PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC

{0}------------------------------------------------ Ko5.717 MAY 1 3 2005 CooperVision, Inc. Scottsville, NY 14546 711 North Road Bonnie Tsymbal 711 North Road (585) 264-3210 (585) 889-5688 March 17th, 2005 CooperVision, Inc. Scottsville, NY 14546 5 E & E C M C C C C C C C C C C Premarket Notification Omafilcon A FIP's A. B. OHIR. A. H. M. H. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. ### 510(k) SUMMARY - 1. Submitter: #### Submitted on Behalf of: - 트 Company Name: ಂಗ್ //siona2 - t Address: #### 2. Official Correspondent: - 트 Company Name: - 트 Address: - 보 Phone: - 트 Fax: . #### 3. Date Summary Prepared: #### Device Identification: 4. - Proclear UltraVue Toric Trade Name: Proclear UltraVue Multifocal Proclear UltraVue 2000T Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact - l Common Name: - . Classification - . Device Classification: ## Lenses Hydrophilic Soft Contact Lens Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886.5925) - ### 5. Intended Use: Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (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 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 UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be wom 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). {1}------------------------------------------------ ිරියා විද්ධික් හෝ සිට පසු සිංහ ප්‍රධාන පිහිටා පිහිට පිහිට Proclear UltraVue Toric (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 eve care practitioner. The lenses may be disinfected using a chemical disinfection system. #### 6. Device Description #### Proclear UltraVue Toric Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethylenedlycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as astigmatic (toric) lenses with the following dimensions: - 지 Chord Diameter: - Center Thickness (minus): Center Thickness (plus) - 트 Base Curve: - . Spherical Powers: - 8 Cylinder Powers: - B Axis 13.6 to 15.2 mm 0.15 mm to 0.20 mm 0.20 mm to 0.96 mm 8.0 mm to 9.3 mm -20.00 D to +20.00 D -0.75 to -5.00 D 1° to 180° #### Proclear UltraVue/D Multifocal and Proclear UltraVue/N Multifocal Proclear UltraVue/D and Proclear UltraVue/N (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back sufface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear UltraVue/D and Proclear UltraVue/N is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear UltraVue/D 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 UltraVue/N has a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the Chinese characters "人偶用方式", which translates to "doll use method". There is also the character "球", which translates to "ball". The characters are written in a traditional style, and the image appears to be a close-up of a document or label. Premarket Notification The lens material, omafilcon A is a copolymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphoryicholine crosslinked with ethyleneglycol dimethacrylate. The Proclear UltraVue/D and Proclear UltraVue/N (omafilcon A) Soft (Hydrophilic) Contact Lenses are flexible transparent hemispherical shells of the following dimensions: 的影音的一起,一起一起,一起一起, - Chord Diameter: 트 - Center Thickness (minus): l Center Thickness (plus) - . Base Curve: - l Spherical Powers: - Add Powers: 하 - # Central Zone Diameter: 14.5 mm 0.15 mm to 0.20 mm 0.20 mm to 0.96 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 UltraVue/D) 1.7 mm to 2.0 mm (Proclear UltraVue/N) #### Proclear UltraVue/D 2000T Multifocal Toric and Proclear UltraVue/N 2000T Multifocal Toric Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. The front surface of the Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) 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 UltraVue/D 2000T and Proclear UltraVue/N 2000T 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 UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available in two versions. The Proclear UltraVue/D 2000T with 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 UltraVue/N 2000T with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision. {3}------------------------------------------------ 11-12 EN A. R : Both lenses are a flexible transparent hemispherical shell of the following dimensions: 장 프로그램 - 대전 - 100 - 100 - Chord Diameter: . - Center Thickness (minus): 프 Center Thickness (plus) - 트 Base Curve: - . Spherical Powers: - I Cylinder Powers: - 1 Add Powers: - Central Zone Diameter: 14.5 mm 0.15 mm to 0.20 mm 0.20 mm to 0.96 mm 8.3 mm to 8.9mm -20.00 D to +20.00 D -0.75 to -2.75 D +1.00 to +3.50 2.3 mm to 2.6 mm (Proclear UltraVue/D 2000T) 1.7 mm to 2.0 mm (Proclear UltraVue/N 2000T) #### The physical properties of the lenses are: | Refractive Index at 25° C | 1.40 | |---------------------------|------------------------| | Light Transmittance | >90% | | Water Content | 59 % | | Oxygen Permeability* | $21.05 \times 10^{-1}$ | *(cm²/sec) (ml O2/ml x mm Hg) at 35°C. as measured by 2017 Permeometer connected to a curved Rehder guard ring polarographic cell. {4}------------------------------------------------ @operVision� Premarket Notification ### Lathe- Cut Omafilcon A # 7. Substantial Equivalence Table: | | Proclear Tailor Made Toric, Proclear<br>UltraVue Multifocal Proclear UltraVue<br>2000T Multifocal Toric | Proclear UltraVue Toric,<br>Proclear UltraVue Multifocal and Proclear<br>UltraVue 2000T Multifocal Toric | |------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | | Lathed<br>Predicate Device | Finished Inside Polymerization System<br>Subject Device | | Material | Omafilcon A | Omafilcon A | | Water Content | 59% | 59% | | Light | | | | Transmittance | >90% | >90% | | Index of<br>Refraction | 1.40 | 1.40 | | Oxygen | | | | Permeability | 21.05 | 25.0 | | | DESIGN COMPARISON | | | | Proclear UltraVue Toric | Proclear Tailor Made Toric | | | Subject Device | Predicate Device K952152 | | | Omafilcon A | Omafilcon A | | Lens Design | Back Surface Toric | Back Surface Toric | | Intended Use | Correction of visual acuity in patients with | Correction of visual acuity in patients with | | | myopia or hyperopia, and are astigmatic | myopia or hyperopia, and are astigmatic | | Production<br>Method | Finished Inside Polymerization System | Lathe-Cut | | | Proclear UltraVue Multifocal | Proclear UltraVue Multifocal | | | Subject Device | Predicate Device K043129 | | | Omafilcon A | Omafilcon A | | Lens Design | Aspheric Multifocal | Aspheric Multifocal | | Intended Use | Correction of visual acuity in patients with | Correction of visual acuity in patients with | | | myopia or hyperopia, and are presbyopic | myopia or hyperopia, and are presbyopic | | Production<br>Method | Finished Inside Polymerization System | Lathe-Cut | | | Proclear UltraVue 2000T Multifocal Toric<br>Subject Device<br>Omafilcon A | Proclear UltraVue 2000T Multifocal Toric<br>Predicate Device K0423129<br>Omafilcon A | | Lens Design | Aspheric Multifocal Toric | Aspheric Multifocal Toric | | Intended Use | Correction of visual acuity in patients with | Correction of visual acuity in patients with | | | myopia or hyperopia, and are astigmatic and<br>presbyopic | myopia or hyperopia, and are astigmatic and<br>presbyopic | | Production<br>Method | Finished Inside Polymerization System | Lathe-Cut | {5}------------------------------------------------ Premarket Notification ### 8. 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its body and head, and two wavy lines representing its legs or feet. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 1 3 2005 Cooper Vision c/o Ms. Bonnie Tsymbal Sr. Manager Regulatory Affairs and Quality Assurance 711 North Road Scottsville, NY 14546 Re: K050717 Trade/Device Name: Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Proclear UltraVue/D and Proclear UltraVue/N Muttifocal (omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Proclear UltraVue Toric (omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 18, 2005 Received: March 24, 2005 Dear Ms. Tsymbal: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use batted in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, the case of the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereloro, manver of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is clausified (600 as a votrols. Existing major regulations affecting your device can may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reacts concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I Dri b issualite over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it cach and 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 CFN Fat 807), adomig (21 OFR Part 820), good if applicable, the electronic forul in the quality by stells (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 Office of Compliance at (301) 827-8910. 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/industry/support/index.html. Sincerely yours, David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for CooperVision. The logo is in black and white. The text "CooperVision" is written in a stylized font, with the first two "o"s connected by a line underneath. To the right of the text is a black square with a white swirl inside. Regulatory Affairs 711 North Road Scottsville, NY 14546 (585) 385-6810 Fax: (585) 889-5688 #### Indication for Use Statement 510(k) Number: Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric Device Name: (omafilcon A) Soft (hydrophilic) Contact Lens Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (hydrophilic) Contact Lens Proclear UltraVue Toric (omafilcon A) Soft (hydrophilic) Contact Lens Indication for Use: Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (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 3.00 diopters or less, portune manyonic. 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 UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic 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 leass wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only). Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the r rrection 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. #### PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use X | |------------------------| | (Per 21 CFR Subpart D) | | | (Division Sign-Off)<br>Division of Ophthalmic Ear,<br>Nose and Throat Devises | |---------------|-------------------------------------------------------------------------------| | 510(k) Number | K050717 AND/OR | Over-The-Counter (Per 21 CFR Subpart C)