AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS

K973847 · Martin Dalsing · LPL · Dec 8, 1997 · Ophthalmic

Device Facts

• Record ID: K973847
• Device Name: AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS
• Applicant: Martin Dalsing
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.

Device Story

AL-47 Toric is a lathe-cut, hydrophilic soft contact lens made of isofilcon. Designed for daily wear, the lens is hydrated in aqueous solution to become pliable, conforming to the corneal curvature to provide a refractive optical surface. It functions by focusing light rays on the retina to compensate for refractive errors, specifically myopia, hyperopia, and astigmatism. The device is prescribed by eye care professionals for patients with non-diseased eyes. It requires maintenance in a compatible storage solution to remain hydrated; dehydration causes warping and hardening, which is reversible upon rehydration. The lens provides a transparent optical medium with high light transmission.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of physical/chemical properties (water content, refractive index, light transmission, oxygen permeability) against predicate devices.

Technological Characteristics

Material: isofilcon (hydrophilic polymer, FDA Group 1, nonionic). Water content: 36%. Refractive index: 1.43 (hydrated). Specific gravity: 1.19 (hydrated). Oxygen permeability (DK): 3.7. Light transmission: >93%. Form factor: Lathe-cut soft contact lens. Sterilization: Standard manufacturing procedures.

Indications for Use

Indicated for correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes, including myopia, hyperopia, and refractive astigmatism up to 10 Diopters.

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

• Optima Toric (Bausch & Lamb Co)
• Soft 38 Toric (California optics)
• AL-47 (spherical) (Alden Optical)

Reference Devices

• AL-47 (spherical) (PMA # P820078)

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.

K973847 The assigned 510(k) number is:

#### Applicant information:

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| Date Prepared: | October 10, 1997 | |
|-----------------|----------------------------|--|
| Name: | Alden Optical Laboratories | |
| Address | 13295 Broadway | |
| | Alden, New York 14004 | |
| Contact Person: | Charles H. Creighton | |
| Phone Number: | 800.253.3669 | |
| Consultant: | Martin Dalsing | |
| Phone Number: | 970.243.5490 | |

#### Device Information:

| Device Classification: | Class II |
|------------------------|----------------------------------|
| Classification Number: | LPL |
| Trade Name: | AL-47 Toric |
| Classification Name: | Lenses, Soft Contact, Daily Wear |

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#### Equivalent Devices:

The AL-47 Toric is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include Optima Toric manufactured by Bausch & Lamb Co, the Soft 38 Toric manufactured by California optics and the AL-47 (spherical) manufactured by Alden Optical.

#### Device Description:

The AL-47 Toric (isofilcon) soft contact lenses are fabricated from isofilcon, 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.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (isofilcon) soft hydrophilic contact lens has 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 lens dries out, it will become hard and appear somewhat warped; it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 36% water by weight. The physical properties of the lens are:

Refractive Index Light Transmission: Water Content Specific Gravity Oxygen Permeability

1.435 (hydrated) greater than 93% T 35.5 % by weight 1.19 (hydrated) 3.7 X 1011 (cm /sec) (ml Oxml x mm Hg @ 21 C), (as measured by Schema Versatae)

#### Intended Use:

The AL-47 Toric (isofilcon) Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia, hyperopia and possesses refractive astigmatism not exceeding 10 Diopters.

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#### 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 (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to AL-47 (spherical), PMA # P820078. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, 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.

The following matrix illustrates that the production method, lens function and material of the AL-47 Toric contact lens is substantially equivalent to the predicate devices. In addition, the water content, polymer, DK value, refractive index, specific gravity, and light transmission are as well substantially equivalent.

| | Characteristic | AL-47 Toric | PREDICATE<br>DEVICE(S) |
|-----|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 1.) | PRODUCTION<br>METHOD | Lathe-Cut | SAME |
| 2.) | LENS FUNCTION | Refractive medium that focuses light rays<br>from near and distant objects on the retina,<br>while compensating for refractive error,<br>including (astigmatism) | SAME |
| 3.) | MATERIAL | Hydrophilic Polymer | SAME |
| a. | Water Content | 36% | 38%/45% |
| b. | Polymer Content | 65% | 62%/55% |
| c. | Polymer | isofilcon | polymacon/hefilcon B |
| d. | DK Value | 3.7 | 18.8/13.0 |
| e. | Refractive Index | 1.43 (hydrated) | 1.43 (hydrated) |
| f. | Specific Gravity | 1.19 (hydrated) | 1.180 (hydrated) |
| g. | FDA polymer group<br>number | Group # 1<br>Low water <50% water, nonionic | Same |
| h. | Light Transmission | greater than 93% T | SAME |

#### Substantial Equivalence Matrix

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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 eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 8 1997

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

Re: K973847

Trade Name: AL-47 (isofilcon) Toric Hydrophilic Contact Lens for Daily Wear (lathecut, clear) Regulatory Class: II Product Code: 86 LPL Dated: October 8, 1997 Received: October 8, 1997

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: AL-47 Toric (isofilcon) Soft (Toric) Daily Wear Contact Lens

INDICATIONS FOR USE:

The AL-47 Toric (isofilcon) Soft 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 possesses refractive astigmatism not exceeding 10 Diopters.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OL

Over-The-Counter Use

. . .

(Optional Format 1-2-96)

Kavin Wabaton
Division Sign Off

(Division Sign-Off) Division of Ophthalmic Devices £973847 510(k) Number _

AL-47 Toric (isofilcon) Soft (Toric) Daily Wear Contact Lens