AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

K022687 · Ciba Vision Corporation · LYL · Nov 19, 2002 · Ophthalmic

Device Facts

• Record ID: K022687
• Device Name: AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
• Applicant: Ciba Vision Corporation
• Product Code: LYL · Ophthalmic
• Decision Date: Nov 19, 2002
• 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 as recommonded by your eye care practitioner.

Device Story

AOSEPT Clear Care is an aqueous chemical solution for soft (hydrophilic) contact lens care. Formulation includes 3% hydrogen peroxide (stabilized with phosphonic acid), sodium chloride, phosphate buffer, and non-ionic surfactant. Device functions via chemical disinfection and cleaning action. Used by patients at home for daily lens maintenance. Output is a cleaned, disinfected, and stored contact lens. Benefits include removal of protein deposits and microbial disinfection, supporting lens hygiene and patient ocular health.

Clinical Evidence

Preclinical and clinical studies were completed and previously submitted under K003345 and K013512 to support safety and effectiveness.

Technological Characteristics

Aqueous solution containing 3% hydrogen peroxide, phosphonic acid stabilizer, sodium chloride, phosphate buffer, and non-ionic surfactant. Chemical disinfection principle.

Indications for Use

Indicated for simultaneous cleaning, daily protein removal, disinfecting, and storing of soft (hydrophilic) contact lenses for patients 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

• Allergan Ultracare Disinfecting Solution/Neutralizer

Submission Summary (Full Text)

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## 510(k) SUMMARY

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: Steven Dowdley Telephone No: 678-415-3897

#### 2. Device Name

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

#### ന് Predicate Devices

Allergan Ultracare Disinfecting Solution/Neutralizer

#### 4. Description of the Devices

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.

#### 5. Indications for Use

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

#### Description of Safety and Substantial Equivalence 6.

A series of preclinical and clinical studies were completed on this product and were previously submitted under submission K003345 and K013512.

#### 7. Substantial Equivalence

AOSept Clear Care Cleaning and Disinfection Solution is substantially equivalent to currently marketed AOSept Clear Care Cleaning and Disinfection Solution in cleaning, disinfecting, daily protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 9 2002

CIBA Vision Corp. c/o Steven Dowdley, RAC 11460 Johns Creek Parkway Duluth, GA 30097-1556

Re: K022687

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: LYL Dated: October 4, 2002 Received: October 7, 2002

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 (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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# 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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. Ralph 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

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# PART III. INDICATIONS FOR USE STATEMENT ME CORRECT CONTRACT

510(k) Number: This is a new 510 (k) Notification. (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 as recommonded by your eye care practitioner.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ☐ or over-the-counter: ☑

Off ് Vision of Ophthalmic Ear, Nose and Throat Dev

Nose and Throat
510(k) Number K022687