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510(k) Data Aggregation
(84 days)
TARGET VITAL-PORT VASCULAR ACCESS SYSTEM
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 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 The port reservoir is covered by a self-sealing silicone rubber septum through which fluids are administered or withdrawn.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.
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.
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