(139 days)
The r4 Pherocious 14 apheresis triple lumen catheter is designed for short and long term (>30 days) apheresis, intravenous infusion, blood sampling and CECT via the jugular veins or subclavian vein. The maximum recommended flow rate is 5 ml/sec for power injection of contrast media. The maximum pressure of the power injector utilized should not exceed 300 psi.
The r4 Vascular, Inc Pherocious™ is a family of apheresis triple lumen catheters designed to perform apheresis, intravenous infusion, blood sampling and power injection. The catheters, made of radiopaque polyurethane tubing are inserted via jugular, subclavian or femoral veins. Pherocious™ has a kink resistant, atraumatic, staggered tip design. The lumen with the purple connector, extension leg, and clamp may be used for CT injection as denoted by the text, "power injectable," printed on the extension leg. The remaining lumens with the red and blue connectors and blue and red or white clamps are for blood products. The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Pherocious™ kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic. The Pherocious 110 product line has catheters in 10.5 Fr and 12.5 Fr triple lumen. The catheters come in a variety of lengths for patient specificity. The Pherocious 10 is similar to Bard TriFusion with the addition of the ability to CECT inject that is substantially equivalent to the Zeus.
The provided text describes a 510(k) premarket notification for the r4 Vascular, Inc. Pherocious™ intravascular catheter. The submission asserts substantial equivalence to predicate devices and includes information about performance testing.
However, the provided text does not contain the specific details required to fully address all parts of your request, particularly regarding acceptance criteria and a detailed study report for AI/machine learning device performance. This document is for a medical device (catheter), not specifically an AI/ML diagnostic or prognostic tool. Therefore, the questions related to AI device performance (MRMC studies, standalone performance, training set, experts for ground truth) are not applicable or cannot be answered from this text.
Here's the information that can be extracted and a clear indication of what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | Met established criteria of safety and effectiveness | "Met all established acceptance criteria for performance testing and design verification testing." |
| CECT Injection Flow Rate | Maximum recommended flow rate 5 ml/sec | The device is designed for this flow rate. |
| CECT Injection Pressure | Maximum pressure not to exceed 300 psi | The device is designed for this pressure. |
| Biocompatibility | Requirements according to ISO-10993 Part 1 for externally communicating, blood-contacting, long-term devices | Test profiles for these requirements will be met. (Implies met, but no specific data presented) |
| Standards Compliance | ISO 10555-1:1997, ISO 594, ISO 10993 | "Testing was based on FDA guidance documents and recognized standards... and other standards were used to determine the appropriate methods for evaluating the device's performance." "Pherocious™ met the performance criteria of safety and effectiveness testing performed." |
Missing Information:
- Specific numerical acceptance criteria for each test performed (e.g., tensile strength, flow resistance, leakage rates, etc.).
- Detailed quantitative results of the device performance against each specific criterion. The document only provides a high-level qualitative statement that criteria were met.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance testing was generated in accordance with the above referenced guidance document and standards."
However, no specific sample size for a test set (e.g., number of catheters tested) is provided.
No information on data provenance (e.g., country of origin, retrospective/prospective) is available, as this is a physical medical device, not a data-driven diagnostic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This document describes a physical medical device (catheter) evaluation, not a study involving expert-established ground truth for an AI/ML algorithm.
4. Adjudication Method for the Test Set:
Not applicable. As above, this is for a physical device, not an AI/ML algorithm requiring expert adjudication of results.
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 section describes a physical medical device. No AI component is mentioned, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used:
For a physical device like a catheter, "ground truth" typically refers to established engineering principles, material science specifications, and performance requirements outlined in recognized standards (e.g., ISO, FDA guidance documents). For instance, burst pressure, tensile strength, flow rates, and biocompatibility are measured against predefined acceptable limits. The document states:
- "Testing was based on FDA guidance documents and recognized standards to evaluate the devices' performance."
- Referenced standards include: FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, ISO 10555-1:1997, ISO 594, ISO 10993 Part 1.
8. The Sample Size for the Training Set:
Not applicable. This relates to AI/ML devices. The Pherocious™ is a physical catheter, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, this is for a physical device, not an AI/ML algorithm.
§ 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.”