C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS

K041608 · Unilens Corp., USA · LPL · Jul 7, 2004 · Ophthalmic

Device Facts

• Record ID: K041608
• Device Name: C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS
• Applicant: Unilens Corp., USA
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The C-Vue33 Toric Multifocal Contact Lens is 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. Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.

Device Story

Soft hydrophilic contact lens; front surface asphere design; multiple aspheric zones; eccentric lenticulation for ballast/axis stabilization; toroidal posterior optic zone; flattened peripheral curve. Material: methafilcon A (copolymer of 2-hydroxyethyl methacrylate and methacrylic acid, crosslinked with ethyleneglycol dimethacrylate). Prescribed by eyecare practitioners for daily wear in planned replacement programs. Corrects refractive errors; improves vision in presbyopic and astigmatic patients. Patient self-use for daily vision correction.

Clinical Evidence

No clinical data. Substantial equivalence based on material chemistry, physical construction, and established safety profile of the methafilcon A material.

Technological Characteristics

Material: methafilcon A (HEMA/methacrylic acid copolymer crosslinked with EGDMA). Water content: 55%. Refractive index: 1.415. Oxygen transmissibility: 18.83 x 10^-11 (cm2/sec)(ml O2/ml x mm Hg). Design: front surface asphere, toroidal posterior optic, eccentric lenticulation. Dimensions: 14.0-15.0mm diameter, 8.4-9.3mm base curve. Powers: -20.00 to +20.00D. Chemical disinfection compatible.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, presbyopia, and astigmatism (up to 4.00D) in aphakic or non-aphakic patients with non-diseased eyes.

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

• LifeStyle MV2™ Toric (polymacon) Soft (hydrophilic) Multifocal Contact Lens

Reference Devices

• BENZ-MF (methafilcon A) (K003861)

Submission Summary (Full Text)

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K041608

### 510(k) Summary

### Applicant Information

1

JUL - 7 2004

| Date prepared: | June 1, 2004 |
|-----------------|---------------------------------------------|
| Name: | Unilens Corp., USA |
| Address: | 10431 72nd Street, North<br>Largo, FL 33777 |
| Contact person: | Josepha Bruno, Director 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-Vue55 Toric (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens |

#### Equivalent device

The C-Vue's Toric (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device: LifeStyle MV2™ Toric (polymacon) Soft (hydrophilic) Multifocal Contact Lens

#### Device description

The C-Vue's Tonc (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens is a front surface asphere consisting of multiple aspheric zones with an eccentric lenticulation for ballast and axis stabilization. The base curve has a toroidal posterior optic zone and a flattened peripheral curve which approximates the curvature of the sclera. The most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. The lens material, (methafilcon A), is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid, crosslinked with ethyleneglycol dimethacrylate.

The C-Vue35 Toric Multifocal Contact Lens is a hemispherical shell of the following dimensions:

| Chord diameters | 14.0 to 15.0mm |
|------------------------|-----------------------------------|
| Center thickness | 0.10 to 0.60mm; varies with power |
| Base curves | 8.4 to 9.3mm |
| Powers | -20.00 to +20.00 diopters |
| Add powers | Up to +3.00 diopters |
| Cylinder | Up to 4.00 diopters |
| Axis | 1° to 180° in 1° steps |
| Optical zone diameters | 5.0 to 10.0mm |

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The physical/optical properties of the lens are:

| specific gravity | 1.09 |
|--------------------------------------|------------------------------------------------------|
| refractive index (wet) | 1.415 |
| light transmittance (clear and tint) | greater than 90% in the visible light region |
| water content | 55% |
| oxygen transmissibility | $18.83 \times 10^{-11}$ (cm²/sec)(ml O2/ml x mm Hg)* |

* as measured by Schema Versatae Model 920 connected to a polargraphic cell

### Intended use

The C-Vue33 Toric Multifocal Contact Lens is 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.

Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.

# Substantial equivalence

The new device 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 distributed by Unilens Corp., USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-MF (methafilcon A), 510(k) K003861. 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 device identified above.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2004

Unilens Corp., USA c/o Ms. Josepha Bruno Director, Quality Assurance 10431 72nd Street North Largo, FL 33777

Re: K041608

Trade/Device Name: C-Vue35 Toric Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: June 9, 2004 Received: June 15, 2004

Dear Ms. Bruno:

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.

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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Page 2 - Ms. Josepha Bruno

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Akeryl Rosenthal

A. Ralph Rosenthal, 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): _ KO4-1608 _________________________________________________________________________________________________________________________________________

Device Name: C-Vue's Toric Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens

Indications for Use:

The C-Vue's Toric Multifocal Contact Lens is 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.

Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

| 510(k) Number | K041608 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

AND/OR

| Over-The-Counter-Use<br>(Part 21 CFR 807 Subpart C) | |
|-----------------------------------------------------|--|
|-----------------------------------------------------|--|

Concurrence of CDRH, Office of Device Evaluation (ODE)