UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR

K141917 · Unicon Optical Co., Ltd. · LPL · Oct 17, 2014 · Ophthalmic

Device Facts

• Record ID: K141917
• Device Name: UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR
• Applicant: Unicon Optical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D or less astigmatism. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear are indicated for single-use disposable wear and are to be discarded after each removal. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

Aspherical soft contact lens; manufactured via cast-molding; composed of etafilcon A (HEMA/MAA copolymer) with UV absorber and Blue 15:3 tint. Designed for daily wear; single-use disposable. Prescribed by eye care professionals for patients with myopia/hyperopia and low astigmatism. Lens provides refractive correction and UV radiation protection for the cornea. Device is non-electronic; no software or algorithms involved.

Clinical Evidence

No new clinical data provided. Safety and effectiveness were established based on previous clinical performance testing of etafilcon A lenses and comprehensive non-clinical bench testing, including biocompatibility, sterilization, oxygen permeability, and mechanical properties.

Technological Characteristics

Material: Etafilcon A (HEMA/MAA copolymer cross-linked with TMPTMA and EGDMA). Water content: 58%. Manufacturing: Cast-molding. UV protection: Benzotriazole absorber. Tint: Blue 15:3. Sterilization: Moist heat (overkill method per EN/ISO 17665:2006). Dimensions: 7.85-10.0mm base curve, 12.0-15.0mm diameter. Non-electronic; no software.

Indications for Use

Indicated for daily wear correction of myopia and hyperopia in aphakic or non-aphakic persons with non-diseased eyes and <= 1.00D astigmatism. Single-use disposable.

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

• VISTAKON (Etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear (K051900)

Submission Summary (Full Text)

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

October 17, 2014

Unicon Optical Co., Ltd. % Mr. Michael Lee President No. 45, Mingsheng Rd., Danshui District New Taipei, 251 TW

Re: K141917

> Trade/Device Name: Unicon (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 8, 2014 Received: July 15, 2014

Dear Mr. Lee.

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.

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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 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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

# Eric A. Mann -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) K141917

#### Device Name

Unicon (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear

#### Indications for Use (Describe)

The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eye who may have 1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear are single disposable wear and are to be discarded after each removal. UNICON (etaffilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

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

| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear

#### 510(k) Summary

| 5.1 | Type of Submission: | Traditional |
|-----|---------------------|------------------------------------------------------------------------------------------------------|
| 5.2 | Preparation Date: | 7th July, 2014 |
| 5.3 | Submitter: | UNICON Optical Co., LTD. |
| | Address: | No 16, Gongye E. 9th Rd., Hsinchu Science Park,<br>Baoshan Township, Hsinchu County 30075,<br>Taiwan |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | Robert |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear |
|-------------------------|-------------------------------------------------------------------------------------|
| Common Name: | Soft (hydrophilic) contact lenses for daily wear |
| Classification Name: | LENS, CONTACT, (DISPOSABLE) |
| Device Classification: | II |
| Regulation Number: | 886.5925 |
| Panel: | Ophthalmic |
| Product Code: | MVN ; LPL |

#### 5.5 Identification of the Predicate Device:

| Predicate Device<br>Name: | VISTAKON (Etafilcon A) Soft (hydrophilic)<br>Contact Lens (spherical), Clear and Visibility<br>Tinted with UV Blocker for Daily Disposable<br>Wear |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | VISTAKON |
| Product Code: | MVN ; LPL |
| 510(k) Number: | K051900 |

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#### 5.6 Intended Use and Indications for Use of the subject device.

The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D or less astigmatism. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear are indicated for single-use disposable wear and are to be discarded after each removal. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

#### 5.7 Device Description

UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is available as aspherical lenses manufactured by case-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear with visible tint is light tinted blue using Blue 15:3 to make the lens more visible for handling. The lenses also contain a UV absorber { { 2-[ 3-( 2 -( 2 -( 2 -( ) - 4 - h dr ox y p hen y l which is included during the manufacturing process as a monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380nm.

With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic)

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Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.

#### 5.8 Non-clinical Testing

A series of non-clinical studies were completed on this product. The tests and studies were performed in UNICON QC lab and subcontracted test services which were according to the FDA guidance (Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, February 27, 1997) and related recognized consensus standards. All the test results were met the requirements of products specification.

The following tests were conducted on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear'':

- . Sterilization Test
- o Shelf Life Test
- Biocompatibility
- -Cytotoxicity
- Irritation -
- -Acute Systemic toxicity
- Water Content
- . Mechanical Properties of Materials
- . Refractive Index
- Oxygen Permeability
- Transmittance
- Extractables Test

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- . Specific Gravity
The Sterilization Method used on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear" is moist heat sterilization and the study for sterilization is based on the EN/ISO 17665 : 2006 Sterilization of health care product-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The overkill method is used as validation method for sterilization and the results demonstrates achievement of the required sterility assurance limit (SAL) of 10 °.

#### 5.9 Clinical Testing

The safety and effectiveness of etafilcon A lenses have been established through previous clinical performance testing. And the pre-clinical testing results are sufficient in establishing substantial equivalence.

#### 5.10 EMC and Electrical safety

The devices do not require EMC/Electrical Safety evaluation.

#### 5.11 Substantial Equivalence Determination

The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the cleared VISTAKON (Etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear which is the subject of K051900. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

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UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear

| | Proposed Device | Predicate Device |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | UNICON (Etafilcon A) Soft<br>(Hydrophilic) Contact Lens<br>with UV Blocker for Daily<br>Wear | VISTAKON (Etafilcon A) Soft<br>(hydrophilic) Contact Lens<br>(spherical), Clear and Visibility<br>Tinted with UV Blocker for<br>Daily Disposable Wear |
| Regulatory<br>Number | 886.5925 | 886.5925 |
| Classification | II | II |
| Intended Use | The UNICON (Etafilcon A)<br>Soft (Hydrophilic) Contact Lens<br>with UV Blocker for Daily<br>Wear is indicated for daily wear<br>for the correction of ametropia<br>(myopia and hyperopia) in<br>aphakic or non-aphakic persons<br>with non-diseased eyes who<br>may have 1.00D or less<br>astigmatism. The UNICON<br>(Etafilcon A) Soft (Hydrophilic)<br>Contact Lens with UV Blocker<br>for Daily Wear are indicated for<br>single-use disposable wear and<br>are to be discarded after each<br>removal. The UNICON<br>(Etafilcon A) Soft (Hydrophilic)<br>Contact Lens with UV Blocker<br>for Daily Wear helps protect<br>against transmission of harmful<br>UV radiation to the cornea and<br>into the eye. | The VISTAKON (Etafilcon A)<br>Soft (hydrophilic) Contact Lens<br>(spherical), Clear and Visibility<br>Tinted with UV Blocker for Daily<br>Disposable Wear for the<br>correction of refractive ametropia<br>(myopia and hyperopia) in<br>aphakic or not-aphakic persons<br>with not diseased eyes who may<br>have 1.00D or less of<br>astigmatism.<br>VISTAKON (Etafilcon A) Soft<br>(hydrophilic) Contact Lens, Clear<br>and Visibility Tinted with UV<br>Blocker for Daily Disposable<br>Wear help protect against<br>transmission of harmful UV<br>radiation to the cornea and into<br>the eye.<br>The VISTAKON (Etafilcon A)<br>Soft (hydrophilic) Contact Lens,<br>Clear and Visibility Tinted with<br>UV Blocker for Daily Disposable<br>Wear is to be prescribed for Daily<br>Disposable Wear and is to be<br>discarded after each removal. |
| Prescription Use | Yes | Yes |
| Single Use | Yes | Yes |

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| Material | Etafilcon A | Etafilcon A |
|-------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------|
| Base Curve | 7.85mm to 10.0mm | 7.85mm to 10.0mm |
| Diameter | 12.0mm to 15.0mm | 12.0mm to 15.0mm |
| Water Content | 58% | 58% |
| UV<br>transmittance<br>@280~315 nm<br>@316~380 nm | Avg < 5%<br>Avg < 30% | Avg < 5%<br>Avg < 30% |
| UV absorbing | Benzotriazol | Benzotriazole |
| Refractive Index | 1.399 | 1.40 |
| Manufacturing<br>Method | Cast Molded | Cast Molded |
| Sterilization<br>method | Traditional moist heat | Traditional moist heat |
| Primary<br>packaging | PP container with aluminum<br>foil sealing | PP container with aluminum<br>foil sealing |
| Power | +6.00D to -13.00D | +20.00D to -20.00D |
| Specific Gravity | 1.14 | 0.98-1.12 |
| Tensile Strength | 1.66 Mpa | 2.00 Mpa |
| Break Elongation | 393% | 189% |
| Secant Modulus | 0.43 Mpa | 1.06 Mpa |
| Oxygen<br>permeability<br>(edged corrected)<br>@ 35°C | 30.8 x 10-11 (cm2/sec)<br>(mlO2/ml-mmHg) | 28 x 10-11 (cm2/sec)<br>(mlO2/ml-mmHg) |
| Visible Light<br>Transmittance | Minimum 90% | Minimum 85% |
| Color & Tint | Blue 15:3 | Reactive Blue Dye #4 |
| FDA 21 CFR<br>(Color additive) | 74.3045<br>[Phthalocyaninato(2-)]<br>copper | 73.3121<br>Poly(hydroxyethyl<br>methacrylate)-dye copolymers |

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## 5.12 Similarity and differences

The difference between the proposed device and predicate device is color additive. The color additive used on proposed device is Blue 15:3 ([Phthalocyaninato (2-)]copper) which has already been approved by US FDA. According to FDA 21 CFR 874.3045, this color additive may be safely used for coloring contact lenses. Therefore, the difference of proposed device and predicate device did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in intended use, main materials, design, safety and performance claims.

### 5.13 Conclusion

After analyzing bench tests and clinical test, it can be concluded that UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is substantially equivalent to the predicate device.