Search Results

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 FlowTriever 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 two main components packaged separately: Aspiration Guide Catheter 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 Aspiration Guide 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 Aspiration Guide Catheter to capture the targeted thrombus. Additional clot may also be removed by aspiration with the provided 60 cc syringe. After the procedure is complete, the Aspiration Guide Catheter and FlowTriever Catheter are removed from the patient.

The provided document is a 510(k) premarket notification for a medical device called the FlowTriever Retrieval/Aspiration System. It is not an AI/ML device, therefore, the information requested in the prompt, such as acceptance criteria and studies proving the device meets it, in the context of AI/ML, isn't directly applicable or present in this document.

However, I can extract information about the non-clinical testing performed to establish substantial equivalence for the modified device.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document broadly states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not provide a specific table of acceptance criteria with corresponding performance values.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not applicable as this is not an AI/ML device and therefore no "test set" in that context. The testing mentioned in the document is non-clinical performance and safety testing.

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):

Not applicable as this is not an AI/ML device and therefore no "ground truth" establishment by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable as this is not an AI/ML device.

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 as this is not an AI/ML device and no human reader studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of AI/ML. For this medical device, the "ground truth" for its performance is established through adherence to engineering and safety specifications validated by the non-clinical tests listed.

8. The sample size for the training set:

Not applicable as this is not an AI/ML device and therefore no "training set."

9. How the ground truth for the training set was established:

Not applicable as this is not an AI/ML device.

Information on Non-Clinical Testing (relevant to device performance):

The document mentions several non-clinical tests performed to support the substantial equivalence of the modified FlowTriever Retrieval/Aspiration System:

• Packaging Testing
• Leak Testing
• Vacuum Testing
• Tensile Testing
• Simulated Use Testing
• Accelerated 2-year shelf-life testing (specifically for the modification to the 60 cc syringe)

These tests were performed in accordance with a Design Failure Modes and Effects Analysis (DFMEA) and demonstrated compliance with relevant product specifications, indicating that all acceptance criteria were met.

Important Note: The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This further emphasizes that the device's performance was evaluated through non-clinical means for this 510(k) submission.

Ask a specific question about this device