TARGET VITAL-PORT VASCULAR ACCESS SYSTEM

{0} 510(k) Premarket Notification TARGET Vital-Port® Vascular Access System K970442¹⁹ # 510(k) Summary of Substantial Equivalence: APR 30 1997 ## Submitted By: Neal E. Fearnot, President MED Institute, Incorporated P.O. Box 2402 West Lafayette, Indiana 47906 (317) 463-7537 January 31, 1997 ## Device: Trade Name: TARGET Vital-Port® Vascular Access System Common/Usual Name: Implantable Vascular Access System, Implanted Infusion Port Proposed Classification: Implanted Subcutaneous Intravascular Catheter ## Predicate Devices: The TARGET Vital-Port® Vascular Access System has the same intended use, design, and materials of construction as predicate Vital-Port® systems manufactured by COOK Vascular™ Incorporated. ## Device Description: The TARGET Vital-Port® Vascular Access System is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the TARGET Vital-Port® Vascular Access System are identical to those used in predicate Vital-Port® systems. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing. ## Substantial Equivalence: The TARGET Vital-Port® Vascular Access System will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by COOK Vascular™ Incorporated. This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency. {1} 510(k) Premarket Notification TARGET Vital-Port® Vascular Access System 20 # 510(K) Summary Of Safety And Effectiveness Implanted subcutaneous intravascular catheter systems for central vessel access are useful since repeatedly puncturing veins and arteries for injection, infusion or blood sampling results in vessel wall damage, vessel stenosis and occlusion, and eventual obliteration of usable vessels. Injection of certain drugs, especially chemotherapeutic agents, causes damage to the vessel wall because of the high concentration of the drug before adequate mixing occurs in the blood stream. The use of central vessel catheters reduces the number of punctures required for repeated vessel access and enables injection into major veins and arteries to protect peripheral vessels. Two types of central vessel catheters are implanted catheters with an externalized end, and totally implantable systems. This summary focuses on totally implanted vascular access systems comparable to the TARGET Vital-Port® Vascular Access System. Totally implantable vascular access systems consist of a port reservoir or chamber with an attached catheter. The port reservoir is covered by a self-sealing silicone rubber septum through which fluids are administered or withdrawn. The attached catheter is surgically placed in the targeted vessel and the port reservoir is implanted under the skin; the system is accessed using a non-coring needle. Clinical use of totally implantable vascular access systems has been described since the early 1980's. These systems have been used for all classes of antineoplastic drugs, blood products, and TPN (total parenteral nutrition). Reported advantages of the totally implantable vascular access system as compared to external catheters include decreased risk of infection, patient acceptance due to improved appearance, decreased patient responsibility, and freedom of activity when the port is not in use. Although {2} 510(k) Premarket Notification TARGET Vital-Port® Vascular Access System 21 the implantable vascular access systems currently marketed are available in various sizes and materials, the indications for use and fundamental design of the systems are substantially equivalent. Studies have been performed comparing groups of patients having totally implantable vascular access systems and groups of patients having external percutaneous catheters which have a long history of medical use. These patient groups needing long-term venous access were analyzed for major differences in complications, patient acceptance, and costs of long-term maintenance. Reported complications for these devices included infection, venous thrombosis, catheter occlusion and catheter breakage. In these studies, the complication rate of patients having implantable vascular access systems was notably lower than that of patients having percutaneous catheters.¹⁻³ Comparative studies also indicated that implantable vascular access systems were more readily accepted by the patient than were percutaneous catheters due to ease of maintenance, comfort and overall acceptance.¹,³ Costs of implantable vascular access systems and percutaneous catheters were found comparable over the short-term,³ however, beyond a six month duration, costs were reportedly lower for maintaining implantable vascular access systems due to the daily catheter care and heparin flushing required by the percutaneous catheters.¹,³ Results from these comparative studies show favor of use of the implantable vascular access system over the percutaneous catheters in patients receiving prolonged intravenous therapy. Given the acceptance of use by both physicians and patients in the comparative studies with percutaneous catheters, a number of articles have been published in which the long-term performance of implantable vascular access systems has been assessed. {3} 510(k) Premarket Notification TARGET Vital-Port® Vascular Access System 22 Indications for use of these systems have included the administration of chemotherapeutic agents, intravenous fluids, antibiotics, blood and blood products, and blood withdrawal. Because of the historical experience and the large number of articles published, the information available pertaining to the use of totally implantable vascular access systems is extensive. The following table summarizes types and causes of safety and/or effectiveness problems to which totally implantable vascular access systems similar to the TARGET Vital-Port® Vascular Access System are susceptible, and literature citations upon which the safety and effectiveness summary is based. This summary includes a review of 16 published articles dating from 1985 to 1991. The feasibility and efficacy for use of the TARGET Vital-Port® Vascular Access System is shown in the clinical use and performance of these comparable totally implantable systems. In addition to the complications reported in these publishings, there are numerous potentially occurring complications which are associated with any surgically implanted device for long-term usage. These potential complications include device reaction (e.g., fibrotic tissue encapsulation and allergies to the bio-materials), acute complications associated with any surgical procedure (e.g., pain, blood loss, hematoma, hemothorax, air embolism, cardiac tamponade), and complications associated with chronic use (e.g., implant rejection, endocarditis, damage to the port-catheter system, and system dislodgement). The majority of complications associated with totally implantable vascular access systems may be minimized using meticulous care and monitoring the patient {4} 510(k) Premarket Notification TARGET Vital-Port® Vascular Access System 23 closely. The history of clinical use of implantable vascular access systems shows its suitability for long-term intravascular therapy. {5} 510(k) Premarket Notification TARGET Vital-Port Vascular Access System 24 # SUMMARY TABLE # TYPES AND CAUSES OF SAFETY AND/OR EFFECTIVENESS PROBLEMS # OF TOTALLY IMPLANTABLE VASCULAR ACCESS SYSTEMS | PROBLEM | CAUSE | COMMENT | REF. | | --- | --- | --- | --- | | Local infection or catheter-related sepsis | May result from insufficient use of aseptic technique in accessing port, or from bacterial colonization along catheter. | Infection can usually be resolved with local care or systemic antibiotics. Meticulous attention to sterile technique upon port access may minimize occurrence. | 1,3-6,14-16 | | Skin erosion or necrosis | Causes include inadequate implantation depth of port reservoir, toxic drug extravasation, and port pocket infection. | Place port reservoir a minimum depth of 5 mm. Monitor closely for signs of drug extravasation and local infection. | 5,6,15 | | Venous thrombosis | Primarily due to presence of a foreign body. | May be resolved with anticoagulant treatment, as with streptokinase, heparin, or Coumadin. | 4-6,14,15 | | Occlusion | Causes include thrombin formation, drug crystallization, catheter kinking due to inadequate port anchoring, and catheter compression between first rib and clavicle. | Confirm placement of catheter tip in area of high blood flow. Periodic flushing is important to minimize occurrence. Changing patient position may resolve symptoms. If necessary, treat with streptokinase, urokinase, or heparin. | 1,3-6,11,14,15 | | Extravasation | Causes include needle dislodgement upon port access, disconnection between port and catheter, development of thrombosis at catheter tip which may cause retrograde flow, and catheter fracture. | Confirm complete needle entry into port chamber. Monitor for evidence of catheter damage or catheter-to-port disconnection, using radiographic techniques as necessary. | 3-6,9,14,15 | | Catheter migration | Catheter tip may drift between jugular and SVC due to pressure changes within thoracic cavity or change in anatomic position. | Tip may shift and return to initial position in SVC with no intervention. Otherwise, radiographic techniques may be used, if necessary, to reposition catheter. | 4,14,15 | | Catheter embolization | Catheter separation from port may be a result of disconnection, or catheter fracture due to compression between first rib and clavicle. | Use more lateral insertion to avoid catheter compression. If compression is evident, radiologically monitor patient. Upon system placement, confirm catheter-to-port connection. | 4,6-8,10-14,15 | | Difficult access | May occur in obese patients or if excessive fatty tissue develops on chest wall. | Place port reservoir at supported location, and at appropriate depth. | 3,15 | | Needle phobia | Reported to occur primarily in patients unfamiliar with device use. | Familiarity of use typically resolves fear over time. | 3 | | Pneumothorax | Reported as result of surgical procedure. | Potential complication associated with surgical procedure. Use careful technique in placing system, and monitor patient closely. | 5,6,15 | | Cardiac Arrhythmia | Reported during surgical placement of system. | Potential complication associated with surgical procedure. Continuously monitor patient closely throughout procedure. Pharmaceutic or electrical intervention may be required. | 15 | | Arterial Puncture | Reported during surgical placement of system. | Potential complication associated with surgical procedure. Use careful technique in placing system, and monitor patient closely. | 15 | {6} 510(k) Premarket Notification Target Vital-Port® Vascular Access System 25 # BIBLIOGRAPHY [1] Greene FL, Moore W, Strickland G, et al. Comparison of a totally implantable access device for chemotherapy (Port-A-Cath) and long-term percutaneous catheterization (Broviac). Southern Medical Journal 1988;81(5):580-3. [2] May GS and Davis C. Percutaneous catheters and totally implantable access systems. Journal of Intravenous Nursing 1988;11(2):97-103. [3] Ross MN, Haase GM, Poole MA, et al. Comparison of totally implanted reservoirs with external catheters as venous access devices in pediatric oncologic patients. Surgery, Gynecology and Obstetrics 1988;167:141-4. [4] Moore CL, Erikson KA, Yanes LB, et al. Nursing care and management of venous access ports. Oncology Nursing Forum 1986;13(3):35-9. [5] Freytes CO, Reid P, and Smith KL. Long-term experience with a totally implanted catheter system in cancer patients. Journal of Surgical Oncology 1990;45:99-102. [6] Brincker H and Saeter G. Fifty-five patient years' experience with a totally implanted system for intravenous chemotherapy. Cancer 1986;57:1124-9. [7] Kirvelä O and Satokari K. In situ breakage of a totally implanted venous access system. Journal of Parenteral and Enteral Nutrition 1989;13(1):99-101. [8] Prager D and Hertzberg RW. Spontaneous intravenous catheter fracture and embolization from an implanted venous access port and analysis by scanning electron microscopy. Cancer 1987;60:270-3. [9] Bach F, Videbaek C, Holst-Christensen J, et al. A serious complication of long-term venous access. Cancer 1991;68:538-9. [10] Lafreniere R. Indwelling subclavian catheters and a visit with the "pinched-off sign". Journal of Surgical Oncology 1991;47:261-4. [11] Hinke DH, Zandt-Stastny DA, Goodman LR, et al. Pinch-off syndrome: a complication of implantable subclavian venous access devices. Radiology 1990;177:353-6 [12] Carr ME. Catheter embolization from implanted venous access devices: case reports. Angiology 1989;12:319-23. {7} 510(k) Premarket Notification Target Vital-Port® Vascular Access System 26 [13] Franey T, DeMarco LC, Geiss AC, et al. Catheter fracture and embolization in a totally implanted venous access catheter. Journal of Parenteral and Enteral Nutrition 1988;12:528-30. [14] Lokich JJ, Bothe A, Benotti P, and Moore C. Complications and management of implanted venous access catheters. Journal of Clinical Oncology 1985;3(5):710-17. [15] Brothers TE, Von Moll LK, Niederhuber JE, et al. Experience with subcutaneous infusion ports in three hundred patients. Surgery 1988;166(4):295-301. [16] Groeger JS, Lucas AB, Thaler HT, et al. Infectious morbidity associated with long-term use of venous access devices in patients with cancer. Ann Intern Med 1993;119:1168-74.