ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES

K091327 · Alden Optical Labs., Inc. · LPL · Jun 25, 2010 · Ophthalmic

Device Facts

• Record ID: K091327
• Device Name: ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
• Applicant: Alden Optical Labs., Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Alden HP 54 Spherical soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The Alden HP 54 Toric soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters. The Alden HP 54 Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and presbyopia, with add powers not exceeding 4.00 diopters. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The Alden HP 54 Toric Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters, and presbyopia with add powers not exceeding 4.00 diopters. The lenses are available for either conventional wear or planned replacement modalities.

Device Story

Alden HP 54 contact lenses (spherical, toric, multifocal, toric multifocal) are soft (hydrophilic) lenses designed for vision correction. Lenses are prescribed by eye care professionals for patients with refractive errors, astigmatism, or presbyopia. Lenses are worn by patients for conventional or planned replacement modalities. Device functions as a physical refractive element placed on the eye to improve visual acuity.

Technological Characteristics

Soft (hydrophilic) contact lens; material: hioxifilcon D; classification: Class II; product code: LPL; regulation: 21 CFR 886.5925.

Indications for Use

Indicated for aphakic and non-aphakic persons with non-diseased eyes requiring correction of refractive ametropia (myopia/hyperopia), astigmatism (up to 10.00D), and/or presbyopia (add powers up to 4.00D).

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Alden Optical Laboratories C/O Charles H. Creighton CEO 13295 Broadway Alden, NY 14004

JUN 2 5 2010

Re: K091327

Trade/Device Name: Alden HP 54 (hioxifilcon D) Spherical, Toric, Multifocal and Toric Multifocal Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 19, 2010 Received: March 23, 2010

Dear Mr. Creighton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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## Page 2 -- Mr. Charles H. Creighton

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, 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 Alden HP 54 Spherical Lenses Device Name: Alden HP 54 Toric Lenses Alden HP 54 Multifocal Lenses Alden HP 54 Toric Multifocal Lenses The Alden HP 54 Spherical soft contact lens is indicated for the correction of Indications for Use: visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The Alden HP 54 Toric soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters. The Alden HP 54 Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and presbyopia, with add powers not exceeding 4.00 diopters. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not . interfere with visual acuity. The Alden HP 54 Toric Multifocal soft contact lens is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes, with refractive ametropia (myopia or hyperopia), and/or possess refractive astigmatism not exceeding 10.00 diopters, and presbyopia with add powers not exceeding 4.00 diopters. The lenses are available for either 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 L (Per 21 CFR 801.109)

or

Over-The-Counter Use ___

(Optional Format 1-2-96)

Kaven Wahuton

Division of Onhthalmic De

510(k) Number