VISINE FOR CONTACTS

K991620 · Pfizer, Inc. · LPN · Sep 24, 1999 · Ophthalmic

Device Facts

• Record ID: K991620
• Device Name: VISINE FOR CONTACTS
• Applicant: Pfizer, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Visine for Contacts is an ophthalmic lubricating/rewetting solution; formulated for use with daily and extended wear soft contact lenses. Device functions by applying 1-2 drops directly to the eye while lenses are in place; followed by blinking to distribute the solution. Solution moistens lenses; removes particulate matter; soothes and refreshes dry, irritated eyes. Used by patients in home or daily settings; over-the-counter. Benefits include relief of minor irritation, discomfort, and blurring associated with lens wear.

Clinical Evidence

No clinical data provided. Safety established via comparative analysis of formulation components against currently marketed predicate devices.

Technological Characteristics

Ophthalmic solution containing hydroxypropyl methylcellulose and glycerin (rewetting agents), potassium sorbate and EDTA (preservatives), and a sodium borate and boric acid buffering system. Non-sterile/sterile (implied by ophthalmic use) liquid formulation.

Indications for Use

Indicated for users of daily and extended wear soft (hydrophilic) contact lenses to moisten lenses and relieve minor eye irritation, discomfort, or blurring.

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

• Lens Express (not specified)
• Lubricant Drops - Paco (not specified)
• Clear Eyes CLR (not specified)

Submission Summary (Full Text)

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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 [phone] Telephone Number [phone] 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

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- 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

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)