(53 days)
A P.A.S. PORT® 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® Elite 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 P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole. The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.
The provided text describes a 510(k) submission for the P.A.S. PORT® Elite Implantable Venous Access System. This is a medical device, not a diagnostic AI/ML algorithm. Therefore, the questions related to AI/ML specific criteria (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets in the context of AI, data provenance for AI) are not applicable to this document.
However, I can extract the acceptance criteria and the study that proves the device meets those criteria, based on the information provided for this medical device.
Acceptance Criteria and Device Performance for P.A.S. PORT® Elite Implantable Venous Access System
The submission indicates that the P.A.S. PORT® Elite System is a modification of an existing device and is compared to two predicate devices. The acceptance criteria are largely implied by the functional and biocompatibility testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device functions according to specifications for an implanted infusion port. | Septum Puncture: Testing conducted in accordance with FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. Results indicated functionality according to specification. |
| System Leakage: Testing conducted in accordance with FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. Results indicated functionality according to specification. | ||
| Clearance Testing: Testing conducted in accordance with FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports," dated October 1990. Results indicated functionality according to specification. | ||
| Biocompatibility | System components are biocompatible for human implantation. | Biocompatibility Testing: Conducted on system components. Results indicated materials used in the system are biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The studies were in-vitro (laboratory) functional and biocompatibility tests, not studies involving human or animal subjects that typically have "sample sizes" in this context.
- Data Provenance: Not specified, but the testing was "in-vitro," meaning in a controlled laboratory environment, likely at the manufacturer's facility. The country of origin of the data is not mentioned, but the manufacturer is SIMS Deltec, Inc. based in St. Paul, MN, USA.
- Retrospective or Prospective: Not applicable, as these were laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for in-vitro functional and biocompatibility tests is typically established by engineering and materials science standards and measurements, not by expert consensus from medical professionals in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human interpretation. This submission describes engineering verification and validation testing.
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 device is not an AI/ML algorithm. No MRMC comparative effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the functional tests was compliance with the FDA "Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990), implying established engineering and performance specifications.
- For biocompatibility, the ground truth was meeting established biocompatibility standards for materials used in implantable devices.
8. The sample size for the training set
- Not applicable. There is no "training set" for this type of medical device submission, as it does not involve AI/ML.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 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.