PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM

{0}------------------------------------------------ ### JAN 2 3 2004 K033686 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### PORT-A-CATH® II Regional Arterial System ### November 21, 2003 #### I. GENERAL INFORMATION | Applicant's Name and Address: | Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 | |--------------------------------|--------------------------------------------------------------------------------------------------------------| | Contact Person: | Patricia LaForte<br>Regulatory Affairs Associate | | Common/Usual Name: | Implantable Access System | | Proprietary Name: | Regional Arterial Port/Catheter System for<br>Local/Regional Drug Delivery | | Equivalence Device Comparison: | PORT-A-CATH® II Trans-Arterial Percutaneous<br>System<br>PORT-A-CATH® II Implantable Venous Access<br>System | #### II. DEVICE DESCRIPTION A system consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, a single lumen silicone catheter, a hemostasis sy assembly, and a micro-catheter assembly ### III. INTENDED USE OF DEVICE The PORT-A-CATH® II Regional Arterial Portal System is indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes. {1}------------------------------------------------ ### 510(k) Summary of Safety and Effectiveness Page 2 of 4 ### IV. DEVICE COMPARISON | | PORT-A-CATH® II<br>Regional Arterial<br>Drug Delivery System | PORT-A-CATH® II<br>Trans-Arterial<br>Percutaneous System | PORT-A-CATH® II<br>Implantable Venous<br>Access System | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | MANUFACTURER | Deltec, Inc. | Deltec, Inc. | Deltec, Inc. | | 510(K) NUMBER | Subject Device | K992697 | K932840 | | INDICATION FOR USE | A system is indicated<br>when patient therapy<br>requires prolonged or<br>repeated intra-arterial<br>infusions. | A system is indicated<br>when patient therapy<br>requires prolonged or<br>repeated intra-arterial<br>infusions. | A system is indicated<br>when patient therapy<br>requires repeated access<br>to the venous system for<br>the parenteral delivery of<br>medications, fluids, and<br>nutritional solutions, and<br>for the sampling of<br>venous blood. | | PORTAL AND<br>CONNECTOR<br>MATERIALS | | | | | Housing | Polysulfone/Titanium | Polysulfone/Titanium | Polysulfone/Titanium | | Septum | Silicone | Silicone | Silicone | | Connector | Polypropylene/Titanium | Polypropylene/Titanium | Polypropylene/Titanium | | PORTAL DIMENSIONS<br>(Nominal) | | | | | Height<br>Portal Base<br>Septum Diameter | 15.2 mm<br>30.5 mm<br>11.4 mm | 11.5 mm<br>25.0 mm<br>9.5 mm | 15.2 mm<br>30.5 mm<br>11.4 mm | | PORTAL<br>CONNECTING<br>CATHETER | | | | | OD/ID | 2.8mm/1.0mm | 1.9mm/1.0mm | 2.8mm/1.0mm | | | PORT-A-CATH® II<br>Regional Arterial<br>Drug Delivery System | PORT-A-CATH® II<br>Trans-Arterial<br>Percutaneous System | PORT-A-CATH® II<br>Implantable Venous<br>Access System | | LENGTH<br>MATERIAL | 38cm<br>Silicone | 76cm<br>Polyurethane | 76cm<br>Silicone | | PORTAL TUBE<br>CONNECTOR | CATH-SHIELD®<br>Connector | ULTRA-LOCK®<br>Connector | CATH-SHIELD®<br>Connector | | INTRA-VASCULAR<br>CATHETER<br>OD/ID<br>Length<br>Material | 1.0mm/0.72mm<br>100cm<br>Pebax/PTFE/Stainless<br>Steel | All same as above<br>(same catheter connects<br>to portal and to vascular<br>system) | All same as above<br>(same catheter connects<br>to portal and to vascular<br>system) | | CATHETER TO<br>CATHETER<br>CONNECTOR | Boot- Silicone<br>Clamp - Acetal<br>Sleeve - Tecoflex 93A<br>Bushing - Polyvinyl Chloride<br>(TOTM plasticized) | n/a1 | n/a | | ACCESSORIES<br>Needles | 1 blunt / 1 huber | 1 blunt / 1 huber | 1 blunt / 1 huber | | Sharps Safety | 1 Point Lok® | n/a | n/a | | Portal Access | 1 GRIPPER PLUS® | n/a | n/a | | Other | n/a | Guidewire, introducer<br>needle, introducer,<br>syringe | Vein Pick | {2}------------------------------------------------ ### 510(k) Summary of Safety and Effectiveness Page 3 of 4 ### DELTEC, INC. ### Comparison Chart (Continued) 1 n/a = not applicable {3}------------------------------------------------ #### III. SUMMARY OF STUDIES #### A. Functional Testing In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995. The testing included tensile strength, flow-rate, catheter stiffness, catheter flexural fatigue, system leakage, and guidewire removal testing. In-vitro Simulated Life Testing to document performance of the PORT-A-CATH® II Regional Arterial System under simulated, but accelerated, in-use conditions was performed. In-vivo testing of the PORT-A-CATH® II Regional Arterial System to evaluate the feasibility of the implantation and immediate post-implant performance of an arterial port-catheter system into the hepatic or other target arteries using minimally invasive, image-guided techniques was conducted. Biocompatibility testing was conducted on system components. #### B. Clinical Studies Clinical studies were not deemed necessary regarding PORT-A-CATH® II Regional Arterial System due to their similarity in materials, design and function to current Deltec systems. #### C. Conclusions Drawn from the Studies The results of the testing indicated that the PORT-A-CATH® II Regional Arterial Portal System functions according to specifications and the materials used in the system are biocompatible. Therefore, these systems are considered acceptable for human use. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The overall design is simple and conveys a sense of government authority and public service. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 3 2004 Ms. Patricia LaForte Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112 Re: K033686 Trade/Device Name: PORT-A-CATH® II Regional Arterial Portal System Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Codc: LJT Dated: November 21, 2003 Received: November 24, 2003 Dear Ms. LaForte: 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 cither 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. {5}------------------------------------------------ Page 2 - Ms. LaForte 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 (OS) 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 (301) 594-4618. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Cls SG. Liu, Ph.D. Chiu Lin, Ph., D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if known): _____________________ Device Name: PORT-A-CATH® II Regional Arterial Portal System Indications for Use: "The PORT-A-CATH® II Regional Arterial Portal System will be indicated when patient therapy requires prolonged or repeated intra-arterial access for injection or infusion regimes." (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Zork Dillard, Interim Branch Chief (Division Sian-Off) Division of Anesthesiology, Ge Infection Control, Dental De 510(k) Number: K0331 Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use # 000042