PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS

{0}------------------------------------------------ ## 4. Device Description ## NOV 2 2 2006 The Proclear (omafilcon A) are Daily Wear soft contact lenses intended for single use daily disposable wear or Scheduled Replacement wear. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The Proclear lens is available in several designs. Spherical or aspherical soft contact lens; Toric is a back surface toric; Multifocal has multiple curves with complementary reverse geometry (N and D) which allows for correction of presbyopia in persons who are myopic or hyperopic; Multifocal Toric has an aspheric front surface with anterior having two multifocal zones with a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The omafilcon A lens material is equivalent to other omafilcon A daily wear hydrophilic contact lenses cleared under several 510(k) notifications. Omafilcon A is composed of polymer of 2-hydroxy-ethylmethacylate and 2-metacryloloyoxyethyl phosphoryIcholine cross linked with ethylmethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive Vat Blue 6. The physical properties and available dimensions follow: | Chord Diameter | 13.0 mm to 15.5 mm | |---------------------------------|---------------------------------------------------------------------------------| | Central Zone Diameter | 1.7 mm to 2.6 mm | | Center Thickness | 0.035 mm to 0.96 mm (varies with power and lens design) | | Base Curve | 8.00 mm to 9.50 mm | | Power Range | -20.00 D to +20.00 D | | Add power range | +0.25D to +5.00D as applicable | | Cylinder Power | -0.50 D to -10.00D as applicable | | Axis | Axis 1° to 180° as applicable | | Refractive Index | 1.40 | | Water Content | 60% ± 2% | | Oxygen Permeability | | | Polarographic Fatt Method | 21 x 1011 (cm²/sec) (ml O2/ml x mm Hg) | | Modified Fatt Method Guard Ring | 25 x 10-11 (cm²/sec) (ml O2/ml x mm Hg) | | Edge corrected | at 35° C. as measured by 201T Permeometer connected to a<br>polarographic cell. | | Light Transmittance | >90% | ## 5. Intended Use ## Proclear XC and Proclear 1 day Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eves that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear 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 have astigmatism of 5.00D or less. Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in not {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the company name in a sans-serif font, with a stylized "C" that resembles two interlocking circles. To the right of the name is a square graphic with a white circle inside, possibly representing a contact lens. The text and graphic are black against a white background. aphakic persons with non-diseased eves. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity. Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic. Proclear XC and Proclear 1 Day (omafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only). Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. ## FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system. ## DISPOSABLE WEAR When prescribed for Daily Disposable Wear the lens is to be discarded after each removal. ## 6. Predicate Device(s) ## Predicate Device Materials ## omafilcon A: Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K952152) Proclear Compatibles Daily Wear Contact Lens (Omafilcon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (Omafilcon A) Soft Contact Lenses (K974408) ## VAT Blue 6 (tint): Biomedics 52 1-Day (ocufilcon B) UV Blocking Daily Wear Soft (hydrophilic) Contact Lens (K020389) ### Predicate Device Lens Designs and Indications for Use Proclear Compatibles Daily Wear (Omafilcon A) Soft Contact Lenses (K970095) Proclear Compatibles Multifocal (Omafilcon A) Soft Contact Lenses (K032873) Proclear Multifocal (Omafilcon A), Proclear Toric (Omafilcon A) and Proclear Multifocal Toric (Omafilcon A) Soft) Soft Contact Lenses (K050717) Biomedics 52 1-Day (ocufilcon B) UV Blocking Daily Wear Soft (hydrophilic) Contact Lens (K020389) {2}------------------------------------------------ # perVision � ## 7. Characteristics of Substantial Equivalence ## MATERIAL COMPARISON TABLE | Reference | SUBJECT<br>DEVICE<br>Proclear Aspheric,<br>Proclear Toric,<br>Proclear Multifocal,<br>Proclear Multifocal<br>Toric | PREDICATE<br>DEVICE<br>K970095<br>K974408 | PREDICATE<br>DEVICE<br>K952152<br>K974408 | PREDICATE<br>DEVICE<br>K020389 | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|--------------------------------------------| | Material<br>USAN Name | Omafilcon A | Omafilcon A | Omafilcon A | Ocufilcon B | | FDA Category<br>(Group) | Group II<br>Non-lonic<br>High Water<br>Content | Group II<br>Non-lonic<br>High Water<br>Content | Group II<br>Non-lonic<br>High Water<br>Content | Group IV<br>Ionic<br>High Water<br>Content | | Manufacturing<br>method | Cast Molded | Cast Molded | Lathe-Cut | Cast Molded | | Sterilization | Steam: validated<br>autoclave | Steam:<br>validated<br>autoclave | Steam:<br>validated<br>autoclave | Steam:<br>validated<br>autoclave | | Packaging | Blister Pack | Blister Pack | Vial | Blister Pack | | Labeled Water<br>Content<br>(Thermogravimetric<br>method) | 60% | 62% | 59% | 52% | | Visibility Tint | Vat Blue 6 | C.I Reactive<br>Blue 4 | Clear | Vat Blue 6 | | Color Process | Entrapment | Reactive | No tint | Entrapment | {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "CooperVision" in a stylized font. The word is written in black and has a unique design, with the first "C" enclosed in a partial circle that extends under the first two letters. To the right of the word, there is a square containing a white circle, possibly representing an eye or lens, set against a dark background. ## LENS DESIGN AND INDICATIONS FOR USE COMPARISON TABLE No change to established spherical, asphere, toric, multifocal toric lens designs. | | SUBJECT DEVICE | PREDICATE DEVICE K032873 | |-----------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Lens<br>Design | Multifocal | Multifocal | | Intended<br>use | Correction of Visual acuity in patients with<br>myopia or hyperopia and are presbyopic | Correction of Visual acuity in patients with<br>myopia or hyperopia and are presbyopic | | | SUBJECT DEVICE | PREDICATE DEVICE K050717 | | Lens<br>Design | Multifocal Toric | Multifocal Toric | | Intended<br>use | Correction of Visual acuity in patients with<br>myopia or hyperopia and are astigmatic<br>and presbyopic | Correction of Visual acuity in patients with<br>myopia or hyperopia and are astigmatic<br>and presbyopic | | | SUBJECT DEVICE | PREDICATE DEVICE K970095 | | Lens<br>Design | Sphere, Asphere | Sphere | | Intended<br>use | Correction of Visual acuity in patients with<br>myopia or hyperopia | Correction of Visual acuity in patients with<br>myopia or hyperopia | | | SUBJECT DEVICE | PREDICATE DEVICE K050717 | | Lens<br>Design | Toric | Toric | | Intended<br>use | Correction of Visual acuity in patients with<br>myopia or hyperopia and are astigmatic. | Correction of Visual acuity in patients with<br>myopia or hyperopia and are astigmatic. | | | SUBJECT DEVICE | PREDICATE DEVICE K020389 | | Indication | Daily Disposable | Daily Disposable | | Intended<br>use | When prescribed for Daily Disposable<br>Wear the lens is to be discarded after each<br>removal. | When prescribed for Daily Disposable<br>Wear the lens is to be discarded after<br>each removal. | ## 8. Physiochemical Studies Results from physical, optical and chemical properties show substantial equivalency with the predicate devices, and are within established specifications for the lenses. ## 9. Toxicology Studies Results from in-vivo and in-vitro studies were conducted and verify that lenses remain nontoxic and biocompatible with the ocular environment. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the word "CooperVision" in a stylized font. To the right of the word is a square with a white circle inside, resembling an eye. ## 10. Clinical Studies The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required. ## 11. Conclusions Based on evaluation of material, manufacturing methods, lens parameters and indicated use, the omafilcon A soft contact lens described in this document is substantially equivalent with the predicate devices. Evaluation of chemical/physical properties, biocompatibility and stability studies, confirm the lenses are within established finished product specifications, remain stable, and are non-toxic and biocompatible with the ocular environment and the lens is shown to be safe for its indicated use. {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 CooperVision, Inc. c/o Lisa Hahn Global Regulatory Affairs Director 1215 Boissevain Ave. Norfolk, VA 23507 NOV 2 2 2006 Re: K061948 Trade/Device Name: Proclear® XC (omafilcon A) and Proclear® 1 day (omafilcon A) Hydrophilic Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: MVN, LPL Dated: November 17, 2006 Received: November 20, 2006 Dear Ms. Hahn: 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 — Lisa Hahn 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 1egally marketed predicate device results in a classification for your device and thus, permitts your revice 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 (240) 276-0115. Also, please note the regulation only, pro "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon vitain 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. M.B. Eychlemin SimD Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use ## 510(k) Number (if known): K061948 Device Name: Proclear XC Proclear 1 day #### Indications For Use: Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear 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 have astigmatism of 5.00D or less. Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in not aphakic persons with nondiseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity. Multifocal Toric: (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic. Proclear XC and Proclear 1day (omafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only). Daily wear replacement schedules may vary from patient and should be decided by evecare practitioners in consultation with their patients. ## FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system. #### DISPOSABLE WEAR When prescribed for Daily Disposable Wear the lens is to be discarded after each removal. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| |--------------------------------------------------------|--| Myra Smith Page 1 of (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises