ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES

K042242 · Alden Optical Labs., Inc. · LPL · Sep 15, 2004 · Ophthalmic

Device Facts

• Record ID: K042242
• Device Name: ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES
• Applicant: Alden Optical Labs., Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Sep 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) Sphere and Toric Soft Contact Lenses 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/or possess refractive astigmatism not exceeding 10 Diopters. They are available for either conventional wear or planned replacement modalities.

Device Story

Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) are soft (hydrophilic) contact lenses designed for daily wear. Lenses correct refractive errors including myopia, hyperopia, and astigmatism. Intended for use by patients with non-diseased eyes; prescribed by eye care professionals. Lenses are available in sphere and toric designs and support conventional or planned replacement modalities. Benefit is improved visual acuity for patients with refractive vision impairments.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material properties.

Technological Characteristics

Soft (hydrophilic) contact lenses composed of methafilcon A (Alden HP 55) and hioxifilcon A (Alden HP 59G). Available in sphere and toric designs. Daily wear modality.

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. For daily wear.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2004

Alden Optical Laboratories, Inc. c/o Charles H. Creighton, President 13295 Broadway Alden, NY 14004

Re: K042242

Trade/Device Name: Alden HP 55 (methafilcon A) and Alden HP59G (hioxifilcon A) Sphere & Toric Soft Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II

Product Code: LPL Dated: August 17, 2004 Received: August 19, 2004

Dear Mr. Creighton:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becarely be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroours) to regardy and the Medical Device Amendments, or to connieres that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have occh recise in a trequire approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The 1 ou may, merciolo, market the Act include requirements for annual registration, listing of general controls provision 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to satil additions, 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 I least of advised that I Dris 1558aarse or our device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must of any I ederal statutes and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), acceming (21 CFR Part 820); and if applicable, the electronic forul in the quality by over in the end of the Act); 21 CFR 1000-1050.

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## Page 2 - Charles H. Creighton

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,

A Kalpi 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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## Attachment E

## Indications For Use Statement

| Device Name: | Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A)<br>Sphere and Toric Soft Contact Lenses for Daily Wear |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A)<br>Sphere and Toric Soft Contact Lenses For Daily Wear, are indicated<br>for the correction of visual acuity in aphakic and not aphakic persons with<br>non-diseased eyes with myopia or hyperopia, and/or possess refractive<br>astigmatism not exceeding 10 Diopters. They are available for either<br>conventional wear or planned replacement modalities. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use *x*
(Per 21 CFR 801.109)

or

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Emanuel W. Branson, Ph.D.

Division of Ophthalmic Devices

510(k) Number K042242