WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

K032069 · AngioDynamics, Inc. · DQY · Aug 27, 2003 · Cardiovascular

Device Facts

• Record ID: K032069
• Device Name: WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
• Applicant: AngioDynamics, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ANGIODYNAMICS WorkHorse™ II Percutaneous Transluminal Angioplasty Balloon 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

WorkHorse™ II is a percutaneous transluminal angioplasty (PTA) balloon catheter. Used by physicians in clinical settings to dilate stenotic vessels. Device consists of a catheter with an inflatable balloon at the distal end. Inserted percutaneously into the target artery or dialysis fistula; balloon is inflated to compress obstructive lesions against the vessel wall, restoring blood flow. Output is mechanical dilation of the vessel. Benefits include minimally invasive treatment of peripheral arterial disease and maintenance of dialysis access patency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Percutaneous transluminal angioplasty balloon catheter. Mechanical dilation principle. Standard catheter materials and construction. Non-coronary application. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of iliac, femoral, or 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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AUG 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032069

WorkHorse™ II Percutaneous Transluminal Angioplasty Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: August 13, 2003 Received: August 19, 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.

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## Page 2 - Ms. Teri Juckett

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, "Mishranding 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/dsma/dsmamain.html.

Sincerely yours,

Bram D. Zuckerman, MD

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

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

WorkHorse™ II Percutaneous Transluminal Angioplasty Device Name: Balloon

Indications for Use:

The ANGIODYNAMICS WorkHorse™ II Percutaneous Transluminal Angioplasty Balloon 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------|---------|
| Division of Cardiovascular | Devices |
| 510(k) Number | K032069 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|