Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA

K170286 · Largan Medical Co., Ltd. · LPL · Sep 18, 2017 · Ophthalmic

Device Facts

• Record ID: K170286
• Device Name: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
• Applicant: Largan Medical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Sep 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Largan (hioxifilcon 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 or 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 (hioxifilcon 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 (hioxifilcon 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.

Device Story

Hemispherical flexible soft contact lenses; made of hioxifilcon A (41%) and water (59%); includes UV-blocking monomer and Reactive Blue 247 handling tint. Designed for daily wear; prescribed by eye care practitioners for single-use disposable or frequent replacement schedules. Corrects refractive errors (myopia, hyperopia, astigmatism, presbyopia) by altering light refraction entering the eye. Supplied sterile in buffered saline. Benefits include vision correction and UV protection. Used by patients in daily life; requires chemical disinfection if not single-use.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including physiochemical studies per ISO 18369 and toxicology/biocompatibility assessments.

Technological Characteristics

Material: 41% hioxifilcon A, 59% water. UV blocker: benzotriazole monomer. Handling tint: Reactive Blue 247. Manufacturing: Cast molded. Diameter: 13.0-15.0 mm. Base curve: 8.0-9.0 mm. Oxygen permeability (Dk): 22 (Fatt method). Refractive index: 1.403. Sterilization: Sterile in buffered saline.

Indications for Use

Indicated for correction of myopia, hyperopia, astigmatism, and presbyopia in phakic or aphakic persons with non-diseased eyes. Power range -10.00D to +3.00D; astigmatic correction -0.25D to -5.00D; add powers +0.25D 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

• AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Daily Wear Contact Lens (K052290)

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2017

Largan Medical Co. Ltd. % Jennifer Ting RA Manager Jens Medical Consulting Ltd 6F, No 39, Ln 224, Luzhou Dist., New Taipei City, TW 247 Taiwan R.O.C.

Re: K170286

Trade/Device Name: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan (hioxifilcon 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: August 12, 2017 Received: August 24, 2017

Dear Jennifer Ting:

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.

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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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Denise L. Hampton -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) K170286

#### Device Name

Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact Lens Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact lens for ASTIGMATISM Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact lens for PRESBYOPIA

#### Indications for Use (Describe)

The Largan (hioxifilcon 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 (hioxifilcon 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 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 (hioxifilcon 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 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.

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

| <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary K170286

Preparation Date: August 14, 2017

## 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,<br>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 (hioxifilcon A) 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 | CRF 886.5925 |
| Review Panel | Ophthalmic |
| Product Code | LPL/MVN |

## 1.4 Legally Marketed Equivalent Device:

| Predicate Device Name | AQUASOFT ALL-DAY & ALL-DAY T<br>(hioxifilcon A) Daily Wear Contact Lens. |
|-----------------------|--------------------------------------------------------------------------|
| Manufacturer | ClearLab Pte Ltd. |
| 510(k) Number | K052290 |
| Product Code | LPL |

## 1.5 Device Description

The Largan (hioxifilcon 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 41% hioxifilcon A and 59% water. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.3% (< 5%) in the UVB range of 280-315nm and14.2 % (< 50%) 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:

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The Largan (hioxifilcon 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 or 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 (hioxifilcon 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 (hioxifilcon 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 (hioxifilcon 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:0.102 mm for -1.00D (varies with power)
- Power: +3.00 to -10.00 D

# Largan (hioxifilcon 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:0.102 mm for -1.00D (varies with power) ●
- . Power: +3.00 to -10.00 D
- Cylinder: -0.25D ~ -5.00 D .
- . Axis: 10° to 180° (in 10° increments)

## Largan (hioxifilcon 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:0.102 mm for -1.00D (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.

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| Similarities and differences | | |
|--------------------------------|---------------------------------------------------|------------------------------------------------------|
| Item | Device | Predicate (K052290) |
| Product Name | Largan daily wear soft contact lens | AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens |
| Manufacturer | Largan Medical Inc. | ClearLab Pte Ltd. |
| Intended Use | Myopia, Hyperopia, astigmatism, Presbyopia | Myopia, Hyperopia, astigmatism |
| Lens Design | aspherical, toric, or multifocal | spherical, toric |
| Replacement Schedule | Daily Wear | The same |
| Chemical composition | Hioxifilcon A | The same |
| Classification | Group II (Nonionic, High water) | The same |
| Water Content | 59 % (>50%), | 57 % (>50%), |
| Oxygen Permeability (DK, 35°C) | 22 (Fatt method) | 20 (Fatt method) |
| Base Curve Range (mm) | 8.0~9.0 | 8.0 ~ 9.2 |
| Diameter (mm) | 13.0~15.0 | 13.0~15.0 |
| Center Thickness | Varies with design and power (0.102 mm at -1.00D) | Varies with design and power (0.08 mm at -3.00D) |
| Powers | -10.00D to +3.00D | -20.00D to +20.00D |
| Refractive Index | 1.403 | 1.4058 |
| Light Transmittance | 90% | >95% |
| Blue handling tint | Reactive Blue 247 | Reactive Blue 19 |
| Method of Manufacture | Cast Molded | Cast Molded |

# 1.9 Nonclinical Tests Performed

- Physiochemical studies were conducted according to ISO 18369 First edition 1.9.1 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 AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens (K0052290) current marketed by CearLab Pte Ltd, 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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens" is as safe, as effective and performs as well as the predicate device.