MOIST PUNCTAL PLUG SYSTEM

K021936 · Moist Medical, Inc. · LZU · Oct 16, 2002 · OP

Device Facts

• Record ID: K021936
• Device Name: MOIST PUNCTAL PLUG SYSTEM
• Applicant: Moist Medical, Inc.
• Product Code: LZU · OP
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.

Device Story

The MOIST Punctal Plug System is a mechanical device designed to treat dry eye disorder. It functions by occluding the punctal opening (upper or lower) to prevent tear outflow, thereby increasing tear volume on the ocular surface. The device is intended for use by clinicians to alleviate irritation and discomfort associated with insufficient ocular moisture.

Technological Characteristics

Mechanical punctal plug system for tear duct occlusion. No software, electronics, or energy sources involved.

Indications for Use

Indicated for patients with dry eye disorder, including those with allergies, cataracts, or dry eye secondary to contact lens use, experiencing eye irritation and discomfort due to insufficient moisture.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem is a symbol that resembles a bird or a wing-like shape, composed of three curved lines. The text is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 6 2002

MOIST Medical, Inc. c/o Mr. George W. Murray General Manager 2180 Wickersham Lane Germantown, Tennessee 38139

Re: K021936

> Trade Name: MOIST Punctal Plug System Classification Regulation Number: Unclassified Regulatory Class: II Product Code: LZU Dated: September 10, 2002 Received: September 12, 2002

Dear Mr. Murray:

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 such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

MOIST Punctal Plug System Device Name:

Indications For Use:

Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rusanand Jms
Division Sign-Off

ision of Onhthalmir. Far

510(k) Number K021936

Prescription Use
(Per 21 CFR 801.109)