DELTA PUNCTUM PLUG

K050851 · Delta Life Science, Inc. · LZU · Aug 19, 2005 · OP

Device Facts

• Record ID: K050851
• Device Name: DELTA PUNCTUM PLUG
• Applicant: Delta Life Science, Inc.
• Product Code: LZU · OP
• Decision Date: Aug 19, 2005
• 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 disorder 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

Delta Punctum Plug is a mechanical device designed for insertion into the punctal opening of the eye. It functions by physically blocking the outflow of tears through the upper or lower punctum. By occluding the drainage pathway, the device increases tear volume on the ocular surface, thereby alleviating irritation and discomfort associated with dry eye disorder. The device is intended for use by clinicians to treat patients with insufficient ocular moisture. It provides a passive, mechanical solution to tear retention.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the established nature of the device type and intended use.

Technological Characteristics

Mechanical punctum plug; designed for insertion into the punctal opening to occlude tear drainage. No energy source, software, or electronic components.

Indications for Use

Indicated for patients suffering from dry eye disorder, including those with allergies, cataracts, or dry eye secondary to contact lens use, requiring increased tear retention via punctal occlusion.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2005

Delta Life Sciences, Inc. c/o Mr. George W. Murray 1975 Nonconnah Blvd. Memphis, TN 38132

Re: K050851

Trade/Device Name: Delta Punctum Plug Regulatory Class: Unclassified Product Code: LZU Dated: August 3, 2005 Received: August 4, 2005

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 (Scctions 531-542 of the Act); 21 CFR 1000-1050. 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

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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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K050851

Device Name: Delta Punctum Plug

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 disorder 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mercury

(Division Sign-Off) Division of Ophthalmic E Nose and Throat Devis

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