ALCON MULTI-PURPOSE SOLUTION

K071236 · Alcon, Inc. · LPN · Dec 12, 2007 · Ophthalmic

Device Facts

• Record ID: K071236
• Device Name: ALCON MULTI-PURPOSE SOLUTION
• Applicant: Alcon, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.

Device Story

ALCON® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous chemical solution for contact lens care. It contains sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304 (surfactant), and POLYQUAD® (polyquaternium-1) 0.00025% preservative. The device is used by patients at home for daily maintenance of silicone hydrogel contact lenses. The solution cleans via the surfactant TETRONIC® 1304 and disinfects via chemical action. Patients use the solution to rinse and store lenses, which helps maintain lens hygiene and comfort. Clinical evidence indicates the solution results in less corneal staining compared to control solutions, potentially improving patient comfort and ocular health.

Clinical Evidence

Two clinical studies compared the subject device to Advanced Medical Optics COMPLETE® MoisturePLUS™ Multi-Purpose Solution. The primary endpoints focused on safety and efficacy. Results showed the subject device was clinically acceptable, with subjects using the subject regimen exhibiting statistically less corneal staining compared to the control regimen when used with silicone hydrogel lenses.

Technological Characteristics

Sterile, buffered, isotonic, aqueous solution. Ingredients: sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304, and POLYQUAD® (polyquaternium-1) 0.00025% preservative. Functions via chemical disinfection and surfactant-based cleaning. Complies with EN ISO 14729:2001 and EN ISO 14730:2000 microbiological standards.

Indications for Use

Indicated for daily cleaning, conditioning, rinsing, chemical disinfection, and storage of silicone hydrogel contact lenses for patients as recommended by an eye care practitioner.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• ALCON® Opti-Free® RepleniSH® Multi-Purpose Disinfecting Solution
• ALCON® Unique-pH® Multi-Purpose Solution

Reference Devices

• Advanced Medical Optics COMPLETE® MoisturePLUS™ Multi-Purpose Solution

Submission Summary (Full Text)

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# 071236

# 510(k) SUMMARY

#### Submitted by:

Kim B. Kracke Assistant Director, Regulatory Affairs Alcon, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 [phone] (Phone) [phone] (Fax)

DEC 1 2 2007

# Device Name:

Proprietary Name: ALCON® Multi-Purpose Solution

Common Name: Soft (hydrophilic) Contact Lens Care Solution

Classification Name: Under 21 CFR §886.5928 titled Soft (hydrophilic) contact lens care products, this solution is classified as a Class II -- Special Controls Product.

## Indications for Use:

For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.

## Description:

ALCON® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution containing sodium chloride, sodium borate, propylene glycol, sorbitol, edetate disodium, TETRONIC® 1304, hydroxypropyl guar and POLYQUAD® (polyquaternium-1) 0.00025% preservative.

TETRONIC® is a trademark of BASF.

## Substantial Equivalence:

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ALCON® Multi-Purpose Solution is substantially equivalent in terms of its actions and indications for use to ALCON® Opti-Free® RepleniSH® Multi-Purpose Disinfecting Solution and ALCON® Unique-pH® Multi-Purpose Solution.

# Safety and Effectiveness:

## Cleaning Studies:

ALCON® Multi-Purpose Solution is an isotonic aqueous solution which contains a surface active agent, TETRONIC® 1304. The cleaning efficacy of the solution has been evaluated through the determination of the Critical Micelle Concentration (CMC). The TETRONIC® 1304 concentration is well above the CMC, which ensures the effective cleaning function of the product. These findings are supported by results of clinical evaluations.

#### Compatibility Studies:

Lens compatibility studies performed show that ALCON® Multi-Purpose Solution is compatible with silicone hydrogel lenses.

# Microbiology Studies:

A series of studies based on EN ISO 14729:2001 Ophthalmic optics -- Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses, the ANSI Contact Lens Care Products Standard and EN ISO 14730:2000 Ophthalmic optics- Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date were completed to demonstrate the microbiological efficacy of ALCON® Multi-Purpose Solution. These results indicate ALCON® Multi-Purpose Solution meets satisfactory levels of disinfection and preservative efficacy.

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# Biocompatibility:

Based on the results of the preclinical evaluations, ALCON® Multi-Purpose Solution is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.

# Clinical Studies:

Two clinical studies were conducted using ALCON® Multi-Purpose Solution. The control product was Advanced Medical Optics COMPLETE® MoisturePLUS™ Multi-Purpose Solution. The safety and efficacy of the ALCON® Multi-Purpose Solution were clinically acceptable. Subjects assigned to the ALCON® Multi-Purpose Solution regimen had statistically less corneal staining compared to the control regimen with silicone hydrogel lenses.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its wings forming a protective shape.

MAY 29 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alcon Research, Ltd. c/o Kim Kracke Assistant Director, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099

Re: K071236

Trade/Device Name: Alcon Multi-Purpose Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: October 25, 2007 Received: October 26, 2007

Dear Ms. Kracke:

This letter corrects our substantially equivalent letter of December 12, 2007.

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 (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 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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This letter will allow you to continue 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 vours.

Sincerely yours,

Eweneth Boun PhD

Image /page/4/Picture/5 description: The image contains a handwritten word, "for", in a simple, cursive style. The letters are connected, and the word is written in black ink on a white background. The "f" has a loop extending above and below the main body of the letter, and the "or" is written in a continuous stroke.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known):

Device Name:

Alcon Multi-Purpose Solution

Indications For Use:

For use in the daily cleaning, conditioning, rinsing, chemical (not heat) disinfection, and storage of silicone hydrogel contact lenses as recommended by your eye care practitioner.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nya Smith

(Division Sign-Off) Division of Ochthalmic Ear, Nosse aren Inroat Devises

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