Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

K162317 · St. shine Optical Co., Ltd. · LPL · Oct 21, 2016 · Ophthalmic

Device Facts

• Record ID: K162317
• Device Name: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
• Applicant: St. shine Optical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye. The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye. The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV Multifocal lens also acts to enhance or alter the apparent color of the eye. The Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

Device Story

Hydrophilic soft contact lenses (hefilcon A) for daily disposable wear; spherical, toric, and multifocal designs. Input: patient refractive error/astigmatism/presbyopia requirements. Operation: lens placed on eye to correct refractive ametropia; UV-absorbing compound incorporated into polymer; pigments (iron oxides, titanium dioxide, etc.) provide cosmetic color alteration. Output: corrected vision and altered eye appearance. Used by patients; prescribed by eye care professionals. Benefits: vision correction and cosmetic enhancement; single-use design eliminates cleaning/disinfection requirements.

Clinical Evidence

No clinical data. Bench testing only: stability, cytotoxicity, ocular irritation, acute systemic injection, and physical/chemical testing performed per FDA guidance.

Technological Characteristics

Material: hefilcon A (HEMA/NVP copolymer crosslinked with EGDMA); 42% water content. UV-absorbing compound: 2-[3-(2H-Benzotriazol-2y1)-4-hydroxyphenyl] ethyl methacrylate. Pigments: iron oxides, titanium dioxide, phthalocyanine green, carbazole violet, copper phthalocyanine. Form factor: spherical, toric, multifocal. Manufacturing: molded. Packaging: PP blister pack with hyaluronic acid saline solution.

Indications for Use

Indicated for daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic or non-aphakic persons with non-diseased eyes; includes cosmetic eye color enhancement/alteration. Contraindicated for diseased eyes.

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

• Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (K123484)
• Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal (K121201)

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 & 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 an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.

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

October 21, 2016

St. Shine Optical Co., Ltd. Ms. Ella Lee Project Manager, R&D Div. 4,5F No. 276-2, Sec. 1, Ta Tung Rd., Hsi Chih Dist. New Taipei City, TW 22146

Re: K162317

Trade/Device Name: Saview-Colors Aqua 42 UV (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) 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: August 15, 2016 Received: September 2, 2016

Dear Ms. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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,

Kesia Alexander

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) K162317

#### Device Name

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

#### Indications for Use (Describe)

The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with nondiseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV lens also acts to enhance or alter the apparent color of the eye.

Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

| 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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### Submitter Information:

| Address: | St. Shine Optical Co., Ltd. | | |
|-------------------|----------------------------------------|--|--|
| | 4,5F No. 276-2, Sec. 1, Ta Tung Rd. | | |
| | Hsi Chih Dist., 22146, New Taipei City | | |
| | Taiwan R.O.C. | | |
| Registration No.: | 9617499 | | |
| Contact Person: | Ella Lee | | |
| | Project Manager, R&D Div. | | |
| Telephone: | 886-2-2647-9356 | | |
| Fax: | 886-2-8691-6776 | | |
| Date Prepared: | Aug.10, 2016 | | |

### Device:

| Common Name: | Soft (Hydrophilic) Contact Lens |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Name: | Saview-Colors Aqua 42 UV (hefilcon A) Soft<br>(Hydrophilic) Contact Lens<br>Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft<br>(Hydrophilic) Contact Lens<br>Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft<br>(Hydrophilic) Contact Lens |
| Classification Name: | Soft (Hydrophilic) Contact Lens (daily wear) |
| Device Classification: | Class II (21 CFR 886.5925) |
| Product Code: | LPL, MVN |
| Panel: | Ophthalmic |

#### Predicate Devices:

The predicate devices are Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K123484 and Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal(methafilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K121201.

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### Description of Devices:

The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing compound 2-[3-(2H-Benzotriazol-2y1)-4-hydroxyphenyl] ethyl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container containing hyaluronic acid polymer in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74. The lens designs include spherical, toric and multifocal lenses.

## Indication for Use:

The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors Aqua 42 UV Multifocal lens also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric and Saview-Colors Aqua 42 UV Multifocal lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

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## Non-Clinical Testing:

The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.

- Stability Testing
- Toxicology Testing
- Cytotoxicity ■
- Ocular Irritation ■
- Acute Systemic Injection ■
- Physical/Chemical Testing

# Clinical Testing:

Clinical data is not required for this submission.

# Description of Safety and Substantial Equivalence:

Information submitted in the 510(k) establishes that the Saview-Colors Aqua 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of acute systemic injection, ocular irritation and in vitro cytotoxicity tests showed the Saview-Colors Aqua 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.

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| | Saview-Colors Aqua 42<br>UV, Saview-Colors Aqua<br>42 UV Toric, and<br>Saview-Colors Aqua 42<br>UV Multifocal (hefilcon<br>A) Soft (Hydrophilic)<br>Contact Lens | Saview-Colors 42 UV,<br>Saview-Colors 42 UV<br>Toric, and<br>Saview-Colors 42 UV<br>Multifocal (hefilcon A)<br>Soft (Hydrophilic)<br>Contact Lens (K123484) | Saview-Aqua 55 UV,<br>Saview-Aqua 55 UV<br>Toric, and<br>Saview-Aqua 55 UV<br>Multifocal Soft<br>(Hydrophilic) Contact<br>Lens (K121201) | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Material<br>(Classification) | hefilcon A<br>(Group 1) | hefilcon A<br>(Group 1) | methafilcon A<br>(Group 4) | |
| Indication for<br>use | myopia, hyperopia,<br>presbyopia and<br>astigmatism | myopia, hyperopia,<br>presbyopia and<br>astigmatism | myopia, hyperopia,<br>presbyopia and<br>astigmatism | |
| Water content | 42 % | 42 % | 55 % | |
| Visible light<br>transmittance | 97.06 % | 97.06 % | 96.78 % | |
| UV<br>Transmittance | UVA : 9.22 %<br>UVB : 0.49 % | UVA : 9.22 %<br>UVB : 0.49 % | UVA : 12.370 %<br>UVB : 1.025 % | |
| Dk (35° C) | $10.89×10^{-11}$ | $10.89×10^{-11}$ | $21.4x10^{-11}$ | |
| Powers | +12.00D to -20.00D; | +12.00D to -20.00D; | +12.00D to -20.00D | |
| Refractive index | 1.4347 (wet) | 1.4347 (wet) | 1.404 (wet) | |
| Method of<br>manufacture | Moulded | Moulded | Moulded | |
| Packaging | PP Blister Pack | PP Blister Pack | PP Blister Pack | |
| Colorants | Iron oxides<br>Titanium dioxide<br>[Phthalocyaninato (2-)]<br>copper<br>Phthalocyanine green<br>Carbazole violet | Iron oxides<br>Titanium dioxide<br>[Phthalocyaninato (2-)]<br>copper<br>Phthalocyanine green<br>Carbazole violet | Copper phthalocyanine<br>(visibility tinted) | |
| | Package Storage<br>saline solution | Saline solution containing<br>hyaluronic acid polymer | Saline solution | Saline solution<br>containing hyaluronic<br>acid polymer |

# Table 1 Comparison Chart

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### Conclusion:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens and to establish substantial equivalence to the predicate devices. Information submitted in the 510(k) also establishes that the Saview-Colors Aqua 42 UV lenses do not raise questions of safety and effectiveness. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.