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

Device Description

Alcon Multi-Purpose Disinfecting Solution (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.

AI/ML Overview

The provided text describes the Alcon Multi-Purpose Disinfecting Solution (MPDS) and its clearance through a 510(k) premarket notification. It outlines the safety and effectiveness studies conducted, but does not present acceptance criteria in a table format with numerical performance metrics for the device. The term "acceptance criteria" is used in a general sense, referring to compliance with guidelines.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance Study for Alcon Multi-Purpose Disinfecting Solution (MPDS)

The Alcon Multi-Purpose Disinfecting Solution (MPDS) was evaluated against guidelines set forth in the FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products, as well as relevant ANSI and EN ISO standards for microbiological requirements (EN ISO 14729:2001) and antimicrobial preservative efficacy (EN ISO 14730:2000).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table. Instead, it refers to meeting established guidelines and demonstrating clinical equivalence or superiority. The reported performance is qualitative.

Category	Acceptance Criteria (Implied based on guidance/standards)	Reported Device Performance
Cleaning Efficacy	Effective removal of protein deposits and reduction of lipid deposition from contact lenses. Surfactant concentrations above Critical Micelle Concentration (CMC).	Alcon MPDS is "effective at removing protein deposits and reducing lipid deposition from silicone hydrogel and soft (hydrophilic) lenses." Studies "also demonstrated cleaning activity." Surfactant concentrations are "well above the CMC."
Compatibility	Compatibility with soft (hydrophilic) and silicone hydrogel lenses, ensuring no adverse effects on lens material or performance.	"The results of lens compatibility studies show that Alcon MPDS is compatible with soft (hydrophilic) and silicone hydrogel lenses."
Microbiology	Meeting or exceeding criteria for disinfection and preservative efficacy as defined by FDA guidance (May 1, 1997), ANSI Z80, EN ISO 14729:2001, and EN ISO 14730:2000. This typically involves specific log reductions for various microorganisms and maintenance of antimicrobial activity over time.	"Alcon MPDS exceeds the criteria for disinfection and preservative efficacy."
Biocompatibility	Compliance with guidelines set forth in FDA's May 1, 1997 Guidance, ensuring safety for consumer under recommended and reasonably foreseeable misuse conditions. This typically involves cytotoxicity, sensitization, irritation, and other systemic toxicity tests.	"Based on the results of the comprehensive preclinical evaluations, Alcon MPDS is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse."
Clinical Efficacy	Clinically acceptable safety and efficacy in silicone hydrogel and soft contact lens wearers, comparable to or better than a legally marketed predicate device (Bausch & Lomb™ renu® fresh™). Outcomes on comfort and moisture from insertion to removal should be adequate.	"The safety and efficacy of Alcon MPDS was clinically acceptable and similar to or better than the control." "The results indicate that Alcon MPDS provides comfort and moisture from insertion to removal."

2. Sample Size and Data Provenance (for test set/clinical study)

Sample Size: Not explicitly stated for the clinical study. The text only mentions "a clinical study was conducted" with "silicone hydrogel and soft (hydrophilic) contact lens wearers."
Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" and is prospective in nature, as it evaluates the safety and efficacy of the new Alcon MPDS in lens wearers.

3. Number of Experts and Qualifications (for ground truth)

This information is not provided in the given text. For a medical device like a contact lens solution, ground truth regarding safety and efficacy in a clinical setting would typically be established by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed.

4. Adjudication Method (for test set)

This information is not provided in the given text. While a clinical study was performed, the method of adjudicating outcomes (e.g., adverse events, comfort scores) is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically relevant for diagnostic imaging AI devices, not for a contact lens care solution. Therefore, there is no effect size of human readers improving with or without AI assistance.

6. Standalone Performance (Algorithm only)

No, a standalone (algorithm only) performance study was not conducted. This device is a chemical solution, not an AI algorithm. Its performance is inherent to its chemical formulation and interaction with biological and material components.

7. Type of Ground Truth Used (for test set)

The ground truth for the clinical study would be based on clinical assessments and patient reports of outcomes (e.g., safety events, comfort levels, visual acuity where relevant) in comparison to the control product. For microbiological studies, ground truth is established by standard laboratory culture methods. For cleaning and compatibility, it's based on laboratory analytical methods.

8. Sample Size for the Training Set

This concept is not applicable as the device is a chemical solution, not an AI algorithm that requires a training set. The development of the solution involved chemical formulation and in-vitro testing.

9. How the Ground Truth for the Training Set was Established

This concept is not applicable for a chemical solution. The "ground truth" during development would be based on scientific principles, chemical analysis, and iterative testing in vitro to optimize the formulation for its intended functions (cleaning, disinfection, compatibility).

Summary

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MAY 1 0 2011

510(k) SUMMARY

Submitted by:

Beth L. Schultz Manager II, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 568-6143 (Phone) (817) 551-4630 (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) contct lens care products, this solution is classified as a Class II - Special Controls Product.

Indications for Use:

Description:

+Tetronic® is a trademark of BASF.

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K102860

Substantial Equivalence:

Alcon MPDS 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.

Alcon MPDS is substantially equivalent in terms of its actions and intended use to Bausch & Lomb™ renu® fresh™ multi-purpose solution (K974723), Bausch & Lomb™ BioTrue™ multi-purpose solution (K083757), Alcon OPTI-FREE® Replenish® Multi-Purpose Disinfecting Solution (K050729) and Alcon Multi-Purpose Solution (K071236). A summary of the test results is provided below:

Safety and Effectiveness:

Cleaning:

The cleaning efficacy of Alcon MPDS was evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants. Cleaning efficacy studies conducted with Alcon MPDS indicate that it is effective at removing protein deposits and reducing lipid deposition from silicone hydrogel and soft (hydrophilic) lenses. Studies also demonstrated cleaning activity when lenses were soaked in Alcon MPDS.

Compatibility:

The results of lens compatibility studies show that Alcon MPDS is compatible with soft (hydrophilic) and silicone hydrogel lenses.

Microbiology:

Alcon conducted a series of studies based on FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products., ANSI Z80, 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 and EN ISO 14730:2000 Opthalmic optics- Contact lens care products- Antimicrobial preservative efficacy testing and guidance on determining discard date to demonstrate the

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microbiological efficacy of Alcon MPDS. Alcon MPDS exceeds the criteria for disinfection and preservative efficacy.

Biocompatibility:

Alcon MPDS was tested in compliance with 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 MPDS is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.

Clinical:

A clinical study was conducted to evaluate the safety and efficacy of the Alcon® MPDS in silicone hydrogel and soft (hydrophilic) contact lens wearers. The control product was Bausch & Lomb™ renu@ fresh™ Multi-Purpose Solution. The safety and efficacy of Alcon MPDS was clinically acceptable and similar to or better than the control. Alcon MPDS is substantially equivalent to the control. The results indicate that Alcon MPDS provides comfort and moisture from insertion to removal.

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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 stylized eagle with three stripes representing health, human services, and the U.S. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Alcon Research, Ltd. C/O Beth L. Schultz O.D. Manager II, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099

MAY 1 0 2011

) Re: K102860 g

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: April 28, 2011 Received: April 29, 2011

Dear Dr. Schultz:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Dr. Beth L. Schultz

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Marina B. Eydelman, 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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K102860

Indications for Use

K102860 510(k) Number (if known):

Alcon Multi-Purpose Disinfecting Solution Device Name:

Indications for Use:

Prescription Use Over-The-Counter Use AND/OR X (Part 21 CFR 801 Subpart D) (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)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K102860

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

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