(130 days)
The STD Med Primo Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
The STD Med Primo Port kit contains 1 Titanium port, 1 catheter of choice, and 2 corresponding catheter locks, The catheter is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in area of the subclavian fossa. The port is accessed percutaneously using a noncoring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.
The provided text describes a 510(k) premarket notification for the STD Med Primo Port, a totally-implantable vascular access device. The submission focuses on demonstrating substantial equivalence to a predicate device and meeting pre-determined acceptance criteria through bench testing.
Here's a breakdown of the requested information based on the provided text, with points that cannot be determined from the text explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance for each test. It states that "Performance data demonstrated that the STD Med Primo Port is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria." and that "The Primo Port meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness".
The categories of tests performed are listed under "Performance Testing":
| Acceptance Criteria Category (Test Performed) | Reported Device Performance |
|---|---|
| Overall dimensions | Met pre-determined criteria |
| Septum durability | Met pre-determined criteria |
| Port leakage | Met pre-determined criteria |
| Fluid dynamics clearance | Met pre-determined criteria |
| Catheter-to-port connection | Met pre-determined criteria |
| Flow rate | Met pre-determined criteria |
| Obturation | Met pre-determined criteria |
| Priming volume | Met pre-determined criteria |
| Needle insertion & retention forces | Met pre-determined criteria |
| Stem strength | Met pre-determined criteria |
Note: The actual quantitative criteria and specific numerical results are not detailed in the provided text, only that the device "met pre-determined acceptance criteria."
2. Sample Size used for the test set and the data provenance
- Sample Size: Not specified in the document. The text only refers to "bench tests performed."
- Data Provenance: Not applicable, as this was laboratory bench testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a physical device test, not a subjective assessment requiring expert ground truth in the way medical image analysis or clinical diagnosis would. The "ground truth" for these tests would be objective measurements against predefined engineering specifications.
4. Adjudication method for the test set
- Not applicable. As this involves objective physical testing, there would be no subjective adjudication in the typical sense. Measurements would be taken, and they either pass or fail the pre-defined criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. This study is for a physical medical device (implantable port), not an AI/software device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is for a physical medical device, not an algorithm.
7. The type of ground truth used
- Ground truth: Objective engineering specifications and performance standards established for device function (e.g., specific dimensions, leakage rates, force thresholds, flow rates). These "bench tests performed in accordance with FDA's October 1990 Guidance on 510(k) Submission for Implanted Infusion Ports" would have predefined metrics for passing.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device submission.
§ 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.