AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K031521 · Ciba Vision Corporation · LPN · Jun 27, 2003 · Ophthalmic

Device Facts

• Record ID: K031521
• Device Name: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
• Applicant: Ciba Vision Corporation
• Product Code: LPN · Ophthalmic
• Decision Date: Jun 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

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 Story

AOSEPT Clear Care is an aqueous contact lens solution containing 3% hydrogen peroxide, sodium chloride, phosphate buffer, and non-ionic surfactant. Used by patients for simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. The solution functions as a chemical disinfectant. Patients follow the recommendations of their eye care practitioner for lens care. The device benefits patients by maintaining lens hygiene and compatibility with various soft lens materials.

Clinical Evidence

Clinical studies previously submitted and reviewed under K003345 and K013512 support the safety and effectiveness of the solution. Additional in vitro studies confirmed compatibility with Lotrafilcon A (silicone hydrogel) lenses, showing no significant difference in optical or physical properties compared to saline control. Microbiological efficacy testing met FDA stand-alone criteria. Cytotoxicity testing confirmed the solution is non-toxic and a non-irritant.

Technological Characteristics

Aqueous solution containing 3% hydrogen peroxide (stabilized with phosphonic acid), sodium chloride, phosphate buffer system, and non-ionic surfactant. Chemical disinfection principle. Compatible with soft (hydrophilic) and silicone hydrogel contact lenses. Meets FDA May 1, 1997 Guidance for Industry, Premarket Notification 510(k) Guidance Document for Contact Lens Care products.

Indications for Use

Indicated for simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses, including silicone hydrogel lenses, 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 (K003345, K013512)

Reference Devices

• SOLO-Care Multipurpose Solution

Submission Summary (Full Text)

{0}------------------------------------------------

### 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

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.

### 5. Indications for Use

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 eve care practitioner.

### 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

{1}------------------------------------------------

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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [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 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

{4}------------------------------------------------

# 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:

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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | <input type="checkbox"/> | or | over-the-counter: | <input checked="checked" type="checkbox"/> |
|-------------------|--------------------------|----|-------------------|--------------------------------------------|
|-------------------|--------------------------|----|-------------------|--------------------------------------------|


(Division Sign-Off)

Division of Ophthalmic Ear,

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