COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS

K990815 · Colorsoft Laboratories Corp. · LPL · Jun 3, 1999 · Ophthalmic

Device Facts

• Record ID: K990815
• Device Name: COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
• Applicant: Colorsoft Laboratories Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The COLORSOFT, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The COLORSOFT visibility-handling tint provides for ease of patient handling and does not effect iris color. Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer's recommendation.

Device Story

COLORSOFT lenses are previously prescribed soft contact lenses modified via a tinting process. Manufacturing involves affixing FDA-listed reactive color additives to the anterior surface of the lens corresponding to the iris. Additives are reacted with poly hydroxyethyl methacrylate (pHEMA) and thoroughly washed to remove unbound reactive agents. Available in various shades (Blue, Green, Aquamarine, Yellow, Violet, Red, Chocolate, Amber) and patterns (clear pupil, annular, black pupil). Used by patients for cosmetic enhancement; prescribed by eye care practitioners. Lenses function as a refractive medium to focus light on the retina. Tinting does not alter original optical parameters, though light transmittance is decreased. Patients maintain lenses using original manufacturer-recommended disinfection procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive characteristics, material safety of FDA-listed color additives, and maintenance of original lens optical parameters.

Technological Characteristics

Material: poly hydroxyethyl methacrylate (pHEMA). Tinting: reactive color additives (e.g., reactive blue 21, reactive red 11, etc.) affixed to anterior surface. Patterns: clear pupil (2.0-8.0mm), annular (8.0-13.5mm), black pupil (2.0-12.5mm). Connectivity: None. Energy source: None. Sterilization: Per original lens manufacturer's recommendation.

Indications for Use

Indicated for daily wear to enhance or alter apparent eye color in patients requiring contact lenses. Contraindications not specified.

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

• DURASOFT 2 COLORS (K990815)

Submission Summary (Full Text)

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JUN 3 ............................................................................................................................................................................

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K990815 |
|--------------------------------|---------|
|--------------------------------|---------|

Applicant information:

| Date Prepared: | March 12, 1999 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | Colorsoft Laboratories Corporation |
| Address | 623 Glacier Drive<br>Grand Junction, CO 81503 |
| Contact Person: | Ms. Deanna Werber |
| | President |
| Phone Number: | [phone] |
| USA Consultant: | Martin Dalsing,<br>Med-Vice Consulting, Inc.<br>Consultant for Colorsoft Laboratories Corporation<br>623 Glacier Drive<br>Grand Junction, CO 81503<br>[phone]<br>Fax #: [phone]<br>E-mail: [e-mail] |

Device Information:

| Device Classification: | Class II |
|------------------------|-----------------------------------------------|
| Classification Number: | LPL |
| Trade Name: | COLORSOFT, Color Enhanced Tinted Soft Contact |

lens for Daily Wear

Lenses, Soft Contact, Daily Wear Classification Name:

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#### Substantially Equivalent Devices:

The "COLORSOFT" tinted soft contact lens is substantially equivalent to the DURASOFT 2 COLORS tinted soft contact lens, the predicate device.

### INDICATIONS FOR USE:

The COLORSOFT. Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eve color. The COLORSOFT visitint provides for ease of patient handling and does not effect iris color.

Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer's recommendation.

#### Device Descriptive Characteristics:

COLORSOFT. Color Enhanced Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to Colorsoft Laboratories to be modified by a tinting process using color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed color reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The COLORSOFT. Color Enhanced Tinted Soft Contact Lens are available in a light, medium or dark shade of the following enhance colors; Colorsoft Blue, Deep Blue, Aspen Green, Aquamarine, Yellow, Violet, Red, Chocolate, and Amber. COLORSOFT, Color Enhanced Tinted Soft Contact Lens are also available in a standard blue visibility-handling tint.

The color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 21, reactive blue 19, reactive blue 4, reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.

The following are tint patterns available to the practitioner:

- Clear Pupil diameter (2,00mm to 8,00mm), standard is 4,5mm. ।
- Annular (iris) diameter (8.00mm to 13.5mm), standard is 11.5mm diameter. -
- -Black pupil diameter (2.0mm to 12.5mm), standard is 4.0mm diameter.

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The following table summarizes Colorsoft Laboratories claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned

| 1.) | INTENDED USE | Daily wear, Soft (hydrophilic) contact<br>lens | Daily wear, Soft (hydrophilic) contact<br>lens |
|-----|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.) | INDICATION | The Colorsoft Choices Soft Contact<br>Lenses for daily wear are indicated for<br>enhancing and/or altering the apparent<br>eye color. The Colorsoft Choices visitint<br>provides for ease of patient handling and<br>does not effect iris color. The lens is to<br>be disinfected following the original<br>manufacturer's instructions. | The Durasoft 2 Colors for daily wear are<br>indicated for enhancing and/or altering<br>the apparent eye color, including ocular<br>masking. |
| 3.) | ACTIONS | In its hydrated state, when placed on the<br>cornea, the lenses act as a refracting<br>medium to focus light rays on the retina. | In its hydrated state, when placed on the<br>cornea, the lenses act as a refracting<br>medium to focus light rays on the retina. |
| 4.) | FDA "listed"<br>colored additives | The reactive colored additives consist of<br>reactive black 5, reactive blue 4, reactive<br>blue 19, reactive 21, reactive blue 163,<br>reactive yellow 15, reactive yellow 86,<br>reactive orange 78, reactive red 11 and<br>reactive red 180. | The colored pigments consist of iron<br>oxides, chromium oxide greens, titanium<br>dioxide, [phthalo-cyaninato (2-)] copper<br>carbazole violet and phthalocyanine<br>green. |
| a. | Uses<br>and<br>restrictions | The color additives listed above may be<br>used to color contact lenses in amounts<br>not to exceed the minimum reasonably<br>required to accompish the intended<br>coloring effect. | The color additives listed above may be<br>used to color contact lenses in amounts<br>not to exceed the minimum reasonably<br>required to accompish the intended<br>coloring effect. |
| 5.) | Color Additive<br>Characteristics | The color additives used are not removed<br>by lens handling and<br>cleaning/disinfecting procedures. The<br>optical and performance characteristics<br>are not altered by the lens coloring<br>process. | The color additives used are not removed<br>by lens handling and<br>cleaning/disinfecting procedures. The<br>optical and performance characteristics<br>are not altered by the lens coloring<br>process. |
| 6.) | Colors Offered | Colorsoft Blue, Deep blue, Aspen Green,<br>Jade, Aquamarine, Yellow, Violet, Red,<br>Chocolate, and Amber | Sky blue, Jade green, Aquamarine and<br>Violet blue |

Table #1 - Substantial Equivalence

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1939

Mr. Martin Dalsing Med-Vice Consulting, Inc. Consultant for Adventure in Colors, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K990815 Trade Name: COLORSOFT, Color Enhanced Tinted Soft Contact lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: March 12, 1999 Received: March 11, 1999

Dear Mr. Dalsing:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Martin Dalsing

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

Device Name:

COLORSOFT, Color Enhanced Tinted Soft Contact lens for Daily Wear

#### INDICATIONS FOR USE:

The COLORSOFT, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The COLORSOFT visibility-handling tint provides for ease of patient handling and does not effect iris color.

Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens is to be disinfected according to the original lens manufacturer's recommendation.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W.C. Brown, Ph.D.

X Prescription Use (Per 21 CFR 801 109)

Division Sion-Off Division of Ophthalmic Devices

J

Over-The-Counter Use

510(k) Number K990815
(Optional format 1-2-96)