(58 days)
The FlowTriever2 Catheter is indicated for:
• The non-surgical removal of emboli and thrombi from peripheral blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).
The Inari FlowTriever Retrieval/Aspiration System is a single-use, sterile medical device comprised of the following components, each packaged separately:
• FlowTriever2 Catheter - Model 11-102
• Triever20® - Model 21-101
• Triever24® - Model 22-101
• Triever16® - Model 25-101
The FlowTriever2 Catheter is used to engage and retrieve emboli and thrombi. It consists of a coaxial catheter assembly with an outer Delivery Catheter and an inner catheter having a flexible shaft attached to distal self-expanding wireform element. A "Y" connector with a rotatable hemostatic valve and stopcock is attached to the proximal end of the outer Delivery Catheter. Radiopaque markers are positioned near the distal tip of the Delivery Catheter and at the proximal and distal ends of the self-expanding FlowTriever element to aid with fluoroscopic visualization.
The Triever20 and Triever24 (packaged separately) provides a conduit for FlowTriever2 Catheter deployment, aspiration, and clot removal. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. A Dilator compatible with a 0.035" guidewire is provided for the Triever20 and Triever24 to aid insertion.
Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or 24 Fr) over the pre-inserted guidewire to a location proximal to the targeted thrombus. Thrombus is removed via aspiration using the Triever16, after which it can be withdrawn and flushed to remove residual thrombus, leaving the Triever Catheter in place as a conduit for subsequent thrombectomy passes. The user may elect to perform a thrombectomy pass using the FlowTriever2 Catheter or through the Triever16 using aspiration alone.
The Inari FlowTriever Retrieval/Aspiration System has not been evaluated for use in the neurovasculature.
The provided text is related to the FDA 510(k) premarket notification for the FlowTriever2 Catheter, specifically for an expanded indication for the treatment of pulmonary embolism (PE). This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical and clinical testing.
The information primarily describes the device, its indications for use, comparison with a predicate device, and the specifics of a clinical study (FLARE-FT2) to support the expanded indication. However, it does not delineate specific acceptance criteria with reported device performance in a table format as requested. Furthermore, it does not specify details about sample sizes for test sets, ground truth establishment methods for test/training sets, or specific information about MRMC studies, as the device is not an AI/ML diagnostic system.
Based on the provided text, here's an attempt to extract the requested information, with notable limitations due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the primary safety and effectiveness endpoints of the FLARE-FT2 clinical study. These endpoints serve as the "acceptance criteria" and the study results are the "reported device performance."
| Acceptance Criteria (Endpoint) | Reported Device Performance (FLARE-FT2 Study Result) |
|---|---|
| Primary Safety Endpoint: Incidence of Serious Adverse Events (SAE), defined as a composite of device-related mortality, major bleeding, and intra-procedural device or procedure-related adverse events (clinical deterioration, pulmonary vascular injury, or cardiac injury) measured at 48 hours. | The study met the performance goal for the primary safety endpoint. (Specific rates not provided in this summary) |
| Primary Effectiveness Endpoint: Change in mean and systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure. | The study met the performance goal for the primary effectiveness endpoint. (Specific changes not provided in this summary) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): A total of 50 patients were enrolled in the FLARE-FT2 clinical study.
- Data Provenance: The study was a prospective, single-arm, multicenter confirmatory study. The country of origin is not explicitly stated, but clinical studies are generally conducted in a controlled, multi-center environment, likely within the US given FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document describes a clinical study for a medical device (catheter) used for embolectomy/thrombectomy, not an AI/ML diagnostic software. Therefore, the concept of "ground truth" established by experts for a "test set" in the context of an algorithm's performance is not directly applicable here. The outcomes measured in the clinical study (SAE, changes in pulmonary arterial pressure) are direct physiological measurements or clinical events, not classifications requiring expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
As this is a clinical trial evaluating a medical device, not an AI/ML diagnostic, adjudication methods like N+1 consensus are not detailed for establishing ground truth of image interpretations. Clinical trials typically have a different structure for reviewing and adjudicating adverse events and clinical outcomes, often involving independent clinical event committees (CECs) or data safety monitoring boards (DSMBs), but the specifics are not included in this 510(k) summary.
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. This document does not mention an MRMC study. The device is a physical catheter for thrombectomy and embolectomy, not an AI/ML-driven diagnostic or assistive software requiring comparison of human reader performance with and without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This question is irrelevant as the device is a physical catheter, not an algorithm.
7. The type of ground truth used:
The "ground truth" in the context of this device's clinical study refers to directly measured safety and effectiveness outcomes in patients.
- Safety: Incidence of Serious Adverse Events (SAE), including device-related mortality, major bleeding, and intra-procedural adverse events. These are clinical outcomes directly observed and recorded.
- Effectiveness: Change in mean and systolic pulmonary arterial pressure (a physiological measurement).
8. The sample size for the training set:
As this is a physical medical device and its clearance is based on a clinical trial for effectiveness and safety, not on an AI/ML model for which a "training set" would be used, this concept is not applicable here. The 50 patients in the FLARE-FT2 study represent the clinical evaluation data.
9. How the ground truth for the training set was established:
Not applicable, as no AI/ML model with a separate training set is described. The "ground truth" for the clinical study was established through direct patient observation and physiological measurements.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).