(30 days)
Triever Catheters are 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.
Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Triever Catheters are also intended for use in transit in the right atrium but not in conjunction with FlowTriever Catheters.
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 and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately: Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr) FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm) The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient.
This document is a 510(k) summary for the Triever Catheters (K210195) and does not contain the detailed information necessary to fully answer your request.
Here's a breakdown of why and what information is missing:
- Acceptance Criteria and Device Performance Table: The document states that "Clinical testing was not required for the determination of substantial equivalence" and that the submission "added a warning... in patients with severe pulmonary hypertension." This implies there were no new performance studies conducted to establish acceptance criteria or report new device performance metrics for the modified device. The original predicate device (K202345) would have had such studies, but their details are not present here.
- Sample size and data provenance for test set: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- Number of experts and qualifications for ground truth: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- Adjudication method: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- MRMC comparative effectiveness study: Not applicable, as no clinical studies are mentioned.
- Standalone algorithm performance: Not applicable, as this is a medical device (catheter system), not an AI algorithm.
- Type of ground truth used: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- Sample size for training set: Not applicable, as this is a medical device (catheter system), not an AI algorithm.
- How ground truth for training set was established: Not applicable, as this is a medical device (catheter system), not an AI algorithm.
Summary of available information:
The document explicitly states:
- Clinical testing was not required for the determination of substantial equivalence for this specific submission (K210195).
- The determination of substantial equivalence was based on the fact that the modification (adding a warning to the Instruction for Use regarding severe pulmonary hypertension) does not raise new or different questions of safety and effectiveness compared to the predicate device (Triever Catheters K202345).
- The device has the same indications for use as the predicate device.
To obtain the information you're looking for regarding acceptance criteria, performance data, and study details, you would need to access the information associated with the predicate device (K202345) or any prior 510(k) submissions for the Triever Catheters where such performance data would have been required for initial clearance.
§ 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).