(199 days)
Not Found
No
The device is a lubricating and rewetting solution for contact lenses, and the description focuses on its chemical composition and performance studies related to stability, compatibility, toxicology, and microbiology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is intended to lubricate and rewet contact lenses and relieve dryness, discomfort, and irritation associated with lens wear, rather than treat a disease or condition. It acts as an eyedrop for comfort and lens maintenance.
No
The device is described as lubricating and rewetting drops for contact lenses, intended to relieve dryness, discomfort, and irritation. It does not mention any function for diagnosing a medical condition.
No
The device description clearly states it is a sterile, buffered, isotonic, preserved solution, which is a liquid formulation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lubricate and rewet contact lenses and relieve associated discomfort. This is a direct interaction with a medical device (contact lens) and the eye, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a sterile solution for direct application to contact lenses and the eye. It does not describe reagents, instruments, or systems used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, REFRESH® OPTIVE™ Contacts Lubricating and Rewetting Drops falls under the category of a medical device, specifically a contact lens solution, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LPN, MRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sponsor performed stability, compatibility, toxicology and microbiology testing and a clinical study with this formulation to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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 and
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
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.
1
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.
2
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
3
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:
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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