Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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. June 25, 2018 Largan Medical Co. Ltd. Amy Tien, RA Specialist 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist. Taichung, 40850, Taiwan Re: K181230 Trade/Device Name: Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 (methafilcon A) Daily Wear 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: April 16, 2018 Received: May 9, 2018 Dear Amy Tien: 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. 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 {1}------------------------------------------------ (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. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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) K181230 #### Device Name Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA #### Indications for Use (Describe) The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a Daily Wear Soft (hydrophilic) Contact Lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. Type of Use (Select one or both, as applicable) | <div> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 K181230 ## Preparation Date: June 21, 2018 #### 1.1 Establishment Information: | Name | Largan Medical Co. Ltd. | |-----------|-------------------------------------------------------------------------------------------| | Owner | Adam Lin | | Title | CEO | | Address | 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist.,<br>Taichung, 40850, Taiwan | | Phone No. | 886-4-3600-0203 | | Fax No. | 886-4-3601-0203 | | E-mail | info@larganmed.com.tw | #### 1.2 Contact Person: | Phone No. | 886-4-3600-0203 | |--------------|--------------------------| | Fax No. | 886-4-3601-0203 | | Contact Name | Amy Tien | | E-mail | amytien@larganmed.com.tw | # 1.3 Device Identification: | Proprietary Name | Largan 55(Methafilcon A) Daily Wear Soft Contact Lens | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | Soft (hydrophilic) Contact Lenses | | Classification Name | Lenses, Soft Contact, Daily Wear,<br>(21 CFR 886.5925, Product Code LPL)<br>Lenses, Soft Contact, Daily Wear (Disposable),<br>(21 CFR 886.5925, Product Code MVN) | | Classification | II | | Regulation Number | CFR 886.5925 | | Review Panel | Ophthalmic | | Product Code | LPL/MVN | #### 1.4 Legally Marketed Equivalent Device: | Predicate Device Name | Frequency 55, Frequency 55 UV,<br>Frequency 55 Aspheric, Encore, Encore<br>Toric, CooperFlex and Onevue<br>(methafilcon A) Soft (hydrophilic)<br>Contact Lens | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | CooperVision, Inc. | | 510(k) Number | K993252 | | Product Code | MVN; LPL | ## 1.5 Device Description The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 45% methafilcon A and 55% water. A light blue color tinted with "reactive 06/21/2018 {4}------------------------------------------------ Blue 246" is for handling visibility purpose. Benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.53% (< 0.05Tv) in the UVB range of 280-315nm and 22.36 % (< 0.5Tv) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution. ## 1.6 Indication for Use: The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. # 1.7 Technological characteristic Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens characteristics: - Diameter Range : 13.0 to 15.0 mm . - . Base Curve : 8.0 to 9.0 mm - . Center Thickness : 0.084 mm for -3.00D (varies with power) page2 06/21/2018 {5}------------------------------------------------ - . Power : +3.00 to -10.00 D # Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism characteristics: - . Diameter Range : 13.0 to 15.0 mm - . Base Curve : 8.0 to 9.0 mm - . Center Thickness : 0.084 mm for -3.00D (varies with power) - . Power : +3.00 to -10.00 D - . Cylinder: -0.25D ~ -5.00 D - . Axis: 10°to 180°(in 10°increments) # Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia characteristics: - . Diameter Range : 13.0 to 15.0 mm - . Base Curve : 8.0 to 9.0 mm - . Center Thickness : 0.130 mm for -3.00D (varies with power) - . Power : +3.00 to -10.00 D - . Additional Powers: +0.25D ~ +3.50D #### 1.8 Comparison table: The characteristic comparison to predicate device is summarized in the following table. | Similarities and differences | | | |------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Item | Device | Predicate (K993252) | | Product Name | Largan 55 (methafilcon A)<br>Daily Wear Soft<br>(hydrophilic) Contact Lens | Frequency 55, Frequency<br>55 UV, Frequency 55<br>Aspheric, Encore, Encore<br>Toric, CooperFlex and<br>Onevue (methafilcon A)<br>Soft (hydrophilic) Contact<br>Lens | | Manufacturer | Largan Medical Inc. | CooperVision Inc. | | Intended Use | Myopia, Hyperopia,<br>astigmatism, Presbyopia | Myopia, Hyperopia,<br>astigmatism | | Lens Design | aspherical, toric, or<br>multifocal | spherical, toric | | Replacement Schedule | Daily Wear | The same | | Chemical composition | Methafilcon A | The same | | Classification | Group IV (Ionic, High<br>water) | The same | | Water Content | 55 % (>50%) | 55 % (>50%) | 06/21/2018 {6}------------------------------------------------ | Oxygen Permeability<br>(DK, 35°C) | 18<br>(Fatt method) | 19.7<br>(Fatt method) | |-----------------------------------|---------------------------------------------------------|-----------------------------------------------------| | Base Curve Range<br>(mm) | 8.0~9.0 | 8.0~9.5 | | Diameter (mm) | 13.0~15.0 | 14.2~15.0 | | Center Thickness | Varies with design and<br>power<br>(0.084 mm at -3.00D) | Varies with design and<br>power<br>(0.15 mm~0.60mm) | | Powers | -10.00D to +3.00D | -20.00D to +20.00D | | Refractive Index | 1.405 | 1.41 | | Light Transmittance | 90% | >96% | | Blue handling tint | Reactive Blue 246 | Reactive Blue No.4 | | Method of<br>Manufacture | Cast Molded | Cast Molded | #### 1.9 Nonclinical Tests Performed 1.9.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses. 1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment. #### 1.10 Clinical Studies The technical characteristics, formulation, manufacturing process of the subject device are equivalent to Frequency 55, Frequency 55 UV, Frequency 55 Aspheric, Encore, Encore Toric, CooperFlex and Onevue (methafilcon A) Soft (hydrophilic) Contact Lens (K993252) current marketed by CooperVision Inc., therefore no clinical data is required. #### 1.11 Conclusion Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens" is as safe, as effective and performs as well as the predicate device. page4 06/21/2018