55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K051184 · United Contact Lens, Inc. · LPL · Jul 1, 2005 · Ophthalmic

Device Facts

• Record ID: K051184
• Device Name: 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
• Applicant: United Contact Lens, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The 55 Toric (ocutilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Device Story

Hemispherical flexible hydrophilic contact lenses; cover cornea and adjacent sclera. Available in single vision, double slab-off back surface (toric), and aspheric (multifocal) designs. Prescribed by eye care practitioners for daily wear or frequent replacement. Patients use lenses to correct refractive errors; disinfection via chemical or hydrogen peroxide systems. Benefits include vision correction for ametropia and presbyopia.

Clinical Evidence

Bench testing only. Pre-clinical testing included systemic injection, primary ocular irritation, cytotoxicity, and physicochemical testing. Results confirmed non-toxicity, non-irritation, and stability of physical properties. Shelf life testing confirmed sterility and physical property stability.

Technological Characteristics

Material: ocufilcon C (HEMA and methacrylic acid cross-linked with ethyleneglycol dimethacrylate, 55% water). Tint: Reactive Blue 19. Designs: single vision, double slab-off (toric), aspheric (multifocal). Manufacturing: molded. Sterilization: not specified.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, astigmatism, and presbyopia in aphakic or non-aphakic persons 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

• 55 F (ocufilcon C) Soft (Hydrophilic) Single Vision Contact Lens (P920008/K941607)
• 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens (P920008/K941607)
• 55 Toric Contact Lens (P920008/K941607)

Submission Summary (Full Text)

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JUL 1 - 2005

K051184

Image /page/0/Picture/2 description: The image shows the words "United Contact Lens" in a stylized font. Below the words "United Contact Lens" is a black box with the words "SOFT CONTACT LENSES" in white font. The words "United Contact Lens" are stacked on top of each other, with "United" on top, "Contact" in the middle, and "Lens" on the bottom.

19111 - 615 Avenue NE, Suite 5. Arlington, Washington 98223 Office: 425-743-7343 Fax: [phone] Toll Free: 800-446-1666

### 510(k) Summary

#### Submitter Information:

United Contact Lens Inc. 19111 61st Ave. NE #5 Arlington, WA 98223 Registration No. 2918644

| Contact Person: | Garold L. Edwards, O.D., F.A.A.O. |
|-----------------|-----------------------------------|
| | Regulatory Consultant |
| Telephone: | (408) 221 - 3860 |
| Fax: | (425) 743 - 8795 |

May 4, 2005 Date Prepared:

### Device Name:

| Common Name: | Soft (Hydrophilic) Contact Lens |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Proprietary Names: | 55 SV (ocufilcon C) Soft<br>(Hydrophilic) Contact Lens for Daily Wear<br><br>55 Multifocal (ocufilcon C) Soft (Hydrophilic)<br>Contact Lens for Daily Wear<br><br>55 Toric (ocufilcon C) Soft (Hydrophilic)<br>Contact Lens for Daily Wear |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |

### Predicate Devices:

The 55 F (ocufilcon C) Soft (Hydrophilic) Single Vision Contact Lens, the 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens and the 55 Toric Contact Lens were selected as the predicate devices manufactured in the same facility, using the same formulation, under the same quality system packaging and sterilization processes as the subject devices.

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# Description of Devices:

The 55 SV, 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells which cover the cornea and a portion of the adjacent sclera. The 55 Contact Lens is available in a single vision lens design, the 55 Toric Contact Lens is available in a double slab-off back surface design and the 55 Multifocal Contact Lens is available in an aspheric lens design. The lens material (ocufilcon C) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). Lenses are tinted using the color additive Reactive Blue 19.

| PARAMETER | 55 SV, 55 Toric and 55<br>Multifocal Soft<br>(hydrophilic) Contact<br>Lenses for Daily Wear | 55 F, Toric 55 and Multifocal<br>(ocufilcon C) Soft<br>(hydrophilic) Contact Lenses<br>for Daily Wear |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Submission number | N/A | P920008/K941607 |
| Material | ocufilcon C | ocufilcon C |
| Material classification | Hydrophilic Lens Group 4 | Hydrophilic Lens Group 4 |
| Indication for use | myopia, hyperopia,<br>astigmatism and<br>presbyopia | myopia, hyperopia,<br>astigmatism and presbyopia |
| Water content | 54.9% | 54.4% |
| Visible light<br>transmittance | 98.9% | 98.3% |
| Dk (35° C) | $18.77 x 10^{-11}$ | $18.78 x 10^{-11}$ |
| Powers | +12.00 D to -20.00 D;<br>Continuous add power to<br>+3.00 (55 Multifocal only);<br>Cylinder powers -0.50 D to<br>-2.50 D (55 Toric only) | +20.00D to -20.00 D<br>Continuous add power to<br>+3.00 (55 Multifocal only);<br>Cylinder powers -0.50 D to<br>6.00D (Toric 55 only) |
| Color | Blue visibility,<br>Reactive Blue #19 | clear |
| Refractive index | 1.415 | 1.414 |
| Method of<br>manufacture | Molded | Lathed |

# Comparison to Predicate Device

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### Indications for Use:

The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens is inclicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non- diseased eyes.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

### Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the 55 SV, the 55 Multifocal, and the 55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.

Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. The 55 SV lenses were extracted and evaluated for presence of residue. Results showed no evidence of unsafe amounts of residue in the extracts. Physicochemical testing of the 55 lenses demonstrated equivalency to the predicate devices.

## Conclusion:

Information submitted in the 510(k) establishes that the 55 SV, the 55 Multifocal and the 55 Toric Contact Lenses (ocufilcon C) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that the physical lens properties are stable. Therefore, the devices are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, bold font and is horizontally aligned. The background is plain and white, which makes the text stand out.

Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.

JUL 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United Contact Lens, Inc. c/o Garold L. Edwards, O.D., F.A.A.O Regulatory Consultant 2091 Upper Scenic Drive Felton, CA 95018

Re: K051184

Trade/Device Name:

55 SV (ocufilcon C) Soft (hydrophilic) Contact Lens for Daily Wear 55 Multifocal (ocufilcon C) Soft (hydrophilic) Contact Lens for Daily Wear 55 Toric (ocufilcon C) 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: May 4, 2005 Received: May 9, 2005

Dear Mr. Edwards:

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 - Garold L. Edwards, O.D., F.A.A.O

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/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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 STATEMENT

#### Device Names:

55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

55 Toric (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

### Indications for Use:

The 55 SV (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The 55 Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The 55 Toric (ocutilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Prescription Use X

Over-the-Counter Use_

06 001

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n of Ophthalmic Ear, and Throat Devises

K051184 510(k) Number