CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

K082393 · Unilens Corp., USA · LPL · Sep 11, 2008 · Ophthalmic

Device Facts

• Record ID: K082393
• Device Name: CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
• Applicant: Unilens Corp., USA
• Product Code: LPL · Ophthalmic
• Decision Date: Sep 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The CVUE ADVANCED (hioxifilcon D) Single Vision and Multifocal Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity. The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or not-aphakic persons with non-diseased eyes. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Device Story

C-VUE Advanced contact lenses are semi-scleral flexible hemispherical shells made of hioxifilcon D (non-ionic copolymer of 2-HEMA and GMA). Designed for daily wear to correct refractive errors; available in single vision, multifocal, and toric designs. Practitioners prescribe lenses for frequent/planned replacement; patients perform daily cleaning and chemical disinfection. Lenses cover cornea and partial sclera; provide refractive correction via specific optical zone geometries. Benefits include vision correction for ametropia and presbyopia in non-diseased eyes.

Clinical Evidence

No clinical data provided. Substantial equivalence based on established safety profile, pre-clinical toxicology, and manufacturing/chemistry data equivalent to predicate device K062854.

Technological Characteristics

Material: hioxifilcon D (46% copolymer, 54% water). Non-ionic copolymer of 2-HEMA and GMA, cross-linked with EGDMA. Oxygen permeability (Dk): 23 x 10-11 Fatt Units (ANSI Z80.20:2004). Refractive index: 1.408. Hemispherical shell form factor. Available with phthalocyanato (2)-(copper) visibility tint.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, astigmatism, and presbyopia in aphakic or non-aphakic persons with non-diseased eyes. Includes frequent/planned replacement wear.

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

• C-VUE Toric Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens
• Benz-G 4X 54% (hioxifilcon D) Lathed Sphere and Toric Lenses (K062854)

Submission Summary (Full Text)

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K082393

Special 510(k) hioxifilcon D contact lenses Unilens Corp., USA 10431 7210 Street North, Largo, FL 33777 USA

Registration No. 1034196

# 510(k) Summary

Applicant Information

SEP 1 1 2008

| Date prepared: | 18 August 2008 |
|-----------------|-------------------------------------------------|
| Name: | Unilens Corp., USA |
| Address: | 10431 72nd Street, North<br>Largo, FL 33777 |
| Contact person: | Alan J. Frazer<br>Director of Quality Assurance |
| Phone number: | [phone] |
| Fax number: | [phone] |

Device Information

| Device classification: | Class II |
|------------------------|---------------------------------------------------------------------|
| Classification number: | LPL |
| Classification name: | Lenses, Soft Contact, Daily Wear |
| Trade name: | C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic)<br>Contact Lens |

Equivalent device

The C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device:

C-VUE® Toric Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens; and Benz-G 4X 54% (hioxifilcon D) Lathed Sphere and Toric Lenses

#### Device description

CVUE ADVANCED (hioxifilcon D) soft contact lenses are semi-scleral flexible shells which cover the cornea and may cover a portion of the adjacent sclera and are available as aspheric single vision, multifocal, toric multifocal designs. Torics have a toroidal posterior optic zone, and multifocals have the most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. All lenses share a base curve with a flattened peripheral curve which approximates the curvature of the sclera. The lens material, (hioxifilcon D), is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2, 3dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is

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available with or without a blue visibility handling tint, phthalocyanato (2) -(copper).

The CVUE ADVANCED (hioxifilcon D) soft contact lens is a hemispherical shell of the following dimensions:

| Chord diameter: | 12.5 to 17.0mm |
|--------------------------|---------------------------------|
| Center thickness: | 0.13 to 0.73; varies with power |
| Base curve: | 7.0 to 10.5mm |
| Powers: | -20.00 to +20.00 diopters |
| ADD powers (multifocal): | Up to +3.00 diopters |
| Cylinder (toric): | Up to 4.00 diopters |
| Axis (toric): | 0° to 180° in 1° steps |
| Optical zone diameters: | 5.0 to 10.0mm |

The physical/ootical properties of the lens are:

| Refractive Index | 1.408 (hydrated) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Light Transmission - tinted | greater than 90% |
| Water Content | 54% |
| Specific Gravity | 1.299 (dry) |
| Oxygen Permeability (Dk Value) | 23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects |

## Intended Use (Indications)

The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.

The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or notaphakic persons with non-diseased eyes,

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

## Substantial equivalence

The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses will be manufactured according to specified process controls and a quality management system currently in place. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and

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#### Special 510(k) hioxifilcon D contact lenses Unilens Corp., USA 10431 72™ Street North, Largo, FL 33777 USA

distributed by Unilens Corp., USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 4X (hioxifilcon D), 510(k) K062854. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with its wings spread.

SEP 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Unilens Corp.,USA Alan J. Frazer Director of Quality Assurance 10431 72nd Street, North Largo FL 33777

Re: K082393

Trade/Device Name: C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: August 18, 2008 Received: August 19, 2008

Dear Mr. Frazer:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Marlina B. Egleston, M.D.

Malvina B. Eydelman, M.I 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

Ko82393 510(k) Number (if known):

Device Name: C-Vue® Advanced™ (hioxifiocon D) soft (hydrophilic) contact lenses

Indications for Use:

The CVUE ADVANCED (hioxifilcon D) Single Vision and Multifocal Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.

The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or not-aphakic persons with non-diseased eyes.

Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Att

Nose and Throat Devis

510(k) Number K082343

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