ANGIODYNAMICS, INC. VENACURE 1470 LASER

K110225 · AngioDynamics, Inc. · GEX · May 13, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110225
• Device Name: ANGIODYNAMICS, INC. VENACURE 1470 LASER
• Applicant: AngioDynamics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, VenaCure 1470 Laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

Device Story

Class IV diode laser (1470nm) for endovascular coagulation; delivers up to 12 Watts of energy. Used with fiber optic delivery system procedure kits. Operated by clinicians in clinical settings for treatment of varicose veins and superficial venous reflux. Laser energy induces thermal coagulation of target veins; results in vein closure. Benefits include minimally invasive treatment of venous insufficiency.

Clinical Evidence

Bench testing only. No clinical data presented. Performance validated through series of protocols including EMC, software verification/validation, product life cycle, electrical safety, laser safety, environmental testing, and optical output performance.

Technological Characteristics

Class IV diode laser; 1470nm wavelength; 12W maximum output power. System includes fiber optic delivery system. Bench testing performed for EMC, electrical safety, laser safety, and optical output stability.

Indications for Use

Indicated for patients with superficial venous reflux, varicose veins, and varicosities of the Greater Saphenous Vein or other incompetent superficial veins in the lower limb.

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 Delta 15 (K051995)
• AngioDynamics Delta 30 (K051995)
• Biolitec 15W Ceralas D 1470nm Diode Laser (K082225)

Submission Summary (Full Text)

{0}------------------------------------------------

K 110225

MAY 13 2011

# 510(k) Summary of Safety and Effectiveness for the VenaCure 1470 Laser:

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

# 1. General Information

ਵ

! .

| Submitter: | AngioDynamics, Inc.<br>14 Plaza Drive<br>Latham, NY 12110 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Teri Juckett<br>14 Plaza Drive<br>Latham, NY 12110<br>Phone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | January 11, 2011 |
| Names. | |
| Device Name: | AngioDynamics, Inc. VenaCure 1470 Laser |
| Classification Name: | Class II<br>Laser Instrument, Surgical Powered |

## 3. Predicate Devices

. 2.

The AngioDynamics VenaCure 1470 Laser is substantially equivalent to the AngioDynamics Delta 15 and AngioDynamics Delta 30 Lasers, K051995, and the Biolitec 15W Ceralas D 1470nm Diode Laser, K082225.

Product Code: GEX

## 4. Device Description

The purpose of this Traditional 510(k) is to notify FDA of the proposed new AngioDynamics VenaCure 1470 Laser, which is equivalent to the AngioDynamics Delta 15 and AngioDynamics Delta 30 Lasers.

{1}------------------------------------------------

The AngioDynamics VenaCure 1470 Laser is a Class IV Diode Laser with a wavelength of 1470nm. The predicate Biolitec Laser has the same 1470nm wavelength.

The 1470 Laser is intended for use in delivering up to 12 Watts of energy and is intended to be used with AngioDynamics Fiber Optic Delivery System Procedure Kits for use in 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.

#### 5. Indications for Use

ﺮ ﻣ

The AngioDynamics VenaCure 1470 Laser is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

#### 6. Performance Data

The AngioDynamics VenaCure 1470 Laser has undergone a comprehensive series of test protocols, listed below, in order to qualify and validate the performance of the devices. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The AngioDynamics VenaCure 1470 Laser is therefore validated for use on this basis.

EMC Testing Software Verification / Validation Product Life Time & Life Cycle Testing Electrical Safety Testing Laser Safety Testing Environmental Testing Optical Output Performance Output Power Stability System Performance Product Shock and Vibration Transit Testing

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

AngioDynamics, Inc. % Ms. Teri Juckett 14 Plaza Drive Latham, New York 12110

# MAY 1 3 2011

Re: K110225

Trade/Device Name: AngioDynamics, Inc. VenaCure 1470 Laser and Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and in plastic surgery and in dermatology

Regulatory Class: Class II Product Code: GEX Dated: April 07, 2011 Received: April 11, 2011

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

{3}------------------------------------------------

Page 2 - Ms. Teri Juckett

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/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/ReportaProblem/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.

AS B. R h
for.

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

Enclosure .

{4}------------------------------------------------

# INDICATIONS FOR USE

KI10225 510(k) Application: Traditional 510(k): Device Modification

AngioDynamics, VenaCure 1470 Laser Device Name:

#### Indications for Use:

The AngioDynamics, VenaCure 1470 Laser is indicated for use in the treatment of rne AngloDynamos, Tontoosities with superficial reflux of the Greater Saphenous Vein, and varieose voms and varioonise weffixing veins in the superficial venous system in the lower limb.

Prescription Use __ X Over-the-Counter Use

(Per 21 CFR 801.109)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ogden for mxm
(Division Sign-Off)

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

510(k) Number K110225