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

Alcon Multi-Purpose Disinfecting Solution ID 90746 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Device Description

Alcon Multi-Purpose Disinfecting Solution ID 90746 is a sterile, buffered, isotonic, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, AMP-95, tetronic 1304, with edetate disodium 0.05%, Polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.

AI/ML Overview

The provided text describes the regulatory submission for a contact lens care product, "Alcon Multi-Purpose Disinfecting Solution ID 90746," and its approval based on substantial equivalence to existing devices. The document outlines microbiological studies, preclinical toxicology tests, and a clinical study to demonstrate safety and efficacy.

Here's an analysis of the acceptance criteria and study information, extracting what is available and noting what is not explicitly stated in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Reference/Standard)	Reported Device Performance
Microbiological Studies	Meets FDA Guidelines for contact lens solutions; Stand-Alone criteria for disinfection against bacteria, yeast, and mold.	The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold.
Preclinical Toxicology (Safety)	Substantives the safety of the product combination for use with all soft (hydrophilic) contact lenses (Group I, II, III, and IV).	Toxicological tests were conducted, including cytotoxicity (agar overlay) and ocular safety (irritation) evaluations, to substantiate safety. (Specific metrics not quantified beyond "safety").
Compatibility/ Cleaning Efficacy	Compatibility with soft contact lenses and ability to clean laboratory-deposited lenses.	Studies demonstrated the compatibility and cleaning efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen. (Specific metrics not quantified beyond "compatibility and cleaning efficacy").
Clinical Safety & Efficacy	Demonstrate safety and efficacy for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses.	The clinical study demonstrated the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses. (Specific metrics not quantified beyond "safe and effective").

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

Clinical Study Test Set: "65 patients/130 eyes - 3 months".
Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "clinical," implying prospective data collection for the purpose of the submission.

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

This information is not provided in the text. The clinical study evaluated safety and efficacy; however, it doesn't describe an "expert ground truth" for a classification task in the way a diagnostic device might. The outcome measures would be related to clinical observations by medical professionals involved in the study, but their specific roles or number for establishing a ground truth are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the text.

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. The device is a contact lens care solution, not an AI-assisted diagnostic or imaging tool involving human readers.

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

This is not applicable. The device is a contact lens care solution and does not involve an algorithm with standalone performance. Its effectiveness is based on chemical and physical properties and their interaction with lenses and biological systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the Microbiological Studies: The ground truth was based on the "FDA Guidelines for contact lens solutions" and "Stand-Alone criteria for disinfection." These are established regulatory and industry standards for germicidal efficacy.
For Preclinical Toxicology: Ground truth for safety was established through standardized toxicology tests like "cytotoxicity (agar overlay)" and "ocular safety (irritation) evaluations."
For Compatibility/Cleaning Efficacy: Ground truth for compatibility and cleaning efficacy was established through laboratory studies evaluating interaction with lenses and removal of deposited materials.
For the Clinical Study: The ground truth for safety and efficacy would have been based on clinical observations and assessments by ophthalmologists or optometrists involved in the study, measuring parameters related to lens comfort, ocular health, and cleaning performance over the 3-month period. The text does not specify exact outcome measures beyond "safe and effective."

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm that requires a "training set." The development of the solution would involve formulation and laboratory testing, but not in the context of a machine learning training set.

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

This is not applicable for the reasons stated in point 8.

Summary

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December 8, 1997

K974624

510(K) SUMMARY

Submitted by:

MAR - 4 1998

Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 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 Solution

Proprietary Name: Alcon Multi-Purpose Disinfecting Solution ID 90746

Indications for Use:

Alcon Multi-Purpose Disinfecting Solution ID 90746 is indicated for the daily cleaning, rinsing, disinfecting, and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. For use in chemical (not heat) disinfection.

Alcon Multi-Purpose Disinfecting Solution ID 90746 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Description:

Substantial Equivalence:

Alcon Multi-Purpose Disinfecting Solution ID 90746 is substantially equivalent, in terms of its actions and indications for use, to OPTI-FREE® EXPRESS Multi-Purpose Solution, OPTI-ONE® Multi-Purpose Solution and OPTI-FREE® Rinsing, Disinfecting and Storage Solution, all approved under PMA 830034. Alcon Multi-Purpose Disinfecting Solution ID 90746 meets the

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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:

Non-Clinical Data A.

Microbiological Studies

During simultaneous enzymatic cleaning and disinfection, the product was evaluated for microbiological safety and effectiveness using the FDA Guidelines for contact lens solutions. The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold.

Preclinical

Preclinical toxicology tests have been conducted to substantiate the safety of the product combination for use with all soft (hydrophilic) contact lens (Group I, II, III, and IV). The studies include: (1) cytoxicity (agar overlay); (2) ocular safety (irritation) evaluations.

Compatibility/Cleaning Efficacy

Studies were conducted to determine product compatibility with soft contact lenses and its ability to clean laboratory deposited lenses. The studies demonstrated the compatibility and cleaning efficacy of the OFTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen.

Clinical B.

A study was conducted to clinically evaluate the safety and efficacy of OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen for cleaning, and disinfection of all soft (hydrophilic) contact lenses (65 patients/130 eyes - 3 months). This clinical study demonstrated the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a bird. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1998

Mr. Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099

Re: K974624

Trade Name: Alcon Multi-Purpose Disinfecting Solution ID 90746 Regulatory Class: II Product Code: 86 LPN Dated: December 8, 1997 Received: December 11, 1997

Dear Mr. Larsen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ralph H. Larsen

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K974 62Y

Device Name: Alcon Multi-Purpose Disinfecting Solution ID 90746

Indications for Use:

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

Alcon Multi-Purpose Disinfecting Solution ID 90746 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
(Division Sign-Off)
Division of Ophthalmic Devices
10(k) Number K974624

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use X

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.”