OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens to simultaneously enzymatically clean them while they are being disinfected (soaked) in Alcon Multi-Purpose Disinfecting Solution ID 90746, OPTI-FREE Rinsing, Disinfection and Storage Solution, OPTI-FREE EXPRESS Multi-Purpose Solution or OPTI-ONE Multi-Purpose Solution. Use as recommended by your eye care practitioner.

Device Description

OPTI-FREE® SUPRACLENS® Daily Protein Remover is a sterile, preservative-free aqueous suspension, containing pancreatin as the active cleaning agent.

AI/ML Overview

This document describes the acceptance criteria and supporting studies for the OPTI-FREE® SUPRACLENS® Daily Protein Remover.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Microbiological Safety & Effectiveness	Meet FDA Stand-Alone criteria for disinfection against bacteria, yeast, and mold during simultaneous enzymatic cleaning and disinfection.	"The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold."	Non-Clinical: Microbiological Studies
Preclinical Toxicology	Demonstrate safety for use in cleaning all soft (hydrophilic) contact lenses (Group I, II, III, and IV).	"Preclinical toxicology tests have been conducted to substantiate the safety of the product for use in cleaning, of all soft (hydrophilic) contact lens (Group I, II, III, and IV)." Specific tests included cytotoxicity (agar overlay) and ocular safety (irritation) evaluations.	Non-Clinical: Preclinical Toxicology Tests
Compatibility/Cleaning Efficacy	Demonstrate product compatibility with soft contact lenses.	"The studies demonstrated the compatibility... of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen."	Non-Clinical: Compatibility Studies
Compatibility/Cleaning Efficacy	Demonstrate cleaning efficacy for laboratory deposited lenses.	"The studies demonstrated... cleaning efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen."	Non-Clinical: Cleaning Efficacy Studies
Clinical Safety & Efficacy	Clinically evaluate safety and efficacy of the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen for cleaning, rinsing, and disinfection of all soft (hydrophilic) contact lenses.	"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."	Clinical Study

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

Clinical Study Test Set:
- Sample Size: 65 patients / 130 eyes
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions typically involve prospective data collection within a controlled clinical trial setting, likely within the US given the submission to the FDA. The document does not specify if it was retrospective or prospective, but clinical trials are generally prospective.
Non-Clinical Studies (Microbiological, Preclinical, Compatibility/Cleaning Efficacy):
- Sample Size: Not specified in the provided text for these studies.
- Data Provenance: Not specified. These are laboratory-based studies.

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

This information is not provided in the document. The clinical study evaluated safety and efficacy, which generally involves clinicians assessing outcomes, but the number and qualifications of experts for establishing 'ground truth' in the context of diagnostic performance are not applicable or detailed for this type of product (a contact lens cleaning solution).

4. Adjudication Method for the Test Set

Not applicable/Not specified. For a contact lens cleaning solution, outcomes are typically measured through objective and subjective clinical assessments (e.g., irritation, protein removal, microbial counts) rather than a diagnostic 'ground truth' established by multiple expert readers requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices where human readers interpret medical images or data. The OPTI-FREE® SUPRACLENS® is a contact lens cleaning solution, not a diagnostic device.

6. Standalone Performance Study

Yes, a standalone study was performed in the context of microbiological effectiveness.
- The "Microbiological Studies" section states, "The formulation meets the Stand-Alone criteria for disinfection of contact lens against bacteria, yeast and mold." This refers to established regulatory guidelines for testing the disinfectant properties of contact lens solutions acting alone without human intervention in the disinfection process itself.

7. Type of Ground Truth Used

Microbiological Studies: Ground truth was based on established FDA Guidelines for contact lens solutions, which define the "Stand-Alone criteria" for microbial reduction (bacteria, yeast, mold). This is a quantitative, laboratory-based standard.
Preclinical Toxicology: Ground truth was based on scientific standards for cytotoxicity and ocular irritation, measured through laboratory tests (agar overlay, ocular irritation evaluations).
Compatibility/Cleaning Efficacy: Ground truth was based on objective measures of compatibility with contact lens materials and the ability to remove laboratory-deposited substances.
Clinical Study: Ground truth for safety and efficacy was established through clinical observation and assessment by eye care practitioners, likely involving a combination of objective clinical findings and potentially patient-reported outcomes (e.g., comfort).

8. Sample Size for the Training Set

Not applicable/Not specified. This device is a cleaning solution, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning model development. The product development would involve formulations and testing.

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

Not applicable. As stated above, this is not an AI/machine learning device, so there is no training set or associated ground truth establishment in that context.

Summary

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December 8, 1997

R 974625

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:

Contact Lens Cleaning Solution Common Name: OPTI-FREE® SUPRACLENS® Daily Protein Remover Proprietary Name:

Indications for Use:

Description:

OPTI-FREE® SUPRACLENS® Daily Protein Remover is a sterile, preservative-free aqueous suspension, containing pancreatin as the active cleaning agent.

Substantial Equivalence:

This product is substantially equivalent, in terms of its actions and indications for use, to Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover. Only the labeling is being changed to allow Alcon Multi-Purpose Disinfecting Solution ID 90746 to be used as a diluent. This product was previously approved for marketing under Premarket Approval Application P820001/S18. OPTI-FREE® SUPRACLENS® Daily Protein Remover 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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A. Non-Clinical Data

Microbiological Studies

The product was evaluated for microbiological safety and effectiveness using the FDA Guidelines for contact lens solutions. During simultaneous enzymatic cleaning and disinfection, 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 for use in cleaning, of 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 OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Multi-Purpose Disinfecting Solution ID 90746 regimen.

Clinical в.

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, rinsing, 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1098

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

Re: K974625 Trade Name: OPTI-FREE ® SUPRACLENS ® Daily Protein Remover 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 see 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 forenthal

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):_ Қ974 Ա 25

Device Name: OPTI-FREE® SUPRACLENS® Daily Protein Remover

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Myrdahl
(Division Sign-Off)

vision of Ophthalmic Devices (1k) Number_ K97462

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

446

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.”