Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

K213983 · Yung Sheng Optical Co., Ltd. · LPL · Sep 2, 2022 · Ophthalmic

Device Facts

• Record ID: K213983
• Device Name: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
• Applicant: Yung Sheng Optical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Sep 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Device Story

Soft (hydrophilic) contact lens manufactured from Omafilcon A (HEMA/MPC copolymer) via cast molding. Designed for daily wear or frequent replacement to correct refractive ametropia. Contains benzotriazole UV-blocking monomer; tinted with Reactive Blue 246. Supplied in blister packs with phosphate-buffered saline containing PMB wetting agent. Prescribed by eye care professionals; if used for frequent replacement, requires chemical or hydrogen peroxide disinfection. Lens helps protect against transmission of UV radiation to the cornea. Provides vision correction for patients with myopia, hyperopia, and low astigmatism.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only, including physiochemical studies (ISO 18369-3/4) and toxicology studies (ISO 10993-5/10/11).

Technological Characteristics

Material: Omafilcon A (HEMA/MPC copolymer); 59% water content. Design: Aspheric. UV blocker: Benzotriazole monomer. Tint: Reactive Blue 246. Sterilization: Moist heat (steam) in validated autoclave. Packaging: Blister pack with PMB wetting agent. Oxygen permeability (Dk): 25 x 10^-11. Refractive index: 1.390.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes, including those 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

• Proclear (omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens (K061948)
• Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses (K162223)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

September 2, 2022

Yung Sheng Optical Co., Ltd Wen-Han Chen RA Manager No. 8, Keya 2nd Road, Daya District Taichung City, 428 Taiwan

Re: K213983

Trade/Device Name: Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens 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 26, 2022 Received: July 26, 2022

Dear Wen-Han 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. 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 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.

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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 (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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K213983

#### Device Name

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use (Describe)

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The eye care professionals may prescribe the lens for single use daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

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

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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

# 510(k) Summary

- 1. Type of Submission: Traditional 510(k)

| 2. Submitter: | Yung Sheng Optical Co., Ltd. |
|------------------------------------|--------------------------------------------------|
| Address: | No.8, Keya 2nd Rd., Daya District, Taichung City |
| | 42881, Taiwan |
| Phone: | [phone] Ext.3509 |
| Fax: | [phone] |
| Contact: | Wen-Han Chen |
| Date prepared: | November 24, 2021 |
| Establishment Registration Number: | 3004021238 |

#### 3. Identification of the Device

| Proprietary/Trade name: | Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear |
|-------------------------|----------------------------------------------------------------------------------------|
| Common Name: | Contact Lens |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Device Classification: | II |
| Regulation Number: | 886.5925 |
| Panel: | Ophthalmic |
| Product Code: | LPL for Lenses, Soft Contact, Daily Wear MVN for Lens, Contact, (Disposable) |
| 510(k) Number: | K213983 |

#### 4. ldentification of the Predicate Device

| Predicate Device Name: | Proclear (omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens |
|------------------------|---------------------------------------------------------------------------------|
| Manufacturer: | CooperVision Inc. |
| Product Code: | LPL for Lenses, Soft Contact, Daily Wear<br>MVN for Lens, Contact, (Disposable) |
| 510(k) Number: | K061948 |
| Predicate Device Name: | Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses |
| Manufacturer: | Supervision Optimax Sdn Bhd |
| Product Code: | LPL for Lenses, Soft Contact, Daily Wear<br>MVN for Lens, Contact, (Disposable) |
| 510(k) Number: | K162223 |

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

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

### 6. Device Description

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Omafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-Methacryloyloxyethyl phosphoryIcholine (MPC) crosslinked with ethylene glycol dimethacrylate (EDGMA), and has 59% water by weight. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 316 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive Reactive Blue 246.

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

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 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butylmethacrylate copolymer (PMB) wetting agent.

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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

## 7. Characteristics of Substantial Equivalence

| Material and Process comparison table | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate device | Predicate device |
| Device Name | Eye Secret 59 UV Aspheric<br>(Omafilcon A) Soft (hydrophilic)<br>Contact Lens for Daily Wear | Proclear (omafilcon A) Daily<br>Disposable/Daily Wear Soft<br>Contact Lens | Aveo (omafilcon A) 1-Day<br>Aspheric Soft (Hydrophilic)<br>Contact Lenses |
| Manufacturer | Yung Sheng Optical Co., ltd | CooperVision, Inc. | Supervision Optimax Sdn Bhd |
| 510(k) Number | This submission | K061948 | K162223 |
| FDA Category | Group II<br>Non-ionic<br>High water content | Group II<br>Non-ionic<br>High water content | Group II<br>Non-ionic<br>High water content |
| Product Code | LPL and MVN | LPL and MVN | LPL and MVN |
| Intended Use | The Eye Secret 59 UV Aspheric<br>(Omafilcon A) Soft (hydrophilic)<br>Contact Lens for Daily Wear is<br>indicated for daily wear for the<br>correction of refractive<br>ametropia (myopia or<br>hyperopia) in aphakic and not-<br>aphakic persons with non-<br>diseased eyes. The lens may be<br>worn by person who exhibit<br>astigmatism of 2.00 diopters or<br>less that does not interfere<br>with visual acuity. | Proclear (omafilcon A) Daily<br>Disposable/Daily Wear Soft<br>Contact Lens are indicated<br>for daily wear for the<br>correction of visual acuity in<br>not aphakic persons with<br>non-diseased eyes that are<br>myopic or hyperopic and<br>exhibit astigmatism of 2.00D<br>or less that does not<br>interfere with visual acuity. | Aveo (omafilcon A)1-Day<br>Aspheric Soft (Hydrophilic)<br>Contact Lenses are indicated<br>for daily wear for the<br>correction of visual acuity in<br>not aphakic persons with<br>non-diseased eyes that are<br>myopic orhyperopic and<br>exhibit astigmatism of 1.00D<br>or less that does not interfere<br>with visual acuity. The<br>contact lenses are intended<br>for daily wear, single use and<br>are to be discarded at the<br>end of the day. |
| Material<br>USAN Name | Omafilcon A | Omafilcon A | Omafilcon A |
| Manufacturing<br>Method | Cast Molded | Cast Molded | Cast Molded |
| Sterilization | Moist Heat (Steam) in Validated<br>Autoclave | Moist Heat (Steam) in<br>Validated Autoclave | Moist Heat (Steam) in<br>Validated Autoclave |
| Packaging | Blister pack | Blister pack | Blister pack |
| Water Content | $59 \pm 2$ % | $60 \pm 2$ % | $59 \pm 2$ % |
| Tint | Reactive Blue 246 | Vat Blue 6 | Reactive Blue 246 |
| Packaging<br>solution | Phosphate buffered saline<br>solution containing 2-<br>(Methacryloyloxy) ethyl 2-<br>(trimethylammonio) ethyl<br>phosphate-n-<br>butylmethacrylate copolymer<br>wetting agent | Not Stated | Phosphate Buffered Saline |

- Material and Process Comparison Table
● Technological Characteristics Comparison Table

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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

| | Subject Device | Predicate device | Predicate device |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Device Name | Eye Secret 59 UV Aspheric<br>(Omafilcon A) Soft (hydrophilic)<br>Contact Lens for Daily Wear | Proclear (omafilcon A) Daily<br>Disposable/Daily Wear Soft<br>Contact Lens | Aveo (omafilcon A) 1-Day<br>Aspheric Soft (Hydrophilic)<br>Contact Lenses |
| Base Curve | 7.50 ~ 9.00 ± 0.20 mm | 8.00 ~ 9.50 ± 0.20 mm | 8.40 ~ 8.80 ± 0.20 mm |
| Diameter | 12.0 ~ 15.0 ± 0.20 mm | 13.0 ~ 15.5 ± 0.20 mm | 14.0 ~ 14.4 ± 0.20 mm |
| Center Thickness | 0.030 ~ 0.200 mm | 0.035 ~ 0.960 mm | Not Stated |
| Refractive Index | 1.390 ± 0.005 nd | 1.400 ± 0.005 nd | 1.4002 ± 0.005 nd |
| Oxygen<br>Permeability (Dk)<br>x 10-11 (cm²/sec) (ml<br>O2/ml x mmHg) | 25 ± 20% | 21.00 ± 20 % | 25.68 ± 20 % |
| Light<br>Transmittance | 95 ± 5 % | > 90% | 98 % |
| UV-A | < 50 % | Not Stated | Not Stated |
| UV-B | < 5 % | Not Stated | Not Stated |
| Powers | -20.00 ~ +20.00 D | -20.00 ~ +20.00 D | -10.00 ~ +6.00 D |

## 8. Non-Clinical Testing

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear.

- Physiochemical Studies
The physiochemical studies were conducted according to ISO 18369-4:2017 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2017 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses. The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994:

- Finished Lens Parameters
- Refractive Index
- Light Transmittance
- Water Content
- Extractables (Leachability)
- Oxygen Permeability
- . Mechanical Properties Testing
- 1 Physical Compatibility Test with Packaging Solution
- 1 Shelf-life

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- Toxicology Studies Toxicology studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.

| Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for<br>Daily Wear |
|-------------------------------------------------------------------------------------------|
| ● Cytotoxicity Test (ISO 10993-5) |
| ● Ocular Irritation Test (ISO 10993-10) |
| ● Acute Systemic Toxicity Test (ISO 10993-11) |
| ● Skin Sensitization Test (ISO 10993-10) |
| Packaging Solution |
| ● Cytotoxicity Test (ISO 10993-5) |
| ● Ocular Irritation Test (ISO 10993-10) |
| ● Acute Systemic Toxicity Test (ISO 10993-11) |
| PP blister and aluminum foil (which is identical to that cleared under<br>K132854) |
| ● Cytotoxicity Test (ISO 10993-5) |
| ● Ocular Irritation Test (ISO 10993-10) |
| ● Acute Systemic Toxicity Test (ISO 10993-11) |

The results of the non-clinical testing, including physiochemical studies and toxicology studies, demonstrated that Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear which met all the specifications is substantially equivalent to the safety and effectiveness of both predicate devices.

# 9. Summary of Clinical Study

The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate devices. Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.

### 10. Conclusion

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate devices, Proclear (Omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens (K061948) and Aveo (Omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses (K162223)

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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

in term of optical property, physiochemical and pre-clinical toxicology. They are produced from the same material (Omafilcon A), have the same functional and scientific technology, lens characteristics as well as the intended uses are identical. It is concluded that the lenses are as safe, as effective and perform as well as the both predicate devices.