OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with clear and tinted, daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas permeable (silicone acrylate fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, or OPTI-FREE® EXPRESS Multi-Purpose Solution or conditioned in OPTI-SOAK" Conditioning Solution or Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392. Use as recommended by your eye care practitioner.

Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is for the disinfection and conditioning after cleaning and rinsing of clear and tinted, daily and extended wear fluorosilicone acrylate and silicone acrylate rigid gas permeable lenses.

Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

Device Description

OPTI-FREE® SUPRACLENS® Daily Protein Remover is a preservative-free solution which contains propylene glycol, sodium borate, and highly purified porcine pancreatin enzymes as the active cleaning ingredient.

Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is a sterile, aqueous solution buffered to approximate the pH and tonicity of the eye. It contains METHOCEL", a wetting and cushioning agent, boric acid, sodium borate, sodium chloride and mannitol, and is preserved with POLYQUAD® (polyguaternium-1) 0.0011%, and edetate disodium 0.10%.

AI/ML Overview

The provided text describes the regulatory filing for a contact lens cleaning and disinfecting solution, detailing its components, intended use, and substantial equivalence to existing products. It also mentions safety and effectiveness studies. However, the document does not contain the specific kind of performance metrics, acceptance criteria, study details, and ground truth information that would typically be found in a study proving a device meets acceptance criteria in the context of a medical device evaluation for diagnostic or AI-based devices.

The information provided pertains to contact lens solutions, which are regulated differently and typically require demonstration of antimicrobial efficacy, cleaning efficacy, and lens compatibility rather than diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information using the provided text.

Specifically, the document does not provide:

A table of acceptance criteria and reported device performance in terms of diagnostic metrics.
Sample sizes used for a "test set" or information about data provenance for such a test set.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods.
Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone algorithm performance results.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set or how ground truth for a training set was established.

The "studies" mentioned are largely microbiological studies, preclinical cytotoxic evaluations, compatibility/cleaning efficacy evaluations, and a general clinical study stating safety and effectiveness for a contact lens solution regimen. These are not equivalent to a performance study for a diagnostic AI device.

If you can provide a document related to a diagnostic or AI-based device, I would be happy to help extract the information you are seeking.

Summary

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JUN 22 1998

March 26, 1998

510(K) SUMMARY

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:

Contact Lens Cleaning Solution Common Name:

OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Wetting, Proprietary Name: Soaking, Conditioning and Disinfecting Solution ID 84392

Indications for Use:

OPTI-FREE® SUPRACLENS® Daily Protein Remover

OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with clear and tinted, daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas permeable (silicone acrylate fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, or OPTI-FREE® EXPRESS Multi-Purpose Solution or conditioned in OPTI-SOAK" Conditioning Solution or Alcon Wetting, Conditioning and Disinfecting Solution ID 84392. Use as recommended by your eye care practitioner.

Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392

Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 can also be used as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover.

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

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Description :

OPTI-FREE® SUPRACLENS® Daily Protein Remover

: 来源:

Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392

Substantial Equivalence:

This product is substantially equivalent, in terms of its actions and indications for use, to the Alcon OPTI-FREE® SUPRACLENS® Daily Protein Remover (PMA 82002/S18)/OPTI-SOAK Conditioning Solution (PMA 830071/S08) combination. The OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 combination 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 OPTI-FREE SUPRACLENS® Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 was evaluated for disinfection efficacy using the FDA guidelines for contact lens solutions. The results demonstrate that the antimicrobial activity of Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 is not reduced by the addition of OPTI-FREE SUPRACLENS® Daily Protein Remover.

Preclinical

OPTI-FREE® SUPRACLENS® Daily Protein Remover in Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 was determined to be noncytotoxic in an in vitro assay which confirmed safety of the combined use. Based on the results of this study and other preclinical studies, OPTI-FREE® SUPRACLENS® Daily Protein Remover is safe for its intended use with Alcon Wetting, Soaking, Conditioning and

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Disinfecting Solution ID 84392 in the simultaneous cleaning and disinfection of rigid gas permeable contact lenses (silicone acrylate and fluorosilicone acrylate) and similar contact lens polymers and should not present an ocular hazard to the consumer under the recommended lens treatment regimen or under conditions of accidental or intentional misuse.

Compatibility/Cleaning Efficacy

Product compatibility with rigid gas permeable contact lenses and the product's ability to clean laboratory deposited lens were evaluated. These studies demonstrate the Remover dissolved in Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392.

B. Clinical

A clinical study was conducted and demonstrated that the OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 regimen is safe and effective for the daily enzymatic cleaning and conditioning/disinfection of silicone acrylate and fluorosilicone acrylate rigid gas permeable contact lenses.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 222 1998

Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories 6201 South Freeway Fort Worth, TX 76134

Re: K981151

Trade Name: OPTI-FREE SUPRACLENS Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392

Regulatory Class: II Product Code: 86 LPN Dated: March 26, 1998 Received: March 30, 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. 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): K981151

Device Name: OPTI-FREE® SUPRACLENS® Daily Protein Remover/Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392

Indications for Use:

OPTI-FREE® SUPRACLENS® Daily Protein Remover

OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with clear and tinted, daily wear and extended wear soft (hydrophilic) contact lenses or rigid gas (silicone acrylate fluorosilicone acrylate) lenses to simultaneously permeable enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE Multi-Purpose Solution, or OPTI-FREE EXPRESS Multi-Purpose Solution or conditioned in OPTI-SOAK Conditioning Solution or Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392. Use as recommended by your eye care practitioner.

Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392

Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392 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)

Hancel W. Brown, Ph.D.
(Division Sign-Off)

Division of Ophthalmic Devices K981151 510(k) Number .

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.”