Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist

{0}------------------------------------------------ Image /page/0/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 image of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 11, 2016 Bausch & Lomb, Inc. Ms. Barbara Klube-Falso Manager, Regulatory Affairs 1400 North Goodman Street Rochester. NY 14609 Re: K151918 Trade/Device Name: Biotrue Oneday with NaturMoist; Biotrue Oneday for Presbyopia with NaturMoist; Biotrue Oneday for Astigmatism with NaturMoist Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 4, 2016 Received: January 5, 2016 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. {1}------------------------------------------------ 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 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 for 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151918 #### Device Name Biotrue ONEday Contact Lenses with NaturMoist ## Indications for Use (Describe) Spherical: The Bausch + Lomb Lomb Biotrue® ONEday (nesofilcon A) Contact Lens with NaturMoist 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. Multifocal: The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D. Toric: The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear. The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | Date Prepared | July 10, 2015 | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | Bausch & Lomb Incorporated<br>1400 North Goodman Street, Rochester, New York 14609<br>585.338.8503 | | Contact | Barbara Klube-Falso | | Trade names | Biotrue ONEday (nesofilcon A) Soft (Hydrophilic) Contact Lens with<br>NaturMoist<br>Biotrue ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact<br>Lens with NaturMoist<br>Biotrue ONEday for Astigmatism (nesofilcon A) Soft (Hydrophilic)<br>Contact Lens with NaturMoist | | Common name | soft contact lenses (hydrophilic) | | Classification | Class II (21 CFR 886.5925 (b) (1)) | | Predicate Devices | Biotrue ONEday (nesofilcon A) Soft (Hydrophilic) Contact Lenses cleared<br>under K113703,<br>Biotrue ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact<br>Lenses cleared under K132715, and<br>Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic)<br>Contact Lenses cleared under K143632 | ## Device Description: The Biotrue ONEday Contact Lens with NaturMoist is a soft hydrophilic contact lens. The lenses are made from the 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 solution with poloxamine and sodium hyaluronate. 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 380mm. This lens is tinted blue with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106. The physical / optical properties of the lens are: | Specific Gravity: | 1.039 | |----------------------|--------------------------------------------------------------------------------| | Refractive Index: | 1.374 | | Light Transmittance: | 99% | | Water Content: | 78% | | Oxygen Permeability: | 42 x 10-11 [cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C<br>(polarographic method) | {4}------------------------------------------------ The lenses will be manufactured in the following parameter ranges: | Diameter: | 13.5mm to 15.5mm | |-------------------|--------------------------------------| | Center Thickness: | 0.05mm to 0.75mm (varies with power) | | Base Curve: | 7.8mm to 9.5mm | | Power Range: | +20.00D to -20.00D | | Add Power: | +0.75D to +5.00D | | Cylinder Powers: | -0.75D to -5.00D | | Cylinder Axis: | 0º to 180º | # Indications for Use: # Bioture ONEday Contact Lenses with NaturMoist # Spherical: The Bausch + Lomb Biotrue® ONEday (nesofilcon A) Soft (Hydrophilic) Contact Lens with NaturMoist 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. # Multifocal: The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D. ## Toric: The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear. The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal. {5}------------------------------------------------ # Technological Characteristics | Property | Biotrue ONEday<br>SVS<br>(predicate) | Biotrue ONEday<br>Multi-Focal<br>(predicate) | Biotrue ONEday<br>Toric<br>(predicate) | Biotrue ONEday<br>Contact Lenses<br>with NaturMoist<br>(Subject Device) | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Functionality | The contact lens acts<br>as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. | The contact lens<br>acts as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. | The contact lens acts<br>as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. | Same as predicate | | Modality | Daily wear contact<br>lens | Daily wear contact<br>lens | Daily wear contact<br>lens | Same as predicate | | Manufacturing<br>Method | Cast Mold | Cast Mold | Cast Mold | Same as predicate | | Material<br>Group | Group II<br>(high water, no ionic<br>polymers) | Group II<br>(high water, no ionic<br>polymers) | Group II<br>(high water, no ionic<br>polymers) | Same as predicate | | USAN Name | Nesofilcon A | Nesofilcon A | Nesofilcon A | Same as predicate | | Water Content | 78% | 78% | 78% | Same as predicate | | UV Blocker | yes | yes | yes | Same as predicate | | Sterilization | Air over steam | Air over steam | Air over steam | Same as predicate | | Physical/optic<br>al properties | Specific Gravity:<br>1.039<br>Refractive index:<br>1.374<br>Surface Character:<br>Hydrophilic | Specific Gravity:<br>1.039<br>Refractive index:<br>1.374<br>Surface Character:<br>Hydrophilic | Specific Gravity:<br>1.039<br>Refractive index:<br>1.374<br>Surface Character:<br>Hydrophilic | Same as predicate | | Oxygen<br>Permeability | $42 x 10^{-11*}$ | $42 x 10^{-11*}$ | $42 x 10^{-11*}$ | Same as predicate | | Light<br>Transmittance | 99% | 99% | 99% | Same as predicate | | Color Additive | Reactive Blue Dye<br>246 | Reactive Blue Dye<br>246 | Reactive Blue Dye<br>246 | Same as predicate | | Lens Design | Spherical | Multi-Focal | Toric | Same as predicates | | Packaging | Polypropylene<br>blister with plastic<br>coated aluminum<br>foil blister | Polypropylene<br>blister with plastic<br>coated aluminum<br>foil blister | Polypropylene<br>blister with plastic<br>coated aluminum<br>foil blister | Same as predicate | Bausch & Lomb Incorporated {6}------------------------------------------------ | Difference | | | | | |-----------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------| | Packaging<br>Solution | Borate Buffered<br>Saline with<br>poloxamine | Borate Buffered<br>Saline with<br>poloxamine | Borate Buffered<br>Saline with<br>poloxamine | Borate Buffered<br>Saline with<br>poloxamine and<br>sodium<br>hyaluronate | *[cm302(STP) x cm]/(sec x cm² x mmHg)(@35°C (polarographic method) # Summary of Non-Clinical Performance Data Non-Clinical Tests: Testing conducted followed FDA guidance, FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994. The testing performed demonstrated that the devices continue to function 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. Clinical Tests: The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device, therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device. ## Substantial Equivalence: The Biotrue ONEday Contact Lenses with NaturMoist are substantially equivalent to the predicate devices as they have the same functional and scientific technology, lens characteristics and the intended use is identical to that of the predicate device.