(118 days)
The Vital-Port® CT Vascular Access System is indicated for patient therapy requiring repeated vascular access for injection or infusion therapy and/or blood sampling.
When used with a power injectable infusion set, Vital-Port® CT Vascular Access Systems are indicated for power injection of contrast media. The maximum pressure limit setting for power injectors used with the Vital-Port® CT may not exceed 325 psi, and the flow rate may not exceed the indicated maximum flow rate.
The Vital-Port® CT Vascular Access System consists of a plastic port body and catheter lock. There are two Vital-Port® CT body sizes, Standard and Petite. The catheters offered are: 7.5 or 9.5 Fr. silicone catheters or 6.0 or 7.5 Fr. polyurethane catheters. All catheters are 50 cm in length and are supplied either pre-attached or detached. The Vital-Port® CT Vascular Access System is a single lumen, long-term implantable infusion port catheter intended for in patient therapy requiring repeated vascular access, infusion therapy, power injected diagnostic techniques using contrast media and blood infusion/withdrawal. The Vital-Port® CT Vascular Access System port body is available in two configurations, Standard and Petite, with either a pre-attached silicone or polyurethane catheter.
The provided text describes the acceptance criteria and the studies conducted for the Vital-Port® CT Vascular Access System.
Here's a breakdown of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Dynamic Failure Flow Test | Not explicitly stated, but implied to demonstrate no failure during simulated use. | "Testing demonstrated that the vital port did not fail during simulated use." |
| Instantaneous Burst Test | Not explicitly stated, but implied to meet the acceptance criterion. | "Testing demonstrated that the burst test of the port system met the acceptance criterion." |
| Static Burst Test | At or above the acceptance criterion for static failure pressure. | "Testing demonstrated that the static failure pressure was at or above the acceptance criterion." |
| Puncture Life Test | Not explicitly stated, but implied to meet the acceptance criterion. | "Testing demonstrated that the puncture life test met the acceptance criterion." |
| Cyclic Test | Not explicitly stated, but implied to meet the acceptance criterion. | "Testing demonstrated that the cyclic test met the acceptance criterion." |
| MR Safety | Not explicitly stated, but implied to be MR Conditional. | "Testing demonstrated that the Vital-Port® CT Vascular Access System is MR Conditional." |
| Biocompatibility Tests (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, subacute toxicity, genotoxicity, implantation, and hemocompatibility) | Predetermined acceptance criteria as per ISO 10993-1:2009. | "In conformance with the applicable sections of ISO 10993-1:2009, the predetermined acceptance criteria were met." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each individual test or the data provenance (e.g., country of origin, retrospective or prospective). The descriptions simply state "Testing demonstrated..."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are engineering and biocompatibility tests, not clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic AI.
4. Adjudication method for the test set
This information is not applicable as the tests are primarily objective performance and safety tests, not subjective interpretations requiring adjudication.
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
There is no indication that an MRMC comparative effectiveness study was conducted, as this device is a physical medical device (vascular access system), not an AI diagnostic algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical vascular access system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests described is based on engineering standards and regulatory requirements. For example, the biocompatibility tests refer to ISO 10993-1:2009 standards. For the performance tests (burst, flow, cyclic), the ground truth is the predefined performance specification or failure threshold designed to ensure safe and effective operation.
8. The sample size for the training set
This information is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical medical device, not a machine learning model.
§ 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.