Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

K182674 · Largan Medical Co., Ltd. · LPL · Nov 13, 2018 · Ophthalmic

Device Facts

• Record ID: K182674
• Device Name: Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
• Applicant: Largan Medical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Nov 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended 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. 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 Story

Largan U38 is a daily wear, soft, hydrophilic contact lens; hemispherical flexible shell design; aspherical, toric, or multifocal configurations. Material: Polymacon (HEMA and EGDMA copolymer); 38% water content; contains Reactive Blue 247 handling tint and benzophenone UV-absorbing monomer. Used by patients for vision correction; prescribed by eye care practitioners for single-use disposable or frequent/planned replacement. Supplied in sterile buffered saline. Benefits include refractive error correction and UV radiation blocking. No clinical data required due to material equivalence to predicate.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including oxygen permeability, refractive index, water content, polymerization residuals, modulus, tensile strength, elongation, toughness, sterility, shelf-life, and biocompatibility (cytotoxicity, ocular irritation, systemic toxicity).

Technological Characteristics

Material: Polymacon (HEMA/EGDMA); 38% water content; non-ionic. UV-absorbing monomer included. Manufacturing: Cast molded. Standards: ISO 18369-2, -3, -4; ISO 11987; ISO 17665-1/2. Sterilization: Moist heat.

Indications for Use

Indicated for correction of refractive ametropia (myopia/hyperopia), astigmatism, and presbyopia in phakic or aphakic persons with non-diseased eyes. Power ranges: -10.00 to +3.00D; astigmatic correction: -0.25 to -5.00D; add powers: +0.75 to +3.50D.

Regulatory Classification

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.

Predicate Devices

• Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lens (K042824)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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.,<br>Taichung, 40850, Taiwan |
| Phone No. | 886-4-3600-0203 |
| Fax No. | 886-4-3601-0203 |
| E-mail | [e-mail] |

## 1.2 Contact Person:

| Phone No. | 886-4-3600-0203 |
|--------------|--------------------------|
| Fax No. | 886-4-3601-0203 |
| Contact Name | Amy Tien |
| E-mail | [e-mail] |

# 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,<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:

## 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

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.

#### 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.

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.

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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) Daily<br>Wear Soft (hydrophilic) Contact<br>Lens | Frequency 38 and Silver 07<br>(polymacon) Soft (hydrophilic)<br>Contact Lens |
| Manufacturer | Largan Medical Inc. | CooperVision Manufacturing, Ltd. |
| Intended Use | Myopia, Hyperopia,<br>astigmatism, Presbyopia | The same |
| Lens Design | Aspherical, toric, or<br>multifocal | The same |
| Replacement | Daily Wear | The same |
| Chemical | Polymacon | The same |
| Classification | Group I (Nonionic, Low<br>water) | The same |
| Water Content | 38 % (<50%), | The same |
| Oxygen<br>Permeability | 8.0<br>(Fatt method) | The same |
| Base Curve Range<br>(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 of<br>Manufacture | 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.