Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 8, 2023 Bausch & Lomb Incorporated Barbara Klube-Falso Director, Regulatory Affairs 1400 North Goodman street Rochester, NY 14609 ## Re: K220613 Trade/Device Name: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 31, 2023 Received: February 3, 2023 Dear Barbara 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # J Angelo Green -S J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure Image /page/1/Picture/9 description: The image shows the logo for the Food and Drug Administration (FDA). The logo consists of the letters "FDA" in a sans-serif font. The letters are a light blue color. The logo is simple and recognizable, and it is often used on products that have been approved by the FDA. {2}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K220613 #### Device Name Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia Indications for Use (Describe) Kalifilcon A Contact Lens Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens maybe prescribed in spherical powers ranging from +20.00D to -20.00D. #### Kalifilcon A Contact Lens for Astigmatism Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (ന്യാഗ്രം, hyperopia and astigmatism) in aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters. #### Kalifilcon A Contact Lens for Presbyopia Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuty. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D. 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) | <span style="text-decoration: overline;">☑</span> 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 K220613 ## Submitter Information: | Date Prepared: | January 31, 2023 | |-----------------|-----------------------------------------------------| | Name: | Bausch & Lomb Incorporated | | Address: | 1400 North Goodman Street<br>Rochester, NY 14609 | | Contact Person: | Barbara Klube-Falso<br>Director, Regulatory Affairs | | Phone Number: | (585) 338-8503 | | Email: | Barbara.Klube-Falso@bausch.com | #### Device Information: | Trade Name: | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, | |------------------------|--------------------------------------------------------------------------------------| | | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for<br>Astigmatism, and | | | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for<br>Presbyopia | | Common Name: | Soft Daily Disposable Contact Lens | | Classification Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) | | Device Classification: | Class II | Product Code: LPL, MVN #### Predicate Devices: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens and Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism cleared under K200528 and Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens cleared under K210975. #### Device Description: {4}------------------------------------------------ The Bausch + Lomb kalifilcon A material is made from a hvdrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with poloxamine, poloxamer 181, qlycerin, erythritol, and polyguaternium. 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 Bausch + Lomb kalifilcon A Contact Lenses are to be prescribed for single-use disposable wear. The physical properties of the lenses are: | Refractive index | 1.4011 | |---------------------|--------------------------------------------------------------------------------| | Light transmission | 97% | | Water Content | 55% | | Specific Gravity | 1.029 | | Oxygen Permeability | 107 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C<br>(polarographic method) | The lenses will be manufactured in spherical, toric and multifocal designs with the following parameters: | 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 | | Cylinder Power (Toric) | -0.75D to -5.00D | | Cylinder Axis | 0° to 180° | | Add Power (Multi-Focal) | +0.75D to +5.00D | The lenses are packaged in disposable blister packages containing phosphate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters. Expiration dating is supported by product stability. package integrity, and validation of the sterilization process. #### Indications for Use: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D. Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters. Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia, in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or {5}------------------------------------------------ less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D. The lens is to be prescribed for single-use disposable wear and is to be discarded after each removal. | Property | Predicate Device<br>Bausch + Lomb<br>kalifilcon A Contact Lenses<br>K200528 | Predicate Device<br>Bausch + Lomb<br>kalifilcon A Contact Lens for<br>Presbyopia<br>K210975 | Subject Device<br>Bausch + Lomb<br>kalifilcon A Contact<br>Lenses | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Intended Use | Bausch + Lomb kalifilcon A<br>Contact Lens is indicated for the<br>daily wear correction of refractive<br>ametropia (myopia and hyperopia)<br>in aphakic and/or non-aphakic<br>persons with non-diseased eyes<br>that exhibit refractive astigmatism<br>of 2.00 diopters or less, that does<br>not interfere with visual acuity. The<br>lens may be prescribed in<br>spherical powers ranging from<br>+20.00D to -20.00D.<br>Bausch + Lomb kalifilcon A<br>Contact Lens for Astigmatism is<br>indicated for the daily wear<br>correction of refractive ametropia<br>(myopia, hyperopia and<br>astigmatism) in aphakic and/or<br>non-aphakic persons with non-<br>diseased eyes, exhibiting<br>astigmatism of up to 5.00 diopters,<br>that does not interfere with visual<br>acuity.<br>The lens is to be prescribed for<br>single-use disposable wear and is<br>to be discarded after each<br>removal. | Bausch + Lomb (kalifilcon A)<br>Soft (hydrophilic) Contact<br>Lens for Presbyopia is<br>indicated for daily wear for the<br>correction of refractive<br>ametropia (myopia and<br>hyperopia) and presbyopia in<br>aphakic and/or non-aphakic<br>persons with non-diseased<br>eyes, exhibiting astigmatism<br>of 2.00 diopters or less, that<br>does not interfere with visual<br>acuity. The lens may be<br>prescribed in spherical<br>powers ranging from +20.00D<br>to -20.00D with add powers<br>ranging from +0.75D to<br>+5.00D.<br>The lens is to be prescribed<br>for single-use disposable<br>wear and is to be discarded<br>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. | The contact lenses act as a<br>refractive medium that focus<br>light rays from near and<br>distant objects on the retina. | Same as predicate | | Modality | Daily Disposable | Daily Disposable | Same as predicate | | Manufacturing<br>Method | Cast Molded | Cast Molded | Same as predicate | | Material<br>Group | Group 5-B Silicone Hydrogel<br>(high water, non-ionic) | Group 5-B Silicone Hydrogel<br>(high water, non-ionic) | Same as predicate | | USAN Name | kalifilcon A | kalifilcon A | Same as predicate | | Water<br>Content | 55% | 55% | Same as predicate | | UV Blocker | Yes | Yes | Same as predicate | | Sterilization | Air Over Steam | Air Over Steam | Same as predicate | | Packaging | Polypropylene blister with plastic<br>coated aluminium foil blister | Polypropylene blister with<br>plastic coated aluminium foil<br>blister | Same as predicate | | Packaging<br>Solution | Phosphate Buffered Saline | Phosphate Buffered Saline | Phosphate<br>Buffered Saline<br>with<br>polyquaternium | ## Technological Characteristics (comparison to predicate devices): {6}------------------------------------------------ ## Summary of Non-Clinical Testing: The testing performed on the Bausch + Lomb kalifilcon 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 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 The Chemistry / Leachables testing performed on the predicate device, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, K200528, demonstrated that the device functions in a safe and effective manner. The subject device is of the identical lens material, manufacturing process, sterilization process, and packaging as the predicate device, and the finished lens parameters fall within the ranges previously cleared for the predicate device and therefore the previous testing is fully applicable. Due to the additional inqredient in the packaging solution, toxicology and biocompatibility testing was repeated on the subject devices. The results were consistent with the predicate devices, the kalifilcon A contact lenses are non-cytotoxic, not an ocular irritant or a sensitizing agent. #### Summary of Clinical Performance Data {7}------------------------------------------------ Clinical performance data to confirm safety and effectiveness of the kalifilcon A lens material was obtained and provided in K200528. Because the subject device is of the identical lens material, kalifilcon A, the clinical study performed on the predicate device is applicable and no additional clinical study was performed. ### Substantial Equivalence Conclusion: The information submitted in this premarket notification supports the determination that the Bausch + Lomb kalifilcon A Contact Lenses are substantially equivalent in principles of operation, technology, materials and indications for use to the predicate devices listed above.