Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens

K143052 · Yung Sheng Optical Co., Ltd. · LPL · Dec 16, 2014 · Ophthalmic

Device Facts

• Record ID: K143052
• Device Name: Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens
• Applicant: Yung Sheng Optical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye. For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, the eye care professionals may prescribe the lens for single use daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Device Story

Soft hydrophilic contact lenses manufactured via cast molding; composed of polymacon (HEMA crosslinked with EGDMA) with UV-absorbing monomer and color additives. Lenses are tinted edge-to-edge and feature intermittent pigment coatings (e.g., Copper Phthalocyanine, Iron Oxide, Titanium Dioxide). Supplied in sterile isotonic phosphate-buffered saline with sodium hyaluronate and trehalose. Prescribed by eye care professionals for daily wear or daily disposable use to correct myopia and astigmatism. Lenses provide UV protection. Patients benefit from refractive correction and visibility tinting. No clinical data required due to material and process equivalence to predicate.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via non-clinical bench testing and demonstration of equivalence to predicate device (K132854). Preclinical testing included acute systemic injection, white rabbit ocular irritation, and cytotoxicity (ISO 10993-5).

Technological Characteristics

Material: Polymacon (HEMA/EGDMA copolymer). Manufacturing: Cast molding. UV protection: <5% UVB (280-315nm), <50% UVA (316-380nm). Water content: 38%. Refractive index: 1.440 ± 0.005. Tinting: C.I. Reactive Blue No. 4 with pigments (Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet, D&C Yellow No. 10). Packaging: Sterile isotonic phosphate-buffered saline with 0.01% sodium hyaluronate and 0.1% trehalose.

Indications for Use

Indicated for correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes; includes patients with astigmatism ≤ 2.00 diopters.

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

• Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

December 16, 2014

Yung Sheng Optical Co., Ltd. Mr. Wen-Han Chen Regulatory Affairs Supervisor 3F-1, No. 6 Jhongke Road, Daya District Taichung City 42881 Taiwan

Re: K143052

> Trade/Device Name: Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 38 UV Aspheric Color (polymacon) 1-Day 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: October 15, 2014 Received: October 23, 2014

Dear Mr. Chen:

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 (21 CFR

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

Kesia Y. Alexander -S

for Malvina 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) K143052

#### Device Name

Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens

#### Indications for Use (Describe)

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.

For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, the eye care professionals may prescribe the lens for single use daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

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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Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens

# 510(k) Summary

- 5.1 Type of Submission: Traditional

| 5.2 | Submitter: | Yung Sheng Optical Co., Ltd. |
|-----|------------------------------------|------------------------------------------------------------------------|
| | Address: | 3F-1, No.6, Jhongke Road, Daya District, Taichung<br>City 42881 Taiwan |
| | Manufacturer | No.8, Keya 2nd Road, Daya District, Taichung City |
| | Address | 42881, Taiwan |
| | Phone: | [phone] #156g157 |
| | Fax: | [phone] |
| | Contact: | Wen-Han Chen / Tsung-Jen Yeh |
| | Establishment Registration Number: | N/A |
| | Date Prepared | November 17, 2014 |

#### Identification of the Device: 5.3

| Proprietary/Trade<br>name: | Eye Secret 38 UV Aspheric Color (polymacon<br>Soft (hydrophilic) Contact Lens for Daily Wear<br>Eye Secret 38 UV Aspheric Color (polymacon)<br>1-Day Soft (hydrophilic) Contact Lens |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Contact Lens |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Device Classification: | II |
| Regulation Number: | 21 CFR 886.5925 (b) (1) |
| Panel: | Ophthalmic |
| Product Code: | LPL for Lenses, Soft Contact, Daily Wear<br>MVN for Lens, Contact, (Disposable) |

## 5.4 Identification of the Predicate Device:

| Predicate Device Name: | Eye Secret 38 UV Aspheric (polymacon)<br>Soft (hydrophilic) Contact Lens for Daily<br>Wear |
|-----------------------------------------|--------------------------------------------------------------------------------------------|
| Manufacturer: | Yung Sheng Optical Co., Ltd. |
| 510(k) Number or Clearance Information: | K132854 |

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Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens

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

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.

For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, the eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

# 5.6 Device Description

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 50 % in the UVA range of 316 to 380 nm.

The lenses are tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4 and printed with an intermittent coating containing a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10. The Lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.

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# 5.7 Summary of Clinical Study

Polymacon lenses have been used widely. Their safety and effectiveness have been well documented and cleared by FDA. Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854) submitted by Yung Sheng Optical Co., Ltd. is an example.

Clinical studies for the Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.

# 5.8 Non-clinical Testing

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens. The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are equivalent to the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, February 27, 1997:

No Toxicity

- 1. Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
- 2. White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
- 3. Cytotoxicity Test: The test article meets the requirements of ISO 10993-5.

Ni Extractables

Ni Finished Lens Parameters

Ng Light Transmittance

Ni Refractive Index

Ni Water Content

Ng Shelf-life

Ng Mechanical Properties Comparative Testing

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Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens

No Specific Gravity Comparative Testing

Ni Physical Compatibility Test with Contact Lens Care Solution and Packaging Solution

The results of the non-clinical testing demonstrated that the Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are substantially equivalent to the predicate device.

# 5.9 Substantial Equivalence Determination

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens submitted in this 510(k) file are substantially equivalent in intended use, technology/principles of operation, materials and performance to the cleared Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear which is the subject of K132854. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

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Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens

| Comparison Table | | | |
|-------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Eye Secret 38 Color | Eye Secret 38 Color 1-Day | Predicate Device (K132854) |
| Product Name | Eye Secret 38 UV Aspheric<br>Color (polymacon) Soft<br>(hydrophilic) Contact Lens for<br>Daily Wear | Eye Secret 38 UV Aspheric<br>Color (polymacon) 1-Day Soft<br>(hydrophilic) Contact Lens | Eye Secret 38 UV Aspheric<br>(polymacon) Soft (hydrophilic<br>Contact Lens for Daily Wear |
| Regulatory Number | 886.5925 | 886.5925 | 886.5925 |
| Classification | II | II | II |
| Intended Use | The same | The same | Eye Secret 38 UV Aspheric<br>(polymacon) Soft (hydrophilic<br>Contact Lens for Daily Wear is<br>indicated for daily wear for<br>the correction of refractive<br>ametropia (myopia) in aphakic<br>and not-aphakic persons with<br>non-diseased eyes. The lenses<br>may be worn by person who<br>exhibit astigmatism of 2.00<br>diopters or less that does not<br>interfere with visual acuity. |
| Prescription Use | Yes | Yes | Yes |
| Material | polymacon | polymacon | polymacon |
| Manufacturing<br>Method | Cast Molded | Cast Molded | Cast Molded |
| Water Content | 38 % | 38 % | 38 % |
| Powers | -0.00 D ~ -20.00 D | -0.00 D ~ -20.00 D | -0.50 D ~ -12.00 D |
| Light Transmittance | 95 % ± 5 % | 95 % ± 5 % | 95 % ± 5 % |
| UV-A | < 50 % | < 50 % | < 50 % |
| UV-B | < 5 % | < 5 % | < 5 % |
| Refractive Index | 1.440 ± 0.005 nd | 1.440 ± 0.005 nd | 1.440 ± 0.005 nd |
| Base Curve | 8.6 ± 0.2 mm | 8.7 ± 0.2 mm | 8.6 ± 0.2mm |
| Diameter | 14.0 ± 0.2 mm | 14.0 ± 0.2 mm | 14.0 ± 0.2mm |
| Center Thickness | 0.06 mm to 0.11 mm<br>(varies with power) | 0.06 ± 0.02 mm | 0.08 mm to 0.11 mm<br>(varies with power) |

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Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens

# 5.10 Conclusion

After analyzing bench tests, safety testing data, it can be concluded that the Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are substantially equivalent to the predicate device.