.00 | $-7.34 \pm 0.123$ | {3}------------------------------------------------ ### 510(K) PREMARKET NOTIFICATION ### SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE ### TABLE 3 | Opaque (Colors) lens comparison | | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate device | Subject device | | | FRESHLOOK COLORBLENDS | BIOMEDICS®UV Colors | | Indications | Extended and Daily Wear | Daily Wear | | Pigments | Iron Oxides 21 CFR 73.3125<br>Titanium Dioxide 21 CFR 73.3126<br>Copper Phthalocyanine Blue 21 CFR 74.3045<br>Copper Phthalocyanine Green 21 CFR 73.3124<br>Chrome Oxide 21 CFR 73.3111<br>Carbazole Violet 21 CFR 73.3107 | Iron Oxides 21 CFR 73.3125<br>Titanium Dioxide 21 CFR 73.3126<br>Copper Phthalocyanine Blue 21 CFR 74.3045<br>Copper Phthalocyanine Green 21 CFR 73.3124<br>Chrome Oxide 21 CFR 73.3111<br>Carbazole Violet 21 CFR 73.3107 | | Tint Process | Pad Printing | Pad Printing | | Print Zone | corresponds to the iris | corresponds to the iris | | Location of print | Front surface | Front surface | | Manufacturing method | Cast molded | Cast molded | #### 6. NON CLINICAL STUDIES Non-clinical studies are summarized below: #### Chemistry - Material property data were generated on the BIOMEDICS® UV sphere and the BIOMEDICS® UV™Colors . lenses. The material properties were substantially equivalent. - The lens care product manufacturers have previously shown compatibility of Group IV lenses with their . products. - . The shelf life stability for BIOMEDICS® UV Colors lenses is based upon stability protocols included with this notification. - . Studies were conducted to determine the residual monomers on the subject device and on the predicate device. The levels of residual monomers were substantially equivalent. HEMA, MA, EDGMA and UV Blocker. - . Color extraction study was conducted to assess the color fastness of the pigments used to print the Colors lens. The pigments were not detected in the saline extracts above the detection limit for each of the pigments in any of the samples. ### Toxicology, lenses materials In accordance with the May 1994 Guidance Document for Daily Wear contact lenses, toxicology studies have been conducted on the BIOMEDICS® UV Colors containing UV blocker. Blue and Red Printed lenses (worst case scenario) were used in the studies. The results are summarized below: #### ● Cytotoxicity Test: A Cytotoxicity Test has been conducted on the subject device according to ISO 10993: Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity: In vitro Methods guidelines, was conducted on the test articles, to determine the potential for Cytotoxicity. The negative controls and the positive controls performed as anticipated. Under the conditions of the study, the test articles were not cytotoxic. {4}------------------------------------------------ ### 510(K) PREMARKET NOTIFICATION ## SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE | Reference | OCDC55 | |-----------|--------| | Section | 3 | | Version | 1 | | Page | 5 / 6 | #### Acute Systemic Injection Test in the mouse: . · Acute Systemic Injection Lest in the mouse. An evaluation of the test articles for systemic toxicity in mice after and Medical Prolection of Madical intraperitoneal administration has been conducted according to the ISO 1093: Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity. Devices, Fari II. Tests for Systems from the test article extracts. Each test article met the test requirements. #### Ocular Eye Irritation Test in the rabbit: . · Octuar Eye Irritation of 0.9% NaCl and conomics of the subject atticle after a single after a single instillation in the rabbit has been conding to ISO 10993: Biological Evaluation of Medical devices, Part 10: Tests for the Irritation and Sensitization. Patt 10. Tests for the firmation and belief the rest article extracts are not considered irritants to the ocular tissue of rabbits. #### Solution Compatibility Solution Companibility efficacy of their care products with lens groups for which they are approved. Solution compatibility was performed using Allergan Complete and Essilor (OSL) Concerto. Solution companists was personics assig rinersity between any of the colored printed lenses, with or without cleaning. Non-clinical studies and manufacturing information provided by reference PMA890023 S4/S7 and K984046 - Cast molded manufacturing process . - Packaging process . - Toxicology packaging materials ● - Microbiology and sterilization . #### 7. CLINICAL DATA It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Biomedics® UV Colored lenses. This determination was based on the following: - Colorodics® UV Colors lenses were proven to be substantial equivalent to the predicate Biomedics® UV . Sphere lenses (PMA890023/54 and S7 and K984046). Showed substantial equivalence in physiochemical characteristics and parameters. The Biomedics® UV Colors lens design was proven to be equivalent to the predicate device: FRESHLOOK Colorblends (phemfilcon A) Sphere (Hydrophilic) Contact lenses marketed internationally by Wesley Jessen under PMA 830037 S33/S39 and K954603. #### 8. CONCLUSIONS DRAWN FROM STUDIES #### Validity of Scientific Data: A contract laboratory using Good Laboratory Practices conducted the Toxicology and Color Extraction studies. Chemistry leachables studies were conducted in-house. #### Substantial Equivalence: Information provided in this 510K establishes that the Biomedics® UV Colors lenses are equivalent in optical, chevical and physical properties of the predicate devices and do not raise any questions of safety and Therefore, the device is substantially equivalent to the predicate devices, Biomedics® UV effectiveness. (ocufilcon D) Soft (Hydrophilic) Spherical and FRESHLOOK Colorblends (phemfilcon A) Sphere (Hydrophilic) Contact lenses marketed internationally by Wesley Jessen under PMA 830037 S33/S39 and K954603. Risk and Benefits: {5}------------------------------------------------ ## 510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE OCDC55 Reference Section : 3 Version : 1 : 6 / 6 Page The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) The risks of the subject device are the same as those normally and the same as those for other soft (hydrophilic) contact lenses. # 9. ROUTE CHOSEN IN THE FLOW CHART FOR 510 (K) DAILY WEAR CONTACT LENS MATERIALS SUBMISSION ### FIGURE 1 BIOMEDICS® UV Colors Image /page/5/Figure/8 description: This image is a flowchart that describes the process for determining whether a new medical device is substantially equivalent to a predicate device. The flowchart starts with a 510(k) submission and then asks a series of questions to determine whether the new device is substantially equivalent. The questions include whether the device is clear, whether it uses listed colors, and whether it is an FDA-approved care regimen. The flowchart also considers whether the device has the same USAN with the same suffix, the same USAN with a different suffix, or a new USAN. {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings, and 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 DEC 2 0 2001 Ocular Sciences Inc. c/o Richard Lippman, OD FAAO Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852 Re: K013377 Trade/Device Name: BIOMEDICS®UV Colors (ocufilcon D) Soft (Hydrophilic) Contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Daily Wear Soft (hydrophilic) Contact Lens Regulatory Class: II Product Code: LPL Dated: October 11, 2001 Received: October 12, 2001 Dear Dr. Lippman: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 to bears in 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ ### INDICATION FOR USE STATEMENT 510(k) Number (if known) Device Name: Indications for Use: BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn not-apilance persons with how alsoused of and the may of 2.00 diopters or less that does not interfere with visual acuity. The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for The DROMLDICOS OF OF Offer the apparent color of the eye. The eye care practitioner may daily wear to chiance or after single use disposable wear and for frequent replacement prescribed the ocheast for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The Biomedics® UV Colors 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) OR Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-the -counter-use Lianiel W. Brown, Ph.D. Division of Ophthalmic Devices 510(k) Number_K013377