The Largan U38(Polymacon) 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 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia) 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 +0.75 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, astigmatisam and presbyopia. The Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. It is supplied in a sterile package with buffered saline solution.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a soft contact lens, which means the device (Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens) is being compared to a legally marketed predicate device (Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens, K042824). In this context, the acceptance criteria are generally that the new device is "substantially equivalent" to the predicate device in terms of safety and effectiveness, based on comparable technological characteristics and non-clinical performance data.

Here's an breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the Largan U38 contact lens's characteristics and performance are comparable to the predicate device (Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens). The "Reported Device Performance" in this case refers to the characteristics and non-clinical test results of the Largan U38 lens, which were presented to demonstrate this comparability.

Characteristic / Test	Acceptance Criteria (Predicate Device K042824)	Reported Device Performance (Largan U38)	Outcome / Comparability
Material	Polymacon	Polymacon	Same
Classification	Group I (Nonionic, Low water)	Group I (Nonionic, Low water)	Same
Water Content	38% (<50%)	38% (<50%)	Same
Oxygen Permeability	8.0 (Fatt method)	8.0 (Fatt method)	Same
Intended Use	Myopia, Hyperopia, Astigmatism, Presbyopia	Myopia, Hyperopia, Astigmatism, Presbyopia	Same
Lens Design	Aspherical, Toric, or Multifocal (implied by predicate)	Aspherical, Toric, or Multifocal	Same
Replacement	Daily Wear	Daily Wear	Same
Base Curve Range (mm)	8.4-9.0	8.0-9.0	Comparable
Diameter (mm)	14.0-15.0	13.0-15.0	Comparable
Center Thickness	Varies with design and power (0.03 mm to 0.40 mm)	Varies with design and power (0.100 mm at -3.00D)	Comparable
Powers	-20.00D to +20.00D	-10.00D to +3.00D	Range Difference Accepted
Refractive Index	1.430	1.435	Comparable
Light Transmittance	>97%	90%	Comparable
Blue handling tint	C.I. Reactive Blue #4	Reactive Blue 247	Different formulation, but for same purpose (handling visibility)
Method of Manufacture	Cast Molded	Cast Molded	Same
Oxygen permeability, refractive index, water content, polymerization residuals, modulus, tensile strength, elongation to break, toughness, sterility, and shelf-life tests	Within established specifications for predicate (implied via K042824 clearance)	Within established specifications for the lenses (Largan U38)	Acceptable
Toxicology (Cytotoxicity, ocular irritation, systemic toxicity for material and packaging)	Non-toxic, biocompatible (implied via K042824 clearance)	Non-toxic, biocompatibility acceptable	Acceptable

2. Sample size used for the test set and the data provenance

The document indicates that no clinical data was required for the Largan U38 contact lens because "The lens material is the same as Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824)." This implies that the "test set" for proving substantial equivalence primarily relied on non-clinical tests comparing the physical, chemical, and optical properties of the Largan U38 lens to established standards and the predicate device.

Sample Size for Non-Clinical Tests: Not explicitly stated for each test, but typically these involve a sufficient number of units to demonstrate reproducibility and meet statistical requirements for the specific ISO standards cited (e.g., ISO18369-2, ISO18369-3, ISO18369-4, ISO11987, ISO17665-1, ISO17665-2).
Data Provenance: The manufacturing company is Largan Medical Co., Ltd. located in Taichung, Taiwan, so the non-clinical test data would originate from their facilities or contracted labs, likely in Taiwan. The data is reported in the context of a 510(k) submission, confirming it's a prospective submission of data collected for this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical studies were performed for the Largan U38, there isn't a "ground truth" established by external experts in the traditional sense of clinical trial adjudication (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would be the accepted scientific and engineering standards (e.g., ISO standards) and the performance characteristics of the legally marketed predicate device.

Experts: The expertise would reside in the engineers and scientists performing the non-clinical tests and the regulatory reviewers at the FDA. The FDA's Ophthalmic and Ear, Nose, and Throat Devices panel would review the submission. No specific number or qualifications of "experts establishing ground truth" are detailed as would be for a clinical study.

4. Adjudication method for the test set

No formal adjudication method (like 2+1 or 3+1 consensus) is described because no specific clinical test set requiring expert interpretation or consensus was performed for the Largan U38's substantial equivalence determination. The assessment was based on comparing the non-clinical test results against predefined specifications and the predicate device's characteristics.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a medical device (contact lens), not an AI/CAD system. Therefore, no MRMC study or AI-assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This submission is for a medical device (contact lens), not an AI algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence for the Largan U38 contact lens was primarily:

Established scientific and engineering specifications: Adherence to relevant ISO standards (e.g., ISO18369, ISO11987, ISO17665).
Predicate device characteristics: The established safety and effectiveness profile of the legally marketed Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824).
Non-clinical test results: Data from physical, optical, chemical, and sterility tests performed on the Largan U38.
Material composition: The fact that the lens material (Polymacon) is identical to the predicate device was a key factor in waiving clinical studies.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this contact lens submission, as it's not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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November 13, 2018

Largan Medical Co., Ltd Amy Tien RA Specialist 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung, 40850 Taiwan

Re: K182674

Trade/Device Name: Largan U38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 20, 2018 Received: September 26, 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. 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 eyaluate 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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

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) K182674

Device Name

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

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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K182674 510(k) Summary

Preparation Date: Sep 20, 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 U38(Polymacon) Daily Wear Soft (hydrophilic) 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:

1.4.1 Lens material, lens design, and intended use:

Predicate Device Name	Frequency 38 and Silver 07
	(polymacon)Soft
	(hydrophilic) Contact Lens
Manufacturer	CooperVision, Inc.
510(k) Number	K042824
Product Code	LPL

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1.5 Device Description

1.6 Indication for Use:

The Largan U38(Polymacon) 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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-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 U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eves and whose powers are from -10.00 to +3.00 diopters with add powers from +0.75 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.

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1.7 Technological characteristic

Largan U38(Polymacon) 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:0.100 mm for -3.00 D
Power: +3.00 to -10.00 D

Largan U38(Polymacon) 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:0.100 mm for -3.00 D
Power: +3.00 to -10.00 D ●
Cylinder: -0.25D to -5.00 D .
Axis: 10° to 180° (in 10° increments)

Largan U38(Polymacon) 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:0.100 mm for -3.00 D
. Power: +3.00 to -10.00 D
Additional Powers: +0.75D to +3.50D .

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1.8 Comparison table:

The characteristic comparison to predicate device is summarized in the following table.

Item	Subject Device	Predicate (K042824)
Product Name	Largan U38(Polymacon) DailyWear Soft (hydrophilic) ContactLens	Frequency 38 and Silver 07(polymacon) Soft (hydrophilic)Contact Lens
Manufacturer	Largan Medical Inc.	CooperVision Manufacturing, Ltd.
Intended Use	Myopia, Hyperopia,astigmatism, Presbyopia	The same
Lens Design	Aspherical, toric, ormultifocal	The same
Replacement	Daily Wear	The same
Chemical	Polymacon	The same
Classification	Group I (Nonionic, Lowwater)	The same
Water Content	38 % (<50%),	The same
OxygenPermeability	8.0(Fatt method)	The same
Base Curve Range(mm)	8.0~9.0	8.4~9.0
Diameter (mm)	13.0~15.0	14.0~15.0
	Varies with design and	Varies with design and
Center Thickness	power	power
	(0.100 mm at -3.00D)	(0.03 mm to 0.40 mm)
Powers	-10.00D to +3.00D	-20.00D to +20.00D
Refractive Index	1.435	1.430
Light Transmittance	90%	>97%
Blue handling tint	Reactive Blue 247	C.I. Reactive Blue #4
Method ofManufacture	Cast Molded	Cast Molded

1.9 Nonclinical Tests Performed

1.9.1 Oxygen permeability, refractive index, water content, polymerization residuals, modulus, tensile strength, elongation to break, toughness, sterility, and shelf-life tests were performed. The physical, optical, chemical and sterility properties of the lens are within established specifications for the lenses.

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· ISO18369-2 Ophthalmic optics Contact lenses Part 2: Tolerances
· ISO18369-3 Ophthalmic optics Contact lenses Part 3: Measurement Methods
· ISO18369-4 Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials
· ISO11987 Ophthalmic optics -- Contact lenses-Determination of shelf-life
· ISO17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
· ISO17665-2 sterilization Of Health Care Products Moist Heat Part 2: Guidance on the Application of ISO 17665-1.
1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
- ●Polymacon material Cytotoxicity, ocular irritation, systemic toxicity
- · Packaging materials Cytotoxicity, ocular irritation, systemic toxicity

1.10 Clinical Studies

The lens material is the same as Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824). Therefore, no clinical data is required.

1.11 Conclusion

Comparison to the predicate devices for chemical composition, physical and optical properties. it shows that " Largan U38(Polymacon) Daily Wear Soft (hydrophilic) Contact Lens " is as safe, as effective and performs as well as the predicate devices.

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.