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.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve OPTI-ZYME® Enzymatic Cleaner.

Device Description

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%, POLYQUAD® (polyquaternium-1) 0.001% and AL-6289 0.0005% as preservatives.

AI/ML Overview

This document describes a minor specification modification to a Multi-Purpose Disinfecting Solution. The submission focuses on demonstrating that the modified product remains substantially equivalent to the previously cleared version and meets safety guidelines. It is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Guidelines Met)	Reported Device Performance
FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products	Multi-Purpose Disinfecting Solution ID 90746 (minor specification) meets these guidelines. (Source: {1})
Safety: Ocular hazard under normal use conditions	Based on an eight-day ocular irritation study, the product "should not present an ocular hazard to the consumer under normal use conditions." (Source: {1})

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

Sample Size for Ocular Irritation Study: Not explicitly stated, but the study was conducted "in rabbits." {1}
Data Provenance: The ocular irritation study was conducted on rabbits, a common animal model for ocular safety. The location/country of origin is not specified, but the submission is to the U.S. FDA, implying the study adheres to U.S. regulatory standards. The study appears to be prospective, designed specifically to evaluate the safety of the modified formulation.

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

Not Applicable. This is a chemical solution for contact lens care, not an AI/ML device involving expert interpretation of images or other data. The "ground truth" for the safety study is the observed biological response in the rabbits.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML device, there's no adjudication in the sense of reconciling expert opinions for ground truth. The safety study involves direct observation and assessment of ocular irritation.

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

Not Applicable. This is a chemical solution, not an AI/ML device.

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

Not Applicable. This is a chemical solution, not an algorithm.

7. The Type of Ground Truth Used

Biological Response/Observed Safety Outcomes: For the ocular irritation study, the ground truth is the observed physiological response in the rabbits to the application of the modified solution. This typically involves grading irritation (e.g., redness, swelling, discharge) according to established scales.

8. The Sample Size for the Training Set

Not Applicable. This is a chemical solution, not an AI/ML device that requires a training set.

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

Not Applicable. This is a chemical solution, not an AI/ML device.

Summary

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K9845775

Submitted by:

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:	Multi-Purpose Disinfecting Solution ID 90746(Minor specification modification)

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 eve care practitioner.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Multi-Purpose Disinfecting Solution ID 90746 can also be used to dissolve OPTI-ZYME® Enzymatic Cleaner

Description:

Substantial Equivalence:

Multi-Purpose Disinfecting Solution ID 90746 (minor specification modification) is substantially equivalent, in terms of its actions and indications for use, to Multi-Purpose Disinfecting Solution ID 90746 (K973332). Multi-Purpose Disinfecting Solution

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ID 90746 (minor specification modification) 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:

The risk analysis method used to assess the impact of the minor specification modification was prEN 1441, Risk Assessment of Medical Devices. Also an eight day ocular irritation evaluation of the formulation with the minor specification modification was conducted with soft contact lenses in rabbits. Based on the results of this study, Multi-Purpose Disinfecting Solution ID 90746 (minor specification modification) should not present an ocular hazard to the consumer under normal use conditions. Multi-Purpose Disinfecting Solution ID 90746 (minor specification) 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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Image /page/2/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 lines representing its wings, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 1999

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

Re: K984575

Trade Name: Multi-Purpose Disinfecting Solution ID 90746 Product Code: 86 LPN Dated: December 22, 1998 Received: December 23, 1998

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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Mr. Ralph H. Larsen - Page 2

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. Ralph 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Multi-Purpose Disinfecting Solution ID 90746

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.

For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Multi-Purpose Disinfecting Solution ID 90746 can be used to dissolve 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)

	Myra Smuth
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K984575

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.”