(136 days)
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No
The document describes a rewetting drop for contact lenses and does not mention any AI or ML technology in its intended use, device description, or performance studies.
No.
The product is a rewetting drop for contact lenses that moisturizes and removes particulate matter that may cause irritation to the eyes. It is not intended for the treatment or prevention of any disease or condition.
No
Explanation: The device is described as rewetting drops for contact lenses to relieve minor irritation and discomfort. There is no mention of diagnosing any condition or disease.
No
The device description clearly indicates a liquid solution ("Rewetting Drops") intended for direct application to the eye and contact lenses, which is a physical substance, 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 moisten contact lenses and relieve minor eye irritation and discomfort while wearing lenses. This is a direct application to the eye and contact lens, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the product's function as a rewetting and soothing agent for the eyes and contact lenses.
- Lack of IVD Characteristics: There is no mention of analyzing a biological sample (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition.
IVDs are devices used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This product does not fit that description.
N/A
Intended Use / Indications for Use
VISINE FOR CONTACTS Rewetting Drops may be used with daily and extended wear soft (hydrophilic) contact lenses for the following:
- Moistening of daily wear soft lenses while on the eyes during the day
- Moistening of extended wear soft lenses upon awakening and as needed during the day
- Moistening of extended wear soft lenses prior to retiring at night
Placing 1 or 2 drops of VISINE FOR CONTACTS Rewetting Drops on the eye followed by blinking 2 or 3 times will relieve minor irritation, discomfort and blurring which may occur while wearing lenses.
Product codes
86 LPN
Device Description
Visine for Contacts is specially formulated to use while wearing contact lenses to moisten lenses, soothe, refresh and moisturize dry, irritated eyes. Visine for Contacts is safe and effective for individuals with eyes sensitive to thimerosal. It moistens lenses and helps remove particulate matter that may cause irritation and/or discomfort.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eyes
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies showed no clinically or statistically significant differences between Visine For Contacts and currently marketed products for any parameters. Therefore, Visine for Contacts is as safe as the marketed products when used as directed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
SEP 2 4 1999
510(k) Summary
1991620
Submitter:
Contact Person:
Name of Device Trade Name: Common Name: Classification Name:
Legally Marketed Devices:
Product Description:
Intended Use:
Indications:
Consumer Health Care Group Pfizer Inc New York, NY 10017
John Tomaszewski Director, Requlatory Affairs (212) 573-2394 Telephone Number (212) 537-1186 Facsimile Number
Visine for Contacts Lubricating/rewetting eye drops In-eye contact lens solution
Lens Express/Lubricant Drops - Paco Clear Eyes CLR - Ross Products
Visine for Contacts is specially formulated to use while wearing contact lenses to moisten lenses, soothe, refresh and moisturize dry, irritated eyes. Visine for Contacts is safe and effective for individuals with eyes sensitive to thimerosal. It moistens lenses and helps remove particulate matter that may cause irritation and/or discomfort.
Visine for Contacts may be used for the moistening of daily and extended wear soft lenses while in the eyes as needed. For the temporary relief of burning and irritation due to dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye.
VISINE FOR CONTACTS Rewetting Drops may be used with daily and extended wear soft (hydrophilic) contact lenses for the following:
- Moistening of daily wear soft lenses while on the eyes during . the day
- Moistening of extended wear soft lenses upon awakening and as needed during the day
1
- Moistening of extended wear soft lenses prior to retiring at . night
Placing 1 or 2 drops of VISINE FOR CONTACTS Rewetting Drops on the eye followed by blinking 2 or 3 times will relieve minor irritation, discomfort and blurring which may occur while wearing lenses.
Visine for Contacts is substantially equivalent to currently Technological Characteristics: marketed devices, such as Clear Eyes CLR and Lens Express, with the same intended use. As compared to Clear Eyes CLR and Lens Express, Visine for Contacts contain the same basic components, the rewetting agents include hydroxypropyl methylcellulose and glycerin. Visine for Contacts also contains potassium sorbate and EDTA as preservatives, and a buffering system of sodium borate and boric acid.
Safety:
Studies showed no clinically or statistically significant differences between Visine For Contacts and currently marketed products for any parameters. Therefore, Visine for Contacts is as safe as the marketed products when used as directed.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Pfizer Pharmaceuticals Group John Tomaszewski, MS, RAC Director, Consumer Healthcare Regulatory Affairs 235 East 42nd Street, 6th Floor/MS-5 New York, NY 10017-5755
Re: K991620 Trade Name: Visine For Contacts Regulatory Class: II Product Code: 86 LPN Dated: August 24, 1999 Received: August 25, 1999
Dear Mr. Tomaszewski:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. John Tomaszewski
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Afrey L. Rosenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page Page
510(k) Number (if known): K991620
Device Name: VISINE FOR CONTACTS Indications for Use:
VISINE FOR CONTACTS Rewetting Drops may be used with daily and extended wear soft (hydrophilic) contact lenses for the following:
- Moistening of daily wear soft lenses while on the eyes during . the day
- Moistening of extended wear soft lenses upon awakening and . as needed during the day
- Moistening of extended wear soft lenses prior to retiring at night .
Placing 1 or 2 drops of VISINE FOR CONTACTS Rewetting Drops on the eve followed by blinking 2 or 3 times will relieve minor irritation, discomfort and blurring which may occur while wearing lenses.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W.C. Brown, PH.D
(Division Sign-Off)
Division of Ophthalmic Devices
Prescription Use __ 510(k) Number K991620 OR __ Over-The-Counter Use x
(Per 21 CFR 801.109)
(Optional Format 1-2-96)