(26 days)
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Sheath. The ClotTriever Thrombectomy System is indicated for:
The non-surgical removal of soft thrombi and emboli from blood vessels.Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a 60 cc syringe. The ClotTriever Catheter consists of polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque.
The provided document is a 510(k) summary for the ClotTriever Thrombectomy System, which is a medical device for removing thrombi and emboli. It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device, but it explicitly states that clinical testing was not required. Therefore, the document does not contain information about a study proving the device meets acceptance criteria related to clinical performance or human reader effectiveness.
However, based on the non-clinical testing section, I can provide information about the acceptance criteria and performance as described for those tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual & Dimensional Inspections | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Retraction Force of Handle | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Leak Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Vacuum Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Syringe Tensile Testing | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Clot burden Removal Performance Test | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
| Simulated Use, Tensile Test | Not explicitly stated, implied to be conformity to design specifications. | All acceptance criteria were met. |
2. Sample size used for the test set and the data provenance:
For the non-clinical tests listed, the sample sizes are not explicitly provided in this 510(k) summary. The data provenance is generally "non-clinical testing" conducted by the manufacturer, Inari Medical, Inc. The document does not specify country of origin for the data (as it's laboratory testing, this is typically internal to the manufacturer). It is, by definition, a prospective testing of the device prototypes/units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These are non-clinical engineering and performance tests, not clinical evaluations requiring expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable for these non-clinical tests.
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. This device is a thrombectomy system (a mechanical device), not an AI-powered diagnostic tool. Clinical testing was also not performed or required for this particular submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" would be established engineering specifications, performance standards, and physical measurements/observations during the tests. For example, for "Syringe Leak Testing," the ground truth would be the absence of leaks under specified conditions.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).