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) contact lenses as recommended by your eye care practitioner.

Device Description

Clear Care Cleaning and Disinfecting Solution is an aqueous solution contains hydrogen peroxide 3% (stabilized with phosphoric acid), sodium chloride, a phosphate buffer system and a non-ionic surfactant.

AI/ML Overview

Here's a breakdown of the provided information regarding the acceptance criteria and supporting studies for the Clear Care Cleaning and Disinfecting Solution.

Acceptance Criteria and Device Performance

The provided document describes studies aimed at demonstrating improved patient comfort and substantial equivalence to existing products, rather than defining explicit quantitative "acceptance criteria" in terms of specific performance metrics (e.g., minimum percent reduction in bacterial count). Instead, the acceptance is based on demonstrating statistically significant improvements in comfort symptoms and substantial equivalence in wearing time compared to control products.

The primary focus of this 510(k) submission is to add specific statements to the package insert regarding improved comfort. Therefore, the "acceptance criteria" are implicitly met by demonstrating these improvements through clinical trials.

Interpretation of Acceptance Criteria and Reported Performance

Acceptance Criteria (Implied)	Reported Device Performance and Study Findings
1. Improved Comfort (Specifically for prior MPS users)	A multicenter comparison of AOSept Clear Care and multipurpose contact lens care systems: Among previous multipurpose users, significant improvements were found after switching to AOSept Clear Care in: - Frequency of dryness - Intensity of dryness - During-the-day comfort - End-of-the-day comfort
2. Lasting Comfort for All-Day Lens Wear	AOSept Clear Care multicenter study: The improvements in comfort were found in each measure of comfort in this study; frequency and intensity of dryness, during the day and end of the day comfort all showed significant improvements. (This supports the claim of lasting comfort).
3. Substantial Equivalence to Control Products	AOSept Improved UKClinical Trial R-162-C-002: The data from this study demonstrated that Clear Care was substantially equivalent to the control multipurpose solution in terms of lens wearing time and hours of comfortable wearing time.
4. Maintenance of existing safety and efficacy claims	Non-clinical tests: Solution remains unchanged from those cleared under Premarket 510(k) Notifications K003345 and K013521. This implies that the previous non-clinical safety parameters (e.g., disinfection efficacy, compatibility with lenses) are still met. (Specific performance metrics for these are not detailed in this document but are referenced as previously cleared).

Study Information

Due to the nature of this submission (a 510(k) for revised labeling based on clinical comfort data), the typical structure of an AI/ML device study isn't directly applicable. However, I will describe the provided clinical studies in the requested format, interpreting "test set" as the enrolled patient population in the clinical trials, and "ground truth" as the patient-reported outcomes.

Clinical Study 1: A multicenter comparison of AOSept Clear Care and multipurpose contact lens care systems

Sample size used for the test set and the data provenance:
- Sample Size: 148 patients were enrolled.
- Data Provenance: Prospective, multicenter study conducted at 18 eyecare offices throughout the United States.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This study relies on patient-reported outcomes for comfort and dryness symptoms. Therefore, there were no external "experts" establishing a "ground truth" in the traditional sense of medical image interpretation. The patients themselves provided the subjective data based on their experience. The "experts" involved would be the eyecare practitioners (ophthalmologists, optometrists) at the 18 centers who conducted the evaluations, but their role was data collection rather than ground truth establishment of the primary endpoints.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the primary endpoints are patient-reported symptoms (subjective data directly from the participant). There's no external adjudication process for a patient's feeling of dryness or comfort.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this was not an MRMC study. It was a comparative effectiveness study comparing patient-reported outcomes with different contact lens care systems.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a contact lens solution, not an algorithm or AI device.
The type of ground truth used:
- Patient-reported outcomes (subjective measures of dryness frequency, dryness intensity, comfort during the day, and end-of-day comfort).
The sample size for the training set:
- Not applicable. This is a clinical trial, not an AI/ML development process with a distinct training set. The entire enrolled patient population serves as the "test set" for the study's conclusions.
How the ground truth for the training set was established:
- Not applicable.

Clinical Study 2: AOSept Improved UKClinical Trial R-162-C-002

Sample size used for the test set and the data provenance:
- Sample Size: 182 subjects.
- Data Provenance: Prospective, randomized, masked, contra-lateral with crossover clinical trial conducted in the UK.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Similar to Study 1, the primary endpoints (wearing time, comfortable wearing time) would likely be patient-reported or measured, not subject to expert "ground truth" establishment in a diagnostic sense. The eyecare professionals conducting the trial would be responsible for data collection.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as endpoints are objective measures (wearing time) or patient-reported (comfortable wearing time).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this was not an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a contact lens solution.
The type of ground truth used:
- Measured (for lens wearing time) and patient-reported outcomes (for comfortable wearing time).
The sample size for the training set:
- Not applicable.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K030522

SEP 1 2 2003

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 Clear Care Cleaning and Disinfecting Solution

1. Submitter Information

CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, Georgia 30097 Contact Person:Steven Dowdley Telephone No: 678-415-3897

2. Device Name

Classification Name: Soft (hydrophilic) Contact Lens Solution Proprietary Name: Clear Care Cleaning and Disinfecting Solution

Predicate Device(s) 3.

AOSEPT Clear Care Cleaning and Disinfecting Solution Opti-Free Express Multipurpose Solution

Description of the Devices 4.

ട്. Indications for Use

6. Reason for 510(k) Submission

The purpose of this 510(k) submission is to revise the package insert for Clear Care to include the following statements:

Clinical studies show that Clear Care may provide better comfort to contact lens . wearers who have experienced discomfort from preserved multipurpose solutions that do not contain peroxide.
. Clear Care provides lasting comfort for all day lens wear.

7. Description of Safety and Substantial Equivalence

Non clinical test and results:

Solution remain unchanged from those cleared under Premarket 510(k) Notification's K003345 and K013521.

Clinical Results:

A multicenter comparision of AOSept Clear Care and multipurpose contact lens care systems.

The primary objective of this study was to compare patient dryness and discomfort symptoms found with using several currently marketed multipurpose solutions versus AOSept Clear Care. In the study, subjects were evaluated for the frequency of dryness,

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the intensity of dryness, symptoms, comfort and vision. The study was an open label, multi-center study, and was completed at 18 eyecare offices throughout the United States. To reduce bias in the results, patients were masked by not disclosing the name of the sponsor. A total of 148 patients were enrolled in the study.

Conclusion: Among previous multipurpose users, significant improvements were found after switching to AOSept Clear Care. The improvements in comfort were found in each measure of comfort in this study; frequency and intensity of dryness, during the day and end of the day comfort all showed significant improvements.

AOSept Improved UKClinical Trial R-162-C-002

This was a one-month prospective, randomised, masked, contra-lateral with crossover clinical trial of 182 subjects. There were two arms to the trial - 100 subjects using Clear Care with one control product and 75 subjects using Clear Care with a currently marketed multipurpose solution as the control.

Conclusion - The data from this study demonstrated that Clear was substantially equivalent to the control multipurpose solution in terms of hens wearing time and hours of comfortable wearing time.

8. Substantial Equivalence

Clear Care Cleaning and Disinfection Solution is substantially equivalent to the selected predicate products for cleaning, disinfecting, daily protein removal and storing of soft (hydrophilic) contact 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a bird-like figure with three curved lines representing its wings or body. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2003

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

Re: K030522

Trade/Device Name: 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: June 19, 2003 Received: June 23, 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, 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 (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 (QS) 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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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. Paizi 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:

Device Name: Clear Care Cleaning and Disinfecting Solution

Indications for Use:

Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily Olour Ouro Grounning and Elemes.neg of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) contact lenses as recommended by your eye care practitioner.

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	K030522
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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.”