(67 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature.
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.
The provided text describes a 510(k) premarket notification for the Inari Medical FlowTriever Retrieval/Aspiration System. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the text:
1. Table of Acceptance Criteria and the Reported Device Performance
The document states that "Test results demonstrated that all acceptance criteria were met," and "This testing FlowTriever demonstrated compliance with relevant product specifications." However, it does not explicitly list the specific quantitative acceptance criteria for each test or the exact performance values achieved. It only lists the types of tests performed.
| Test Category | Specific Test | Acceptance Criteria (Not explicitly stated in text) | Reported Device Performance (Not explicitly stated in text) |
|---|---|---|---|
| Material/Component Integrity | Visual and Dimensional Inspections | Implied: Within specified tolerances | Implied: Met specified tolerances |
| Functional Performance (Catheter) | Guidewire Compatibility Verification | Implied: Compatible with designated guidewires | Implied: Demonstrated compatibility |
| Leakage Verification, AGC Hemostasis Valve And Accessory Devices | Implied: No leakage beyond acceptable limits | Implied: No leakage detected | |
| Air Leakage From AGC Hemostasis Valve During Syringe Pullback | Implied: No air leakage beyond acceptable limits | Implied: No air leakage detected | |
| Air Leakage During Syringe Pullback | Implied: No air leakage beyond acceptable limits | Implied: No air leakage detected | |
| Vacuum Testing | Implied: Achieved and maintained specified vacuum levels | Implied: Met specified vacuum requirements | |
| Retraction Force Testing | Implied: Within specified force range | Implied: Within specified force range | |
| Push Button Force | Implied: Within specified force range | Implied: Within specified force range | |
| Retraction Aspirator Device Retraction | Implied: Consistent and effective retraction | Implied: Demonstrated consistent and effective retraction | |
| Simulated Use, Track and Tensile | Implied: Met performance requirements for simulated use, tracking, and tensile strength | Implied: Met performance requirements | |
| Stopcock Torque Testing | Implied: Within specified torque range | Implied: Within specified torque range | |
| Burst Testing of Hemostasis Valve and Stopcock | Implied: Withstood specified burst pressures | Implied: Withstood specified burst pressures |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test. The data provenance is non-clinical testing, meaning it involves engineering and bench testing, not patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies do not apply in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the study described is non-clinical testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation of outcomes. The "ground truth" here is adherence to engineering specifications and performance standards.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3. The testing involves objective measurements against predefined specifications, not subjective human assessment requiring adjudication.
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, an MRMC comparative effectiveness study was not done. The device is a physical medical device (embolectomy catheter), not an AI-driven diagnostic or assistive system that would involve human readers. Clinical testing was explicitly stated as "not required for the determination of substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was based on established product specifications, engineering standards, and the intended use of the device. The tests were designed to verify that the modified device met these predefined criteria.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this non-clinical engineering and performance testing for a physical medical device. This is not an AI/machine learning study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).