BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

{0}------------------------------------------------ # 510(k) Summary - Page 1 # 1. Owner's Name & Address: CooperVision, Inc. 6140 Stoneridge Mall Road, Suite 500 Pleasanton, CA 94588 JAN - 5 2010 - 2. Contact Person: Lisa Hahn Director, Global Regulatory Affairs CooperVision, Inc. 1215 Boissevain Avenue Norfolk, VA 23507 Telephone (757) 664-2421 Facsimile (866) 890-1584 Soft (Hydrophilic) Contact Lenses - 3. Date Prepared: - April17, 2009 # 4. Device Identification: 트 Trade Name: · Biomedics® 55 (ocufilcon D) . Common Name: - 트 Classification Names: Lenses, Soft Contact, Daily Wear (21 CFR 886.5925, Product Code LPL) Salargest agains and San Morth having the shows of the mach the mail Lens, Contact, (Disposable) (21 CFR 886.5925, Product Code MVN) {1}------------------------------------------------ K091339 Image /page/1/Picture/1 description: The image shows the CooperVision logo. The logo consists of the word "CooperVision" in a stylized font, with a graphic of an eye inside a square to the right of the word. The registered trademark symbol is located to the right of the square. ## 510(k) Summary – Page 2 # 5. Legally Marketed Devices to Which CooperVision, Inc. is Claiming Equivalence: | Substantial Equivalence Table | | | |-------------------------------|--|--| | | | | | | MODIFIED DEVICE | UNMODIFIED DEVICE<br>K972303 | |-----------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | | ocufilcon D | ocufilcon D | | Material<br>USAN Name | ocufilcon D | ocufilcon D | | FDA Category<br>(Group) | Group II Non-Ionic<br>High Water | Group II Non-Ionic<br>High Water | | Indication for<br>Use | Daily Wear for Frequent/Planned<br>Replacement Wear or for Daily<br>Disposable Wear | Daily Wear for Frequent/Planned<br>Replacement Wear or for Daily<br>Disposable Wear | | Water Content | 55% | 55% | | DK<br>(cm²/sec) ml O₂/ml x mm<br>Hg at 35°C (Fatt method) | 19.6 x 10⁻¹¹ | 19.6 x 10⁻¹¹ | | Light<br>Transmittance | >95% | >95% | | Refractive Index | 1.41 | 1.41 | | Manufacturing<br>Method | Cast-Molded | Cast-Molded | | Sterilization | Steam | Steam | | Packaging | Blister Pack | Blister Pack | | Blue Handling<br>Tint | Yes<br>Entrapment Dye | Yes<br>Entrapment Dye | | Surfactant in the<br>Final Product<br>Saline | Yes | None | # 6. Standards No applicable mandatory performance standards or special controls exist for this device. allettillations in and states and the contribution in the secondination of the sedent has a le control and the section Special 510(k) ocufilcon D {2}------------------------------------------------ #### 510(k) Summary - Page 3 Image /page/2/Picture/1 description: The image shows the number K091339 at the top. Below that is the CooperVision logo. The logo has the word Coopervision in bold letters, and to the right of that is a black square with a white eye inside of it. #### 7. Device Description The lenses, Biomedics® 55 (ocufilcon D) soft (hydrophilic) contact lenses, are a hemispherical shell available in a spheric, toric or multifocal design, intended for daily wear for frequent/planned replacement wear or for single use daily disposable wear. The lens material is equivalent to other ocufilcon D daily wear soft (hydrophilic) contact lenses cleared under several predicate device 510(k) Premarket notifications. The lenses are in-monomer tinted from edge to edge for visibility purposes with Vat Blue 6. The Biomedics® 55 (ocufilcon D) soft (hydrophilic) contact lenses are available as sphere, asphere, toric or multifocal lenses with the following dimension ranges: - Chord Diameter: 12.5 to 18.0 mm - 0.025 to 0.40 mm (varies with power) Center Thickness 프 6.50 mm to 10.8 mm Base Curve: 트 - -20.00 D to +20.00 D ■ Spherical Powers: - 1 Add Powers: - +0.25 D to +3.00 -0.25 to -10.00 D Cylinder Powers: - 1 1° to 180° 트 Axis The physical properties of the lenses are: - Refractive Index at 25°C 1.41 ■ - Oxygen Permeability (Dk) 19.6 x 10-11 (cm2/sec) ml Oz/ml x mm Hg at 35°C (Fatt method) ■ Childelaladolano in the letter the sidentify and interest and come of the with the children in the - Light Transmittance >95% ■ - · Water Content 55 % {3}------------------------------------------------ #### 8. Predicate Devices Information: The modified device includes sphere/asphere, toric and multifocal configurations. The predicate devices are as follows: The predicate devices are the ocufilcon D Daily Wear Soft Contact Lenses: K972303, August 20, 1997; Predicate K012425, October 12, 2001; Devices Information K020193, February 28, 2002; and P890023/S004, August 28, 1996; #### 9. Nonclinical Tests Performed: Physiochemical and toxicological studies were conducted as applicable to support a determination of substantial equivalence. #### 10. Conclusions of NonClinical Tests Performed: #### Physiochemical: ● The physical, optical and chemical properties of this lens remain unchanged from the unmodified device, and are within established specifications for the lenses. #### 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 ocufilcon D soft contact lenses currently marketed by CooperVision, therefore no clinical data is required. ದಿಂದ ವಿರುದು ಮಾಡಿದೆ ಎಂದು ನಿರ್ವಹಿಸಿದರು. ವಿವಿಧಿಯ ಮುದ್ರಿ ಮಾಡಿದ್ದ ಮಾಡಿದ್ದ ಪ್ರದ {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for CooperVision. The logo consists of the word "CooperVision" in a stylized font, followed by a graphic of an eye. The eye graphic is enclosed in a square and has a registered trademark symbol next to it. 1091339 ### 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 as the unmodified device currently marketed by CooperVision, Inc. 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. Special 510(k) ocufilcon Pg 8 Bellerathan Shamble of Architection of Richtranskinner of Shipper of Ship and Schilders and {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 CooperVision, Inc. c/o Ms. Lisa Hahn Director, Global Regulatory Affairs 1215 Boissevain Avenue Norfolk, VA 23507 JAN - 5 2010 Re: K091339 Trade/Device Name: Biomedics® 55% (ocufilcon D) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886,5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: II Product Code: LPL, MVN Dated: December 11, 2009 Received: December 14, 2009 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 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 mav 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdagoy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation.(21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 vours. R. K. Thampy M.L. Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and A Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): K091339 #### Device Name: Biomedics® 55 (ocufilcon D) Soft (Hydrophilic) Contact Lens for Daily Wear for Frequent/Planned Replacement Wear or Daily Disposable Wear Indications for Use: Spherical and Aspherical - Biomedics 55 (ocufilcon D) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from - 20.00D to +20.00D diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. Toric - Biomedics 55 (ocufilcon D) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters. Multifocal - Biomedics 55 (ocufilcon D) MULTIFOCAL lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +10.00 diopters and with add powers from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for single use daily disposable wear or for planned replacement. As prescribed for single use daily disposable wear, patients are instructed to dispose of the lens at each removal. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system. Prescription Use X (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) Anna Postell (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number t091339