(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 3 sizes: 6-10 mm, 11-14 mm, and 15-18 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.
I'm sorry, but the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them, as it pertains to an AI/ML medical device. The document is an FDA 510(k) clearance letter for the Inari Medical FlowTriever Retrieval/Aspiration System, which is a physical medical device (an embolectomy catheter system), not an AI/ML-based device.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set or data provenance for an AI/ML model.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results for AI assistance.
- Standalone performance results for an AI algorithm.
- Type of ground truth used for an AI/ML study.
- Sample size for an AI/ML training set.
- How ground truth for an AI/ML training set was established.
The document focuses on demonstrating substantial equivalence of a modified version of the FlowTriever system to a previously cleared predicate device, based on the physical and functional aspects of the catheter system and leveraging prior non-clinical testing. It explicitly states: "The FlowTriever Retrieval/Aspiration System is identical to the version cleared under K173672. Appropriate rationales were provided to support that the testing provided under K173672 may be appropriately leveraged to support clearance of this device for the proposed intended use. Therefore, additional verification testing is not necessary to establish compliance to design specifications." This indicates that no new in vivo or in vitro performance studies, let alone AI/ML studies, were conducted for this specific 510(k) submission.
§ 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).