(62 days)
The Vital-Port® Vascular Access System Power Injectable Port is intended for use for patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/ withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using media with a maximum viscosity of 11.8 cP.
The Vital-Port Vascular Access System Power Injectable Port is a titanium body vascular access port with a silicone septum and silicone filled suture holes. The subject device's catheter is a 7.5 Fr silicone catheter that may be supplied pre-attached or detached. The catheter lock is polysulfone with a silicone strain relief. The supplied catheter is 50 cm in length.
When used with a power injectable infusion set, the Vital-Port Vascular Access System Power Injectable Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8 cP. The maximum pressure limit setting for power injectors used with the Vital-Port may not exceed 325 psi and the flow rate may not exceed 5 ml/s.
The provided document describes the Cook Incorporated Vital-Port® Vascular Access System Power Injectable Port and its substantial equivalence to a predicate device. It primarily focuses on the device's ability to withstand power injections of contrast media.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Dynamic Failure Flow Test | Minimum of 5 ml/s without a failure | Met: Achieved a maximum sustainable flow rate of at least 5 ml/s without failure. |
| Instantaneous Burst Test | Mean burst pressure greater than the mean reservoir pressures characterized in previous testing | Met: Mean burst pressure was greater than the mean reservoir pressures. |
| Static Burst Test | Withstand 120 psi (827.3 KPa) for three minutes without failure | Met: All test articles withstood or exceeded 120 psi for three minutes without failure. |
| Cyclic/Puncture Life Test | No leakage at a flow rate of 5 ml/s | Met: All test articles showed no leakage at a flow rate of 5 ml/s. |
| Life Cycle Power Injection Test | Maintain system integrity after multiple power injections | Met: Each Vital-Port configuration maintained system integrity during all consecutive power injections. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each test. It refers to "test articles" and "all devices" but does not provide specific numbers.
The data provenance is from retrospective testing conducted by Cook Incorporated as part of their 510(k) submission. There is no information provided about the country of origin of the data beyond the manufacturer being in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the tests described are engineering and mechanical performance tests of a medical device, not clinical studies requiring expert interpretation of patient data or images to establish a 'ground truth'. The 'ground truth' for these tests is defined by the physical properties and performance limits of the device itself under specific conditions.
4. Adjudication Method for the Test Set
This is not applicable. The tests performed are objective, quantitative measurements of physical parameters (flow rate, pressure, leakage, integrity). The results are either met or not met based on predetermined numerical criteria, not on subjective assessment requiring adjudication by multiple readers or experts.
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
This is not applicable. The device is an implanted vascular access system, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study comparing human reader performance with or without AI assistance was not conducted and is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is engineering and performance specifications. These are defined by established industry standards, design requirements, and a comparison to the predicate device's known performance. For example, "no leakage at 5 ml/s" is an objective engineering performance metric.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context. The manufacturing process and design may involve iterative testing and refinement, but this is distinct from "training data" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device. The design specifications and performance requirements are established through engineering design processes, regulatory guidance, and comparison to existing predicate devices.
§ 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.