ANGIODYNAMICS PROFILER PTA BALLOON CATHETER

K051060 · AngioDynamics, Inc. · DQY · May 26, 2005 · Cardiovascular

Device Facts

• Record ID: K051060
• Device Name: ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
• Applicant: AngioDynamics, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 26, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANGIODYNAMICS Profiler™ PTA Balloon Catheter is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.

Device Story

AngioDynamics Profiler™ PTA Balloon Catheter; percutaneous transluminal angioplasty device. Used for dilation of iliac, femoral, and renal arteries; treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Operated by physicians in clinical settings. Device functions as a balloon catheter to mechanically dilate stenotic vessels. Not for coronary artery use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous transluminal angioplasty balloon catheter. Class II device (21 CFR 870.1250). Product code DQY. Mechanical dilation mechanism.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty (PTA) of iliac, femoral, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Contraindicated for use in coronary arteries.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2005

Angiodynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 603 Queensbury Ave. Queensbury, NY 12804

Re: K051060

Trade Name: Angiodynamics Profiler™ PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY Dated: April 22, 2005 Received: April 26, 2005

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.

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Page 2 - Mr. Mark Job

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. 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 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,

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

are not designed to be used in the coronary arteries.

510(k) Number (if known): Special 510(k) Device Modification

AngioDynamics Profiler™ PTA Balloon Catheter Device Name: The ANGIODYNAMICS Profiler™ PTA Balloon Catheter is Indications For Use: indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

eQnDe

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KOSIOSO

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