(192 days)
The ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of 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 including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The ClotTriever Thrombectomy System consists of ClotTriever 13 Fr and 16 Fr Sheaths, Protrieve Sheath, ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter, each packaged separately.
The ClotTriever Catheter, ClotTriever BOLD Catheter, and the ClotTriever XL Catheter are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in two stopcocks and a luer lock connection are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the ClotTriever Sheaths, Protrieve Sheath, and ClotTriever Catheters have radiopaque distal tips. The ClotTriever XL Catheter is intended for vessels 10 to 28 mm in the peripheral vasculature.
The ClotTriever XL Catheter is an accessory to the ClotTriever Thrombectomy System and is used for non-surgical removal of thrombi and emboli from blood vessels. It is also used for the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel within the peripheral vasculature, including deep vein thrombosis (DVT).
Here's an overview of the acceptance criteria and study information for the ClotTriever XL Catheter based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pouch Seal Visual Inspection | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Dye Penetration Packaging Usability | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Visual and Dimensional Inspection | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Guidewire Compatibility | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Protrieve and ClotTriever Sheath Compatibility | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Radial Force | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Retraction Force into ClotTriever Sheath | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Deployment/Retraction Force | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Retraction force to expand the collection bag | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Kink Radius | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Fluid Leakage - Protrieve, ClotTriever Sheath, Catheter | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Vacuum Testing - Protrieve, ClotTriever Sheath | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Simulated Use, Track and Rotation (Torque) | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Simulated Use, Track and Tensile | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Particulate Matter | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Conical Fitting with 6% Luer Taper | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Pre-clinical/GLP Animal Safety Evaluation (including In Vivo Functional Testing/Radiopacity Verification) | Not explicitly stated (Implied to meet specifications) | All acceptance criteria were met. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility - Hemolysis, Complement Activation, Thrombogenicity (in vivo/in vitro)) | As suggested by ISO 10993-1 | All acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test. It mentions that "verification and validation tests were identified to support the substantial equivalence" and that "test results demonstrated that all acceptance criteria were met."
The provenance of the data is from non-clinical testing conducted by Inari Medical, Inc. The nature of these tests (e.g., mechanical, simulated use, biocompatibility) implies laboratory-based testing rather than patient data. Therefore, the data would be considered prospective from a testing perspective, as the tests were conducted specifically for this submission. There is no information about country of origin, but it is typically assumed to be where the manufacturer is based (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this submission is based on non-clinical testing (mechanical, performance, and biocompatibility), there is no mention of "experts" in the context of establishing ground truth for a test set based on patient data (e.g., radiologists, pathologists). The "truth" for these tests is based on predefined engineering and scientific specifications, and compliance with standards like ISO 10993-1.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation is based on objective, quantifiable non-clinical test results against established specifications, not subjective interpretation of medical images or patient outcomes.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to support substantial equivalence." This means the submission did not involve studies comparing human readers' performance with and without AI assistance, as the device is a medical instrument (catheter), not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The ClotTriever XL Catheter is a medical device for clot removal, not an algorithm or AI system. Its performance is evaluated through physical and biological testing, not through standalone algorithm performance metrics.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on engineering specifications, established industry standards (e.g., ISO 10993-1 for biocompatibility), and pre-defined performance benchmarks relevant to the safe and effective operation of the catheter. For the animal safety evaluation, the ground truth would be based on in-vivo observations of safety and functional performance.
8. The Sample Size for the Training Set
Not applicable. The ClotTriever XL Catheter is a physical medical device and does not involve AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).