(30 days)
The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System is indicated for:
· The non-surgical removal of emboli and thrombi from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately:
Aspiration Guide Catheter
FlowTriever Catheter (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
Retraction Aspirator
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer Delivery Catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.
The provided text details a 510(k) summary for the Inari FlowTriever Retrieval/Aspiration System, specifically for a modification to increase the diameter of the disks of the FlowTriever Catheter. The document does not describe an acceptance criteria table or a study proving the device meets specific performance criteria in the context of diagnostic accuracy, which would include metrics like sensitivity, specificity, or AUC usually associated with AI/ML devices.
Instead, the document focuses on non-clinical testing to ensure the modified device still functions as intended and is substantially equivalent to its predicate devices. The "acceptance criteria" here refers to whether the device meets its predefined engineering and safety specifications through various mechanical and material tests.
Here's an breakdown based on the provided text, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with quantitative acceptance criteria and their corresponding reported performance values. It states generally: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."
The types of tests performed indicate the areas where acceptance criteria would have been set:
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Visual & Dimensional Inspections | Met |
| Deployment Force, Wireform Catheter from Delivery Catheter | Met |
| Retraction Force, Wireform Catheter into Delivery Catheter | Met |
| Retraction Force, Wireform Catheter into Guide Catheter | Met |
| Simulated Use Track and Tensile | Met |
| Simulated Thrombus Removal Characterization | Met |
| 25 mm Wireform Radial Expansion Force | Met |
| 2-year Shelf-life (leveraged from predicate) | Supported |
| Biocompatibility (leveraged from predicate) | Supported |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for each of the non-clinical tests. It refers to these as "verification and validation testing." The data provenance for such tests would typically be from in-house lab testing, not human patient data, and therefore country of origin in that context is not usually relevant. These are benchtop tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to the non-clinical testing described. "Ground truth" in the context of device function and safety for this type of submission is established by engineering specifications and industry standards, not by expert medical interpretation of images or patient outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies or studies involving human assessment of data (e.g., image interpretation). This submission details non-clinical, benchtop testing.
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 a medical device for mechanical thrombus removal, not an AI/ML diagnostic tool. There is no mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests would have been the engineering specifications and intended functional performance criteria established during the device's design and development, as well as adherence to relevant standards for biocompatibility and materials.
8. The sample size for the training set
Not applicable. There is no machine learning or AI component to this device that would require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).