ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT

K073464 · AngioDynamics, Inc. · GEX · Jan 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073464
• Device Name: ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of variose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incomprence and reflux of superficial veins of the lower extremity.

Device Story

The NeverTouch II 400µm Fiber is a surgical laser accessory used in endovascular procedures. It functions as a delivery system for laser energy to achieve endovascular coagulation of the great saphenous vein. The device is used in a clinical setting by a physician to treat superficial vein reflux and associated varicose veins. By delivering laser energy to the vein wall, the device induces coagulation, which helps treat venous incompetence. The procedure is performed under medical supervision to improve patient outcomes related to superficial venous reflux.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laser surgical instrument accessory; 400µm fiber diameter; used with surgical laser systems for endovascular coagulation; sterile, single-use procedure kit; Class II device under 21 CFR 878.4810.

Indications for Use

Indicated for patients with superficial vein reflux, varicose veins, and varicosties associated with superficial reflux of the great saphenous vein, and incompetence and reflux of superficial veins of the lower extremity.

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.

Predicate Devices

• AngioDynamics, Inc. NeverTouch 600µm Fiber and VenaCure Procedure Kit (K071959)

Reference Devices

• CoolTouch Laser System (K040921)

Submission Summary (Full Text)

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# "Special 510(k): Device Modification" AngioDynamics, Inc. NeverTouch II 400μm Fiber and VenaCure Procedure Kit

Confidential

### General Information:

ANGIODYNAMICS, Inc. intends to introduce the following device into commercial distribution:

| a) | Trade Name: | AngioDynamics, Inc. NeverTouch II 400µm Fiber<br>and VenaCure Procedure Kit | | | |
|----|-------------------------------------------------|--------------------------------------------------------------------------------------------------|--|------------|--|
| b) | Legally Marketed Device: | AngioDynamics, Inc. NeverTouch 600µm Fiber<br>and VenaCure Procedure Kit | | | |
| | 510(k) Number: | K071959 | | | |
| b) | Common Name: | Greater Saphenous Vein Procedure Kit | | | |
| c) | Classification Name: | Laser Instrument, Surgical Powered | | JAN 23 200 | |
| d) | Established Registration Number: | 1319211 | | | |
| e) | Manufacturing Site Address: | ANGIODYNAMICS, Inc.<br>603 Queensbury Avenue<br>Queensbury, New York<br>12804 | | | |
| f) | Sterilization Site Address: | Sterigenics / IBA / Griffith Microscience<br>27 Park Rd.<br>Glens Falls, NY 12801 | | | |
| g) | Sterilizer Establishment<br>Registration Number | 13196189 | | | |
| h) | Classification: | Accessories to Laser Instrument, Surgical<br>Instruments<br>Product Code: GEX<br>21 CFR 878.4810 | | | |

#### i) Device Equivalence:

:

This product is substantially equivalent to the following device:

- AngioDynamics, Inc. NeverTouch 600μm Fiber VenaCure Procedure Kit, . K071959
:

- CoolTouch Laser System, K040921 .
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This device does not present additional risks to patients or different considerations regarding safety and effectiveness than those presented by the predicate devices.

- Performance Standards: None Established j)
#### ANGIODYNAMICS® Contact Information: k)

Teri Juckett, Regulatory Affairs Manager Name:

603 Queensbury Avenue Address: Queensbury, New York 12804

Phone: [phone] extension 1142

Fax: [phone]

- I) Payment Identification Number MD6033627-956733
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

JAN 23 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073464

Trade/Device Name: AngioDynamics, Inc. NeverTouch II 400pm Fiber 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: December 28, 2007 Received: December 31, 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

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Page 2 - Ms. Teri Juckett

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Comrtial ce at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarlet Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N. Millman

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

Enclosure

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K073464 Pg 1 of 1

## INDICATIONS FOR USE

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

Device Name: AngioDynamics, Inc. NeverTouch II 400um Fiber

Indications for Use:

The AngioDynamics, Inc. NeverTouch II Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of variose veins and varicosties associated with superficial reflux of the great saphenous vein, and for the treatment of incomprence and reflux of superficial veins of the lower extremity.

Prescription Use X (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 Pevice Evalual

Office of Device Evaluation (ODE)

Mark A. Millan

(Division Sign-Off Division of General, Restorative, and Neurological Dev

510(k) Number

AngioDynamics NeverTouch II 400µm Fiber and VenaCure Procedure Kit, 510(k) Design History File 525

:

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