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

OPTI-ONE® Multi-Purpose Solution (modified directions for use) can also be as a d:luent for OPTI-ZYME® Enzymatic Cleaner.

Device Description

OPTI-ONE® Multi-Purpose Solution is a sterile, buffered, isotonic, aqueous solution, containing borates, citrate, mannitol, and sodium chloride with Pationic® and Tetronic® surfactants and edetate disodium 0.05% and POLYQUAD® (polyquaternium-1) 0.0011% preservatives.

AI/ML Overview

The provided 510(k) summary for K031193, OPTI-ONE® Multi-Purpose Solution, focuses on demonstrating substantial equivalence to a predicate device and adherence to FDA guidelines for contact lens care products. While some study details are mentioned, it primarily summarizes the findings rather than providing in-depth study protocols and results with specific acceptance criteria and performance metrics in a structured format often seen in clinical trial reports.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for its clinical study. Instead, it makes a general statement about clinical acceptability and similarity to the control. For the microbiology study, it references FDA guidelines and ISO 14729:2001 requirements as the acceptance criteria.

Study Type	Acceptance Criteria	Reported Device Performance
Cleaning Studies	(Implicit) Ability to effectively clean laboratory deposited lenses using a no-rub regimen.	Demonstrated ability to clean laboratory deposited lenses.
Microbiology Studies	Meets FDA guidelines for Regimen Test. Meets ISO 14729:2001 Regimen Test Requirements.	OPTI-ONE® Multi-Purpose Disinfecting Solution evaluated by the test regimen meets FDA guidelines and ISO 14729:2001 Regimen Test Requirements.
Clinical Study	Clinically acceptable performance for safety and efficacy. Similar to Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution (control).	The efficacy of OPTI-ONE® Multi-Purpose Solution (modified directions for use) is clinically acceptable and similar to Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution used according to its approved label.

2. Sample Size Used for the Test Set and Data Provenance

Cleaning Studies: The sample size for the cleaning study is not specified. The data provenance is implied to be a "laboratory study," suggesting it was conducted in a controlled environment, likely in the US, but this is not explicitly stated. It's retrospective in the sense that the lenses were "laboratory deposited."
Microbiology Studies: The sample size for the microbiology study is not specified. The data provenance is implied to be a "study" conducted in a laboratory, likely in the US.
Clinical Study: The sample size for the clinical study is not specified, only that it was a "90-day clinical study." The data provenance is a "clinical study," implying prospective human subject data, likely from the US, but the country of origin is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. For studies involving contact lens care products, "ground truth" might refer to:

Cleaning Studies: The standard or method for assessing the level of laboratory-deposited debris removal. This would typically be assessed by laboratory technicians or validated instrumental methods, not clinical experts.
Microbiology Studies: The standard microbiological methods for quantifying microbial reduction. Experts would be microbiologists or laboratory personnel.
Clinical Study: Clinical outcomes (e.g., adverse events, comfort, visual acuity, lens condition). These would be assessed by eye care practitioners, such as optometrists or ophthalmologists. However, the exact number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the summary. Clinical studies often employ adjudication for subjective endpoints or adverse events.

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 section is not applicable. The device is a contact lens care solution, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a chemical solution, not an algorithm. Its performance is inherent to the solution itself when used with contact lenses.

7. The Type of Ground Truth Used

Cleaning Studies: Laboratory-deposited lenses (simulated dirt/debris) and likely an objective assessment of cleanliness.
Microbiology Studies: Reduction of specified microorganisms as per FDA and ISO standards (laboratory-based microbiological assays).
Clinical Study: Safety and efficacy outcomes, likely including clinical examinations, patient surveys/feedback on comfort, and documented adverse events. The control used was Bausch & Lomb ReNu MultiPlus®.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. A "training set" typically refers to data used to train machine learning models. This device is a chemical solution assessed through laboratory and clinical studies, not an AI/ML algorithm.

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

This information is not provided and not applicable for the same reasons as point 8.

Summary of Limitations:

The provided 510(k) summary is typical for a medical device product like a contact lens solution, which focuses on demonstrating safety and efficacy through laboratory and clinical studies. It highlights substantial equivalence to a predicate device and compliance with relevant guidelines. However, it lacks the detailed methodological and quantitative information (e.g., precise sample sizes, specific quantitative acceptance criteria values, expert qualifications, and adjudication methods) that would be expected in a full clinical study report, especially for AI/ML-driven devices. The nature of the device (a chemical solution) means many of the requested points related to AI/ML performance (MRMC, standalone algorithm, training sets) are not relevant.

Summary

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KO31193

510(K) SUMMARY

Submitted by:

JUL 0 3 2003

Kim B. Kracke Manager, Regulatory Affairs Alcon Research, Ltd. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-8338 (Phone) (817) 551-4630 (Fax)

Device Name:

Soft (Hydrophilic) Contact Lens Care Solution Common Name:

OPTI-ONE* Multi-Purpose Solution Proprietary Name:

Indications for Use:

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

OPTI-ONE® Multi-Purpose Solution can also be used as the diluent for OPTI-ZYME® Enzymatic Cleaner.

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Description:

Substantial Equivalence:

OPTI-ONE * Multi-Purpose Solution is substantially equivalent in terms of its actions and indications for use to MULTI-PURPOSE SOLUTION ID NO. 81573, approved under P830034/S26 (OPTI-ONE) Multi-Purpose Solution).

OPTI-ONE* Multi-Purpose 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 laboratory study was conducted with OPTI-ONE® Multi-Purpose Solution. The purpose of the study was to evaluate passive cleaning using no rub regimen with soft contact lenses and its ability to clean laboratory deposited lenses.

Microbiology Studies

A study was conducted to evaluate the performance of OPTI-ONE® 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-ONE® Multi-Purpose Disinfecting Solution evaluated by the test regimen meets the FDA guidelines and the ISO 14729:2001 Regimen Test Requirements.

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Clinical Study

A 90-day clinical study was conducted to demonstrate the safety and efficacy of OPTI-ONE* Multi-Purpose Solution using the modified directions for use. The control used in this study was Bausch & Lomb ReNu MultiPlus® Multi-Purpose Solution used according to its approved rub and rinse labeling. The efficacy of OPTI-ONE® Multi-Purpose Solution (modified directions for use) is clinically acceptable and similar to Bausch & Lomb ReNu MultiPlus * Multi-Purpose Solution used according to its approved label

Biocompatibility Testing

OPTI-ONE Multi-Purpose 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.

OPTI-ONE Multi-Purpose Solution remains unchanged from the previously approved product (P830034/S26) except for the labeling change revising the directions for use. The labeling changes require no new biocompatibility testing.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 03 2003

Alcon Research. Ltd. c/o Ms. Kim Kracke 6201 South Freeway Fort Worth, TX 76134-0450

Re: K031193

Trade/Device Name: OPTI-ONE® Multi-Purpose Solution (Modified Directions for Use) Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: April 14, 2003 Received: April 16, 2003

Dear Ms. Kracke:

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 (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 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Patipi forenthal

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: OPTI-ONE Multi-Purpose Solution (modified directions for use)

Indications for Use:

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

OPTI-ONE® Multi-Purpose Solution (modified directions for use) can also be as a d:luent for OPTI-ZYME® Enzymatic Cleaner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sorrola

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

510(k) Number K031193

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR Over-The Counter Use X

(Per 21 CFR 801.109)

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.”