ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS

K112452 · AngioDynamics, Inc. · DQO · Mar 30, 2012 · Cardiovascular

Device Facts

• Record ID: K112452
• Device Name: ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
• Applicant: AngioDynamics, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Mar 30, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

Device Story

Angiographic catheters used for diagnostic imaging procedures; inserted into vasculature to deliver contrast media for visualization of blood vessels. Operated by physicians in clinical settings (e.g., interventional radiology, cardiology). Device facilitates diagnostic imaging; aids in identifying vascular anatomy and pathology. Benefits include enabling minimally invasive diagnostic assessment of vascular system.

Clinical Evidence

No clinical data provided; device cleared based on bench testing and substantial equivalence to predicate devices.

Technological Characteristics

Intravascular diagnostic catheter; materials and construction consistent with predicate angiographic catheters. Standard catheter form factor; non-powered, passive device. Sterilization via standard methods for medical devices.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

AngioDynamics, Inc. c/o Ms. Teri Juckett Regulatory Affairs Manager 14 Plaza Drive Latham, NY 12110

MAR 3 0 2012

Re: K112452

Trade Name: AngioDynamics, Inc. Soft-Vu, Mariner, Accu-Vu, and AngiOptic Angiographic Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: II (two) Product Code: DQO Dated: March 15, 2012 Received: March 16, 2012

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

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Page 2 - Mr. Terri 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); 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" (21 CFR 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,

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

Enclosure

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K112452

## INDICATIONS FOR USE

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

ANGIODYNAMICS Soft-Vu, Mariner, Accu-Vu, and AngiOptic Device Name: Angiographic Catheters

Indications for Use: AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

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 Device Evaluation (ODE)

Euful

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(Divi on Off)
Division of Cost & Secondary Devices