ALCON MULTI-PURPOSE DISINFECTING SOLUTION

K050729 · Alcon Research, Ltd. · LPN · Sep 14, 2005 · Ophthalmic

Device Facts

• Record ID: K050729
• Device Name: ALCON MULTI-PURPOSE DISINFECTING SOLUTION
• Applicant: Alcon Research, Ltd.
• Product Code: LPN · Ophthalmic
• Decision Date: Sep 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

For use in the daily cleaning, conditioning, rinsing, removing protein deposits, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner. ALCON® Multi-Purpose Disinfecting Solution can also be used with OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Device Story

Sterile, buffered, isotonic, aqueous solution for contact lens care; contains sodium citrate, sodium chloride, sodium borate, propylene glycol, dual-action conditioning system (Tetronic 1304t, nonanoyl ethylenediaminetriacetic acid), and preservatives (POLYQUAD 0.001%, ALDOX 0.0005%). Used by patients at home for daily cleaning, rinsing, disinfection, and storage of silicone hydrogel and soft contact lenses. Passive cleaning mechanism; surfactant concentration above Critical Micelle Concentration (CMC) ensures efficacy. Compatible with OPTI-FREE SUPRACLENS Daily Protein Remover. Benefits include effective disinfection, reduced lens deposits, improved wettability, and enhanced comfort compared to predicate solutions.

Clinical Evidence

Clinical evidence includes three studies: 3-month study (asymptomatic soft lens wearers), 1-month study (silicone hydrogel wearers), and 1-month study (symptomatic soft lens wearers). Compared against Bausch & Lomb ReNu MultiPlus and Advanced Medical Optics Complete MoisturePLUS. Results showed statistically lower lens deposits, lower corneal staining, and improved comfort. Wettability study showed statistically significant improvement (p ≤ 0.0001) in lens wettability compared to Bausch & Lomb ReNu Multi-Purpose Solution.

Technological Characteristics

Sterile, buffered, isotonic, aqueous solution. Ingredients: sodium citrate, sodium chloride, sodium borate, propylene glycol, Tetronic 1304t, nonanoyl ethylenediaminetriacetic acid. Preservatives: POLYQUAD (polyquaternium-1) 0.001%, ALDOX (myristamidopropyl dimethylamine) 0.0005%. Chemical disinfection (non-heat).

Indications for Use

Indicated for daily cleaning, conditioning, rinsing, protein removal, chemical disinfection, and storage of silicone hydrogel and soft (hydrophilic) 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

• Bausch & Lomb ReNu Multi-Purpose Solution

Reference Devices

• Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution
• Advanced Medical Optics Complete MoisturePLUS Multi-Purpose Solution
• OPTI-FREE® SUPRACLENS® Daily Protein Remover

Submission Summary (Full Text)

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SEP 1 4 2005
K050729

#### 510(k) SUMMARY

## Submitted by:

Kim B. Kracke Senior Manager, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, Texas 76134-2099 [phone] (Phone) [phone] (Fax)

#### Device Name:

Proprietary Name: ALCON® Multi-Purpose Disinfecting 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, removing protein deposits, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

ALCON® Multi-Purpose Disinfecting Solution can also be used with OPTI-FREE® SUPRACLENS® Daily Protein Remover.

## Description:

ALCON® Multi-Purpose Disinfecting Solution is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, sodium borate, propylene glycol, a proprietary dual action conditioning system (Tetronic® 1304t, nonanoyl

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ethylenediaminetriacetic acid) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0005% as preservatives. * Tetronic® is a trademark of BASF.

## Substantial Equivalence:

ALCON® Multi-Purpose Disinfecting Solution is substantially equivalent in terms of its actions and indications for use to Bausch & Lomb ReNu Multi-Purpose Solution.

ALCON® Multi-Purpose Disinfecting Solution meets the guidelines set forth in FDA 's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.

## Safety and Effectiveness:

#### Cleaning Effectiveness Studies

Laboratory studies were conducted with ALCON® Multi-Purpose Disinfecting Solution. The purpose of these studies was to evaluate passive cleaning using a no rub regimen with silicone hydrogel and soft contact lenses and the ability to clean laboratory deposited lenses. The results indicate that ALCON® Multi-Purpose Disinfecting Solution is effective at passively cleaning all soft contact lenses including silicone hydrogel lenses. This data is supported by results of clinical evaluations.

Additional laboratory studies conducted with OPTI-FREE® SUPRACLENS® Daily Protein Remover in combination with ALCON® Multi-Purpose Disinfecting Solution indicate improved cleaning efficacy on soft contact lenses.

The cleaning efficacy of the solution has been evaluated through the determination of the Critical Micelle Concentration (CMC). The surfactant concentration is well above the CMC, which ensures the effective cleaning function of the product.

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#### Compatibility Studies

Lens compatibility studies performed with silicone hydrogel and FDA Groups I and IV contact lenses show that ALCON® Multi-Purpose Disinfecting Solution is compatible with all soft contact lenses including silicone hydrogels.

#### Wettability Studies

In vitro and ex vivo wettability studies were carried out on ALCON® Multi-Purpose Disinfecting Solution versus Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution marketed disinfection product. The in vitro study results correlated with the ex vivo study data where the ALCON® Multi-Purpose Disinfecting Solution formulation showed significantly lower wetting angles indicating excellent wettability. Comparatively, the Bausch & Lomb ReNu Multi-Purpose Solution product showed high contact angles in the plateau region of the in vitro wetting data and this correlated with the ex vivo data where high wetting angles were observed. All of the ex vivo wetting angles were observed after eight hours of contact lens wear.

# Microbiology Studies

A series of studies based on the FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products, 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 Disinfecting Solution.

The product meets the Stand Alone Antimicrobial Activity of the above standards both in the presence and absence of organic soil. The product passes the Regimen Criteria in the presence of soil when tested according to the directions for use. In addition, results showed that the combination of ALCON® Multi-Purpose Disinfecting Solution with OPTI-FREE® SUPRACLENS® Daily Protein Remover meets the primary criteria of the Stand Alone test.

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# Biocompatibility

ALCON® Multi-Purpose Disinfecting Solution meets the guidelines set forth in FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products. Based on the results of the comprehensive preclinical evaluations, ALCON® Multi-Purpose Disinfecting Solution is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.

# Clinical Studies

A series of clinical studies was conducted using ALCON® Multi-Purpose Disinfecting Solution. A three-month clinical study with asymptomatic soft (hydrophilic) lens wearers, a one-month study with silicone hydrogel lens wearers and a one-month study with symptomatic soft (hydrophilic) lens wearers were conducted to demonstrate the safety and efficacy of the ALCON® Multi-Purpose Disinfecting Solution regimen with silicone hydrogel and soft (hydrophilic) contact lenses. The control products were the Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution regimen and the Advanced Medical Optics Complete MoisturePLUS Multi-Purpose Solution regimen used according to the current approved label. The safety and efficacy of the ALCON® Multi-Purpose Disinfecting Solution regimen were clinically acceptable and similar to the marketed comparator regimens when used according to the approved label. Lenses cared for with the ALCON® Multi-Purpose Disinfecting Solution regimen had statistically lower levels of lens deposits than the control regimens. In at least one of the three studies, subjects assigned to the ALCON® Multi-Purpose Disinfecting Solution regimen had statistically lower corneal staining and significantly improved comfort (on some measures of comfort) compared to one of the predicate product regimens. An additional clinical study was conducted to evaluate the effect of the ALCON® Multi-Purpose Disinfecting Solution regimen on the wetting characteristics of soft (hydrophilic) contact lenses. (This study is also cited above in the Wettability Studies section.) The control product was Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution regimen used according to the current approved label. Lenses were rinsed and disinfected overnight in the assigned multi-purpose solution. The differences in lens wettability after wear between ALCON® Multi-Purpose Disinfecting Solution and Bausch & Lomb ReNu Multi-Purpose Solution were statistically significant (p ≤ 0.0001) in favor of ALCON® Multi-Purpose Disinfecting Solution.

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2005

Ms. Kim B. Kracke Senior Manager, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, TX 76134

Re: K050729

Trade/Device Name: Alcon Multi-Purpose Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: September 12, 2005 Received: September 13, 2005

Dear Ms. Kracke:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the 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 encrosale) to regard to the Medical Device Amendments, or to connitiered phor to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, de vices mat nave been roomsalied in approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains 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 If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of A may oe subject to succeral 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 i lease oc advised that 1971 bration that your device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must or any it catal statutes and regainments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fall 607), adoling (21 CFR Rates), go CFR Part 820); and if applicable, the electronic form in the quant) byochlo (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kim B. Kracke

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/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Alcon Multi-Purpose Disinfecting Solution

| 510(k) Number (if known): | K050729 |
|---------------------------|---------|
|---------------------------|---------|

Alcon Multi-Purpose Disinfecting Solution Device Name:

Indications for Use:

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

Alcon Multi-Purpose Disinfecting Solution can also be used with OPTI-FREE® SUPRACLENS® Daily Protein Remover.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use | X |
|------------------------------------------|----|----------------------|---|
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(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices

| 510(k) Number | K050729 |
|---------------|---------|
|---------------|---------|

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