(122 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) Triever Catheters are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient.
The provided document is a 510(k) summary for the Triever Catheters. It describes a device modification to include "clot in transit in the right atrium" in the Indications for Use (IFU) statement. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in a quantitative manner typical of performance studies for AI software.
However, based on the information provided, we can extract the following:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: No heart damage (perforation, valve damage) related to treatment in the right atrium. | No right atrium treatment related cases in which any heart damage, i.e., perforation, valve damage, etc. was noted. |
| Effectiveness: Sufficient clot removal. | Average clot removal estimated to be almost 90%. |
| Clinician satisfaction with clot removal performance. | Inari Account Managers' assessment of clinician satisfaction based on clot removal performance. |
| No new or different questions of safety and effectiveness raised by the expanded IFU. | The information provided demonstrates that including clot in transit in the right atrium to the indications for use statement does not raise new or different questions of safety and effectiveness. |
| (Implicit) General anesthesia for delicate patients should be carefully considered. | One adverse event (patient death) was attributed to the use of general anesthesia in a tenuous patient, not the device itself. |
2. Sample size used for the test set and the data provenance
- Sample Size: Clinical data was collected and evaluated for 47 patients.
- Data Provenance: The nature of the study (evaluating use of Triever Catheters in the right atrium from approximately 7,650 venous thromboembolism procedures performed) suggests this data is retrospective, compiled from existing patient records where the device was used in this specific scenario. The country of origin is not specified, but the submission is to the FDA, suggesting a US context or data relevant to US regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth. The assessments appear to be based on clinical outcomes and "Inari Account Managers' assessment of clinician satisfaction."
4. Adjudication method for the test set
The document does not describe an adjudication method. The clinical data appears to be a review of outcomes from actual patient cases.
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. This study is focused on the safety and effectiveness of a medical device (catheter) for a specific indication, not on the performance of an AI algorithm or human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this document describes a medical device (catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for effectiveness (clot removal) appears to be based on outcomes data from patient treatments and possibly clinical assessment during or after the procedure. For safety, it relies on the absence of reported adverse events like heart damage.
8. The sample size for the training set
This document does not describe the development or training of an algorithm, so there is no mention of a training set sample size.
9. How the ground truth for the training set was established
Not applicable, as no algorithm training set is described.
§ 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).