(71 days)
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 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.
The provided text describes a 510(k) summary for the Inari FlowTriever Retrieval/Aspiration System (K191710). This document is a premarket notification for a medical device and is primarily focused on demonstrating substantial equivalence to a predicate device, rather than detailed acceptance criteria and performance data typically found in a clinical study report for an AI-powered device.
Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth for an AI device are not applicable or cannot be extracted from this particular document.
However, I can extract information related to the device's performance based on the non-clinical testing performed to support substantial equivalence.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not explicitly list specific numerical acceptance criteria or detailed performance metrics for each test. The tests performed are verification and validation tests to ensure the modified device meets specified requirements.
| Test Item | Acceptance Criteria (Not explicitly stated with values) | Reported Device Performance (Implied) |
|---|---|---|
| Visual & Dimensional Inspection | Conforms to specifications | Met |
| Guidewire and Sheath Compatibility | Compatible with specified guidewires and sheaths | Met |
| Snap Fit, Dilator Luer to Guide Catheter | Secure fit and proper function | Met |
| Hemostasis Valve Leakage Testing | No leakage under specified conditions | Met |
| Vacuum Testing | Maintains vacuum under specified conditions | Met |
| Air leakage During Aspiration | No air leakage during aspiration | Met |
| Retraction Force Testing | Within specified force limits | Met |
| Kink Radius Testing | Resists kinking at specified radius | Met |
| Determination of Flowrate | Achieves specified flow rate | Met |
| Burst Testing | Withstands specified pressure without bursting | Met |
| Clot Burden Removal Validation | Effective in clot removal (details not provided) | Met |
| Push Button Force | Within specified force range for activation | Met |
| Simulated Use and Tensile Testing | Withstands simulated use and tensile forces | Met |
| Simulated Use and Torque | Functions correctly under simulated use and torque | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved various non-clinical engineering and bench tests, as well as an animal study. The number of units or repetitions for each test is not provided.
- Data Provenance: The testing was "non-clinical testing" and "animal testing." No human data or specified country of origin for data is mentioned. It is implied the testing was conducted by the manufacturer, Inari Medical, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This document describes the evaluation of a medical device (embolectomy catheter) through non-clinical and animal testing, not an AI or imaging device requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
- Not Applicable. As above, the document details non-clinical and animal testing, not a study involving human readers or requiring adjudication for a test set in the context of AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. This document does not mention any MRMC study or AI assistance. The device is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
- For Non-Clinical Tests: Engineering specifications, physical measurements, and performance standards.
- For Animal Testing: Observation of device safety and performance in an animal model.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, this is not an AI 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).