PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for CooperVision. The logo is black and white and features the company name in a stylized font. There is a registered trademark symbol to the right of the name. SEE BEYOND THE OR ## 510(k) Summary | 510(k) SUMMARY | | | |----------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Applicant Name & Address: | CooperVision, Inc.<br>711 North Road<br>Scottsville, NY 14546 | | 2. | Contact: | Bonnie Tsymbal<br>Telephone (585) 264-3210<br>Facsimile (585) 889-5688 | | 3. | Date Prepared: | June 17, 2008 | | 4. | Device Identification: | | | | Trade Name: | Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses<br>Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses<br>Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses | | | Common Name: | Soft Contact Lenses | | | Classification Name: | Lenses, Soft Contact, Daily Wear | | | Device Classification: | Class II (21 CFR 886.5925) | | | Product Code: | LPL | #### Intended Use: 5. Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic. The 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). Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The 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 of from Aqueous Tear Deficiency (non-Sjogren's only). Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic; possess astigmatism of 10.00 diopters or less. The 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 the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and time they 1 {1}------------------------------------------------ ## 510(k) Summary are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eve care practitioner. The lenses may be disinfected using a chemical disinfection system. ## 6. Device Description ## Proclear Toric XR Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lens is a back surface toric. The lenses are made of polymer of 2-hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphoryicholine crosslinked with ethylenedycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive Vat Blue 6. Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as astigmatic (toric) lenses with the following dimensions: - I Chord Diameter: - 트 Center Thickness - Base Curve: 트 - 트 Spherical Powers: - I Cylinder Powers: - 지 Axis #### Proclear Multifocal XR Proclear Multifocal XR (omafilic) Contact Lenses are available as a multifecal lens with an aspherical front surface and scherical back surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear Multifocal XR is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear Multifocal XR / D (dominant) has a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear Multifccal XR / N (non-dominant) has a spherical central zone for the correction of near vision and an aspherical annular zone for the mediate and distance vision. The lenses are tinted edge for visibility purposes with the color additive Vat Blue 6. The lens material, omafilcon A is a copolymer of 2-hydroxy-ethylmethacryloyloxyethyl phosphorycholine crosslinked with ethylenedycol dimethacrylate. The Proclear UltraVue/D and Proclear UltraVue/N (omatilcon A) Soft (Hydrophilic) Contact Lenses are flexible transparent hemispherical shells of the following dimensions: - Chord Diameter: 트 - Center Thickness (minus): - エ Base Curve: - 트 Spherical Powers: - Add Powers: - Central Zone Diameter: ■ 13.6 to 15.2 mm 0.09 mm to 0.65 mm 8.3 mm to 8.9mm -20.00 D to +20.00 D +1.00 to +4.00 D 2.3 mm to 2.6 mm (Proclear Multifocal XR / D) 1.7 mm to 2.0 mm (Proclear Multifocal XR / N) Proclear Multifocal Toric 13.6 to 15.2 mm 0.09 mm to 0. 65 mm 8.0 mm to 9.3 mm -20.00 D to +20.00 D -0.75 to -5.00 D 1° to 180° {2}------------------------------------------------ GoperVisiona® ## 510(k) Summary Proclear Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxyethylmethacrylate and 2-methacryloyloxycholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge to edge for visibility purposes with the color additive Vat Blue 6. The front surface of the Proclear Multifocal Toric (omafilic) Contact Lenses is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The Proclear Multifocal Toric contact lenses are designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear Multifocal Toric (omafilic) Contact Lenses are available in two versions. The Proclear Multifocal Toric / D with a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of internediate and near vision. The Proclear Multifocal Toric / N with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision. Both lenses are a flexible transparent hemispherical shell of the following dimensions: | Chord Diameter: | 13.6 to 15.2 mm | |---------------------------|-----------------------------------------------------------------------------------------------------| | Center Thickness (minus): | 0.035 mm to 0.96 mm | | Base Curve: | 8.3 mm to 8.9mm | | Spherical Powers: | -20.00 D to +20.00 D | | Cylinder Powers: | -0.75 to -3.00 D | | Add Powers: | +1.00 to +4.00 | | Central Zone Diameter: | 2.3 mm to 2.6 mm (Proclear Multifocal Toric / D)<br>1.7 mm to 2.0 mm (Proclear Multifocal Toric/ N) | The physical properties of the lenses are: | Refractive Index at 25º C | 1.40 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Light Transmittance | >90% | | Water Content | 59 % | | Oxygen Permeability* | 21.05 x 10-11<br>*(cm²/sec) (ml O2/ml x mm Hg) at 35°C. as measured by 201T<br>Permeometer connected to a curved Rehder guard ring polarographic<br>cell | {3}------------------------------------------------ # 510(k) Summary # 7. Substantial Equivalence Table: | | SUBJECT DEVICE | PREDICATE DEVICE<br>K050717 | PREDICATE DEVICE<br>K061948 | |-------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | | Proclear Toric XR<br>Proclear Multifocal XR<br>Proclear Multifocal Toric | Proclear UltraVue Toric<br>XR<br>Proclear UltraVue<br>Multifocal XR<br>Proclear UltraVue<br>Multifocal Toric | Proclear Sphere/Asphere 1-Day<br>Proclear Toric 1-Day<br>Proclear Multifocal 1-Day<br>Proclear Multifocal Toric 1-Day | | Material<br>USAN Name | Omafilcon A | Omafilcon A | Omafilcon A | | FDA Category<br>(Group) | Group II Non-Ionic<br>High Water | Group II Non-Ionic<br>High Water | Group II Non-Ionic<br>High Water | | Water Content | 59% | 59% | 60% | | Light<br>Transmittance | >90% | >90% | >90% | | Index of<br>Refraction | 1.40 | 1.40 | 1.40 | | Oxygen<br>Permeability | 21.05 | 21.05 | 20.45 | | Manufacturing<br>Method | Finished Inside<br>Polymerization System | Finished Inside<br>Polymerization System | Cast Molded | | Sterilization | Steam Validated Autoclave | Steam Validated Autoclave | Steam Validated Autoclave | | Packaging | Blister Pack | Blister Pack | Blister Pack | | Shelf-Life | 5 Yrs. | 5 Yrs. | 5 Yrs. | | Visibility Tint | VAT Blue #6 | C.I. Reactive Blue #4 | VAT Blue #6 | | Tinting Process | Entrapment | Reactive | Entrapment | | | SUBJECT DEVICE | PREDICATE DEVICE<br>K050717 | PREDICATE DEVICE<br>K061948 | | | Proclear Toric XR | Proclear UltraVue Toric | Proclear Toric | | Lens<br>Design | Back Surface Toric | Back Surface Toric | Back Surface Toric | | Intended<br>Use | Correction of visual acuity in<br>patients with myopia, hyperopia<br>and are astigmatic | Correction of visual acuity in<br>patients with myopia, hyperopia<br>and are astigmatic | Correction of visual acuity in<br>patients with myopia, hyperopia<br>and are astigmatic | | | SUBJECT DEVICE | PREDICATE DEVICE<br>K05717 | PREDICATE DEVICE<br>K061948 | | | Proclear Multifocal XR | Proclear UltraVue Multifocal | Proclear Multifocal | | Lens<br>Design | Multifocal | Multifocal | Multifocal | | Intended<br>Use | Correction of visual acuity in<br>patients with myopia or<br>hyperopia, and are presbyopic | Correction of visual acuity in<br>patients with myopia or<br>hyperopia, and are presbyopic | Correction of visual acuity in<br>patients with myopia or<br>hyperopia, and are presbyopic | | | SUBJECT DEVICE | PREDICATE DEVICE<br>K05717 | PREDICATE DEVICE<br>K061948 | | Lens<br>Design | Multifocal Toric | Multifocal Toric | Multifocal Toric | | Intended<br>Use | Correction of visual acuity in<br>patients with myopia or<br>hyperopia, and are presbyopic | Correction of visual acuity in<br>patients with myopia or<br>hyperopia, and are presbyopic | Correction of visual acuity in<br>patients with myopia or<br>hyperopia, and are presbyopic | {4}------------------------------------------------ @operVisiona® 510(k) Summary ## 8. Lens Design and Indications Table: #### ഗ് Physiochemical Studies: Resuits from physical, optical and chemical properties show substantial equivalency with the predicate devices, and are within established specifications for the lenses. {5}------------------------------------------------ ## 510(k) Summary ## 10. Toxicology: Results from in-vivo and in-vitro studies were conducted and verify that the lenses remain non-toxic and are biocompatible with the ocular environment. ## 11. 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. ### 12. Conclusion: The device will be manufactured according to specified process controls and an established quality assurance program. The device will undergo the same manufacturing, packaging and sterilization procedures to devices currently marketed by CooperVision, Inc. Scottsville, NY manufacturing facility. Being similar with respect to indications for use, 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 basis. {6}------------------------------------------------ Image /page/6/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, rendered in black. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 9 2008 CooperVision Bonnie Tsymbal Director, Regulatory Affairs and Quality Assurance. 711 North Road Scottsville NY 14546 Re: K081865 Trade/Device Name: Proclear Multifocal Toric XR, Proclear Multifocal XR, Proclear Toric XR (omafilcon A) Daily Wear Soft (hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: June 30, 2008 Received: September 15, 2008 Dear Ms. Tsymbal: 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. {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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, M. B. Egelston, m.D. 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 {8}------------------------------------------------ Ooper Visione ## Indication for Use Statement | 510(k) Number: | K081865 | |----------------|------------------------------------------------------------------------------| | Device Name: | Proclear Multifocal Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses | | | Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses | | | Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses | ### Indication for Use: Proclear Multifocal Toric XR (omafilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The 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). Proclear Multifocal XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The 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). Proclear Toric XR (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 5.00 diopters or less. The 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 the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system. Prescription Use X (Per 21 CFR Subpart D) AND/OR Over-The-Counter (Per 21 CFR Subpart C) PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Myra Smith ivision of Ophthalmic Ear. Nose and Throat Devises 510(k) Number