ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT

K070378 · AngioDynamics, Inc. · GEX · Mar 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070378
• Device Name: ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. 600um Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Device Story

Device consists of 600μm optical fiber used within VenaCure Procedure Kit. Intended for endovascular coagulation of great saphenous vein. Operates by delivering laser energy to induce thermal coagulation of vein wall, resulting in vein closure. Used in clinical setting by physicians. Procedure involves percutaneous insertion of fiber into target vein under ultrasound guidance; laser energy applied to treat superficial reflux and varicose veins. Benefits include minimally invasive treatment of venous incompetence.

Clinical Evidence

Bench testing only.

Technological Characteristics

600μm optical fiber; laser energy delivery system for thermal coagulation; sterile, single-use kit components.

Indications for Use

Indicated for patients with superficial vein reflux, varicose veins, and varicosities of the great saphenous vein and 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)

{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 or bird-like symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 9 2007

Regulatory Affairs Manager 6003 Queensbury Avenue Queensbury, New York 12804

Angiodynamics, Inc.

% Ms. Teri Juckett

Re: K070378

Trade/Device Name: Angiodynamics, Inc. 600μm Fiber and Venacure Procedure Kit Regulation Number: 21 CFR 801.109 Regulation Name: Prescription devices Regulatory Class: II Product Code: GEX Dated: February 6, 2007 Received: February 8, 2007

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.

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 (OS) 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}------------------------------------------------

Page 2 - Ms. Teri Juckett

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), 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 yours,

sincerely, years,

Mark A. Milkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## INDICATIONS FOR USE

510(k) Application: Special 510(k): Device Modification

Device Name: AngioDynamics, Inc. 600um Fiber

## Indications for Use:

The AngioDynamics, Inc. 600um Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Prescription Use (Per 21 CFR 801.109) OR

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)
Mark Melkerson

(Division Sign-C

Division of General, Restorative, and Neurological Devices

510(k) Number K070378

AngioDynamics 600um Fiber and VenaCure Procedure Kit, 510(k) Design History File 512

Page 7 of 25