AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K030522 · Ciba Vision Corporation · LPN · Sep 12, 2003 · Ophthalmic

Device Facts

• Record ID: K030522
• Device Name: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
• Applicant: Ciba Vision Corporation
• Product Code: LPN · Ophthalmic
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

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 Story

Clear Care Cleaning and Disinfecting Solution is an aqueous chemical solution containing 3% hydrogen peroxide, stabilized with phosphoric acid, sodium chloride, a phosphate buffer system, and a non-ionic surfactant. It is used by contact lens wearers to clean, disinfect, remove protein, and store soft (hydrophilic) contact lenses, including silicone hydrogel lenses. The solution acts as a chemical disinfectant and cleaner. It is intended for use by the patient at home. Clinical evidence suggests that switching to this solution from preserved multipurpose solutions may improve comfort, specifically reducing frequency and intensity of dryness during and at the end of the day.

Clinical Evidence

Two clinical studies were presented. 1) A multicenter, open-label study (n=148) comparing Clear Care to multipurpose solutions; results showed significant improvements in frequency/intensity of dryness and comfort. 2) A one-month prospective, randomized, masked, contralateral crossover trial (n=182) comparing Clear Care to a control multipurpose solution; results demonstrated substantial equivalence in lens wearing time and comfortable wearing time.

Technological Characteristics

Aqueous solution containing 3% hydrogen peroxide, phosphoric acid (stabilizer), sodium chloride, phosphate buffer, and non-ionic surfactant. Class II medical device (21 CFR 886.5928).

Indications for Use

Indicated for cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses, including silicone hydrogel lenses, for contact lens wearers as recommended by an eye care practitioner.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

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

Submission Summary (Full Text)

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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.

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.

### ട്. Indications for Use

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.

### 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 [phone]. 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 [phone] or [phone] 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)

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(Division Sign-Off)

Division of Ophthalmic Ear,

Nose and Throat Devises

| 510(k) Number | K030522 |
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