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.

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.

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 The port reservoir is covered by a self-sealing silicone rubber septum through which fluids are administered or withdrawn.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.

AI/ML Overview

The provided text is a 510(k) Summary for the TARGET Vital-Port® Vascular Access System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical study data to prove novel safety and effectiveness.

Therefore, many of the requested elements for a study proving device acceptance criteria (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, specific acceptance criteria with performance metrics, ground truth establishment methods) are not present in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or a direct study measuring the TARGET Vital-Port® Vascular Access System's performance against these criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices and summarizing the historical clinical performance and known complications of all totally implantable vascular access systems.

The "Summary Table Types and Causes of Safety and/or Effectiveness Problems" (Section 5) implicitly describes potential areas of concern and outlines common causes and mitigation strategies, which can be seen as addressing potential failure modes rather than setting acceptance criteria for the new device.

Problem (Implicit Concern/Risk)	Cause (Identified in literature)	Comment (Mitigation/Resolution)	References
Local infection or catheter-related sepsis	Insufficient aseptic technique, bacterial colonization	Local care, systemic antibiotics, meticulous sterile technique	1,3-6,14-16
Skin erosion or necrosis	Inadequate implantation depth, toxic drug extravasation, port pocket infection	Place port reservoir a minimum depth of 5 mm, monitor for signs of extravasation/infection	5,6,15
Venous thrombosis	Presence of a foreign body	Anticoagulant treatment	4-6,14,15
Occlusion	Thrombin formation, drug crystallization, catheter kinking, catheter compression	Confirm catheter tip placement, periodic flushing, change patient position, treat with thrombolytics	1,3-6,11,14,15
Extravasation	Needle dislodgement, disconnection between port/catheter, thrombosis at catheter tip, catheter fracture	Confirm complete needle entry, monitor for catheter damage/disconnection (radiographic techniques)	3-6,9,14,15
Catheter migration	Pressure changes within thoracic cavity, change in anatomic position	May resolve spontaneously, reposition using radiographic techniques if necessary	4,14,15
Catheter embolization	Catheter separation (disconnection or fracture due to compression)	Use lateral insertion, monitor radiologically for compression, confirm catheter-to-port connection	4,6-8,10-14,15
Difficult access	Obese patients, excessive fatty tissue	Place port at supported location and appropriate depth	3,15
Needle phobia	Unfamiliarity with device use	Familiarity typically resolves fear	3
Pneumothorax	Surgical procedure	Careful surgical technique, patient monitoring	5,6,15
Cardiac Arrhythmia	Surgical placement of system	Continuous patient monitoring, pharmacologic/electrical intervention	15
Arterial Puncture	Surgical placement of system	Careful surgical technique, patient monitoring	15

Device Performance for TARGET Vital-Port®: The document states that 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." It also claims it "is similar with respect to indications for use, materials and physical construction to predicate devices." This implies that its performance is expected to be substantially equivalent to these predicate devices, whose performance is summarized by the cited literature concerning implantable vascular access systems in general. No specific performance data for the TARGET Vital-Port® itself is reported.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided for the TARGET Vital-Port®. This submission relies on demonstrating substantial equivalence to existing devices through literature review of the general performance of implantable vascular access systems, rather than a specific clinical trial with a dedicated test set for the TARGET Vital-Port® device. The literature review covered 16 published articles dating from 1985 to 1991. The data provenance for these articles would vary by study (e.g., country of origin, retrospective/prospective), but this detail is not provided for each reference.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No specific "ground truth" for a test set of the TARGET Vital-Port® was established as there was no de novo clinical study detailed in this summary. The "truth" is derived from the aggregated clinical experience reported in the cited medical literature regarding adverse events and complications of implantable vascular access systems. The authors of these 16 articles, presumably, are medical professionals, but their specific qualifications are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/None specified. Since no specific test set and ground truth establishment process is described for the TARGET Vital-Port® in this document, no adjudication method is mentioned. The document relies on published findings from various independent studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a medical device (vascular access system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As stated above, this is not an AI algorithm study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is based on aggregate outcomes data and reported complications from published clinical literature regarding similar totally implantable vascular access systems (Section 3 and Section 5). It's essentially a summary of real-world clinical experience and reported adverse events. For instance, "Venous thrombosis" or "Catheter embolization" are documented outcomes.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of device development as described in this 510(k) summary. The device's design is based on the established designs and materials of predicate devices, informed by the overall historical clinical experience of similar systems.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant to the provided text. The device's safety and effectiveness are supported by its substantial equivalence to predicate devices and the historical performance of those predicate devices as detailed in the medical literature.

Summary

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K970442$^{19}$

510(k) Summary of Substantial Equivalence:

APR 3 0 1997

Submitted By: Neal E. Fearnot, President MED Institute, Incorporated P.O. Box 2402 West Lafavette, 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 InfusionPort
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:

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.

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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.

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

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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. 13 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.13 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.13 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.

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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

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closely. The history of clinical use of implantable vascular access systems shows its suitability for long-term intravascular therapy.

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SUMMARY TABLE TYPES AND CAUSES OF SAFETY AND/OR EFFECTIVENESS PROBLEMS OF TOTALLY IMPLANTABLE VASCULAR ACCESS SYSTEMS

Company

PROBLEM	CAUSE	COMMENT	REF.
Local infection or catheter-relatedsepsis	May result from insufficient use of aseptic technique inaccessing port, or from bacterial colonization along catheter.	Infection can usually be resolved with local care or systemicantibiotics. 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 closelyfor 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 withstreptokinase, heparin, or Coumadin.	4-6,14,15
Occlusion	Causes include thrombin formation, drug crystallization,catheter kinking due to inadequate port anchoring, and cathetercompression between first rib and clavicle.	Confirm placement of catheter tip in area of high blood flow.Periodic flushing is important to minimize occurrence. Changingpatient position may resolve symptoms. If necessary, treat withstreptokinase, urokinase, or heparin.	1,3-6,11,14,15
Extravasation	Causes include needle dislodgement upon port access,disconnection between port and catheter, development ofthrombosis at catheter tip which may cause retrograde flow,and catheter fracture.	Confirm complete needle entry into port chamber. Monitor forevidence 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 topressure changes within thoracic cavity or change in anatomicposition.	Tip may shift and return to initial position in SVC with nointervention. Otherwise, radiographic techniques may be used, ifnecessary, 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 andclavicle.	Use more lateral insertion to avoid catheter compression. Ifcompression is evident, radiologically monitor patient. Uponsystem placement, confirm catheter-to-port connection.	4,6-8,10-14,15
Difficult access	May occur in obese patients or if excessive fatty tissuedevelops on chest wall.	Place port reservoir at supported location, and at appropriatedepth.	3,15
Needle phobia	Reported to occur primarily in patients unfamiliar with deviceuse.	Familiarity of use typically resolves fear over time.	3
Pneumothorax	Reported as result of surgical procedure.	Potential complication associated with surgical procedure. Usecareful 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. Usecareful technique in placing system, and monitor patient closely.	15

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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.
May GS and Davis C. Percutaneous catheters and totally implantable access [2] systems. Journal of Intravenous Nursing 1988;11(2):97-103.
Ross MN. Haase GM. Poole MA. et al. Comparison of totally implanted (3) reservoirs with external catheters as venous access devices in pediatric oncologic patients. Surgery, Gynecology and Obstetrics 1988;167:141-4.
Moore CL. Erikson KA. Yanes LB, et al. Nursing care and management of [4] venous access ports. Oncology Nursing Forum 1986;13(3):35-9.
િરો Frevtes 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.
Brincker H and Saeter G. Fifty-five patient years' experience with a totally [6] implanted system for intravenous chemotherapy. Cancer 1986:57:1124-9.
ן71 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 longterm 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.
[1]] 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.

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[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.
Lokich JJ, Bothe A, Benotti P, and Moore C. Complications and management [14] 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.

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

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