ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER

K032376 · AngioDynamics, Inc. · DQO · Aug 26, 2003 · Cardiovascular

Device Facts

• Record ID: K032376
• Device Name: ANGIODYNAMICS ACCU-VU SIZING ANGIOGRAPHIC CATHETER
• Applicant: AngioDynamics, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The ANGIODYNAMICS Accu-Vu Sizing Catheter is for use where angiographic diagnosis is indicated.

Device Story

The Accu-Vu Sizing Angiographic Catheter is a diagnostic intravascular catheter used by physicians in clinical settings to facilitate angiographic procedures. The device features radiopaque markers to assist in the visual estimation of vessel dimensions during imaging. By providing a reference for size, the catheter aids the clinician in selecting appropriate interventional devices, such as stents or balloons, during diagnostic or interventional angiography. The device is operated by a physician; output is visual, observed via fluoroscopy or other imaging modalities to inform clinical decision-making regarding vessel sizing and treatment planning.

Clinical Evidence

Bench testing only.

Technological Characteristics

Diagnostic intravascular catheter; includes radiopaque markers for sizing; Class II device; Regulation 870.1200; Product Code DQO.

Indications for Use

Indicated for patients requiring angiographic diagnosis. Prescription use only.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2003

AngioDynamics, Inc. c/o Teri Jucketti Regulatory Affairs Manager 603 Queensbury Avenue Queensbury, NY 12804

K032376 Re:

> AngioDynamics Accu-Vu Sizing Angiographic Catheter Regulation Number: 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: July 30, 2003 Received: August 4, 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 Jucketti

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]. 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,

2

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE

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

ANGIODYNAMICS Accu-Vu Sizing Angiographic Catheter Device Name:

Indications for Use:

The ANGIODYNAMICS Accu-Vu Sizing Catheter is for use where angiographic diagnosis is indicated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> |
|------------------------------------------|-----------------------------------------|
|------------------------------------------|-----------------------------------------|

OR

| Over-the-Counter Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)

Division of Cardiovascular Device:

| 510(k) Number | 14032376 |
|---------------|----------|
|---------------|----------|

4F Accu-Vu Sizing Catheter 510k Submission Design History File Number506 Page 7 of 23