ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT

K102796 · AngioDynamics, Inc. · GEX · Dec 15, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102796
• Device Name: ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Device Story

VenaCure EVLT Procedure Kit facilitates endovascular coagulation of Great Saphenous Vein (GSV). Device utilizes laser energy to treat superficial vein reflux, varicose veins, and varicosities. Procedure performed by physicians in clinical settings. Laser energy delivery induces thermal coagulation of vein, resulting in vessel closure. Benefits include minimally invasive treatment of venous incompetence.

Technological Characteristics

Laser surgical instrument; product code GEX; 21 CFR 878.4810. Device functions via laser energy delivery for endovascular coagulation.

Indications for Use

Indicated for patients with superficial vein reflux, varicose veins, and varicosities associated with Great Saphenous Vein (GSV) incompetence and reflux of lower extremity superficial veins.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Submission Summary (Full Text)

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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 or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 1 5 2010

AngioDynamics, Inc. % Ms. Teri Juckett Senior Regulatory Affairs 603 Queensbury Avenue Queensbury, New York 12804

Re: K102796

Trade/Device Name: VenaCure EVLT™ Procedure Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 23, 2010

Received: September 27, 2010

Dear Ms. Juckett:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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## Page 2 - Ms. Teri Juckett

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Application: Traditional 510(k) Submission

AngioDynamics, Inc. VenaCure Procedure Kit Device Name:

Indications for Use:

The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Prescription Use _ X

(Per 21 CFR 801.109)

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Over-the-Counter Use . . .

Please do not write below this line - continue on another page if needed

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

NuiRP Ogden for mom

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102796

AngioDynamics VenaCure Procedure Kit 510(k) Design History File 523

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