(43 days)
A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.
The provided 510(k) summary (K994216) describes the "Plastic Port Implantable Venous Access Systems" and evaluates their safety and effectiveness through in-vitro functional testing and biocompatibility testing. It explicitly states that clinical studies were not deemed necessary due to the device's similarity to existing, legally marketed predicate devices. Therefore, the device performance is primarily assessed against functional specifications and material properties rather than clinical outcomes or diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Catheter to port connection functionality | Functioned according to specifications (implied by "function according to specifications") |
| Septum puncture performance | Functioned according to specifications (implied by "function according to specifications") |
| System leakage | Functioned according to specifications (implied by "function according to specifications") |
| Clearance testing | Functioned according to specifications (implied by "function according to specifications") |
| Biocompatibility of system components | Materials used in the system are biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the in-vitro functional tests. It generally refers to "In-vitro testing" and "Biocompatibility testing."
- Data Provenance: The data provenance is from "In-vitro testing" and refers to laboratory tests, not human or animal subjects. As it's in-vitro testing performed by the manufacturer, it's considered retrospective in the sense that the test results would be analyzed after the experiments were conducted. There is no country of origin specified for the testing data itself, assumed to be internal to the manufacturer (SIMS Deltec, Inc. in St. Paul, MN, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This study primarily involved in-vitro functional testing and biocompatibility testing, not diagnostic or clinical accuracy evaluations requiring expert interpretation of ground truth. The "ground truth" for these tests would be established by engineering specifications and established material testing standards, not by human experts interpreting clinical data.
4. Adjudication Method for the Test Set
- Not applicable. As described above, this study focused on in-vitro functional and biocompatibility testing, which typically relies on objective measurements against predefined specifications rather than expert adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical studies were not deemed necessary regarding Plastic Port Implantable Venous Access Systems due to their similarity in materials, design and function to current SIMS Deltec systems and other commercially available systems." Therefore, there is no information on human reader improvement with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, a standalone performance study was done in the form of in-vitro functional testing and biocompatibility testing. This assessment was purely on the device's physical and material properties against specifications without any human-in-the-loop interaction for performance evaluation.
7. Type of Ground Truth Used
- Engineering specifications and material science standards. For functional testing (catheter to port connection, septum puncture, system leakage, clearance), the ground truth is defined by the device's design specifications and industry standards for performance. For biocompatibility testing, the ground truth is established by recognized biocompatibility standards and material properties deemed safe for human contact.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm requiring a training set. The performance evaluation was based on traditional in-vitro testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned above, there is no training set as this is not an AI/ML device.
§ 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.