AOSept Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

Device Description

The AOSEPT Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphonic acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant. The solution is indicated for use in simultaneous cleaning and disinfecting, daily protein removal, and storing of soft (hvdrophilic) contact lenses as recommended by your eve care practitioner.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report in the format typically used for medical device performance. Instead, it is a 510(k) summary for a contact lens care solution, which refers to previously submitted studies and guidelines for demonstrating substantial equivalence.

However, based on the information provided, I can infer some aspects related to acceptance criteria and the nature of the studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly refers to FDA guidance documents as the source of acceptance criteria. The specific performance metrics are mentioned in relation to meeting these guidelines.

Category	Acceptance Criteria (Inferred from FDA Guidance)	Reported Device Performance
Silicone Hydrogel Lens Compatibility	Lenses should not show significant optical or physical changes when treated with the solution compared to a control (e.g., saline). (Based on FDA's May 1, 1997 Guidance for Industry)	"The study showed there was no significant difference between AOSEPT Clear Care Cleaning and Disinfecting Solution and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses."
In Vitro Cleaning Efficacy (Daily Protein Removal)	The solution should demonstrate cleaning efficacy (specifically protein removal) that is substantially equivalent to a legally marketed predicate device.	"Results of the study showed that AOSEPT Clear Care is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal."
Cytotoxicity	The solution must be non-cytotoxic and a non-irritant.	"Results of the testing demonstrated that AOSEPT Clear Care is non-cytotoxic and is a non-irritant."
Microbiological Efficacy	The solution must meet the "stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products."	"These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products."
Clinical Safety/Equivalence	The solution should demonstrate substantial equivalence in clinical performance and safety compared to other currently marketed solutions. (Clinical studies support substantial equivalence).	"Data from the clinical studies supported the substantial equivalence of AOSEPT Clear Care."

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

The document does not specify the sample sizes used for the test sets in any of the mentioned studies (silicone hydrogel compatibility, cleaning efficacy, cytotoxicity, microbiology, clinical studies).

The data provenance is implied to be from studies conducted to support FDA submissions in the US, given the sender is a US company and referring to FDA guidance. Whether the data is retrospective or prospective is not explicitly stated, but clinical and compatibility studies are typically prospective.

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 mentioned are primarily laboratory (in vitro) or clinical performance studies, not studies relying on expert consensus for "ground truth" in the way an AI diagnostic device would. For clinical studies, the "ground truth" would be established by clinical outcomes and observations, potentially by eye care practitioners, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies where multiple human readers are interpreting data (e.g., medical images) and their discrepancies need to be resolved to establish an agreed-upon ground truth. The studies cited are for a contact lens cleaning solution and do not involve such a process.

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

This information is not applicable/provided. The product is a contact lens care solution, not an AI-powered diagnostic device. Therefore, MRMC studies evaluating human readers with and without AI assistance are not relevant to this device.

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

A form of standalone testing was done for the microbiological efficacy. The summary states: "These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products." This "stand-alone criteria" implies an in vitro test of the solution's ability to kill microorganisms without human intervention.

For other tests (cleaning, cytotoxicity, compatibility), these are inherently "standalone" in the sense that they evaluate the properties and effects of the solution directly, not in conjunction with human interpretation in a diagnostic loop.

7. The Type of Ground Truth Used

Silicone Hydrogel Lens Compatibility: Measured properties of the lenses (optical, physical changes) against a control (saline).
In Vitro Cleaning Efficacy: Quantitative measurement of protein removal, compared to a predicate device.
Cytotoxicity: In vitro assays to determine toxicity and irritant potential.
Microbiology: Quantitative reduction of specific microorganisms in a controlled laboratory setting as per FDA guidance.
Clinical Testing: Clinical observations and outcomes related to contact lens wear, comfort, and ocular health. The ground truth would be based on clinical assessments rather than a single "expert consensus" pathology or outcome data in the context of an AI device.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of a chemical solution. "Training set" is a term used for machine learning models, which this product is not. The studies conducted are traditional laboratory and clinical studies.

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

This information is not applicable as there is no "training set" for this type of device.

Summary

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510(k) SUMMARY PART IX.

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

510(k) SUMMARY FOR AOSEPT Clear Care Cleaning and Disinfecting Solution

1. Submitter Information

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person: Telephone No.

Steven Dowdley 678-415-3897

2. Device Name

Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens Solution AOSEPT Clear Care Cleaning and Disinfecting Solution

3. Predicate Device(s)

AOSEPT Clear Care Cleaning and Disinfecting Solution

4. Description of the Device

5. Indications for Use

6. Description of Safety and Substantial Equivalence

A series of preclinical and clinical studies have been completed on this product and were previously submitted under submission K003345 and K013512. The non-clinical and clinical studies were completed to demonstrate the substantial equivalence of AOSEPT Clear Care Cleaning and Disinfecting Solution to other currently marketed solutions. All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and biocompatible, and is comparable to other currently marketed soft contact lens solutions.

Silicone Hydrogel Lens Compatibility Data

A study was conducted to verify that Lotrafilcon A (silicone hydrogel) lenses are compatible with AOSEPT Clear Care Cleaning and Disinfecting Solution. The study showed there was no significant difference between AOSEPT Clear Care Cleaning and

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Disinfecting Solution and the saline control solution, with respect to optical and physical changes in the measured properties of the lenses. AOSEPT Clear Care Cleaning and Disinfecting Solution 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.

In Vitro Cleaning Efficacy

Results of the study showed that AOSEPT Clear Care is substantially equivalent to SOLO-Care Multipurpose Solution in terms of daily protein removal. This data was previously submitted and reviewed in original 510(k) submission - K003345..

Cytotoxicity

A series of cytotoxicity studies were previously conducted to demonstrate the safety of AOSEPT Clear Care. Results of the testing demonstrated that AOSEPT Clear Care is non-cytotoxic and is a non-irritant. This data was previously submitted and reviewed in original 510(k) submission - K003345.

Microbiology

A series studies were previously completed to demonstrate the microbiological efficacy of AOSEPT Clear Care. These studies were previously submitted under 510(k) K003345. These studies demonstrate that AOSEPT Clear Care meets the stand-alone criteria of the disinfection efficacy test of the FDA May 1, 1997 Guidance for Industry: Premarket Notification 510(k) Guidance Document for Contact Lens Care Products.

Clinical Testing

A series of clinical studies have been conducted, submitted and reviewed in 510(k) submissions K003345 and K013512. Data from the clinical studies supported the substantial equivalence of AOSEPT Clear Care.

7. Substantial Equivalence

The data provided in this 510(k) submission concludes that AOSEPT Clear Cleaning and Disinfecting Solution is substantially equivalent to AOSEPT Clear Care Cleaning and Disinfecting Solution for cleaning, rinsing, chemical (not heat) disinfecting, protein removal, and storing soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner.

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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 or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

CIBA Vision Corporation c/o Steven Dowdley, RAC CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097

Re: K031521

Trade/Device Name: AOSEPT Clear Care Cleaning and Disinfecting Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN Dated: May 12, 2003 Received: May 28, 2003

Dear Mr. Dowdley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Steven Dowdley, RAC

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A kalgi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PART III. INDICATIONS FOR USE STATEMENT

510(k) Number: (Number to be assigned)

AOSept Clear Care Cleaning and Disinfecting Solution Device Name:

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:		or	over-the-counter:
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signature

(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devises
510(k) Number K03/52/

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.”