COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES

K011893 · Contact Color Srl · LPL · Dec 6, 2001 · Ophthalmic

Device Facts

• Record ID: K011893
• Device Name: COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
• Applicant: Contact Color Srl
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contact Color COSMETICA (Polymacon) 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 non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, 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 or for occlusive therapy for conditions such as diplopia or extreme photophobia. The lenses may be disinfected using chemical disinfection systems.

Device Story

Daily wear soft contact lenses; used for cosmetic enhancement, ocular masking, refractive correction, or occlusive therapy. Constructed from Benz 38 (Polymacon) lens blanks; 62% 2-HEMA, 38% water. Opaque pigments (ultramarine blue, titanium dioxide, iron oxides) hand-painted in iris pattern; pigment encapsulated between two layers of polymacon polymer to prevent contact with ocular surface. Prescribed by eye care professionals; patient self-use for daily wear. Benefits include improved cosmetic appearance for ocular abnormalities and vision correction. Disinfected via chemical systems.

Clinical Evidence

Bench testing only. Testing included dye leachability, acute eye irritation, cytotoxicity, and systemic toxicity. Results confirmed no color migration, non-toxicity, and structural integrity of the sandwich-configuration interface bonding.

Technological Characteristics

Material: Polymacon (62% 2-HEMA, 38% water); nonionic. Dimensions: +20 to -20 diopters. Refractive index: 1.43 (hydrated). Dk: 9. Light transmission: >95%. Pigments: Ultramarine blue, titanium dioxide, iron oxides. Construction: Hand-painted iris pattern encapsulated between two polymacon layers. Sterilization: Chemical disinfection.

Indications for Use

Indicated for daily wear in aphakic and non-aphakic patients for cosmetic enhancement/masking of ocular abnormalities (scleral, corneal, iris, lens), correction of refractive ametropia (myopia, hyperopia), and occlusive therapy for conditions like diplopia 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

• Natural Touch (polymacon) Soft (hydrophilic) Contact Lens (K001089)
• Ciba Vision Illusions (tefilcon) Soft (hydrophilic) Contact Lenses (PMA #810005/S25)

Submission Summary (Full Text)

{0}------------------------------------------------

K0//893

# DEC 0 6 2001

### 510(k) Summary as required by 21 CFR 807.92(c)

| <b>1. Submitted by:</b> | Mr. Paolo Cociani<br>Contact Color Srl<br>Via Ludovico di Monreale, 36<br>00152 Rome, Italy |
|-------------------------|---------------------------------------------------------------------------------------------|
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Summary prepared: | 19 November 2001 |

| <b>2. Device Name:</b> | |
|------------------------|-----------------------------------------------------------------------|
| Common Name: | Contact lens |
| Proprietary Name: | Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses |
| Classification Name: | Lenses, soft contact, daily wear |

#### Predicate Devices: 3.

Natural Touch (polymacon) Soft (hydrophilic) Contact Lens 510(k) number: K001089 Aspect Vision Care Ltd. Unit 2, South Point Hamble SO3 4RF Southampton, United Kingdom

Ciba Vision Illusions (tefilcon) Soft (hydrophilic) Contact Lenses PMA #810005/S25 Ciba Vision 11460 Johns Creek Parkway Duluth, Georgia 30097, USA

#### Description of Device: 4.

Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are daily wear soft contact lenses for use in enhancing or altering the apparent color of the eye for prosthetic and theatrical use. The lenses used to produce Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are Benz 38 (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (Clear) supplied by Benz Research & Development of Sarasota, Florida. These lenses have received FDA premarket clearance (K961103). The Benz 38 lens material is polymacon, which in the hydrated state consists of 62% hydrophilic polymer of 2-hydroxyethylmethacrylate (2-HEMA) and 38% water. The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are made by incorporating by hand an opaque pigment in an iris pattern between two layers of the polymacon polymer.

#### Intended Use Statement: ર.

The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in

CONTACT COLOR Srl

Fage 1 of 3

{1}------------------------------------------------

sighted or non-sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, 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 or for occlusive therapy for conditions such as diplopia or extreme photophobia. The lenses may be disinfected using chemical disinfection systems.

#### Comparison with Predicate Devices: ર્ણ.

Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are substantially equivalent to the Aspect Vision Natural Touch (polymacon) Soft (hydrophilic) Contact Lens in that the hydrophilic material used is the same, which is 38% water content Polymacon, a nonionic polymer. They are also both daily wear contact lenses.

In contrast to the method of mixing the pigment with the polymer, which is used for the Natural Touch Soft Contact Lens, the color added to Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses is hand-painted on an inner lens surface and incorporated between two layers of polymacon polymer and therefore does not come into contact with the surface of the eye. This method of incorporating pigment between two polymer layers is similar to that described for the Ciba Vision Illusions contact lenses, which have received premarket approval from FDA.

Because of the incorporation of the pigment between two polymer layers, the internal and external lens surface remains smooth.

| Characteristic | Contact Color COSMETICA<br>(Polymacon) soft<br>(hydrophilic) contact lenses | Aspect Vision<br>Natural Touch<br>(polymacon) Soft<br>(hydrophilic)<br>Contact Lens | Ciba Vision<br>Illusions (tefilcon)<br>Soft (hydrophilic)<br>Contact Lenses |
|---------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications for use | Daily wear in aphakic and not<br>aphakic persons | Daily wear in not<br>aphakic persons | Daily wear in not<br>aphakic persons |
| Material | Polymacon (Benz 38 lenses) | Polymacon | Tefilcon |
| Material type | Nonionic polymer | Nonionic polymer | Nonionic polymer |
| Water content | 38% | 38% | 37.5% |
| Light transmission | > 95% | > 97% | 75.6 to 98%.<br>depending upon<br>over-tint |
| Dk (35°C) | 9 | 8 x 1011 | 9 |
| Refractive index | 1.43 (hydrated) | 1.44 (hydrated) | 1.43 |
| Powers | +20 to -20 | +6.00 to -10.00 | +4 to -10 |
| Pigments | Ultramarine blue, titanium<br>dioxide, and iron oxides | Chromium-cobalt-<br>aluminum oxide.<br>titanium oxide and<br>iron oxides | Opaque pigments<br>are titanium dioxide,<br>carmine, mica |
| Tint process | Incorporation of color, applied<br>by hand, between polymer<br>layers using FDA-cleared lens<br>blanks; no over-tinting | Two stage print pad<br>printing, pre-lens<br>forming | Incorporation of<br>color between<br>polymer layers; then<br>lenses are<br>"over-tinted" |

CONTACT COLOR Srl

{2}------------------------------------------------

In consideration of the requirements of section 510(k) of the Federal Food Drug and Cosmetic Act, the Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are substantially equivalent in terms of their safety and effectiveness to the Natural Touch (polymacon) Soft (hydrophilic) Contact Lens and the Ciba Vision Illusions (tefikon) Soft (hydrophilic) Contact Lenses.

#### Performance Testing: 7.

Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses were subjected to dye leachability testing and toxicology testing, including Acute Eye Irritation, Cytotoxicity, and Systemic Toxicity. The results of these tests demonstrated that the lenses are not susceptible to the migration of color from the lenses and that they are non-toxic. In addition, tests were conducted that verified the integrity of the interface bonding of the sandwich-configuration of the lenses.

#### 8. Conclusion:

Based on the analysis of the comparison in section 6 above and the performance evaluation results contained in section 7, Contact Color Srl has concluded that Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are safe, effective, and perform as well as the legally marketed devices identified in section 3 above.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with two intertwined snakes and a pair of wings at the top. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 0 6 2001

Mr. Paolo Cociani Managing Director Contact Color SrL Via L. di Monreale, 36 00152 Rome, Italy

Re: K011893

Roll Device Name: Contact Color COSMETICA (polymacon) Soft (hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 26, 2001 Received: October 29, 2001

Dear Mr. Cociani:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becaon 910(x) healthcantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encrosure) to device Amendments, or to devices that have been reclassified in enacificin date of the Medical Doviet Federal Food, Drug, and Cosmetic Act (Act). The program therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker the dovice, basyes to equirements for annual registration, listing of devices, controls provisions or the rice networks and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into such additional controls. Existing major regulations (Frenarket Approval), it may be sacyce to an a federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (QS) for Madical 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 mispections, the Food and Dright may result in regulatory action. In addition, FDA may publish comply with the Griff Togalaten and June in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your promanter nombouts of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

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

{5}------------------------------------------------

510(k) Number: [not known]

Device Name: Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses

Indications for Use:

The Contact Color COSMETICA (Polymacon) soft (hydrophilic) contact lenses are indicated The Collact Color COUND From (1 Corporent color of the eye, including ocular masking, for daily wear to clinance of ares that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. The lens may management of conditions outh as coof as refractive ametropia (myopia and hyperopia) in also be presertood for the eersons or for occlusive therapy for conditions such as diplopia, aphakit and not appliakte persons in The lens may be disinfected using chemical disinfection systems.

Concurrence of CDRH Office of Device Evaluation Division of Reproductive, Abdominal, ENT, and Radiological Devices

E.C.

---

(Division Sign-Off)
Division of Ophthalmic Devices

Prescription Use (Per 21CFR 801.109)

OR

Over-The-Counter Use