Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

K180322 · Visco Vision, Inc. · LPL · Apr 20, 2018 · Ophthalmic

Device Facts

• Record ID: K180322
• Device Name: Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
• Applicant: Visco Vision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters. The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens may also be indicated to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

Device Story

Soft contact lens; daily disposable; corrects myopia, hyperopia, astigmatism, and presbyopia; provides cosmetic color enhancement. Material: 53% olifilcon B, 47% water; includes UV-absorbing monomer. Manufactured via molding. Prescribed by eye care practitioners; patient self-use; discarded after single daily wear. No cleaning/disinfection required. Benefits: vision correction and cosmetic alteration of eye appearance.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (physiochemical studies per ISO 18369) and reliance on predicate device material and colorant safety profiles.

Technological Characteristics

Material: 53% olifilcon B, 47% water; Group 5C (nonionic). UV-absorbing monomer (benzotriazole). Colorants: Iron oxide, copper phthalocyanine, titanium dioxide, phthalocyanine green, carbazole violet. Diameter: 13.0-15.0 mm; Base Curve: 8.0-9.2 mm. Oxygen permeability (Dk): 120 (Fatt method). Refractive index: 1.410. Molded manufacturing. Daily disposable.

Indications for Use

Indicated for correction of refractive ametropia (myopia/hyperopia) and presbyopia in phakic/aphakic persons with non-diseased eyes; includes astigmatism correction up to 2.25D; optional cosmetic color enhancement; daily disposable use.

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-Color Aqua 42 UV (hefilcon A) soft (hydrophilic) contact lens (K162317)
• Si-Hy (olifilcon B) silicone hydrogel soft contact len (K160344)

Reference Devices

• Si-Hy (olifilcon B) silicone hydrogel soft (hydrophilic) contact lens (K141348)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 19, 2018

Visco Vision, Inc. Jennifer Ting RA Manager Jens Medical Consulting Ltd. 6F, No. 39, Jixian Rd., Luzhou Dist. New Taipei City, TW 247

Re: K180322

Trade/Device Name: Si-Hy (olifilcon B) color silicone hydrogel soft contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 20, 2018 Received: February 21, 2018

Dear Jennifer Ting:

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

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K180322

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); 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.

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.

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/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.

# Denise L. Hampton -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) K180322

#### Device Name

Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (hydrophilic) Contact Lens

Indications for Use (Describe)

The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Si-Hy (olifileon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may also be indicated to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

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

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## 510(k) Summary

Preparation Date: April 11, 2018

# 1.1 Establishment Information:

| Name | Visco Vision Inc. |
|-----------|-------------------------------------------------------------|
| Address | No. 1, Xingye St., Guishan Dist., Taoyuan City 33341 Taiwan |
| Contact | Ted TT Huang |
| Phone No. | 886-3-3596868 |
| Fax No. | 886-3-3490202 |

## 1.2 Contact Person:

| Name | Evan Huang |
|-----------|-------------------------------|
| Phone No. | 886-3-3596868 |
| Fax No. | 886-3-3490202 |
| e-mail: | [e-mail] |

# 1.3 Device Identification:

| Proprietary Name | Si-Hy (olifilcon B) Color Silicone Hydrogel Soft Contact<br>Lens |
|---------------------|------------------------------------------------------------------|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Soft (hydrophilic) contact lens. (21 CFR 886.5925) |
| Product Codes | LPL, MVN |
| Classification | II |

## 1.4 Legally Marketed Equivalent Device:

#### Intended use

| Predicate Device Name | Saview-Color Aqua 42 UV (hefilcon A)<br>soft (hydrophilic) contact lens |
|-----------------------|-------------------------------------------------------------------------|
| Manufacturer | St. Shine Optical Co., Ltd. |
| 510(k) Number | K162317 |
| Product Codes | LPL, MVN |
| Lens material | |
| Predicate Device Name | Si-Hy (olifilcon B) silicone hydrogel soft contact len |
| Manufacturer | Visco Vision Inc. |
| 510(k) Number | K160344 |
| Product Codes | LPL, MVN |

# 1.5 Device Description

The Si-Hy (olifilcon B) Color Silicone Hydrogel Soft (Hydrophilic) Contact Lenses

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are avaialbe as spherical lens, toric lens and multifocal lens with cosmetic tint in an annular pattern by providing a clear optic zone. They are marked in different color by containing a combination of the following color additives: Iron oxide, [Phthalocyaninato (2-)] copper, Titanium dioxide, Phthalocyanine green, Carbazole violet. The lens material is composed by 53% olifilcon B and 47% water. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.2% (< 5%) in the UVB range of 280-315nm and 8.7% ( < 50%) in the UVA range of 316-380nm. All colored additives used including ultraviolet absorbing additive (benzophenone based) are listed in 21CFR 73 subpart Dand 74 sbupart D.

#### 1.6 Indication for Use:

The Si-Hy (olifilcon B) Color Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The Si-Hy (olifilcon B) Color Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The Si-Hy (olifilcon B) Color Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may also be indicated to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

#### 1.7 Technological characteristic

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## Si-Hy Color SPHERICAL Soft Contact Lenses characteristics:

- Diameter Range: 13.00 to 15.00 mm •
- . Base Curve:8.00 to 9.20 mm
- Center Thickness:0.08 mm for -3.00D (varies with power)
- . Power:+20.00 to -20.00 D

Si-Hy Color TORIC Soft Contact Lenses characteristics:

- . Diameter Range: 13.00 to 15.00 mm
- . Base Curve:8.00 to 9.20 mm
- Center Thickness:0.08 mm for -3.00D (varies with power) .
- Power:+20.00 to -20.00 D •
- . Cylinder: -0.75D ~ -2.25D
- Axis: 10° to 180° (in 10° increments) .

Si-Hy Color MULTIFOCAL Soft Contact Lenses characteristics:

- Diameter Range: 13.00 to 15.00 mm
- Base Curve:8.00 to 9.20 mm .
- . Center Thickness:0.08 mm for -3.00D (varies with power)
- Power:+20.00 to -20.00 D •
- Additional Powers: +0.75D ~ +1.25D (LOW) •
- +1.50D ~ +2.00D (MID)
- +2.25D ~ +2.75D (HIGH)

## 1.8 Comparison table:

The characteristic comparison to predicate device is summarized in the following table.

| Similarities and differences | | | |
|------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------|
| Item | Device | Predicate<br>(K160344) | Predicate (K162317) |
| Product Name | Si-Hy (olifilcon B)<br>Color Silicone Hydrogel<br>soft contact lens | Si-Hy (olifilcon B) Silicone<br>Hydrogel soft<br>contact lens | Saview-Color Aqua 42<br>UV (hefilcon A) soft<br>(hydrophilic) contact lens |
| Manufacturer | Visco Vision Inc. | Visco Vision Inc. | St. Shine Optical Co.,<br>ltd |
| Intended Use | Myopia, Hyperopia,<br>astigmatism, Presbyopia | The same | The same |

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| Lens Design | | | |
|--------------------------------|-----------------------------------------------------------------------------------------------------|-----------------|---------------------------------------------------------------------------------------------------|
| Lens Design | Spherical, toric, or multifocal | The same | The same |
| Replacement Schedule | Daily Disposable (Single use) | The same | The same |
| Chemical composition | olifilcon B | olifilcon B | Hefilcon A |
| Classification | Group 5C (Nonionic, Water < 50 wt %) | The same | The same |
| Water Content | 47 % (<50%), | The same | 42% |
| Oxygen Permeability (DK, 35°C) | 120 (Fatt method) | The same | 10.89 |
| Base Curve Range (mm) | 8.0~9.2 | The same | NA |
| Diameter (mm) | 13.0~15.0 | The same | NA |
| Center Thickness | Varies with design and power (0.08 mm at - 3.00D) | The same | NA |
| Powers | -20.00D to +20.00D | The same | -20.00D -+12.00D |
| Refractive Index | 1.410 | The same | 1.435 |
| Light Transmittance | 94% | The same | 97% |
| Visibility Tint | NA | Reactive Blue19 | NA |
| Color additives for print | Iron oxide, [Phthalocyaninato (2-)] copper Titanium dioxide, Phthalocyanine green, Carbazole violet | NA | iron oxide Titanium dioxide [Phthalocyaninato (2-)] copper Phythalocyanine green Carbazole violet |
| Method of Manufacture | Molded | Molded | Moulded |

#### 1.9 Nonclinical Tests Performed

- 1.9.1 Physiochemical studies were conducted according to ISO 18369, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
- 1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

## 1.10 Clinical Studies

The lens material is the same as the Si-Hy (olifilcon B) silicone hydrogel soft (hydrophilic) contact lens currently available (K141348). The color additives used is the same as Saview-Color Aqua 42 UV (hefilcon A) soft (hydrophilic) contact

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lens currently available (K162317). Therefore, the clinical data is not required.

## 1.11 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Si-Hy (olicofilcon B) color silicone hydrogel soft (hydrophilic) contact lens'' is as safe, as effective and performs as well as the predicate device.