VISCO SOFT CONTACT LENS

K141348 · Visco Vision, Inc. · LPL · Jun 22, 2015 · Ophthalmic

Device Facts

• Record ID: K141348
• Device Name: VISCO SOFT CONTACT LENS
• Applicant: Visco Vision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The VISCO Soft (Hydrophilic) Contact Lenses is indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use 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. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

VISCO Soft Contact Lens is a spherical, silicone hydrogel lens (copolymer of NVP and Siloxane macromer) designed for vision correction. Lens features a light blue tint for handling and a benzotriazole UV-absorbing monomer to block UV radiation. Supplied sterile in buffered saline. Prescribed by eyecare practitioners for daily wear or frequent/planned replacement. Patients perform cleaning and chemical disinfection for frequent replacement schedules. Lens corrects refractive ametropia (myopia/hyperopia) and provides UV protection for the cornea and eye.

Clinical Evidence

Clinical performance demonstrated non-inferiority to the Biofinity (comfilcon A) predicate device. Supporting evidence includes physiochemical studies per ISO 18369 and toxicology/biocompatibility testing confirming safety in the ocular environment.

Technological Characteristics

Material: Silicone hydrogel (copolymer of 1-vinyl-2-pyrrolidinone and Siloxane macromer). Water content: 47%. Oxygen permeability (Dk): 150 (Fatt method). Refractive index: 1.410. UV protection: Benzotriazole monomer. Manufacturing: Cast-molded. Sterilization: Steam. Dimensions: 13.0-15.0 mm diameter, 8.0-9.2 mm base curve. Power range: -20.00D to +20.00D.

Indications for Use

Indicated for phakic or aphakic persons with non-diseased eyes requiring correction of myopia or hyperopia with refractive astigmatism ≤ 2.00D. Suitable for daily wear or frequent/planned replacement.

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)

Reference Devices

• Frequency 55 (K000384)

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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

June 22, 2015

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

Re: K141348

> Trade/Device Name: Visco Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: Mav 18, 2014 Received: May 22, 2014

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 and Part 809); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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 Y. Alexander -A

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) k141348

Device Name VISCO Soft Contact Lens

#### Indications for Use (Describe)

The VISCO Soft (Hydrophilic) Contact Lenses is indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use 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. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 005_510(K) SUMMARY

Preparation Date: May 29, 2015

# 5.1 Establishment Information:

| Name | Visco Vision Inc. |
|-----------|-------------------------------------------------------------------------------|
| Address | 2F, No. 789, Bo-Ai Street, Chubei City, Hsinchu County, 302<br>Taiwan, R.O.C. |
| Phone No. | 886-3-6205516 |
| Fax No. | 886-3-5536268 |

## 5.2 Owner:

| Company | Visco Vision Inc. |
|-----------|--------------------------------------------------------------------------------|
| Name | Ted TT Huang |
| Address | 2F, No. 789, Bo-Ai Street, Chubei City, Hsinchu County, 302-<br>Taiwan, R.O.C. |
| Phone No. | 886-3-6205516 |
| Fax No. | 886-3-5536268 |

## 5.3 US Agent:

| Name | Jessica LeeChen |
|----------|----------------------------------------|
| Address | 44855 Lafayette Dr. Novi, MI 48377 USA |
| Phone No | [phone] |
| E-mail | [e-mail] |

## 5.4 Contact Person:

| Name | Jennifer TING |
|----------|---------------------------|
| Phone No | 886-2-82823192 |
| Fax No | 886-2-82867686 |
| e-mail: | [e-mail] |

## 5.5 Device Identification:

| Proprietary Name | VISCO Soft Contact Lens |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Daily Wear (21 CFR 886.5925<br>Product Code LPL)<br>Lenses, Soft Contact, Daily Wear (Disposable),<br>(21 CFR 886.5925, Product Code MVN) |
| Classification | II |

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#### 5.6 Legally Marketed Equivalent Device:

| Predicate Device Name | Biofinity (comfilcon A) |
|-----------------------|-------------------------|
| Manufacturer | CooperVision Inc. |
| 510(k) Number | K052560 |
| Product Code | LPL, MVN |

## 5.7 Device Description

- The VISCO Soft Contact Lens is a spherical lens with UV blocker. -
- -The VISCO Soft Contact Lens is available in hemispherical shell.
- The lens material is a silicon combination hydrogel. It is a copolymer of - 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. The water content is 47%.
- The VISCO Soft Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose.
- -A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (1.1%) in the UVB range of 280-315nm and less than 50% (9.4%) in the UVA range of 316-380nm.
- The lens is supplied in a sterile state, packaged in a buffered saline solution. -

## 5.8 Indication for Use:

The VISCO Soft (Hydrophilic) Contact Lenses is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 2.00D or less where the astigmatism does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for either single-use 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. The VISCO Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

#### 5.9 Technological characteristics

The spherical lens design specification:

- 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 ●
- Power -20.00D to +20.00D

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The physical properties of the lenses are:

- Refractive index: 1.410 (hydrated)
- Light transmittance: > 94%
- 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)

## 5.10 Comparison table:

●

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

| Similarities | | |
|------------------------------------|-----------------------------------------------------|----------------------------------------------|
| Item | Device | Predicate (K052560) |
| Product Name | VISCO Soft Contact Lens | BIOFINITY (comfilcon A)<br>Soft Contact Lens |
| Manufacturer | VISCO Technology | CooperVision Inc. |
| Intended Use | Myopia, Hyperopia | The same |
| USAN Name | Olifilcon A | comfilcon A |
| Material | Silicone Hydrogel | Silicone Hydrogel |
| Lens Design | Spherical | Spheric, aspheric, toric or<br>multifocal |
| Classification | Class II, | The same |
| Type | Group I (low water, nonionic) | The same |
| Water Content | 47 % | 48 % |
| Oxygen Permeability<br>(DK, 35°C ) | 150<br>(Fatt method) | 128<br>(Fatt method) |
| Base Curve Range | 8.0~9.2 | 8.0~9.5 |
| Diameter (mm) | 13.0~15.0 | 13.5~15.0 |
| Center Thickness | Varies with design and power<br>(0.08 mm at -3.00D) | 0.05 mm – 0.50 mm |
| Powers | -20.00D to +20.00D in 0.25<br>steps | The same |
| Replacement Schedule | Daily wear or Daily<br>Disposable (Single use) | daily wear |
| Refractive Index | 1.410 | 1.40 |
| Light Transmittance | 94% | >97% |

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| Method of<br>Manufacture | Cast-Molded | The same |
|--------------------------|----------------------|--------------------------|
| Surface Treatment | No | No |
| Sterilization | steam | The same |
| Packaging | Blister pack | The same |
| Blue handling tint | Yes, reactive Blue19 | Yes, Phthalocyanine Blue |

| Mechanical Strength | Device | Predicate<br>(K052560) | Predicate<br>(K000384) |
|-------------------------|-----------------|----------------------------|------------------------|
| Product Name | Visco | Biofinity<br>(comfilcon A) | Frequency 55 |
| Tensile strength (Mpa) | $0.55 \pm 0.06$ | $0.50 \pm 0.07$ | 0.66 |
| Modulus (Mpa) | $0.59 \pm 0.05$ | $0.8 \pm 0.1$ | 0.48 |
| Elongation at break (%) | $106 \pm 5$ | $130 \pm 2$ | 179 |
| toughness (J/m³) | $0.26 \pm 0.02$ | | 0.38 |
| Manufacturing method | Cast Mold | Cast Mold | Cast Mold |

## 5.11 Nonclinical Tests Performed

- 5.11.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
- 5.11.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

#### 5.12 Clinical Studies

The clinical performance result proves that the safety and effectiveness of the VISCO soft contact lens is non-inferior to the BIOFINITY (comfilcon A) Soft Contact Lens currently marketed by Cooper Vision Inc.

## 5.13 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "VISCO Soft Contact Lens" is as safe, as effective and performs as well as the predicate device.