BAUSCH + LOMB NESOFILCON A CONTACT LENS

{0}------------------------------------------------ JUN - 5 2012 #### 510(k) SUMMARY ### Submitter Information: | Date Prepared: | May 31, 2012 | |-----------------|--------------------------------------------------------------| | Name: | Bausch & Lomb Incorporated | | Address: | 1400 North Goodman Street<br>Rochester, NY 14609 | | Contact Person: | Barbara Klube-Falso<br>Specialist, Global Regulatory Affairs | | Phone Number: | (585) 338-8503 | | Email: | Barbara.Klube-Falso@bausch.com | #### Device Information: | Trade Name: | Bausch + Lomb nesofilcon A contact lens | |--------------|-----------------------------------------| | Common Name: | Soft daily disposable contact lens | Device Classification: Class II (21 CFR 886.5925) #### Predicate Device: Bausch + Lomb nesofilcon A contact lens is substantially equivalent to the following predicate device: Bausch + Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in K061157 on June 22, 2006. #### Device Description: The Bausch + Lomb contact lens is made from nesofilcon A material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 78% water by weight when immersed in a sterile borate buffered saline with 0.5% poloxamine solution. This packaging solution is currently used with other Bausch + Lomb contact lenses. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106. The Bausch + Lomb nesofilcon A contact lens is to be prescribed for single-use disposable wear. {1}------------------------------------------------ The physical properties of the lens are: | Refractive index | 1.374 | |---------------------|----------------------------------------------------------------------------| | Light transmission | 99% | | Water Content | 78% | | Specific Gravity | 1.039 | | Oxygen Permeability | 42 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method) | The lenses will be manufactured with the following properties: | Diameter | 13.5mm to 15.0mm | |------------------|--------------------| | Center Thickness | 0.05mm to 0.75mm | | Base Curve | 7.8mm to 9.5mm | | Power Range | +20.00D to -20.00D | The lenses are packaged in disposable blister packages containing borate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters measurement. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process. #### Intended Use: Bausch + Lomb nesofilcon A contact lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.00D to -20.00D. The nesofilcon A contact lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal. {2}------------------------------------------------ # Technological Characteristics (comparison to Predicate Device) The table below shows a side-by-side comparison of the predicate device to the new device: | Property | Predicate Device<br>Bausch + Lomb SofLens® Daily<br>Disposable (hilafilcon B) Visibility<br>Tinted Contact Lens | New Device<br>Bausch + Lomb nesofilcon A<br>contact lens | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | Intended Use | Indicated for the daily wear<br>correction of refractive ametropia<br>(myopia,hyperopia and astigmatism)<br>in aphakic and/or non-aphakic<br>persons with non-diseased eyes<br>that exhibit refractive astigmatism<br>up to 2.00 diopters or less, that does<br>not interfere with visual acuity. The<br>lens is to be prescribed for single-<br>use disposable wear, and is to be<br>discarded after each removal. | Same as predicate | | Functionality | The contact lenses act as a<br>refractive medium that focus light<br>rays from near and distant objects<br>on the retina. | Same as predicate | | Modality | Daily wear contact lens | Same as predicate | | Manufacturing<br>Method | Cast Molded | Same as predicate | | Material Group | Group II<br>(high water, no ionic polymers) | Same as predicate | | USAN Name | hilafilcon B | nesofilcon A | | Water Content | 59% | 78% | | Oxygen Permeability1<br>(edge corrected) | 22 | 42 | | Oxygen Permeability1<br>(non-edge corrected) | NA | 50 | | Specific Gravity | 1.119 | 1.039 | | UV Blocker | NA | Yes | 1 - Oxygen Permeability shown was determined by the polarograhic method: x 10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C {3}------------------------------------------------ ## Summary of Non-Clinical Testing: The testing performed on the Bausch + Lomb nesofilcon A contact lens demonstrated that the device functions in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user. In addition, Bausch + Lomb followed the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the following tests were conducted: Toxicology / Biocompatibility In-Vitro Cytotoxicity Ocular Irritation Study Systemic Toxicity ### Chemistry / Leachables Physical, Chemical and Spectral Properties Leachable Monomer and Additives ### Summary of Clinical Performance Data Bausch + Lomb conducted a controlled clinical study, comparing the safety and efficacy of Bausch + Lomb nesofilcon A contact lens to Bausch + Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens. The results of the study support a substantial equivalence determination. ## Substantial Equivalence Conclusion: The cumulative results of laboratory, in vivo testing as well as the clinical study sponsored by Bausch + Lomb demonstrate that the safety, efficacy and performance of Bausch + Lomb nesofilcon A contact lens are substantially equivalent to Bausch + Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens. {4}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN. - 5 2012 Bausch + Lomb, Inc. c/o Ms. Barbara Klube-Falso Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester. NY 14609 K113703 Re: > Trade/Device Name: Bausch + Lomb nesofilcon A contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: MVN, and LPL Dated: May 25, 2012 Received: May 29, 2012 Dear Ms. Klube-Falso: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 may publish further announcements concerning your device in the Federal Register. {5}------------------------------------------------ # Page 2 - Ms. Barbara Klube-Falso 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Kesia Alexander Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Indications for Use Statement #### 510(k) Number (if known): K113703 Device Name: Bausch + Lomb nesofilcon A contact lens #### nesofilcon A Bausch + Lomb nesofilcon A contact lens is indicated for the daily wear correction of refractive ametropia (myopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.00D to -20.00D. The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal. Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) #### Concurrence of CDRH, Office of Device Evaluation (ODE) Hampton for Kwawczyk. (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 413703 510(k) Number _