For the daily cleaning, rinsing, disinfecting and storing of soft (hydrophilic) contact lenses. For use in chemical (not heat) disinfection. Alcon Multi-Purpose Solution ID 90746 can also be used as a diluent for OPTI-ZYME® Enzymatic Cleaner.

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%, Polyquad (polyquaternium-1) 0.0001% and AL-6289 0.0005% as preservatives.

AI/ML Overview

The provided text describes the regulatory submission for the Alcon Multi-Purpose Disinfecting Solution ID 90746, a contact lens care product. As such, the "device" in question is a chemical solution, not a medical imaging or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study components related to software-as-a-medical-device (SaMD) or AI product evaluations (like sample size for test sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context.

However, I can extract the relevant information regarding acceptance criteria and the studies performed for this specific product as provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Guideline	Reported Device Performance
Microbiological Safety & Effectiveness	FDA Guidelines for contact lens solutions	- Meets Stand-Alone criteria for disinfection of contact lenses against bacteria, yeast, and mold. - Finished product is effectively preserved by FDA standards. - Finished product conforms to USP sterility requirements.
Preclinical Toxicology (Safety)	Substantiation of safety for cleaning, rinsing, chemical disinfection, and overnight storage of all soft (hydrophilic) contact lenses (Group I, II, III, and IV).	- Acute oral toxicity studies conducted. - Cytotoxicity (agar overlay) studies conducted. - Mutagenicity (Ames test) studies conducted. - Sensitization/allergic potential (guinea pig maximization test) studies conducted. - Ophthalmic container safety studies conducted. - Ocular safety (irritation) evaluations conducted. - Conclusion: Should not present an ocular hazard to the consumer when used under recommended regimens.
Compatibility/Cleaning Efficacy	Determine product compatibility with soft contact lenses and its ability to clean laboratory-deposited lenses.	- Demonstrated compatibility with soft contact lenses. - Demonstrated cleaning efficacy for laboratory-deposited lenses.
Clinical Safety & Efficacy	Evaluate safety and efficacy for cleaning, rinsing, disinfection, and storage of all soft (hydrophilic) contact lenses.	- Demonstrated safety and efficacy in a clinical study.

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

Microbiological Studies: Not specified, but generally refers to standard in-vitro laboratory testing as per FDA guidelines.
Preclinical Toxicology: Not specified for each test, but standard toxicology models (e.g., guinea pigs for sensitization, Ames test for mutagenicity) would have accepted sample sizes for each.
Compatibility/Cleaning Efficacy: Not specified, generally laboratory-based testing using various lens types with deposited materials.
Clinical Study:
- Sample Size: 249 patients (498 eyes) for 3 months; 121 patients (242 eyes) extending to 6 months.
- Data Provenance: Not explicitly stated, but clinical trials for FDA submissions are typically conducted in the US or under internationally recognized good clinical practice (GCP) guidelines. It's a prospective study given it's a clinical trial for a new product.

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

This is not applicable as the product is a contact lens solution, not an AI or imaging device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" would be the direct measurement of microbiological kill, absence of toxicity, and clinical outcomes based on patient health.

4. Adjudication Method for the Test Set

Not applicable as this is not an interpretive diagnostic device. Clinical outcomes would be assessed by clinical investigators, and lab results by trained technicians.

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 not an AI diagnostic device.

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

Not applicable as this is a chemical solution, not an algorithm. The microbiological and preclinical tests can be considered "standalone" in the sense that they evaluate the product's inherent properties without user interaction beyond recommended usage.

7. The Type of Ground Truth Used

Microbiological Studies: Direct measurements of microbial reduction/kill (e.g., colony-forming units), and adherence to USP sterility standards.
Preclinical Toxicology: Histopathological examination, physiological measurements, and observation of adverse effects in animal models or cell cultures as per standard toxicology protocols.
Compatibility/Cleaning Efficacy: Direct measurement of material effects on lenses and quantification of removed deposits.
Clinical Study: Patient ocular health assessments (e.g., slit lamp examination, visual acuity), comfort ratings, and incidence of adverse events, assessed by ophthalmologists or optometrists.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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November 25, 1997

K973332

510(K) SUMMARY

DEC - 2 1997

Submitted by:

Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134-2099 (817) 551-4877 (Phone) (817) 551-4630 (Fax)

Device Name:

Contact Lens Care Multi-Purpose Solution Common Name:

Alcon Multi-Purpose Disinfecting Solution ID 90746 Proprietary Name:

Indications for Use:

Description:

Substantial Equivalence:

Alcon Multi-Purpose Disinfecting Solution ID 90746 is substantially equivalent in terms of its actions and indications to Alcon OPTI-FREE® Multi-Purpose Solution and Alcon OPTI-ONE® Multi-Purpose Solution. These two products were cleared for marketing under P830034/S27 and P830034/S26 respectively.

Alcon Multi-Purpose Disinfecting Solution ID 90746 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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Safety and Effectiveness:

A. Non-Clinical Data

Microbiological Studies

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.
. The finished product is effectively preserved by FDA standards.
Finished product conforms to USP sterility requirements. ●

Preclinical

Preclinical toxicology tests have been conducted to substantiate the safety of the product for use in cleaning, rinsing, chemical disinfection, and overnight storage of all soft (hydrophilic) contact lens (Group I, II, III, and IV). The studies include: (1) acute oral toxicity; (2) cytoxicity (agar overlay); (3) mutagenicity (Ames test); (4) sensitization/allergic potential (guinea pig maximization test); (5) ophthalmic container safety; and (6) ocular safety (irritation) evaluations.

Alcon Multi-Purpose Disinfecting Solution ID 90746 should not present an ocular hazard to the consumer when used under the recommended treatment regimens for soft (hydrophilic) contact lenses.

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 Alcon Multi-Purpose Disinfecting Solution ID 90746.

B. Clinical

A study was conducted to clinically evaluate the safety and efficacy of Alcon Multi-Purpose Disinfecting Solution ID 90746 for cleaning, rinsing, disinfection and storage of all soft (hydrophilic) contact lenses (249 patients/498 eyes - 3 months) (121 patients/242 eyes - extending to 6 months). This clinical study demonstrated the safety and efficacy of Alcon Multi-Purpose Disinfecting Solution ID 90746.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

DEC - 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099

Re: K973332

Trade Name: Alcon Multi-Purpose Disinfecting Solution ID 90746 Regulatory Class: II Product Code: 86 LPN Dated: August 29, 1997 Received: September 4, 1997

Dear Mr. Pfleger:

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. Michael E. Pfleger

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):_____________________________________________________________________________________________________________________________________________________

Alcon Multi-Purpose Disinfecting Solution ID 90746 Device Name:

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-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 Smith

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number _ K 973332

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.”