(81 days)
The theraPORT® is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.
The theraPORT® Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.
The provided text describes a medical device, the theraPORT® Vascular Access System, and outlines performance testing rather than acceptance criteria and a study to prove meeting those criteria in the context of diagnostic accuracy or clinical outcomes. The device is an implanted system, and the "studies" mentioned focus on engineering performance tests as opposed to clinical trials.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission mentions that performance testing was conducted in accordance with the "Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990." While specific quantitative acceptance criteria are not explicitly stated, the types of tests performed indicate the areas of performance evaluated. The "reported device performance" is summarized as the device "functions properly" and is "substantially equivalent."
| Acceptance Criteria (Implied from tests performed) | Reported Device Performance |
|---|---|
| Catheter-to-port connection strength | Functions properly |
| Septum puncture durability | Functions properly |
| Port leakage integrity | Functions properly |
| Port/catheter clearance | Functions properly |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide the sample sizes for the performance tests conducted. It also does not specify the origin of any data, as the tests described are laboratory-based engineering performance tests, not clinical studies with human subjects or retrospective data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable to the provided document. The ground truth for engineering performance tests is typically defined by engineering specifications and standards, not by expert consensus in a clinical diagnostic sense. No clinical experts were involved in what's described as "performance testing."
4. Adjudication Method for the Test Set
This is not applicable. The tests described are objective engineering performance tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the theraPORT® Vascular Access System to other commercially available systems." Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The theraPORT® Vascular Access System is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests would be defined by engineering standards and specifications outlined in the "Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990." For example, a "catheter-to-port connection strength" test would have a specified minimum force it must withstand, which serves as the ground truth for that particular test.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
§ 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.