(107 days)
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. The maximum pressure of power injector equipment used with the pressure injectable PICC may not exceed 300 psi.
The Arrow PICC have the following characteristics: Radiopaque polyurethane catheters; 4 Fr Single Lumen, trimmable; 5 Fr Double Lumen, trimmable and BlueFlex® Tip; Usable lengths of 5 French catheter is 40 and 60 cm; Usable length of 4 French catheter is 60 cm; Catheters are provided sterile kit configurations. The catheter is labeled for "4cc/pressure injectable" on the catheter distal hub to facilitate the proper use of the device.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance (Summary of Results) |
|---|---|
| Dynamic Flow Rate test | Demonstrates substantial equivalence by performing favorably when compared to the AngioDynamic's catheter. |
| Catheter whip test | Demonstrates substantial equivalence by performing favorably when compared to the AngioDynamic's catheter. |
| Repeat Injection Test | Demonstrates substantial equivalence by performing favorably when compared to the AngioDynamic's catheter. (Specifically to verify the new intended use of power injection of contrast media up to 300 psi). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical trials or AI/algorithm performance. The performance tests described ("Dynamic Flow Rate test," "Catheter whip test," "Repeat Injection Test") are bench tests conducted on the physical device itself. Therefore, sample sizes for these tests are not provided in terms of patient data, nor is data provenance like country of origin or retrospective/prospective mentioned, as these are not relevant to bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for these bench tests would be the measured physical properties or performance characteristics of the device under specific test conditions, compared against established engineering standards or the performance of a predicate device. This doesn't involve expert human assessment in the way clinical ground truth does.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are bench tests, not clinical evaluations that would require adjudication of human interpretation.
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
No, an MRMC comparative effectiveness study was not done. This device is a medical catheter, not an AI or imaging diagnostic tool that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests would be based on objective measurements and engineering standards, compared directly to the performance of the legally marketed predicate devices (AngioDynamic's Morpheus™ CT PICC and Arrow International's existing PICC). The "Repeat Injection Test" specifically verifies the ability to withstand power injection of contrast media at a maximum pressure of 300 psi, which would be a measured performance characteristic.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used for this device.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”