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 Description

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.

AI/ML Overview

The provided text describes REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops and its 510(k) submission (K083812). However, it does not contain details about specific acceptance criteria, a corresponding study, or the performance metrics that would typically be found in an Acceptance Criteria table.

Instead, the document focuses on:

Substantial Equivalence: The primary claim is substantial equivalence to a predicate device (Allergan REFRESH® Contacts Lubricating and Rewetting Drops).
Testing Performed: It mentions that the sponsor performed "stability, compatibility, toxicology and microbiology testing and a clinical study" to support the claim of substantial equivalence.
Indication for Use: The main application of the device is to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses to relieve dryness, discomfort, and irritation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These types of details are usually found in comprehensive clinical study reports or detailed performance data sections of a 510(k) submission, which are not present in this summary.

The document states: "The sponsor performed stability, compatibility, toxicology and microbiology testing and a clinical study with this formulation to support the claim of substantial equivalence." This is a high-level statement that a clinical study was done, but no details about the study design, acceptance criteria, or results are provided.

In summary, the provided text lacks the detailed information required to answer your request.

Summary

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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 .: (714) 246-5844 (714) 246-4051 Fax No .: lemmo joanne@allergan.com E-mail:

Device Information 2.

Classification names:	Soft (hydrophilic) Contact Lens Care Products andRigid 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 andRewetting Drops

3. Predicate Device

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

Description of device 4.

ട്. Indications for use

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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 (800) 638-2041 or (240) 276-3150 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:

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

Page 1 of 1

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.”