LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS

K041138 · CooperVision, Inc. · LPL · Jul 23, 2004 · Ophthalmic

Device Facts

• Record ID: K041138
• Device Name: LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS
• Applicant: CooperVision, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses 1. are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed 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 or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to 2. enhance or alter the apparent color of the eye, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed 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 or for occlusive therapy for conditions such as diplopia, amblyopia an extreme photophobia. When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact 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. 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; random co-polymer of hydroxyethylmethacrylate and methacrylic acid cross-linked with ethyleneglycol dimethacrylate. Lenses modified by affixing colorants (Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, C.I. Reactive Black 5) to the front surface corresponding to the iris. Manufactured via molding or FIPS II; tinting via post-forming ink jetting. Prescribed by eye care practitioners for daily wear; frequent/planned replacement or disposable (single-use) modalities. Patients clean/disinfect lenses or discard after single use. Provides refractive correction or prosthetic/occlusive therapy. Benefits include improved visual acuity, cosmetic enhancement, or management of ocular abnormalities.

Clinical Evidence

Bench testing only. No clinical studies were conducted. Safety and efficacy established through substantial equivalence to predicate devices, including toxicology testing (ocular irritation, cytotoxicity, systemic toxicity) and leachability studies showing <1ppm dye extraction.

Technological Characteristics

Material: Methafilcon A (hydroxyethylmethacrylate/methacrylic acid co-polymer). Water content: 55%. Lens Group 4 (high water, ionic). Dk: 15.04. Index of Refraction: 1.41. Powers: -20.00 to +20.00D. Tinting: Ink jetting post-lens forming. Colorants: Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, C.I. Reactive Black 5.

Indications for Use

Indicated for daily wear to enhance/alter eye color or provide ocular masking for corneal, iris, or lens abnormalities in sighted/non-sighted eyes. Also for correction of myopia, hyperopia, and astigmatism (up to 2.00D for non-toric, up to 12.00D for toric) in aphakic/not-aphakic persons with non-diseased eyes, or for occlusive therapy for diplopia, amblyopia, or extreme photophobia.

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

• Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164)
• Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses (K001090)

Submission Summary (Full Text)

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## Goper Vision P

Leo Colors Methafilcon A

510(k) Summary

Premarket Notification

# Ko41138

- 1. SUBMITTER:
## Submitted on Behalf of:

- Company Name:
- I Address:
- I Phone:
- Fax:

## 2. CONTACT PERSON:

- Company Name:
- E Address:
- 트 Phone:
- 트 Fax:

## Bonnie Tsymbal

April 28, 2004

Unit 2. South Point

011 44 2380 605200 011 44 2380 605299

Hamble SO3 4RF Southampton UK

CooperVision, Inc. 711 North Road Scottsville, NY 14546 [phone] [phone]

CooperVision Manufacturing, Ltd.

- 3. DATE SUMMARY PREPARED:
## 4. DEVICE IDENTIFICATION:

- 프 Trade Name:
Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lens

- I Common Name: Hydrophilic Soft Contact Lens
- I Classification
- 트 Device Classification:

Lenses, Soft Contact, Daily Wear 86LPL Class II (21 CFR 886.5925)

## 5. DEVICE DESCRIPTION:

The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as spherical lenses. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are available as astigmatic lenses. The lens material, methafilcon A, is a random co-polymer of hydroxyethylmethacrylate and methacrylic acid, which is cross-linked with ethyleneglycol dimethacrylate. The lenses are made by modifying the uncolored methafilcon A base lens by affixing colorants on that portion of the front surface that corresponds to the iris. The colorants Titanium Dioxide, C.I. Reactive Blue 21, C.I. Reactive Red 180, C.I. Reactive Yellow 15, and C.I Reactive Black 5 are listed in 21 CFR Part 73.

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| Chemical Name | CI Number | CFR# |
|---------------------------------------------------|-------------------------|---------|
| Titanium dioxide | 77891 | 73.3126 |
| Poly (hydroxyethyl methacrylate)-dye<br>copolymer | C.I. Reactive Blue 21 | 73.3121 |
| Poly (hydroxyethyl methacrylate)-dye<br>copolymer | C.I. Reactive Red 180 | 73.3121 |
| Poly (hydroxyethyl methacrylate)-dye<br>copolymer | C.I. Reactive Yellow 15 | 73.3121 |
| Poly (hydroxyethyl methacrylate)-dye<br>copolymer | C.I. Reactive Black 5 | 73.3121 |

### 6. INTENDED USE

- 1. Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eve, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic 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 or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
- 2. Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed 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 or for occlusive therapy for conditions such as diplopia an extreme photophobia.

#### Frequent/Planned Replacement Wear

When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact 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 eve care practitioner is for daily wear (single use). Patients should be instructed to discard the lenses at each removal.

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#### 7. PREDICATE DEVICE:

The Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear manufactured by Cooper\ision Manufacturing Ltd. Is equivalent to the Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164) and Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lenses for daily wear (K001090)

As the methafilcon A base lens is produced at the same manufacturing facility as the Frequency 55, Frequency Colors and Expressions, the physical, optical and chemical properties are the same. They are all in Lens Group 4, high water ionic polymer as established by FDA and located in the May 1994 Guidance Document for Daily Wear Contact Lenses.

| | Leo Colors<br>Subject Device | Frequency 55<br>Predicate Device<br>K971164 | Frequency Colors<br>Predicate Device<br>K001090 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Methafilcon A | Equivalent | Equivalent |
| Material<br>Classification | Hydrophilic lens, Group 4 | Equivalent | Equivalent |
| Indication for use | Daily Wear<br>Myopia, hyperopia and<br>astigmatism | Daily Wear<br>Myopia and hyperopia | Daily Wear<br>Myopia, hyperopia and<br>astigmatism |
| Water Content | 55% | Equivalent | Equivalent |
| Light transmittance | >90.0% | Equivalent | Equivalent |
| Dk (35°) | 15.04 | Equivalent | Equivalent |
| Index of Refraction | 1.41 | Equivalent | Equivalent |
| Powers | -20.00 to +20.00D | Equivalent | Equivalent |
| Colorants | Titanium Dioxide<br>CI Reactive Blue 21<br>CI Reactive Red 180<br>CI Reactive Yellow 15<br>CI Reactive Black 5. | CI Reactive Blue 4 | Carbozale violet<br>chromim oxide green<br>dihydrodinaphto brown<br>dihydrodioxo yellow<br>phthalocyanine green<br>iron oxide red<br>iron oxide brown<br>iron oxide black<br>phthalocyanine blue<br>and titanium dioxide |
| Tint Process | Ink jetting<br>post lens forming. | In-monomer tint | Pad printing<br>post lens forming |
| Manufacturing<br>Method | Molded or FIPS II | Molded | Molded or FIPS II |

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#### PRECLINICAL INFORMATION 8.

The results of toxicology testing, including Ocular Irritation, Cytoxicity and Systemic Toxicity have demonstrated that the subject lens is non-toxic.

A leachability study was conducted to assess the color fastness of the listed dyes used to tint the Leo Colors. Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses. The study demonstrates that after two weeks of extraction at 37°C in saline, undetectable levels (<1ppm) of dye were observed in the extraction solution.

The physical, optical and chemical properties of the subject lens are equivalent to the predicate device.

#### ഗ CLINICAL DATA

It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Leo Colors, Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses. This determination was based on the following:

- . The Leo Colors, Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses were demonstrated to be substantially equivalent to the predicate Frequency 55 (methafilcon A) Soft (hydrophilic) Contact Lens (K971164) and (K973063)
- . The Leo Colors, Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses were demonstrated to be substantially equivalent to the predicate Frequency Colors and Expressions (methafilcon A) Soft (hydrophilic) Contact Lens (K001090).

## 10. CONCLUSION

The information provided in this 510(k) established that the Leo Colors. Lens Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses is equivalent in optical, chemical and physical properties of the predicate device and does not raise any questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

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

Re: K041138

Trade/Device Name: Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL; MVN Dated: April 29, 2004 Received: May 3, 2004

Dear Ms. Tsymbal:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass bated in the 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. 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), 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,

A. Levy 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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Image /page/6/Picture/0 description: The image shows the logo for CooperVision. The logo is in black and white and features the company name in a stylized font. To the right of the name is a square with a circle inside.

Regulatory Affairs 711 North Road Scottsville, NY 14546 [phone] Fax: [phone]

#### Indication for Use Statement

Device Name:

Leo Colors (methafilcon A) Soft (hydrophilic) Contact Lenses Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses

#### Indication for Use:

- Leo Colors and Leo Aspheric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses l. are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted or non-sighted eves that require a prosthetic contact lens for the management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed 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 or for occlusive therapy for conditions such as diplopia. amblyopia or extreme photophobia.
- Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear to 2. enhance or alter the apparent color of the eye, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lens for the management of conditions such as corneal. iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eves. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less or for occlusive therapy for conditions such as diplopia, amblyopia an extreme photophobia.

#### Frequent/Planned Replacement Wear

When prescribed for Frequent/Planned Replacement Wear, the Leo Colors, Leo Aspheric Colors and Leo Toric Colors (methafilcon A) Soft (hydrophilic) Contact 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)

Fis 6

510(k) Number K041138

Prescription Use
(Per 21 CFR 801.109) ✓

AND/OR

Over-The-Counter