SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503

K022043 · Medennium, Inc. · LZU · Oct 18, 2002 · OP

Device Facts

• Record ID: K022043
• Device Name: SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
• Applicant: Medennium, Inc.
• Product Code: LZU · OP
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

SmartPlug™ is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blocking of the punctum. SmartPlug™ may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, SmartPlug™ may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by SmartPlug™.

Device Story

SmartPlug™ Model 500 is a punctum plug designed to block the punctum to treat dry eye symptoms. Device is inserted into the punctum by a clinician to prevent tear drainage, thereby increasing tear volume on the ocular surface. It aids in managing dry eye syndrome, post-surgical ocular complications, and contact lens intolerance. By retaining natural tears and ocular medications, the device provides symptomatic relief for patients suffering from ocular surface dryness.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Punctum plug device; non-mechanical, non-electronic, passive implantable device. No software or algorithm components.

Indications for Use

Indicated for patients experiencing dry eye symptoms (redness, burning, reflex tearing, itching, foreign body sensation), dry eye syndrome, dry eye components of ocular surface diseases, post-surgical dry eye complications, and contact lens-related dry eye problems.

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 three curved lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 18 2002

Medennium Inc. c/o Julian Abadia, Vice President Ouality Assurance & Regulatory Affairs 15350 Barranca Parkway Irvine; CA 92618

Re: K022043

Trade/Device Name: SmartPlug™ Model 500 Regulation Name: Punctum Plug Regulatory Class: Unclassified Product Code: LZU Dated: September 17, 2002 Received: September 18, 2002

Dear Mr. Abadia:

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

## Indications for Use Statement

K 022043 510(k) Number (if known):

Device Name: SmartPlug™ Model 500

Indications for Use:

SmartPlug™ is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by blocking of the punctum.

SmartPlug™ may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.

When indicated, SmartPlug™ may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by SmartPlug™.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

(Optional Format 1-1-96)

lose and Throat Devises

510(k) Number K022043