Liquid Enzyme ID 90133 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, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Use as recommended by your eye care practitioner.

OPTI-FREE® EXPRESS® Multi-Purpose Solution is for use in chemical (not heat) disinfection and for cleaning, rinsing, disinfecting and storing of clear and tinted, daily and extended wear soft (hydrophilic) contact lenses.

OPTI-FREE® EXPRESS® Multi-Purpose Solution can also be used as a diluent for Liquid Enzyme ID 90133.

OPTI-FREE® Rinsing, Disinfecting and Storage Solution is for use in chemical (not heat) disinfection and for rinsing, disinfecting and storing of clear and tinted, daily and extended wear soft (hydrorophilic) contact lenses.

OPTI-FREE® Rinsing, Disinfecting and Storage Solution can also be used as a diluent for Liquid Enzyme ID 90133.

Device Description

Liquid Enzyme ID 90133 is a sterile, trypsin-based enzymatic cleaner buffered with sodium borate. The liquid enzymatic cleaner is formulated for one drop to be diluted in 5 mL of OPTI-FREE® or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Also, this submission provides for labeling changes for OPTI-FREE® EXPRESS® Multi-Purpose Solution and OPTI-FREE® Rinsing, Disinfecting and Storage Solution to be used as diluents for Liquid Enzyme ID 90133.

AI/ML Overview

The provided text describes the safety and effectiveness studies for Alcon Laboratories' Liquid Enzyme ID 90133 contact lens cleaning solution in conjunction with OPTI-FREE® Rinsing, Disinfecting and Storage Solution or OPTI-FREE® EXPRESS® Multi-Purpose Solution. However, it does not explicitly define acceptance criteria in a quantitative table format or report device performance against such criteria. The document focuses on demonstrating substantial equivalence to previously approved devices and broadly states that the product is "safe and effective".

Based on the information provided, here's what can be extracted and inferred regarding the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not stated, this table will reflect the types of studies conducted and their reported qualitative outcomes.

Acceptance Criteria Type	Acceptance Criteria (Implicit)	Reported Device Performance
Microbiological Disinfection Efficacy	Antimicrobial activity of the disinfectant solution should not be reduced by the enzyme.	"The results demonstrate that the antimicrobial activity of OPTI-FREE® Rinsing, Disinfecting and Storage Solution is not reduced by the addition of Liquid Enzyme ID 90133 against bacteria or fungi."
Preclinical Toxicology & Ocular Safety	Safe for intended use; no significant acute toxicity, ocular toxicity, or irritation.	"Based on the result of these studies, Liquid Enzyme ID 90133 is safe for its intended use... and should not present an ocular hazard to the consumer..."
Compatibility/Cleaning Efficacy (Lab)	Device is compatible with soft contact lenses and effectively cleans laboratory-deposited lenses.	"The studies demonstrated the compatibility and cleaning efficacy of the Liquid Enzyme ID 90133/OPTI-FREE® EXPRESS® Multi-Purpose Solution regimen."
Clinical Safety & Efficacy	Safe and effective for daily simultaneous enzymatic cleaning and disinfection of soft contact lenses in a clinical setting.	"This clinical study demonstrated the Liquid Enzyme ID 90133/OPTI-FREE® EXPRESS® Multi-Purpose Solution regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses."

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

Microbiological Studies: Not explicitly stated, but implies sufficient samples were used to meet FDA guidelines for contact lens solutions. Data provenance is implied to be laboratory-based testing following FDA guidelines.
Preclinical Toxicology: Not explicitly stated for each test, but "Comprehensive preclinical toxicology tests have been conducted." Data provenance is laboratory-based.
Compatibility/Cleaning Efficacy: Not explicitly stated, but implies sufficient samples of "laboratory deposited lenses" were used. Data provenance is laboratory-based.
Clinical Study: 100 patients/200 eyes for a 3-month duration. Data provenance is clinical (human subjects). The country of origin is not specified but is likely the US given the FDA submission. This was a prospective study.

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 document. The studies described are primarily laboratory and clinical performance assessments, not expert consensus tasks for establishing ground truth in the sense of classification or diagnosis.

4. Adjudication Method (for the test set)

This information is not provided as the studies are not based on subjective assessment by multiple experts requiring adjudication. For the clinical study, the assessment of safety and effectiveness would have been based on objective measures and clinical observations.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to a chemical solution for contact lenses, not an AI or imaging device involving human readers or AI assistance.

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

Not applicable. This document describes a chemical product, not an algorithm.

7. The Type of Ground Truth Used

Microbiological Studies: Ground truth would be defined by standard microbiological culture techniques and quantitative measurements of microbial reduction/survival, as per FDA guidelines. This is objective laboratory data.
Preclinical Toxicology: Ground truth would be based on established toxicology protocols, histopathological examination, and clinical observations in animal models (e.g., irritation, acute toxicity). This is objective laboratory data.
Compatibility/Cleaning Efficacy: Ground truth would be based on objective measures of lens integrity, protein/lipid removal, and physical characteristics of the lenses after treatment. This is objective laboratory data.
Clinical Study: Ground truth for safety would be adverse event reporting, slit-lamp examination findings, and other clinical observations. Ground truth for efficacy would be based on objective measures of lens cleanliness and patient-reported outcomes over the 3-month period. This is clinical observation and patient outcomes data.

8. The Sample Size for the Training Set

Not applicable/Not provided. This document does not describe a machine learning or AI model that requires a training set.

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

Not applicable. As above, this document does not describe a machine learning or AI model.

Summary

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.1111 2 4 1998

April 30, 1998

Image /page/0/Picture/2 description: The image shows the number 71561 and the word "Alcon" in a bold, sans-serif font. Below "Alcon" is the word "LABORATORIES" in a smaller font. The text appears to be part of a logo or heading, possibly for a document or publication.

510(K) SUMMARY

Submitted by:

ALCON LABORATORIES, INC 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134-2099 (817) 293-0450

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:

Proprietary Name: Liquid Enzyme ID 90133

Indications for Use:

Liquid Enzyme ID 90133

OPTI-FREE® EXPRESS® Multi-Purpose Solution

OPTI-FREE® EXPRESS® Multi-Purpose Solution can also be used as a diluent for Liquid Enzyme ID 90133.

OPTI-FREE® Rinsing, Disinfecting and Storage Solution

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OPTI-FREE® Rinsing, Disinfecting and Storage Solution can also be used as a diluent for Liquid Enzyme ID 90133.

Description:

Liquid Enzyme ID 90133 is a sterile, trypsin-based enzymatic cleaner buffered with sodium The liquid enzymatic cleaner is formulated for one drop to be diluted in 5 mL of borate. OPTI-FREE® or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Also, this submission provides for labeling changes for OPTI-FREE® EXPRESS® Multi-Purpose Solution and OPTI-FREE® Rinsing, Disinfecting and Storage Solution to be used as diluents for Liquid Enzyme ID 90133.

Substantial Equivalence:

This product is substantially equivalent, in terms of its actions and indications for use, to Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 820001/S18), OPTI-FREE® EXPRESS® (PMA 830034/S27) and OPTI-FREE® Rinsing, Disinfection and Storage Solution. (PMA 830034/S03). Liquid Enzyme ID 90133 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:

A. Non-Clinical Data

Microbiological Studies

The combination Liquid Enzyme ID 90133 in OPTI-FREE® Rinsing, Disinfecting and Storage Solution was evaluated for disinfection efficacy using the FDA guidelines for contact lens solutions. The results demonstrate that the antimicrobial activity of OPTI-FREE® Rinsing, Disinfecting and Storage Solution is not reduced by the addition of Liquid Enzyme ID 90133 against bacteria or fungi.

Preclinical

Comprehensive preclinical toxicology tests have been conducted to evaluate the acute toxicity, ocular toxicity and irritation potential of Liquid Enzyme ID 90133 in conjunction with OPTI-FREE® Rinsing, Disinfecting and Storage Solution. Based on the result of these studies, Liquid Enzyme ID 90133 is safe for its intended use with OPTI-FREE® Rinsing, Disinfecting and Storage Solution in the simultaneous cleaning and disinfection of soft (hydrophilic) contact lenses (Groups I-IV) and should not present an ocular hazard to the consumer under the recommended lens treatment regimen or under conditions of accidental or intentional misuse.

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Compatibility/Cleaning Efficacy

Studies were conducted to determine product compatibility with soft contact lenses and The studies demonstrated the its ability to clean laboratory deposited lenses. compatibility and cleaning efficacy of the Liquid Enzyme ID 90133/OPTI-FREE® EXPRESS® Multi-Purpose Solution regimen.

B. Clinical

A study was conducted to clinically evaluate the safety and efficacy of Liquid Enzyme ID 90133/OPTI-FREE® EXPRESS® Multi-Purpose Solution regimen for cleaning, rinsing, and disinfection of all soft (hydrophilic) contact lenses (100 patients/200 eyes -3 months). This clinical study demonstrated the Liquid Enzyme ID 90133/OPTI-FREE® EXPRESS® Multi-Purpose Solution regimen is safe and effective for the daily simultaneous enzymatic cleaning and disinfection of soft (hydrophilic) contact lenses.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 1998

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

Re: K981561

Trade Name: Liquid Enzyme ID 90133, OPTI-FREE ® EXPRESS ® Multi-Purpose Solution, and OPTI-FREE ® Rinsing, Disinfecting and Storage Solution Regulatory Class: II Product Code: 86 LPN Dated: April 30, 1998 Received: May 1, 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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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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K981561 510(k) Number (if known): __

Device Name: Liquid Enzyme ID 90133

Indications for Use:

Liquid Enzyme ID 90133

Liquid Enzyme ID 90133 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. OPTI-FREE® Rinsing, Disinfecting and Storage Solution, or OPTI-FREE® EXPRESS® Multi-Purpose Solution. Use as recommended by your eye care practitioner.

OPTI-FREE® EXPRESS® Multi-Purpose Solution

OPTI-FREE® EXPRESS® Multi-Purpose Solution can also be used as a diluent for Liquid Enzyme ID 90133.

OPTI-FREE® Rinsing, Disinfecting and Storage Solution

OPTI-FREE® Rinsing, Disinfecting and Storage Solution can also be used as a diluent for Liquid Enzyme ID 90133.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W. C. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices K981561 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

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.”