ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT

K100199 · AngioDynamics, Inc. · GEX · Nov 26, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100199
• Device Name: ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer 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. The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.

Device Story

The AngioDynamics VenaCureEVLT Procedure Kit is a surgical instrument system used for endovascular coagulation of the Great Saphenous Vein. The kit includes a percutaneous introducer to facilitate access. It is designed for use with 810 nm and 980 nm diode lasers equipped with SMA 905 connectors. The device is operated by physicians in a clinical setting to treat superficial vein reflux and varicose veins. By delivering laser energy to the vein, the device induces coagulation, effectively closing the incompetent vein. This minimally invasive procedure benefits patients by treating venous insufficiency and associated varicosities.

Clinical Evidence

bench testing only

Technological Characteristics

The device is a percutaneous introducer and procedure kit designed for use with 810 nm and 980 nm diode lasers. It utilizes SMA 905 connectors for laser integration. The system is a powered laser surgical instrument (Class II, Product Code GEX).

Indications for Use

Indicated for patients with superficial vein reflux, varicose veins, and varicosities of the Great Saphenous Vein (GSV) or lower extremity superficial veins requiring endovascular coagulation.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

AngioDynamics Inc. c/o Ms. Teri Juckett 603 Queensbury Ave Queensbury, NY 12804

NOV 2-6 2010

Re: K100199

Trade/Device Name: AngioDynamics Percutaneous Introducer and VenCureEVLT Procedure Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulatory Class: Class II Product Code: GEX Dated: November 8, 2010 Received: November 10, 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.

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

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Page 2 - Ms. Juckett

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/CDRH0ffices/ucm115809.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,
W.M.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

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## 510(k) Application: Traditional 510(k): Device Modification

Device Name: AngioDynamics, Inc. Percutaneous Introducer and VenaCureEVLT Procedure Kit

## Indications for Use:

The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer 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.

The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.

OR

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.A.

iovascular Devices

**510(k) Number** K100044