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.

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 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.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria for an AI/ML medical device.

The document is a 510(k) premarket notification for a soft (hydrophilic) contact lens, specifically the "Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (CooperVision's Frequency 55 series) based on physical, chemical, and optical properties, and manufacturing process.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document. If you have a different document related to an AI/ML medical device, please provide it.

Summary

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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

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(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

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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)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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.,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,(21 CFR 886.5925, Product Code LPL)Lenses, Soft Contact, Daily Wear (Disposable),(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,Frequency 55 Aspheric, Encore, EncoreToric, CooperFlex and Onevue(methafilcon A) Soft (hydrophilic)Contact Lens
Manufacturer	CooperVision, Inc.
510(k) Number	K993252
Product Code	MVN; LPL

1.5 Device Description

06/21/2018

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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.

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

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. 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)Daily Wear Soft(hydrophilic) Contact Lens	Frequency 55, Frequency55 UV, Frequency 55Aspheric, Encore, EncoreToric, CooperFlex andOnevue (methafilcon A)Soft (hydrophilic) ContactLens
Manufacturer	Largan Medical Inc.	CooperVision Inc.
Intended Use	Myopia, Hyperopia,astigmatism, Presbyopia	Myopia, Hyperopia,astigmatism
Lens Design	aspherical, toric, ormultifocal	spherical, toric
Replacement Schedule	Daily Wear	The same
Chemical composition	Methafilcon A	The same
Classification	Group IV (Ionic, Highwater)	The same
Water Content	55 % (>50%)	55 % (>50%)

06/21/2018

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Oxygen Permeability(DK, 35°C)	18(Fatt method)	19.7(Fatt method)
Base Curve Range(mm)	8.0~9.0	8.0~9.5
Diameter (mm)	13.0~15.0	14.2~15.0
Center Thickness	Varies with design andpower(0.084 mm at -3.00D)	Varies with design andpower(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 ofManufacture	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.

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06/21/2018

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.