(179 days)
The PowerPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.
A family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.
The provided document is a 510(k) summary for the PowerPICC Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing details of a study with acceptance criteria for an AI/ML powered device. Therefore, much of the requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful completion of the listed tests, indicating that the device performed as expected under the specified conditions. The document states that the performance tests were conducted "in determining substantial equivalence" and that "the subject PowerPICC Family Catheters have been demonstrated to be substantially equivalent to the cited predicate and reference devices." This implies that the device met the acceptance criteria derived from these tests.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Free from biological hazard per ISO 10993-1. | Confirmed free from biological hazard; health-based risk assessment performed. |
| Leak Test | Catheter assembly will not leak when distal end is occluded. | Test confirmed non-leakage. |
| Dimensional Test | Compliance with dimensional specifications (OD/ID for single lumen, OD/lumen area for dual). | Ensured compliance with dimensional specifications. |
| Implantable Length | Compliance with dimensional specifications. | Ensured compliance with dimensional specifications. |
| Extension Leg Length | Compliance with dimensional specifications. | Confirmed compliance with dimensional specifications. |
| Catheter Collapse Test | Catheter will not collapse under a vacuum during aspiration. | Demonstrated non-collapse under vacuum. |
| Burst Test | Catheter burst pressure exceeds peak pressure at maximum flow conditions (distal end occluded). | Confirmed burst pressure exceeds peak pressure. |
| Hydraulic Catheter Burst Test | Catheter burst pressure exceeds peak pressure at maximum flow conditions (distal end occluded). | Confirmed burst pressure exceeds peak pressure. |
| Power Injection Conditioning | Catheter does not leak or burst during power injections at maximum indicated flow rate. | Confirmed no leakage or burst. |
| Gravity Flow | Acceptable gravity flow performance for a full-length catheter. | Demonstrated acceptable gravity flow. |
| Luer to Extension Leg Tensile Test | Peak tensile force exceeds minimum peak tensile force. | Demonstrated peak tensile force exceeds minimum. |
| Extension Leg to Trifurcation Tensile Test | Peak tensile force exceeds minimum peak tensile force. | Demonstrated peak tensile force exceeds minimum. |
| Trifurcation to Shaft Tensile Test | Peak tensile force exceeds minimum peak tensile force. | Demonstrated peak tensile force exceeds minimum. |
| Shaft Tensile Test | Evaluate maximum catheter strain and modulus at break. | Evaluated. |
| Radiopacity | Demonstrates catheter radio-detectability. | Demonstrated radio-detectability. |
| Tip Tensile | Peak tensile force exceeds minimum peak tensile force. | Demonstrated peak tensile force exceeds minimum. |
| Suture Wing Integrity Test | Measures maximum force suture wing can withstand prior to break. | Measured maximum force. |
| Priming Volume | Measures volume required to prime a full-length catheter. | Measured priming volume. |
| OD Swell | Catheter does not swell beyond twice the labeled OD during power injection. | Confirmed no excessive swelling. |
| Tip Stability Test | Catheter tip remains in the same orientation during power injection. | Confirmed tip stability. |
| Guidewire Drag Test | Guidewire can be removed without difficulty. | Ensured guidewire removal without difficulty. |
| Luer Testing | Luer connectors meet requirements for Stress Cracking, Resistance to Separation (Axial Load, Unscrewing, Overriding). | Confirmed compliance with luer connector requirements. |
| Particulate | Complies with USP 788 for particulate matter. | Demonstrated compliance with USP 788. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test. It refers to "testing" in general. The data provenance is not mentioned, as these are in vitro and in vivo performance tests on the device itself, rather than studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are physical and biological performance tests, not clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for physical and biological performance testing, not interpretation of data by experts.
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 is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests are the established scientific and engineering principles, material properties, and regulatory standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F640-12, ISO 10555-3, FDA Guidance on Premarket Notification for Intravascular Catheters, ISO 80369-7, USP 788). The device's performance is measured against these defined benchmarks.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.”