CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR

K041700 · Cantor & Nissel , Ltd. · LPL · Jul 30, 2004 · Ophthalmic

Device Facts

• Record ID: K041700
• Device Name: CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR
• Applicant: Cantor & Nissel , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic 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 or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.

Device Story

Hand-painted soft contact lens (hioxifilcon A) designed to mask disfiguring eye conditions or alter eye color; iris pattern applied via FDA-listed color additives. Lens may be clear in center for sighted eyes or opaque for non-sighted eyes. Prescribed by eye care practitioners; patient wears daily. Disinfection restricted to hydrogen peroxide systems. Provides cosmetic improvement and refractive correction; aids in managing conditions like amblyopia or diplopia through occlusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on descriptive characteristics and material safety profile.

Technological Characteristics

Material: hioxifilcon A. Form: Soft contact lens. Opacity: Hand-painted using FDA-listed color additives. Disinfection: Hydrogen peroxide system only. No electronic or software components.

Indications for Use

Indicated for daily wear in sighted or non-sighted patients requiring prosthetic contact lenses for cosmetic management of corneal, iris, or lens abnormalities. Also indicated for correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic/non-aphakic persons, or 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

• Prosthetic (hefilcon A) Soft Lens (K992950)

Submission Summary (Full Text)

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## JUL 3 0 2004

# 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: | K041700 |
|--------------------------------|---------|
|--------------------------------|---------|

Applicant information:

| Date Prepared: | June 1, 2004 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | Cantor & Nissel Limited |
| Address | Manor Road, Brackley<br>Northamptonshire<br>England NN13 7DP |
| Contact Person: | Mr. David Cantor<br>Managing Director/President |
| Phone Number: | 011 44 1280 702002 |
| Fax: | 011 44 1280 703003 |
| USA Consultant: | Martin Dalsing,<br>Med-Vice Consulting, Inc.<br>Consultant for Cantor & Nissel, Inc.<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: | Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A)<br>Soft Contact Lens for Daily Wear |

Lens, Soft Contact, Daily Wear

Classification Name:

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### Substantially Equivalent Devices:

The "Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear" is substantially equivalent to the "Prosthetic (hefilcon A) Soft Lens ~ K992950".

#### Device Descriptive Characteristics:

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a I hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be nand painted inns or a non-sighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially of enses with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.

#### INDICATIONS FOR USE:

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic 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 or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

The lens is disinfected using a hydrogen peroxide lens care system only.

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The following table summarizes Cantor & Nissel Limited claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.

| | Characteristic | CANTOR & NISSEL<br>Hand Painted PROSTHETIC | Prosthetic (hefilcon A) Soft<br>Contact Lens ~ K992950 |
|-----|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | INTENDED USE | Cosmetic Management of<br>conditions such as corneal, iris,<br>or lens abnormalities. | Cosmetic Management of conditions<br>such as corneal, iris, or lens<br>abnormalities. |
| 2.) | INDICATIONS FOR<br>USE STATEMENT | The CANTOR & NISSEL Hand<br>Painted PROSTHETIC<br>(hioxifilcon A) Soft Contact Lens<br>are indicated for daily wear to<br>enhance or alter the apparent eye<br>color, including ocular masking,<br>either in sighted or non-sighted<br>eyes that require a prosthetic<br>contact lens for cosmetic<br>management of conditions such<br>as corneal, iris or lens<br>abnormalities. The lens may also<br>be prescribed for the correction of<br>refractive ametropia (myopia,<br>hyperopia and astigmatism) in<br>aphakic and not aphakic persons<br>or for occlusive therapy for<br>conditions such as diplopia,<br>amblyopia or extreme<br>photophobia. The lens is<br>disinfected using a hydrogen<br>peroxide lens care system only. | The Prosthetic (hefilcon A) Soft<br>Contact Lens is indicated for daily<br>wear to enhance or alter the apparent<br>eye color, including ocular masking,<br>either in sighted or non-sighted eyes<br>that require a prosthetic contact<br>lenses for cosmetic management of<br>conditions such as corneal, iris or<br>lens abnormalities. The lens may<br>also be prescribed for the correction<br>of refractive ametropia (myopia,<br>hyperopia and astigmatism) in<br>aphakic and not aphakic persons or<br>for occlusive therapy for conditions<br>such as diplopia, amblyopia or<br>extreme photophobia. The lens may<br>be disinfected with a chemical<br>disinfection system. |
| 3.) | OPACITY | One or more FDA listed color<br>additives | Partially or totally White |
| 4.) | COLOR ADDITIVE<br>CHARACTERISTICS | The color additives used are not<br>removed by lens handling and<br>approved cleaning/disinfecting<br>procedures. The optical and<br>performance characteristics are<br>not altered by the lens coloring<br>process. | The color additives used are not<br>removed by lens handling and<br>approved cleaning/disinfecting<br>procedures. The optical and<br>performance characteristics are not<br>altered by the lens coloring process. |
| 5.) | OPAQUING AGENT<br>USED | Use of FDA listed reactive dyes<br>in amounts to accomplish desired<br>hand painted iris patterns. | Titanium Dioxide |

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Image /page/3/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 feathers. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the bird. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Cantor & Nissel Ltd. c/o Martin Dalsing Med-Vice Consulting, Inc. 623 Glacier Dr. Grand Junction, CO 81503

Re: K041700

Trade/Device Name: Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft 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: June 1, 2004 Received: June 23, 2004

Dear Mr. Dalsing:

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 - Martin Dalsing

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,

Aherl 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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# INDICATIONS FOR USE STATEMENT

Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens Device Name: for Daily Wcar

#### INDICATIONS FOR USE:

The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in midred or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions sighted or non bighted by or lens abnormalities. The lens may also be prescribed for the correction of refractive suon as contrally in or lease in and astigmatism) in aphakic and not aphakic persons or for occlusive ameropa (if your are as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K041700 |
|---------------|---------|
|---------------|---------|

or

| Prescription Use (Per 21 CFR 801.109) | x |
|---------------------------------------|---|
| Over-The-Counter Use | |

(Optional Format 1-2-96)