ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)

K983053 · Alden Optical Labs., Inc. · LPL · Oct 21, 1998 · Ophthalmic

Device Facts

• Record ID: K983053
• Device Name: ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)
• Applicant: Alden Optical Labs., Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lenses 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 may be disinfected with either a chemical or a heat disinfection system.

Device Story

The Alden Classic Prosthetic is a lathe-cut, hydrophilic soft contact lens fabricated from polymacon. It incorporates specific color additives (Vat Brown 1, Vat Blue 6, Vat Green 1) to alter or enhance eye appearance or provide ocular masking. Available in various designs including clear lenses with black pupils, black occluder lenses, and black annular designs. The lens is prescribed by eye care professionals for cosmetic management of ocular abnormalities, refractive correction, or occlusive therapy. In its hydrated state (38% water), the lens conforms to the corneal curvature. It is intended for daily wear and requires maintenance in compatible storage solutions. The device provides a color-altering optical surface to benefit patients with disfiguring eye conditions or those requiring light occlusion.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, material characterization, and established safety profiles of similar previously cleared devices.

Technological Characteristics

Material: Polymacon (38% water content). Fabrication: Lathe-cut. Refractive Index: 1.43 (hydrated). Oxygen Permeability: 9 x 10^-11 Fatt units. Colorants: Vat Brown 1, Vat Blue 6, Vat Green 1. Form factor: Spherical back surface, various pupil/annular designs. Sterilization: Standard manufacturing procedures.

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 and non-aphakic persons, 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

• WESLEY-JESSEN PROSTHETIC (phemfilcon A) Soft Contact Lens
• BENZ-38 (polymacon) Soft Contact Lens

Reference Devices

• Alden Classic (K973967)
• Alden Classic Tinted (K980554)

Submission Summary (Full Text)

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# 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:

#### K983053

### Applicant information:

| Date Prepared: | August 28, 1998 |
|-----------------|-----------------------------------------|
| Name: | Alden Optical Laboratories |
| Address | 13295 Broadway<br>Alden, New York 14004 |
| Contact Person: | Charles H. Creighton |
| Phone Number: | 800.253.3669 |
| USA Consultant: | MedVice Consulting, Inc. |
| Phone Number: | Martin Dalsing<br>[phone] |

#### Device Information:

| Device Classification: | Class II |
|------------------------|--------------------------------------------------------------------------------|
| Classification Number: | LPL |
| Trade Name: | ALDEN CLASSIC PROSTHETIC (polymacon) Tinted,<br>Soft Contact Lens (lathe-cut). |
| Classification Name: | Lenses, Soft Contact, Daily Wear |

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#### Substantially Equivalent Devices:

The ALDEN CLASSIC PROSTHETIC (polymacon) Tipted, Soft Contact Lens is substantially equivalent to the "WESLEY-JESSEN PROSTHETIC" (phemfilcon A) Soft Contact Leas and the BENZ-38 (polymacon) Soft Contact Lens, the predicate devices.

#### Device Descriptive Characteristics:

The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Leas is fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A tunt mixture containing: Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17-Dimethoxydinaphtho [1,2,3 -> 1' - Im] perylene-5,10-dione, and Brown 16,23 -Dibydrodinaphtho [2,3-a:2',3' -i] napth [2',3';.6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.

The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or leas 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 occhisive therapy for conditions such as diplopia, amblyopia or extreme photophobia.

Tim Patterns Available:

- 1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12,5 mm.
- 2. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
- 3. Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0,5 mm increments. Clear Pupil diameter range 2.0 mm to 7,5 mm in 0.5 mm increments.
- 4. Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

In the hydrated state, the leas conforms to the curvature of the eye covering the cornes and extending sightly beyond the limbus forming a color altering optical surface. The (polymacon) soft hydrophilic contact leas a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the leas dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

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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 | 1.52 (dry) 1.43 (hydrated) |
|---------------------|-----------------------------------------------------------------------------|
| Light Transmission: | greater than 70% T |
| Water Content | 38 % |
| Specific Gravity | 1.28 (dry) 1.18 (hydrated) |
| Color additives | Vat Brown 1, Vat Blue 6, Vat Green 1 |
| Oxygen Permeability | 9 X $10^{-11}$ Fatt Units (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), (revised Fatt |
| | method) |

#### Intended Use:

The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or nonsighted eyes that require a prosthetic contact lenses 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 may be disinfected with either a chemical or a heat disinfection system.

#### Substantial Equivalence:

The device will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Alden Optical Laboratories. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Alden Classic, and Alden Classic Tinted (polymacon), 510(k)'s #K973967 and #K980554. Being similar with respect to materials, physical construction and safety & effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

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The following mattix illustrates the production methods, leas functions and material characteristics of the ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Leas as well as the predicate device.

#### Substantial Equivalence Matrix

| | Characteristic | ALDEN CLASSIC<br>PROSTHETIC | WESLEY-JESSEN<br>PROSTHETIC |
|-----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION<br>METHOD | Lathe-Cut | Lathe-Cut |
| 2.) | LENS FUNCTION | Enhance or alter the apparent eye color,<br>including ocular masking, either in sighted<br>or non-sighted eyes that require a<br>prosthetic contact lenses for cosmetic<br>management of conditions such as corneal,<br>iris or lens abnormalities. The lens may<br>also be prescribed for the correction of<br>refractive ametropia (myopia, hyperopia<br>and astigmatism) in aphakic and not<br>aphakic persons or for occlusive therapy for<br>conditions such as diplopia, amblyopia or<br>extreme photophobia. | Enhance or alter the apparent eye color,<br>including ocular masking, either in sighted<br>or non-sighted eyes that require a<br>prosthetic contact lenses for cosmetic<br>management of conditions such as corneal,<br>iris or lens abnormalities. The lens may<br>also be prescribed for the correction of<br>refractive ametropia (myopia, hyperopia<br>and astigmatism) in aphakic and not<br>aphakic persons or for occlusive therapy for<br>conditions such as diplopia, amblyopia or<br>extreme photophobia. |
| 3.) | MATERIAL | Hydrophilic Polymer | Hydrophilic Polymer |
| a. | Polymer | Polymacon | phemfilcon A |
| b. | Water Content | 38% | 38% |
| c. | Polymer Content | 62% | 62% |
| d. | DK Value | 9 | 12.9 |
| e. | Refractive Index | 1.43 (hydrated) | 1.440 (hydrated) |
| f. | Specific Gravity | 1.18 (hydrated) | 1.17 (hydrated) |
| g. | Light Transmission | Varies depending on prosthetic lens<br>design | Varies depending on prosthetic lens<br>design |
| h. | Color Additives | Vat Green 1,<br>Vat Brown 1,<br>Vat Blue 6, | Iron oxides, chromium oxide greens,<br>titanium dioxide, [phthalocyaninato<br>(2)] copper, carbazole violet and<br>phthalocyanine green. |

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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 consists of a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Alden Optical Laboratories, Inc. c/o Mr. Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503

Re: K983053

Trade Name: ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Daily Wear Contact Lens (lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: August 28, 1998 Received: September 1, 1998

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:

ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens (Lathe cut).

INDICATIONS FOR USE:

The ALDEN CLASSIC PROSTHETIC (polymacon) Tiated, Soft Contact Leas (Lathe-cut) 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 lenses for cosmetic management of conditions such as corneal, ins 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 may be disinfected with either a chemical or a heat disinfection system.

(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 Devices | |
| 510(k) Number | K983053 |

or

| Prescription Use | X | Over-The-Counter Use | |
|----------------------|--------------------------|----------------------|--|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | | |

ALDEN CLASSIC PROSTHETIC (Polyanson) Trated, Soll Carned Lathousel)

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