Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac

K182734 · Unicon Optical Co., Ltd. · LPL · May 16, 2019 · Ophthalmic

Device Facts

• Record ID: K182734
• Device Name: Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
• Applicant: Unicon Optical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: May 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

Device Story

Soft, daily disposable contact lens; cast-molded from etafilcon A (HEMA/MAA copolymer). Features 58% water content; includes UV absorber and blue handling tint. Prescribed by eye care professionals for patients with myopia or hyperopia (≤1.00 D astigmatism). Lens provides optical correction; discarded after single daily use. Benefits include vision correction and convenience of daily replacement.

Clinical Evidence

Bench testing only. No clinical data presented. Safety and effectiveness established through non-clinical laboratory studies, including sterilization, shelf-life, biocompatibility (cytotoxicity, ocular irritation, systemic toxicity), and performance testing (water content, refractive index, oxygen permeability, mechanical properties) per ISO and ASTM standards.

Technological Characteristics

Material: etafilcon A (HEMA/MAA copolymer) cross-linked with TMPTMA and EGDMA. Water content: 58%. UV absorber: 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxyphenyl] ethyl methacrylate. Tint: C.I. Reactive Blue 246. Manufacturing: Cast-molding. Sterilization: Validated per ISO 17665-1. Standards: ISO 18369, ISO 10993, ASTM D882, ASTM D1708.

Indications for Use

Indicated for optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes having 1.00 D or less of astigmatism. For daily disposable wear prescribed by eye care professionals.

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

• Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens (K172692)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 16, 2019

UNICON Optical CO., LTD Hsiao-Wei Shen, Coordinator No 16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township Hsinchu County, 30075 TW

Re: K182734

Trade/Device Name: Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 15, 2019 Received: April 17, 2019

Dear Hsiao-Wei Shen:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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,

for Malvina B. Eydelman, M.D. Director 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) K182734

Device Name

Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

Indications for Use (Describe)

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> |

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

### 510(k) SUMMARY

| 5.1 | Type of Submission: | Traditional |
|-----|---------------------|---------------------------------------------------------------------------------------------------------------|
| 5.2 | Date of Summary: | May 14, 2019 |
| 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 (R.O.C.) |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | HSIAO-WEI SHEN<br>([e-mail]) |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | Unicon Hydrogel (etafilcon A) Soft<br>(Hydrophilic) Daily Disposable Contact<br>Lens |
|------------------------------|--------------------------------------------------------------------------------------|
| Classification Product Code: | LPL, MVN |
| Regulation Number: | 886.5925 |
| Regulation Description: | Soft (hydrophilic) contact lens |
| Review Panel: | Ophthalmic |
| Device Class: | II |

#### ર્ રંડ Identification of the Predicate Device:

| Predicate Device Name: | Tangible Hydrogel with Tangible Polymer<br>(etafilcon A) ASPHERIC Soft<br>(Hydrophilic) Daily Disposable Contact<br>Lens |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Tangible Science LLC |
| Classification Product Code: | LPL, MVN |
| Regulation number: | 886.5925 |

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| Device Class: | II |
|----------------|---------|
| 510(k) Number: | K172692 |

## 5.6 Intended Use/ Indications for Use of the Device

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

## 5.7 Device Description

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as aspherical lenses manufactured by cast-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 Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive 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 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" 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

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### -6.50D to -13.00D in 0.50D per step.

The properties of the lenses are:

| ● | Base Curve (mm): | 7.85 to 10.0 |
|---|----------------------------------------------------------|---------------------------------------------------------------|
| ● | Chord Diameter (mm): | 12.00 to 15.00 |
| ● | Center Thickness (mm): | Varies with power<br>0.080 mm at -3.00D<br>0.200 mm at +3.00D |
| ● | Power (D): | +6.00 to -13.00 |
| ● | Refractive Index (hydrated): | 1.400 ±0.005 |
| ● | Water Content (%): | 58±2% |
| ● | Oxygen Permeability:<br>(x10-11 (cm²/sec)(mlO₂/ml-mmHg)) | 21±20% |
| ● | Visible Light Transmittance (%): | 95±5% |
| ● | UV Transmittance (%): | At 280~315 nm: Avg<5%<br>At 316~380 nm: Avg<30% |

## 5.8 Non-clinical Testing

A series of non-clinical studies were completed on this product. The tests and studies were according to the FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. All the test results met the requirements of products specification.

The following tests were conducted on "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens":

## · Sterilization test

Test results performed in test reports of sterilization test demonstrated that subject device complies with ISO 17665-1:2006, ISO 11737-1:2018, ISO 11737-2:2009, and ISO 11138-3:2017 requirements.

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#### . Shelf life test

Test results performed in test reports of shelf life test demonstrated that subject device complies with ISO 11987:2012 (E), ISO 18369-1:2006, ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ISO 17665-1:2006, and USP 32 – NF27 <71> requirements.

#### Biocompatibilitv tests .

- In Vitro Cytotoxicity -
- -White Rabbit Ocular Irritation
- -Acute Systemic Toxicity

Tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-12:2012 requirements.

#### . Performance tests

- Humectant -
- Water Content -
- Transmittance -
- Refractive Index -
- Oxygen Permeability -
- Mechanical Properties of Materials -
- Extractables of Material Pigment -
- Extractables -
- pH Value -
- Osmolarity -
- Geometric Parameters -
- Specific Gravity -

Tests were conducted in accordance with ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ANSI Z80.20-2004, ASTM D882:2002, and ASTM D1708-13 requirements.

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# 5.9 Clinical Testing

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

# 5.10 Substantial Equivalence Determination

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens (K172692). Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | Unicon Hydrogel (etafilcon A) Soft<br>(Hydrophilic) Daily Disposable<br>Contact Lens | Tangible Hydrogel with Tangible<br>Polymer (etafilcon A) ASPHERIC<br>Soft (Hydrophilic) Daily<br>Disposable Contact Lens | N/A |
| 510(k) No. | K182734 | K172692 | N/A |
| Intended Use | The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes | The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic | Same |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| | who may have 1.00 D or less of<br>astigmatism. Eye care professionals<br>may prescribe the lenses for daily<br>disposable wear. Lenses shall be<br>discarded upon removal. | persons with non-diseased eyes<br>who may have 1.00 D or less of<br>astigmatism. Eye care professionals<br>may prescribe the lenses for daily<br>disposable wear. Lenses shall be<br>discarded upon removal. | |
| Type of use | Prescription Use | Prescription Use | Same |
| Single Use | Yes | Yes | Same |
| UV Blocking | Yes | Yes | Same |
| Production Method | Cast-Molded | Cast-Molded | Same |
| USAN Name | etafilcon A | etafilcon A | Same |
| Color additive | RB246<br>1,4-Bis[4-(2-methacryloxyethyl)ph<br>enylamino] anthraquinone<br>copolymers | [Phthalocyaninato(2-)]copper | Different but<br>RB246 is also<br>approved;<br>therefore it would<br>not affect the<br>equivalence |
| Base Curve | 7.85 mm to 10.0 mm | 7.85 mm to 10.0 mm | Same |
| Chord Diameter | 12.0 mm to 15.00 mm | 12.0 mm to 15.00 mm | Same |
| Center Thickness | Varies with power<br>0.080 mm at -3.00D<br>0.200 mm at +3.00D | 0.01 mm to 0.20 mm | Different but the<br>specification meets<br>the requirement;<br>therefore it would<br>not affect the<br>equivalence |
| Water Content (%) | 58% | 58% | Same |
| Refractive Index<br>(hydrated) | 1.400 | 1.400 | Same |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Oxygen Permeability | $23.42 \times 10^{-11} (cm^2/sec) (ml O_2/ml-mmHg)$ | $29.96 \times 10^{-11} (cm^2/sec) (ml O_2/ml-mmHg)$ | Different but the<br>specification meets<br>the requirement;<br>therefore it would<br>not affect the<br>equivalence |
| Power Range | +4.50D ~ +6.00D in 0.50D per step<br>+4.00D ~ -6.00D in 0.25D per step<br>-6.50D ~ -13.00D in 0.50D per step | +6.00D to -10.00D (in 0.25D steps)<br>Cylinder: -0.75D to -2.50D (in 0.25D steps) Axis: 10° to 180° (in 10° steps) Add: +1.00D to +2.50D (in 0.50D steps) | Different but it<br>would not affect<br>the equivalence |
| Visible Light<br>Transmittance | 95±5% | >98% | Different but the<br>specification meets<br>the requirement;<br>therefore it would<br>not affect the<br>equivalence |
| UV transmittance | at 280~315 nm: Avg<5%<br>at 316~380 nm: Avg<30% | at 280~315 nm: Avg<5%<br>at 316~380 nm: Avg<30% | Same |

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

# 5.11 Similarity and Difference

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens has been compared with "Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens". The subject device has same intended use, principle of operation and similar

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

technological characteristics as the predicate device. Although there are some specifications that are different between two devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.

## 5.12 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is substantially equivalent to the predicate device.