ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

K101017 · AngioDynamics, Inc. · LJT · Jun 17, 2010 · General Hospital

Device Facts

• Record ID: K101017
• Device Name: ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
• Applicant: AngioDynamics, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Jun 17, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smart Port® CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood. When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port® CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Device Story

Smart Port CT Port Access System provides repeated vascular access for infusion and sampling; device consists of implanted port and catheter extensions; enables power injection of contrast media at rates up to 5 ml/sec when used with compatible 19G or 20G infusion sets; used by clinicians in clinical settings; facilitates delivery of medications, fluids, and blood products; benefits patients by providing reliable, long-term venous access.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Subcutaneous implanted intravascular infusion port and catheter; designed for power injection of contrast media; compatible with 19G and 20G infusion sets; maximum flow rate 5 ml/sec.

Indications for Use

Indicated for patients requiring repeated vascular access for medication delivery, nutritional supplementation, fluid/blood administration, blood sampling, and power injection of contrast media (when used with specific 19G/20G infusion sets).

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Submission Summary (Full Text)

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Public Health Service

JUN 1 7 2010

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

Ms. Teri Juckett Senior Regulatory Affairs Professional AngioDynamics, Incorporated 14 Plaza Drive Latham, New York 12110

Re: K101017

Trade/Device Name: AngioDynamics, Inc. Smart Port® CT, Mp and LP Lines Extensions Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: May 17, 2010 Received: May 19, 2010

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 - Ms. 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" (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.

Susan Russo

Anthony Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

## INDICATIONS FOR USE

K 101017

510(k) Application: Special 510K Device Modification

AngioDynamics, Inc. Smart Port® CT, Mp and LP Lines Extensions Device Name:

Indications for Use: The Smart Port® CT Port Access System is indicated for any patient requiring repeated access of the vasculature system, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.

When used with non Y site LifeGuard Safety infusion sets in 20 Ga or 19 Ga sizes, the Smart Port® CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Prescription Use (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 Evalus

Suze Rion

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K10617

AngioDynamics SmartPort CT, MP and LP Line Extensions 510(k) Design History File 100247

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