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

OPTI-FREE® EXPRESS® Multi-Purpose Disinfecting Solution can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Device Description

OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, TETRONIC® 1304, with edetate disodium 0.05%, POLYQUAD® (polyquaternium-1) 0.001% and ALDOX™ (myristamidopropyl dimethylamine) 0.0005% as preservatives.

AI/ML Overview

The provided text describes a 510(k) submission for a contact lens care solution, not a device that involves AI or human interpretation of images/data. Therefore, many of the requested categories (like sample size for test/training sets, experts, adjudication method, MRMC studies, standalone performance in the context of algorithms, and ground truth types related to medical images) are not applicable.

However, I can extract the acceptance criteria and study information relevant to the product's performance as a contact lens disinfecting solution.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Guidance	Reported Device Performance (OPTI-FREE EXPRESS MPS)
Microbiology (Disinfection)	FDA Guidelines / ISO 14729:2001 Regimen Test Requirements	Met both FDA guidelines and ISO 14729:2001 Regimen Test Requirements for various regimens.
	Stand Alone Test (ISO 14729 / FDA 510[k])	Met primary criteria; organic soil had no deleterious effect on antimicrobial activity. (K001214)
	Regimen Test (ISO 14729 / FDA 510[k])	Met criteria using previous approved labeling and a new investigational regimen (less rinsing). (K001214 & new study)
Cleaning (Protein Removal)	Demonstrated ability to clean lenses / remove protein	Demonstrated ability to clean lenses during soaking. Showed superiority over Bausch & Lomb's ReNu Multi-Plus® Multi-Purpose Solution in removing protein (lysozyme) from Group IV lenses.
Safety & Efficacy (Clinical)	Demonstrate safety and efficacy in a clinical setting.	Demonstrated safety and efficacy with a rinse/soak regimen in a 30-day clinical study.
Biocompatibility	FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products	Meets these guidelines. No new biocompatibility testing required for a labeling change as the product formulation remains unchanged.

2. Sample size used for the test set and the data provenance

Microbiology Studies: Not explicitly stated as a number of lenses or microbial samples, but the studies were conducted to meet FDA guidelines and ISO 14729:2001 standards, which typically involve specific sample sizes for microbial challenges.
Cleaning Studies: Not explicitly stated.
Clinical Study: No specific sample size provided, only described as a "30-day, randomized concurrently controlled, observer-masked... and patient-masked, parallel group, multi-site study."
Data Provenance: The studies were conducted by Alcon Research, Ltd. for internal verification and submission to the FDA. The nature of the studies implies prospective data collection for the specific purpose of regulatory submission. The country of origin of the data is not explicitly stated but implies US-based studies due to FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to a contact lens care product. Ground truth in this context would be laboratory measurements of microbial count reduction, protein removal, and clinical observations of safety and efficacy. These are quantified metrics, not expert consensus on interpretations. One of the studies was "observer-masked (investigator and chemical analyst)," implying experts were involved in data collection and analysis, but not for establishing a subjective "ground truth."

4. Adjudication method for the test set

This is not applicable as the studies are focused on quantifiable measurements (e.g., microbial kill, protein levels) rather than subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to a contact lens care product. There is no "human reader" or "AI assistance" involved in its intended use.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable to a contact lens care product. There is no algorithm. However, the document does mention "Stand Alone Test" in the context of antimicrobial activity, referring to a specific laboratory test method (ISO 14729) for the product's disinfection ability without any additional steps. This is a "standalone" test of the product's inherent capacity, not an algorithm's.

7. The type of ground truth used

Microbiology Studies: Lab-based quantitative assays measuring microbial reduction (kill rates) for specific microorganisms.
Cleaning Studies: Lab-based quantitative assays measuring protein (lysozyme) levels on contact lenses.
Clinical Study: Objective measures of safety (e.g., adverse events, corneal health assessments) and efficacy (e.g., continued comfortable wear, absence of infection, potentially protein measurement as noted in cleaning).

8. The sample size for the training set

This is not applicable as there is no AI algorithm being trained for this product.

9. How the ground truth for the training set was established

This is not applicable as there is no AI algorithm being trained for this product.

Summary

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510(K) SUMMARY

Submitted by:

Ralph H. Larsen Sr. Manager, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-4702 (Phone) (817) 551-4630 (Fax)

Device Name:

Common Name:	Contact Lens Care Multi-Purpose Disinfecting Solution
Proprietary Name:	OPTI-FREE® EXPRESS® Multi-Purpose Disinfecting Solution

Indications for Use:

OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

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Description:

Substantial Equivalence:

OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution is substantially equivalent, in terms of its actions and indications for use, to OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution, cleared for marketing under 510(k) K973332 (originally submitted as P830034/S32), K974624, K983780, K001214 (no rub directions for use for lenses replaced within 30 days or less) and K002589 (no rub directions for all lenses). OPTI-FREE EXPRESS 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 Studies

A study demonstrated the ability of the product to clean lenses during soaking. The study was done to demonstrate the contribution of the rinse vs. soaking steps to the levels of lysozyme. Elimination of the post-disinfection rinse showed minimal effect on the total amount of lysozyme removed on group IV lenses. This study demonstrates the superiority of OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution over Bausch & Lomb's ReNu Multi-Plus® Multi-Purpose Solution in removing protein from lenses.

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Microbiology Studies

A study was conducted to evaluate the performance of OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution in a regimen consisting of a 5 second rinse of lenses per side and soaking the lenses for 6 hours. No rubbing step or final rinse step was used. The results show that OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution evaluated by the test regimen (i.e., lenses rinsed for 5 seconds per lens surface and soaking for 6 hours) meets the FDA guidelines and the ISO 14729:2001 Regimen Test Requirements.

Stand Alone Test:

The antimicrobial activity of OPTI-FREE Express FID 90746 was previously evaluated by the ISO 14729 (FDA 510[k]) Stand Alone Test procedure for disinfection of contact lenses (K001214). The results showed that OPTI-FREE Express FID 90746 (no soil) met the primary criteria of the Stand Alone Test. The results also showed that organic soil has no deleterious effect on the antimicrobial activity of OPTI-FREE Express FID 90746 (K001214).

Regimen Test:

Previously, No Rub™ OPTI-FREE Express® was tested and passed the ISO 14729 (FDA 510 [k]) Regimen Test using the approved labeling (i.e., five second rinse per lens surface, six hour soak, and five second rinse per lens surface [no rubbing step]) (K001214). In a new study, OPTI-FREE Express FID 90746 was tested by the Regimen Test using a similar regimen, but with less rinsing of the lens ( five second rinse per lens surface and six hour soak [no rubbing and no final rinse steps]).

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The OPTI-FREE Express FID 90746 Investigational Regimen met the criteria of the ISO 14729 (FDA 510[k]) Regimen Test.

It was concluded that the OPTI-FREE Express FID 90746 Investigational Regimen provides effective disinfection of contact lenses based on ISO 14729 and the FDA 510(k) performance criteria for contact lens disinfectants.

Clinical Study

A 30-day, randomized concurrently controlled, observer-masked (investigator and chemical analyst) and patient-masked, parallel group, multi-site study was conducted to demonstrate the safety and efficacy of OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution. OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution was used with the modified directions for use. The control used in the study was Bausch & Lomb ReNu Multi-Plus® Multi-Purpose Solution.

This study demonstrated the safety and efficacy of OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution with a rinse/soak regimen.

Significantly less residual lysozyme was found on Group IV lenses from subjects in the OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution regimen compared to lenses from subjects in the ReNu Multi-Plus® Multi-Purpose Solution group on Day 30.

Biocompatibility Testing

OPTI-FREE EXPRESS 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.

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OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution remains unchanged from the previously approved product (P830034/S32, K973332) except for the labeling change revising the directions for use. The labeling changes require no new biocompatibility testing.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three faces in profile, all facing to the right. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 8 2002

Alcon Research, LTD c/o Ralph H. Larsen Sr. Manager, Regulatory Affairs 6201 South Freeway Fort Worth, TX 76134-2099

Re: K021143

Trade/Device Name: OPTI-FREE EXPRESS® Multipurpose Disinfecting Solution (Modifed Directions for Use) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: 86 LPN Dated: June 18, 2002 Received: June 20, 2002

Dear Mr. Larsen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (OS) 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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Page 2 -- Mr. Ralph Larsen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph 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

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510(k) Number (if known): K021143

Device Name: OPTI-FREE® EXPRESS® Multi-Purpose Disinfecting Solution

Indications for Use:

OPTI-FREE® EXPRESS® Multi-Purpose Disinfecting Solution can also be used as a diluent for 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)

Myra Smith

510(k) Number K021143

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use

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.”