REFRESH OPTIVE LENS COMFORT REWETTING DROPS

K083812 · Allergan, Inc. · LPN · Jul 9, 2009 · Ophthalmic

Device Facts

• Record ID: K083812
• Device Name: REFRESH OPTIVE LENS COMFORT REWETTING DROPS
• Applicant: Allergan, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Jul 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Use REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to insertion on the eye.

Device Story

REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops is a sterile, buffered, isotonic, preserved aqueous solution. It is applied topically by the patient to soft or RGP contact lenses to provide lubrication, rewetting, and cushioning. The solution contains carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride hexahydrate, potassium chloride, purified water, PURITE® (stabilized oxychloro complex), sodium borate decahydrate, and sodium citrate dihydrate. It is an over-the-counter product used to alleviate dryness and irritation associated with contact lens wear, improving comfort for the lens wearer.

Clinical Evidence

Clinical study performed to support substantial equivalence. No specific performance metrics (e.g., sensitivity, specificity) or sample sizes provided in the summary document.

Technological Characteristics

Sterile, buffered, isotonic, preserved aqueous solution. Ingredients: carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride hexahydrate, potassium chloride, purified water, PURITE® (stabilized oxychloro complex), sodium borate decahydrate, sodium citrate dihydrate. Free of chlorhexidine, thimerosal, and mercury-containing ingredients.

Indications for Use

Indicated for users of soft (hydrophilic) and rigid gas permeable (RGP) contact lenses to lubricate and rewet lenses, relieve dryness, discomfort, and irritation associated with lens wear, and cushion lenses prior to insertion.

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 REFRESH® Contacts Lubricating and Rewetting Drops (K992028)

Submission Summary (Full Text)

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K083 812

Allergan Confidential REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops

JUL = 9 2009

### 510(k) summary

# REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops

## July 2009

#### 1. Applicant Information

Allergan, Inc. 2525 Dupont Drive Irvine, CA 92612-1599 Contact Person: Joanne Lemmo Telephone No .: [phone] [phone] Fax No .: lemmo [e-mail] E-mail:

#### Device Information 2.

| Classification names: | Soft (hydrophilic) Contact Lens Care Products and<br>Rigid Gas Permeable Contact Lens Care Products |
|------------------------|-----------------------------------------------------------------------------------------------------|
| Device classification: | Class II |
| Regulation numbers: | 21 CFR 886.5928 and 21 CFR 886.5918 |
| Product codes: | LPN & MRC |
| Proprietary name: | REFRESH® OPTIVET™ Contacts Lubricating and<br>Rewetting Drops |

#### 3. Predicate Device

The predicate device is Allergan REFRESH® Contacts Lubricating and Rewetting Drops which was cleared under K992028.

#### Description of device 4.

REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, levocarnitine, magnesium chloride hexahydrate, potassium chloride, purified water, PURITE® (stabilized oxychloro complex), sodium borate decahydrate, and sodium citrate dihydrate. This formula does not contain chlorhexidine, thimerosal, or any other mercury-containing ingredients.

#### ട്. Indications for use

Use REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to insertion on the eye.

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#### 6. Substantial Equivalence

The claim of substantial equivalence to Allergan REFRESH® Contacts Lubricating and Rewetting Drops is based on the indication for use as a lubricating and rewetting solution for soft (hydrophilic) and RGP contact lenses. REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops and REFRESH® Contacts Lubricating and Rewetting Drops both contain sodium carboxymethylcellulose as an active ingredient and both formulas are preserved with PURITE® (a stabilized oxychloro complex).

The sponsor performed stability, compatibility, toxicology and microbiology testing and a clinical study with this formulation to support the claim of substantial equivalence.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

### Public Health Service

JUL - 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Allergan, Inc. c/o Beverley Venuti, PhD., RAC Foresight Regulatory Strategies, Inc. 187 Ballardvale St. Suite 180 Wilmington, MA 01887-4461

Re: K083812 Trade/Device Name: REFRESH OPTIVE™ Contacts Lubricating and Rewetting Drops Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LPN, MRC Dated: June 30, 2009 Received: July 2, 2009

Dear Dr. Venuti:

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 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Callaway for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Allergan Confidential

REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops

### Indications for Use

K083812 510(k) Number (if known):

REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops Device Name:

Indications for Use:

Use REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to insertion on the eye.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number: K083812

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