FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR

K020392 · CooperVision, Inc. · LPL · Apr 26, 2002 · Ophthalmic

Device Facts

• Record ID: K020392
• Device Name: FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

1. Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. 2. Frequency 55 Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less. FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE. Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses. Frequent/Planned Replacement Wear: When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner. Disposable Wear: When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

Device Story

Soft (hydrophilic) contact lenses composed of methafilcon A (hydroxyethylmethacrylate and methacrylic acid copolymer) with benzophenone UV-absorbing monomer. Hemispherical shells available in spherical, aspheric, and toric designs. Tinted aqua with C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86 for visibility. Prescribed by eye care practitioners for daily wear; includes frequent/planned replacement or disposable wear options. Lenses require chemical or hydrogen peroxide disinfection. Provides refractive correction for myopia, hyperopia, and astigmatism while blocking UV radiation to the cornea and eye.

Clinical Evidence

Bench testing only. Includes toxicological studies (ISO agarose overlay cytotoxicity, ISO ocular irritation in rabbits, ISO acute systemic toxicity in mice), leachability study for colorfastness (dye levels <1ppm), and HPLC analysis for residual monomers. Optical properties (transmittance, refractive index, Dk) were measured and compared to predicates.

Technological Characteristics

Material: methafilcon A (random copolymer of hydroxyethylmethacrylate and methacrylic acid). UV blocker: benzophenone monomer. Water content: 55%. Refractive index: 1.40. Oxygen permeability (Dk): 15.8 x 10^-11 (cm2/sec)(ml O2/ml x mmHg) at 35°C. Manufacturing: Fully molded. Dimensions: 14.0-15.0mm diameter, 8.0-9.5mm base curve. Disinfection: Chemical or hydrogen peroxide only.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism in aphakic and non-aphakic patients with non-diseased eyes. Frequency 55 UV/Aspheric for astigmatism ≤ 2.00D; Frequency 55 Toric for astigmatism ≤ 12.00D.

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

• Sauflon 55 UV (methafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens (K013649)
• Frequency 55 with UVAM (methafilcon A) (Sphere, Asphere and Toric) Soft (hydrophilic) contact lenses (K982997)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the company name in a stylized font, with the "C" in "Cooper" being a double circle. To the right of the name is a square containing a stylized eye.

K020392

APR 2 6 2002 Frequency 55 UV Methafilcon A

Premarket Notification

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Submitter Information: | CooperVision, Inc.<br>711 North Road<br>Scottsville, NY 14546 |
|---------------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Bonnie Tsymbal<br>Manager, Regulatory Affairs |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Prepared: | February 5 ^th , 2002 |
| 2. Device Name: | |
| Common Name: | Soft (hydrophilic) Contact Lens |
| Trade/Proprietary Name: | Frequency 55 UV (methafilcon A) Soft (hydrophilic)<br>Contact Lens for Daily Wear |
| Device Classification: | Class II |

#### 3. Predicate Device:

The predicate devices are the Sauflon 55 UV (methafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens marketed by Sauflon Pharmaceuticals Ltd. and Frequency 55 with UVAM (methafilcon A) (Sphere, Asphere and Toric) Soft (hydrophilic) contact lenses for daily wear manufactured by Aspect Vision. The predicate devices were cleared under K013649 and K982997 respectively. The devices were selected as the predicate devices based on the material, intended use and design.

#### 4. Device Description:

Frequency 55 UV and Frequency 55 UV Aspheric (methafilcon A) soft (hydrophilic) contact lenses are available as spherical lenses. Frequency 55 UV Toric (methafilcon A) soft (hydrophilic) contact lenses are available as astigmatic (toric) lenses. The lens material, methafilcon A, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 40% in the UVA range of 315 to 380 nm. The lenses are tinted aqua from edge to edge for visibility purposes with the color additives, C.I. Reactive Blue No. 4 and C.I. Reactive Yellow 86.

Frequency 55 UV. Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are hemispherical shells with the following dimensions:

14.0mm to 15.0mm

0.03mm to 0.60mm (varies with power)

8.0mm to 9.5mm

- Diameter: .
- Base Curve: ●
- Center Thickness: .
- Spherical Powers: .
- . Cylindrical Powers:
-
- Axis: .

- -20.00 to +20.00D plano to -12.00 1° to 180°

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The physical/optical properties of the Frequency 55 UV and Frequency 55 UV Aspheric and Frequency 55 UV Toric contact lenses are:

| • Refractive Index: | 1.40 |
|----------------------------|------|
| • % Transmittance @ 590nm: | >90% |

- % Transmittance @ 590nm: .
- % Transmittance @ 280-315nm: <10% . <40%
- %Transmittance 316-380nm .
- Water Content; .
- Oxygen Permeability: .

22.0 x 10.11 (cm2/sec)(ml 02/ml x mmHg) at 35°C Fatt Method for determination of oxygen permeability)

#### Transmittance Curves

55%

The figure below shows transmittance curves comparing the Frequency 55 UV (methafilcon A) contact lens with visibility tint and UV blocker, against those for a 24 yr. old human cornea and 25 yr. old human crystalline lens.

Image /page/1/Figure/13 description: The figure shows a plot of % Transmission vs. Wavelength (nm). The x-axis ranges from 200 to 800 nm, while the y-axis ranges from 0 to 100 % Transmission. There are three different lines plotted on the graph, each representing a different sample. One sample has a sharp increase in transmission around 350 nm, reaching nearly 100% transmission, while another sample has a gradual increase in transmission starting around 350 nm, reaching around 75% transmission.

Data was obtained from measurements taken thru the central 3-5mm portion of a Frequency 55 UV (methafilcon A with UV blocker) soft contact lens with visibility tint and UV blocker. Curve shown is for a -6.75D lens with a center thickness of 0.06 mm which represents the transmittance characteristics of the thinnest version of this UV-absorbing lens to marketed.

..............................................................................................................................................................................

-------- 25 year old crystalline lens *2

N.B.

- Lerman, S., Radiant Energy and the eye, MacMillan, New York, 1980, p.58, Fig 2-21 1.
- Waxler, M. Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 1986, 2. p. 10 Fig. 5

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# 5. Indications for Use:

Frequency 55 UV lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.

# FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.

Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.

# Frequent/Planned Replacement Wear

When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.

### Disposable Wear

When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

# 6. Substantial Equivalence:

#### Comparison to Predicate Device

| | Frequency 55 UV<br>UV416 (methafilcon A) Soft (hydrophilic)<br>Contact Lens for<br>Daily Wear | Sauflon 55 UV<br>UV416 (methafilcon A) Soft (hydrophilic)<br>Contact Lens for DW<br>K013649 | Frequency 55 with<br>UVAM (methafilcon A)<br>Soft (hydrophilic)<br>Contact Lens for DW<br>K982997 |
|-------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Lens Material | methafilcon A | Methafilcon A<br>Equivalent | methafilcon A<br>Equivalent |
| Material Classification | Group 4 >50% ionic<br>polymer | Equivalent | Equivalent |
| Indication | Myopia, hyperopia<br>and astigmatism | Myopia and<br>Hyperopia | Myopia, hyperopia<br>and astigmatism |
| Water Content | 55% | 55% | 55% |
| Light Transmittance (%)<br>At 590nm | 94.61 | 94.61 | 93.58 |
| UVA region (316-380nm) | 36.00 | 36.00 | 4.09 |
| UVB region (280-315nm) | 9.41 | 9.41 | 6.00 |
| Dk (35° C) | $15.8 x 10^{-11}$ | $15.8 x 10^{-11}$ | $14.0 x 10^{-11}$ |
| Powers | +20.00 to -20.00 D | +20.00 to -20.00 D | +20.00 to -20.00 D |
| Tint | Clear or Aquamarine | Aquamarine | Clear or Aquamarine |
| Manufacturing Method | Fully Molded | Fully Molded | Fully Molded |
| Lens Design | Spherical<br>Aspheric<br>Back Surface Toric | Sphere | Spherical<br>Aspheric<br>Back Surface Toric |
| Packaging | Blister Pack | Blister Pack | Blister Pack |

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#### 7. Toxicology

The following toxicological tests were performed on Frequency 55 UV lenses:

- Cytotoxicity Study Using the ISO Agarose Overlay Method a)
Under the conditions of this study, the test article showed no evidence of causing oell Iysis of Onder the conditions of this Stary, the test antists of the negative and positive controls performed as anticipated.

- b) ISO Ocular Irritation Study in the Rabbit
Under the conditions of this study, the test article extracts would not be considered irritants to the ocular tissue of the rabbit.

- ISO Acute Systemic Toxicity Study in the Mouse ে
Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the test requirements.

### 8. Additional Non-Clinical Testing

- a) Leachability Study
Leaching studies were undertaken to demonstrate colorfastness of assessing the acceptability of tinting the Frequency 55 UV lens with CI Reactive Blue and Reactive Yellow 86. This study demonstrates how, after two weeks of extraction at 37°c in saline, undetectable levels of dye (below 1ppm) were observed in the extraction solutions.

- b) Determination of Extractables using High Pressure Liquid Chromatography
Under the conditions of this study, the test extracts did no contain residual monomers within the detection limits of the analysis.

#### 9. Conclusions

The Frequency 55 UV (methafilcon A) Soft (hydrophilic) Contact Lens will be manufactured according to specified process controls and an ISO 9001/EN46001 and CGMP quality assurance program currently in place. The established safety profile (preclinical, toxicological, chemical/optical) of the Frequency 55 UV is equivalent to Sauflon 55 UV and Frequency 55 with UVAM.

Being similar with respect to indications for use, materials and comparable physiochemical properties to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise questions of safety and effectiveness than the predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 6 2002

CooperVision, Inc. c/o Ms. Bonnie Tsymbal Manager, Regulatory Affairs 711 North Road Scottsville, NY 14546

Re: K020392

. K020592
Trade/Device Name: Frequency 55 UV (methafilcon A) Soft (hydrophilic) Regulation Number: 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: February 5, 2002 Received: February 6, 2002

Dear Ms. Tsymbal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave develommed and marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to comments provision to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM allu Cosmette Act (11ct) that to hevice, subject to the general controls provisions of the Act. The You may, ulciclore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advisou that I Dr over device complies with other requirements of the Act that I Dr Hab Intactions and regulations administered by other Federal agencies. You must or any I cutili statutes and regirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Pat 007); mooning (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. Bonnie Tsymbal

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

A. Ralph 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

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CooperVision

#### Indication for Use Statement

711 North Roz Scottsville, New York 1454 (716) 385-68 x (716) 889-569

510(k) Number: K020392

Device Name:

Frequency 55 UV Frequency 55 UV Aspheric Frequency 55 UV Toric

#### Indication for Use:

- 1. Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
- 2. Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less.

FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE.

Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses.

#### Frequent/Planned Replacement Wear

When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner.

#### Disposable Wear

When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

### PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.L. Brown, Ph.D.

Nose and Throat Devises

310(k) Number_K020392

Prescription Use
(Per 21 CFR 801.109) x

Over-The-Counter