(149 days)
Because of its low profile, the P.A.S. PORT II system is intended for peripheral placement in the arm. The portal can be implanted in the upper arm above the antecubital space below the axilla, or below the antecubital space in the upper part of the forearm. A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
The P.A.S. PORT® II System is similar to the current commercially available P.A.S. PORT® System. The systems have the identical outlet tube, catheter connector and catheter. The systems are also identical in that the P.A.S. PORT® II System will be made available with a sensor assembly and/or introducer set.
The P.A.S. PORT® II System will be modified to include a new portal shape, an increased septum diameter, an increased septum puncture life, a change in portal housing material (i.e. polysulfone/titanium), the rear suture hole will be filled with silicone, and a vein pick and a winged infusion set will be included with the systems.
This document is a 510(k) summary for a medical device (PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access Systems). It describes the device, its intended use, and a comparison to predicate devices, along with a summary of studies performed.
Here's the analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (Summary of Studies) |
|---|---|
| Septum Puncture Life | "The testing included septum puncture..." (Implies testing was performed and met an unstated criterion. The device description mentions an "increased septum puncture life" for the new device compared to the predicate, suggesting improvement or meeting a higher standard.) |
| System Leakage | "The testing included... system leakage..." (Implies testing was performed and met an unstated criterion.) |
| Clearance Testing | "The testing included... clearance testing." (Implies testing was performed and met an unstated criterion.) |
| Biocompatibility | "Biocompatibility testing was conducted on all system components." "The materials used in the system are biocompatible." |
| Functional Performance | "The results of the testing indicated that the PORT-A-CATH® P.A.S. PORT® II Implantable Venous Access System functions according to specification..." (Implies overall functional criteria were met.) |
Explanation: The document refers to a "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990, which likely outlines the specific, quantitative acceptance criteria for septum puncture life, leakage, and clearance. However, these specific numerical criteria are not provided in this summary. The summary only states that testing was "conducted in accordance" with the guidance and that the device "functions according to specification" and "materials are biocompatible."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "in-vitro testing" which typically involves a number of units of the device; however, the exact quantity is not mentioned.
- Data Provenance: The testing was "in-vitro testing," meaning it was conducted in a laboratory setting, not on human subjects. Therefore, there is no country of origin or retrospective/prospective data provenance in the clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical implantable medical device, and the "ground truth" for its performance (septum puncture life, leakage, biocompatibility) is established through standardized laboratory testing methods, not expert panel review of clinical data or images.
4. Adjudication Method for the Test Set
Not applicable. As described above, performance was assessed through objective in-vitro tests, not through human interpretation 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
Not applicable. This document describes a physical medical device (implantable venous access system), not an AI algorithm or a diagnostic tool that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established through in-vitro functional testing based on predefined specifications and biocompatibility testing standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device manufacturing processes and materials are inherently "trained" to meet specifications through design, engineering, and quality control, not through a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #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.