Visco (olifilcon A) soft contact lens

K160245 · Visco Vision, Inc. · LPL · Oct 24, 2016 · Ophthalmic

Device Facts

• Record ID: K160245
• Device Name: Visco (olifilcon A) soft contact lens
• Applicant: Visco Vision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The VISCO (olifilcon A) Toric 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 VISCO (olifilcon A) Multifocal Soft Contact lenses are indicated as daily wear for the correction of ametropia (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 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 either single-use daily disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent the lens may be disinfected using a chemical disinfection system only.

Device Story

VISCO (olifilcon A) soft contact lenses; silicone hydrogel material; toric or multifocal configurations; UV-blocking monomer; light blue tint (reactive Blue19). Supplied sterile in buffered saline with Sodium Hyaluronate and Sodium Alginate. Prescribed by eye care practitioners for daily wear (single-use or frequent/planned replacement). Corrects ametropia (myopia/hyperopia) and presbyopia. Patients wear lenses to improve visual acuity. No active components; passive optical device.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including physiochemical studies per ISO 18369 and biocompatibility/toxicology assessments.

Technological Characteristics

Material: olifilcon A (silicone hydrogel, 47% water content). Refractive index: 1.410. Oxygen permeability (Dk): 150 (Fatt method). UV blocking: <5% UVB, <50% UVA. Manufacturing: Cast-molded. Sterilization: Steam. Packaging: Blister pack with buffered saline (Sodium Hyaluronate/Sodium Alginate).

Indications for Use

Indicated for aphakic and non-aphakic persons with non-diseased eyes requiring correction of myopia, hyperopia, astigmatism, or presbyopia. Powers range -20.00 to +20.00D; astigmatic correction -0.75 to -2.25D; add powers +0.75 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

• Biofinity (comfilcon A) (K052560)
• VISCO (olifilcon A) (K141348)

Submission Summary (Full Text)

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

October 24, 2016

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

Re: K160245

Trade/Device Name: VISCO (olifilcon A) Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: September 12, 2016 Received: September 14, 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 (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

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forth in the quality systems (OS) 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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# Indications for Use

510(k) Number (if known) K160245

Device Name VISCO (olifilcon A) Soft Contact Lens

### Indications for Use (Describe)

The VISCO (olifilcon A) Toric 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 VISCO (olifilcon A) Multifocal Soft Contact lenses are indicated as daily wear for the correction of ametropia (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 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 either single-use daily disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent the lens may be disinfected using a chemical disinfection system only.

Type of Use (Select one or both, as applicable)

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(K) SUMMARY

Preparation Date: Sep. 12, 2016

#### Establishment Information: 1.1

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

#### 1.2 Contact Person:

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

#### Device Identification: 1.3

| Proprietary Name | VISCO (olifilcon A) Soft 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 |

#### Legally Marketed Equivalent Device: 1.4

| Predicate Device Name | Biofinity (comfilcon A), K052560, CooperVision Inc. | |
|-----------------------|-----------------------------------------------------|--|
| | VISCO (olifilcon A), K141348, Visco Vision Inc. | |
| Product Code | LPL, MVN | |

#### 1.5 Device Description

The VISCO (olifilcon A) toric/multifocal soft contact lenses are manufactured in toric or multifocal configurations with UV blocker. The lens material, olifilcon A, is a silicon hydrogel with water content 47%. The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing

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monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380mm. The lens is supplied in a sterile state, packaged in a buffered saline solution containing Sodium Hyaluronate and Sodium Alginate

#### 1.6 Indication for Use:

The VISCO (olifilcon A) Toric 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 VISCO (olifilcon A) Multifocal 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 either single-use daily disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

#### 1.7 Technological characteristics

The optical lens design specification:

| ● | Power Range | 20.00D to +20.00D |
|---|------------------------|-------------------------------------------|
| ● | Add Power (Multifocal) | Low (+0.75D ~ +1.25D) |
| | | Mid (+1.50D ~ +2.00D) |
| | | High (+2.25D ~ +2.75D) |
| ● | Cylinder Power (Toric) | -0.75D, -1.25D, -1.75D, -2.25D |
| | | Axis from 10° to 180° (in 10° increments) |
| ● | Diameter | 13.0 mm to 15.0 mm |
| ● | Center Thickness | 0.08mm @ -3.00D (Varies with Power) |
| ● | Base Curve | 8.0 mm to 9.2 mm |

The physical properties of the lenses are:

| • Refractive index: | 1.410 (hydrated) |
|---------------------|------------------|
|---------------------|------------------|

- Light transmittance: > 94%

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- Water content: 47% by weight in normal saline 150 x 10-11 Oxygen permeability ●
- (cm²/sec)(ml O2/ml.mmHg) measured at 35°C

(intrinsic Dk-Colormetric method)

#### 1.8 Comparison table:

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

| Similarities | | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Item | Device | Predicate<br>(K052560) | predicate<br>(K141348) |
| Product Name | VISCO (olifilcon A) Toric<br>Soft Contact Lens<br>VISCO (olifilcon A)<br>Multifocal Soft Contact<br>Lens | BIOFINITY Toric<br>(comfilcon A) Soft Contact<br>Lens<br>BIOFINITY Multifocal<br>(comfilcon A) Soft Contact<br>Lens | Visco (olifilcon A) soft<br>contact lens |
| Manufacturer | Visco Vision Inc. | CooperVision Inc. | Visco Vision Inc. |
| Intended Use | Myopia, Hyperopia,<br>Prysbyopia | The same | Myopia, Hyperopia |
| Replacement<br>Schedule | Daily wear (monthly) or<br>Daily Disposable (Single<br>use) | daily wear (monthly) or<br>extended wear | Daily wear (monthly)<br>or Daily Disposable<br>(Single use) |
| USAN Name | olifilcon A | comfilcon A | olifilcon A |
| Material | Silicone Hydrogel | Silicone Hydrogel | Silicone Hydrogel |
| Lens Design | toric or multifocal | Spheric, aspheric, toric or<br>multifocal | spheric |
| Classification | Class II, | The same | The same |
| Type | Group I (low water,<br>nonionic) | The same | The same |
| Water Content | 47 % | 48 % | 47% |
| Oxygen<br>Permeability<br>(DK, 35°C ) | 150<br>(Fatt method) | 128<br>(Fatt method) | 150<br>(Fatt method) |
| Base Curve<br>Range | 8.0~9.2 | 8.0~9.5 | 8.0~9.2 |
| Diameter (mm) | 13.0~15.0 | 13.5~15.0 | 13.0~15.0 |
| Center Thickness | Varies with power (0.08<br>mm at -3.00D) | 0.05 mm – 0.50 mm | Varies with power<br>(0.08 mm at -3.00D) |
| Powers | -20.00D to +20.00D<br>in 0.25 steps | The same | -20.00D to +20.00D<br>in 0.25 steps |
| Add Power<br>(Multifocal) | Low (+0.75D ~ +1.25D)<br>Mid (+1.50D ~ +2.00D)<br>High (+2.25D ~ +2.75D) | +0.50D to +3.00D | NA |
| Cylinder Power<br>(Toric) | -0.75D, -1.25D, -1.75D,<br>-2.25D<br>Axis from 10° to 180° (in<br>10° increments) | -0.25D -5.00D<br>Axis from 0° to 180° | NA |
| Refractive Index | 1.410 | 1.40 | 1.410 |
| Light<br>Transmittance | 94% | >97% | 94% |
| Method of<br>Manufacture | Cast-Molded | The same | The same |
| Surface Treatment | No | No | No |
| Sterilization | steam | The same | The same |
| Packaging | Blister pack | The same | The same |
| Blue handling tint | Yes, reactive Blue19 | Yes, Phthalocyanine Blue | Yes, reactive Blue19 |
| Indication for Use | <b>Toric</b><br>The VISCO (olifilcon A)<br>Toric Soft Contact lenses<br>are indicated as daily wear<br>for the correction of<br>ametropia (myopia and<br>hyperopia) with<br>astigmatism in aphakic and<br>non-aphakic persons with<br>non-diseased eyes and<br>whose powers are from<br>-20.00 to +20.00 diopters<br>and astigmatic corrections<br>are from -0.75 to -2.25<br>diopters. | <b>Toric</b><br>Biofinity (comfilcon A)<br>toric soft contact lenses are<br>indicated for the correction<br>of ametropia (myopia or<br>hyperopia with<br>astigmatism) in aphakic<br>and non-aphakic persons<br>with non-diseased eyes in<br>powers from -20.00 to<br>+20.00 diopters and<br>astigmatic corrections<br>from -0.25 to -5.00<br>diopters. | NA |
| Multifocal | Multifocal | | |
| The VISCO (olifilcon A) | Biofinity (comfilcon A) | | |
| Multifocal Soft Contact | multifocal lenses are | | |
| lenses are indicated as | indicated for the correction | | |
| daily wear for the | of refractive ametropia | | |
| correction of ametropia | (myopia and hyperopia) | | |
| (myopia and hyperopia) | and emmetropia with | | |
| and emmetropia with | presbyopia in aphakic and | | |
| presbyopia in aphakic and | non-aphakic persons with | | |
| non-aphakic persons with | non-diseased eyes in | | |
| non-diseased eyes and | powers from -20.00 to | | |
| whose powers are from | +20.00 diopters and with | | |
| -20.00 to +20.00 diopters | add powers from +0.50 to | | |
| with add powers from | +3.00 diopters. The lenses | | |
| +0.75 to +2.75 diopters. | may be worn by persons | | |
| The lenses may be worn | who exhibit astigmatism of | | |
| by persons who exhibit | 2.00 diopters or less that | | |
| astigmatism of 1.00 | does not interfere with | | |
| diopters or less where the | visual acuity. | | |
| astigmatism does not | | | |
| interfere with visual acuity. | | | |
| Eye care practitioners may | Eye care practitioners may | Eye care practitioners<br>may prescribe the lens<br>for either single-use<br>disposable wear, or for<br>frequent/planned<br>replacement wear,<br>with cleaning,<br>disinfection, and<br>scheduled<br>replacement. When<br>prescribed for frequent<br>replacement, the lens<br>may be disinfected<br>using a chemical | |
| prescribe the lens for either | prescribe the lens for | | |
| single-use daily disposable | frequent replacement wear, | | |
| wear, or for | with cleaning, disinfecting | | |
| frequent/planned | and scheduled | | |
| replacement wear, with | replacements. | | |
| cleaning, disinfection, and | | | |
| scheduled replacement. | | | |
| When prescribed for | | | |
| frequent replacement, the | | | |
| lens may be disinfected | | | |
| using a chemical | | | |
| disinfection system only. | | disinfection system only. | |
| | | | |
| | | disinfection system | |
| | | only.The VISCO Soft | |
| | | (Hydrophilic) Contact | |
| | | Lenses help protect | |
| | | against transmission of | |
| | | harmful UV radiation | |
| | | to the cornea and into | |
| | | the eye. | |
| NA | Spherical and Aspherical | Spherical | |
| | Biofinity (comfilcon A) | The VISCO Soft | |
| | sphere and Asphere soft | (Hydrophilic) Contact | |
| | contact lenses are indicated | Lenses is indicated for | |
| | for the correction of | daily wear for the | |
| | ametropia (myopia and | correction of refractive | |
| | hyperopia) in aphakic and | ametropia (myopia and | |
| | non-aphakic persons with | hyperopia) in phakic | |
| | non-diseased eyes in | or aphakic persons | |
| | powers from -20.00 to | with non-diseased eyes | |
| | +20.00 diopters. The | who exhibit refractive…