OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB

K021831 · Lacrimedics, Inc. · LZU · Jul 1, 2002 · OP

Device Facts

• Record ID: K021831
• Device Name: OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPB
• Applicant: Lacrimedics, Inc.
• Product Code: LZU · OP
• Decision Date: Jul 1, 2002
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

OPAQUE Herrick Lacrimal Plugs may be used in the treatment of: · Dry Eye symptoms:dryness, redness, itching, burning, intermittont tearing or foreign body sensation. · For treatment of ocular dryness secondary to contact lens use. · To enhance the efficacy of topical ocular medications. · After surgery to provent complications due to Dry Fye. · For the Dry Eye component of: conjunctivitis, keratitis, corncal ulcer, pterygium blepharitis, red lid margins, recurrent chalazion. corneal erosion, filamentary keratitis and other eye diseases. OPAQUE Horrick Lacrimal Plugs are indicated by the patient's positive response to The Lacrimal Efficiency Test TM with dissolvable plugs (Lacrimedics).

Device Story

Opaque Herrick Lacrimal Plug is a mechanical device inserted into the lacrimal punctum to block tear drainage; intended to treat dry eye symptoms and associated ocular conditions. Device is used in a clinical setting by a physician. It functions by retaining tears on the ocular surface, thereby increasing moisture and enhancing the efficacy of topical medications. Patient selection is determined by a positive response to a diagnostic test (Lacrimal Efficiency Test).

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Mechanical lacrimal plug; dimensions 0.3mm, 0.5mm, and 0.7mm. Opaque material composition. Non-powered, standalone device.

Indications for Use

Indicated for patients experiencing dry eye symptoms (dryness, redness, itching, burning, tearing, foreign body sensation), ocular dryness secondary to contact lens use, or dry eye components of various ocular conditions (e.g., conjunctivitis, keratitis, corneal ulcer, blepharitis). Also indicated to enhance topical ocular medication efficacy and post-surgical dry eye management. Indication confirmed by positive response to The Lacrimal Efficiency Test with dissolvable plugs.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lacrimedics, Inc. c/o Mr. Jerry Henderson RA/QA Specialist 310 Prune Alley Eastsound, Wa 98245

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Re: K021831

Trade/Device Name: Opaque Herrick Lacrimal Plug@0.3, 0.5, and 0.7mm Regulation Number: Unclassified Regulation Name: Lacrimal Plug Regulatory Class: Unclassified Product Code: LZV Dated: May 31, 2002 Received: June 4, 2002

Dear Mr. Henderson:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

1 2002

ារបរ

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): K021831

Device Name: Opaque Herrick Lacrimal Plug®

Indications for Use:

OPAQUE Herrick Lacrimal Plugs may be used in the treatment of: · Dry Eye symptoms:dryness, redness, itching, burning, intermittont tearing or foreign body sensation.

· For treatment of ocular dryness secondary to contact lens use.

· To enhance the efficacy of topical ocular medications.

· After surgery to provent complications due to Dry Fye.

· For the Dry Eye component of: conjunctivitis, keratitis, corncal ulcer, pterygium blepharitis, red lid margins, recurrent chalazion. corneal erosion, filamentary keratitis and other eye diseases.

OPAQUE Horrick Lacrimal Plugs are indicated by the patient's positive response to The Lacrimal Efficiency Test TM with dissolvable plugs (Lacrimedics).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109) Qusannow Jones for DRC