MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS

K052606 · Marietta Vision · LPL · Dec 15, 2005 · Ophthalmic

Device Facts

• Record ID: K052606
• Device Name: MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS
• Applicant: Marietta Vision
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 15, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

Hydrophilic soft contact lens; polymacon material (62% polymer, 38% water). Lathe-cut manufacturing; anterior surface tinted with reactive color additives (e.g., reactive black 5, blue 19, etc.) to alter iris appearance. Acts as refractive medium to focus light on retina. Prescribed by eyecare practitioners for daily wear or frequent/planned replacement. Patient cleans/disinfects using chemical (non-heat) systems. Benefits include vision correction and cosmetic enhancement. No electronic components or software.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, material composition, and manufacturing process comparisons to predicate devices.

Technological Characteristics

Material: Polymacon (2-HEMA cross-linked with EGDMA). Water content: 38% +/- 2%. Refractive index: 1.43 (hydrated). Oxygen permeability: 8.4 x 10^-11 (cm2/sec)(ml O2/ml x mm Hg @ 35C). Form factor: Single vision spherical lens. Manufacturing: Lathe-cut. Sterilization: SAL 10^-6. Connectivity: None. Software: None.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia; also used to enhance or alter apparent eye color. Suitable for patients with refractive astigmatism of 0.75 diopters or less. Contraindicated for diseased eyes.

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

• Addvantage 38 (Polymacon) (K942302)
• Marietta Contact Lens, color enhanced (K002647)

Submission Summary (Full Text)

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# SPECIAL 510(k) SUMMARY

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: | |
|--------------------------------|--|
|--------------------------------|--|

K052606

#### Applicant information:

Date Prepared:

September 19, 2005

Marietta Vision 397 N. Sessions Street Marietta, GA 30060

| Name: |
|----------|
| Address: |

Contact Person: Phone number:

John Patterson 770 792 0208

FDA US Agent/ Medvice Consulting, Inc. Official Correspondent: Martin Dalsing Phone number [phone] Fax number [phone]

# Device Information:

| Device Classification: | Class II |
|------------------------|----------------------------------------------------------------------|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | Marietta Contact Lens (polymacon), Tinted Daily Wear<br>Contact Lens |

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# Unmodified Predicate Devices:

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is substantially equivalent to Marietta Vision's own unmodified predicate devices:

- 1. Addvantage 38 (Polymacon), K942302, Marietta Vision,
- 2. Marietta Contact Lens, color enhanced, K002647, Marietta Vision.

# Description of Modified Device:

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2- Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The copolymer consists of 62% polymacon and 38% water by weight when immersed in normal buffered saline solution.

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect.

As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound 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 color additive effect is formed by reacting one or more of the 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 black 5, 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 38% water by weight. The physical properties of the lens are

| Refractive Index | 1.43 (hydrated) |
|-----------------------------|---------------------------------------------------------------------------|
| Light Transmission (tinted) | greater than 90% |
| Water Content | 38% ± 2% |
| Oxygen Permeability | 8.4 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fat<br>method). |

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#### Intended Use:

The Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

#### Technological Characteristics Comparison:

The technological characteristics of the Marietta Contact Lens (polymacon), Tinted Daily Wear Contact Lens as compared to the technological characteristics of the unmodified predicate devices are illustrated in the following table.

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| Technological Characteristic / Device | Marietta Contact Lens<br>(polymacon), Tinted<br>Daily Wear Contact<br>Lens<br>Modified Device | Addvantage 38<br>(polymacon),<br>Unmodified Device<br>K942302 | Marietta Contact Lens<br>Color Enhanced,<br>Unmodified Device<br>K002647 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear<br>for the correction of<br>visual acuity in aphakic<br>and not aphakic persons<br>with non-diseased eyes<br>with myopia or<br>hyperopia. | Indicated for daily wear<br>for the correction of<br>visual acuity in aphakic<br>and not aphakic persons<br>with non-diseased eyes<br>with myopia or<br>hyperopia. | Indicated for daily wear<br>for the correction of<br>visual acuity in aphakic<br>and not aphakic persons<br>with non-diseased eyes<br>with myopia or<br>hyperopia. |
| Functionality | The contact lenses act as<br>a refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina. | The contact lenses act as<br>a refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina. | The contact lenses act as<br>a refractive medium that<br>focus light rays from<br>near and distant objects<br>on the retina. |
| Indications | Daily wear, Soft<br>(hydrophilic) contact<br>lens | Daily wear, Soft<br>(hydrophilic) contact<br>lens | Daily wear, Soft<br>(hydrophilic) contact<br>lens |
| Production<br>Method | Lathe-Cut | Lathe-cut | Lathe-cut |
| FDA Group # | Group # 1 < 50% Water.<br>non-ionic Polymer | Group # 1 < 50% Water<br>non-ionic Polymer | Group # 1 < 50% Water<br>non-ionic Polymer |
| USAN name | polymacon | polymacon | polymacon * |
| Water<br>Uptake(%) | 38.0% | 38.0% | 38.0% * |
| Sterility of<br>Device | SAL = $10^{-6}$ | SAL = $10^{-6}$ | Non-sterile product |

* Unmodified device is approved for all soft hydrophilic lenses (not applicable for silicone hydrogels)

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 15 2005

Marietta Vision C/O Mr. Martin Dalsing Medvice Consulting, Inc. 2214 Sanford Dr. Suite #B7 Grand Junction, CO 81505

Re: K052606

> Trade/Device Name: Marietta (polymacon) Tinted Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: November 11, 2005 Received: November 17, 2005

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. Drue, 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 - Mr. 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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting 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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Marietta Vision Special 510(k): Device Modification, Premarket Notification

# INDICATIONS FOR USE STATEMENT

Device Name:

Marietta Contact Lens (polymacon), Tinted Contact Lens.

INDICATIONS FOR USE:

The Marietta Contact Lens (polymacon), Tinted Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and to enhance and/or alter the apparent eye color. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visua acuity.

The lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the ler may be cleaned and disinfected using a chemical (not heat) lens care system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
(Per 21 CFR 801.109)
510(k) Number K052606
Over-The-Counter Use

(Optional Format 1-2-96)

(Optional Format 1-2-96)