Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016

K160344 · Visco Vision, Inc. · LPL · May 26, 2016 · Ophthalmic

Device Facts

• Record ID: K160344
• Device Name: Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
• Applicant: Visco Vision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: May 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic 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 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 Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of anetropia (myopia and hyperopia) and emmetropia with presbyopia in 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. 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

Si-Hy contact lenses are silicone hydrogel soft lenses designed for daily disposable use. Lenses are manufactured via molding from a composition of 53% olifilcon B and 47% water, incorporating a benzotriazole UV-absorbing monomer and Reactive Blue 19 tint for handling. Available in spherical, toric, and multifocal designs. Prescribed by eye care practitioners for patients with refractive errors. Patients wear lenses daily and discard after removal; no cleaning or disinfection required. The device provides vision correction and UV protection. Clinical benefit is equivalent to predicate devices in safety and effectiveness for daily wear.

Clinical Evidence

Three-month prospective clinical study with at least 50 subjects comparing Si-Hy (olifilcon B) to Vistakon (narafilcon A) predicate. Primary endpoints: visual acuity, adverse reactions, slit lamp findings, and wearing time. Results: mean visual acuity similar between groups (corrected to 0.1 logMAR or better); no significant slit lamp findings (Grade 3/4) noted; no significant differences between groups.

Technological Characteristics

Material: 53% olifilcon B, 47% water. UV blocker: benzotriazole monomer. Tint: Reactive Blue 19. Manufacturing: Molded. Standards: ISO 18369. Oxygen permeability (Dk): 120 (Fatt method). Refractive index: 1.410. Form factor: Spherical, Toric, Multifocal. Diameter: 13-15mm. Base curve: 8.0-9.2mm. Sterilization: Buffered saline solution.

Indications for Use

Indicated for daily wear, single-use correction of refractive ametropia (myopia/hyperopia), astigmatism, and presbyopia in phakic or aphakic persons with non-diseased eyes. Power range: -20.00D to +20.00D. Astigmatic correction: -0.75D to -2.25D. Add powers: +0.75D to +2.75D.

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

• Vistakon (narafilcon A) (K073485)
• Visco (olifilcon A) soft contact lens (K141348)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with three heads, symbolizing service to the nation. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

May 26, 2016

Visco Vision Inc. % Ms. Jennifer Ting, Manager Jens Medical Consulting Ltd. 6F. No. 39, Ln 224, Jixian Rd. Luzhou Dist. 247 New Taipei City Taiwan R.O.C

Re: K160344

Trade/Device Name: Si-Hy (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens; Si-Hy (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses; Si-Hy (olifilcon B) Toric 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: April 20, 2016 Received: April 22, 2016

Dear Ms. 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 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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K160344

#### Device Name

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

#### Indications for Use (Describe)

The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic 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 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 Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of anetropia (myopia and hyperopia) and emmetropia with presbyopia in 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.

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) |
|-------------------------------------------------|
|-------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## 005_510(k) Summary

Preparation Date: May 6, 2016

# 5.1 Establishment Information:

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

# 5.2 Contact Person:

| Company | Jens Medical Consulting Ltd. |
|----------|------------------------------|
| Name | Jennifer TING |
| Phone No | 886-2-82823192 |
| Fax No | 886-2-82867686 |
| e-mail: | [e-mail] |

### 5.3 Device Identification:

| Proprietary Name | Si-Hy (olifilcon B) Silicone Hydrogel Soft (Hydrophilic) Contact Lens |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Daily Wear,<br>(21 CFR 886.5925, Product Code LPL)<br>Lenses, Soft Contact, Daily Wear (Disposable),<br>(21 CFR 886.5925, Product Code MVN) |
| Classification | II |

# 5.4 Legally Marketed Equivalent Device:

# Indication

Vistakon (narafilcon A), K073485, Product Code: MVN

Johnson & Johnson Vision Care Inc.

# Material

Visco (olifilcon A) soft contact lens, K141348, Product Code: LPL/MVN Visco Vision Inc.

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### 5.5 Device Description

The Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B and 47% water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are about 2.2% (<5%) in the UVB range of 280-315nm and 8.7% (<50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

### 5.6 Indication for Use:

The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens 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 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 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.

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.

### 5.7 Technological characteristic

Si-Hy SPHERICAL Soft Contact Lenses characteristics:

- . Diameter Range: 13 to 15 mm
- . Base Curve: 8.0 to 9.2 mm
- . Center Thickness:0.08 mm for -3.00D (varies with power)
- . Power: +20.00 to -20.00 D

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Si-Hy TORIC Soft Contact Lenses characteristics:

- Diameter Range: 13 to 15 mm •
- . Base Curve: 8.0 to 9.2 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 MULTIFOCAL Soft Contact Lenses characteristics:

- Diameter Range:13 to 15 mm
- Base Curve: 8.0 to 9.2 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)

$$+2.2\text{SD} \sim +2.7\text{SD (HIGH)}$$

# 5.8 Comparison table:

| Indication for Use | | | |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lens Design | Si-Hy (olifilcon B) soft contact lens | VISTAKON (Narafilcon A) Contact lens (K073485) | Visco (olifilcon A) soft contact lens (K141348) |
| Spherical | The Si-Hy Spherical Silicone<br>Hydrogel Soft Contact Lenses<br>are indicated as daily wear<br>single use soft contact lens for<br>the correction of refractive<br>ametropia (myopia and<br>hyperopia) in phakic or aphakic<br>persons with non-diseased eyes<br>who exhibit refractive<br>astigmatism of 1.00D or less<br>where the astigmatism does not<br>interfere with visual acuity. | The VISTAKON<br>(narafilcon A) contact Lens<br>is indicated for daily wear<br>single use only for the<br>optical correction of<br>refractive ametropia<br>(myopia and hyperopia) in<br>phakic or aphakic persons<br>with non-diseased eyes who<br>may have 1.00D or less of<br>astigmatism. | The VISCO Soft<br>(Hydrophilic) Contact<br>Lenses is indicated for<br>daily wear for the<br>correction of refractive<br>ametropia (myopia and<br>hyperopia) in phakic or<br>aphakic persons with<br>non-diseased eyes who<br>exhibit refractive<br>astigmatism of 2.00D or<br>less where the astigmatism<br>does not interfere with<br>visual acuity. |
| Toric | The Si-Hy Toric Silicone<br>Hydrogel Soft Contact Lenses<br>are indicated as daily wear for<br>the correction of ametropia<br>(myopia and hyperopia) with<br>astigmatism in aphakic and | The VISTAKON<br>(narafilcon A) contact Lens<br>is indicated for daily wear<br>single use only for the<br>optical correction of visual<br>acuity in phakic or aphakic | NA |
| Multifocal | non-aphakic persons with<br>non-diseased eyes and whose<br>powers are from -20.00 to<br>+20.00 diopters and astigmatic<br>corrections are from -0.75 to<br>-2.25 diopters.<br>The Si-Hy Multifocal Silicone<br>Hydrogel Soft Contact lenses<br>are indicated as daily wear for<br>the correction of ametropia<br>(myopia and hyperopia) and<br>emmetropia with presbyopia in<br>aphakic and non-aphakic<br>persons with non-diseased eyes<br>and whose powers are from<br>-20.00 to +20.00 diopters with<br>add powers from +0.75 to +2.75<br>diopters. The lenses may be<br>worn by persons who exhibit<br>astigmatism of 1.00 diopters or<br>less where the astigmatism does<br>not interfere with visual acuity. | persons with non-diseased<br>eyes that are hyperopic or<br>myopic and may have<br>10.00D or less of<br>astigmatism.<br>The VISTAKON<br>(narafilcon A) contact Lens<br>is indicated for daily wear<br>single use only for the<br>optical correction of<br>distance and near vision in<br>presbyopic, phakic or<br>aphakic persons with<br>non-diseased eyes who may<br>have 0.75D of astigmatism<br>or less. | NA |
| Multifocal<br>Toric | NA | The VISTAKON<br>(narafilcon A) contact Lens<br>is indicated for daily wear<br>single use only for the<br>optical correction of<br>distance and near vision in<br>presbyopic phakic or<br>aphakic persons with<br>none-diseased eyes who<br>may have 10.00D of<br>astigmatism or less. | NA |
| Replacement | Eye care practitioners may<br>prescribe the lens for daily wear<br>(disposable use) single use. The<br>lenses are to be discarded upon<br>removal. Therefore, no cleaning<br>or disinfecting is required. The<br>Si-Hy (olifilcon B) Silicone<br>Hydrogel Soft (Hydrophilic)<br>Contact Lens helps protect<br>against transmission of harmful<br>UV radiation to the cornea and<br>into the eye. | Eye Care Professionals<br>should prescribe the lenses<br>for daily wear single use<br>only (see "Wearing<br>Schedule"). The lenses are<br>to be discarded upon<br>removal. Therefore, no<br>cleaning or disinfection is<br>required. | Eye care practitioners may<br>prescribe the lens for either<br>single-use disposable<br>wear, or for<br>frequent/planned<br>replacement wear, with<br>cleaning, disinfection, and<br>scheduled replacement.<br>When prescribed for<br>frequent replacement, the<br>lens may be disinfected<br>using a chemical<br>disinfection system<br>only.The VISCO Soft<br>(Hydrophilic) Contact<br>Lenses help protect against<br>transmission of harmful<br>UV radiation to the cornea<br>and into the eye. |

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

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| Similarities and differences | | | |
|-----------------------------------|------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------|
| Item | Device | Predicate<br>(K141348) | Predicate (K073485) |
| Product Name | Si-Hy (olifilcon B) Silicone<br>Hydrogel soft contact lens | Visco (olifilcon A)<br>soft contact lens | VISTAKON (Narafilcon<br>A) Contact lens |
| Manufacturer | VISCO VISION Inc. | VISCO VISION Inc. | Johnson & Johnson<br>Vision Care Inc. |
| Intended Use | Myopia, Hyperopia,<br>astigmatism, Presbyopia | Myopia, Hyeropia | Myopia, Hyperopia,<br>astigmatism, Presbyopia |
| Lens Design | Spherical, toric, or<br>multifocal | Spherical | spheric, aspheric, toric or<br>multifocal |
| Replacement Schedule | Daily Disposable (Single<br>use) | Monthly | Daily Disposable (Single<br>use) |
| Chemical composition | Silicone Hydrogel | The same | The same |
| Classification | Group 1 (Nonionic, Low<br>water) | The same | The same |
| Water Content | 47 % (<50%) | 47 % (<50%) | 46 % (<50%), |
| Oxygen Permeability<br>(DK, 35°C) | 120<br>(Fatt method) | 150<br>(Fatt method) | 100<br>(Fatt method) |
| Base Curve Range (mm) | 8.0~9.2 | 8.0~9.2 | 7.80 ~ 10.00 |
| Diameter (mm) | 13.0~15.0 | 13.0~15.0 | 12.0~15.0 |
| Center Thickness | Varies with design and<br>power (0.08 mm at -3.00D) | Varies with design<br>and power (0.08 mm<br>at -3.00D) | Varies with design and<br>power (0.085 mm at<br>-3.00D) |
| Powers | -20.00D to +20.00D | -20.00D to +20.00D | The same |
| Refractive Index | 1.410 | 1.410 | 1.410 |
| Light Transmittance | 94% | 94% | > 85% |
| Blue handling tint | Reactive Blue19 | Reactive Blue19 | Reactive Blue Dye #4 |
| Method of Manufacture | Molded | Molded | Molded |

# 5.9 Nonclinical Tests Performed

- 5.9.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical,

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optical and chemical properties of the lens are within established specifications for the lenses.

- 5.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
### 5.10 Clinical Studies

A three-month clinical study was conducted to demonstrate the safety and efffectiveness of the Si-Hy (olifilcon B) silicone hydrogel soft contact lens by comparison with Vistakon (narafilcon A) Contact Lens when worn on a daily wear basis. At least 50 evaluable subjects were participated. Parameters measured include visual acuities, adverse reactions, symptom, problem and complaints, slit lamp findings, as well as lens wearing time. It was found that the mean VA for both lenses was similar at each visit. The visual acuity could be corrected to 0.1 (log MAR) or better. No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups.

The clinical study provided data to establish substantial equivalence with the predicate, control lens, Vistakon (narafilcon A) soft contact lens, JOHNSON & JOHNSON VISION CARE INC. (K073485), with respect to the safety and effectiveness.

### 5.11 Conclusion

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