ANDIODYNAMICS, INC. ELVS PROCEDURE KIT

K031233 · AngioDynamics, Inc. · GEX · Jun 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031233
• Device Name: ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. ELVS Procedure Kit is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and is also indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The AngioDynamics, Inc. ELVS Procedure Kit is indicated for use with 810 mm and 980 nm Diode Lasers with SMA 905 connectors.

Device Story

ELVS Procedure Kit facilitates endovascular laser treatment of greater saphenous vein reflux; used in clinical settings by physicians. Kit components deliver laser energy to target vein tissue, inducing thermal coagulation. Device operates with 810 nm and 980 nm diode lasers via SMA 905 connectors. Procedure involves catheter/fiber insertion into vein under ultrasound guidance; laser energy applied to achieve vein closure. Benefits include minimally invasive treatment of varicose veins compared to surgical stripping.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Laser surgical instrument kit; utilizes 810 nm and 980 nm diode lasers; SMA 905 connector interface; sterile, single-use components for endovascular access and energy delivery.

Indications for Use

Indicated for patients with superficial vein reflux requiring endovascular coagulation of the greater saphenous vein of the thigh and treatment of associated varicose veins/varicosities.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Public Health Service

JUN 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031233

Trade/Device Name: AngioDynamics, Inc. ELVS 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: II Product Code: GEX Dated: April 16, 2003 Received: May 6, 2003

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 (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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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]. 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) you may obtain. 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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)

AngioDynamics, Inc. ELVS Procedure Kit Device Name:

## Indications for Use:

The AngioDynamics, Inc. ELVS Procedure Kit is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux and is also indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

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

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K63/233

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Use

(Per 21 CFR 801.109)