(60 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 for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheaths, the ClotTriever Catheter, and the ClotTriever Bold Catheter. The ClotTriever Sheaths are comprised of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. The ClotTriever Catheter and the ClotTriever Bold Catheter are comprised of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Three ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath, ClotTriever Catheter and ClotTriever Bold Catheter distal tips are radiopaque. Other accessories provided with the ClotTriever Sheath include a pre-dilator, a funnel loading tool and a Large Bore 60 cc syringe.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
This document is a 510(k) summary for a medical device modification, specifically the "ClotTriever Thrombectomy System" with the introduction of the "ClotTriever Bold Catheter." It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K210689). Therefore, the "study" described is a set of non-clinical tests to verify that the modifications do not introduce new safety or efficacy concerns.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list specific quantitative acceptance criteria values alongside corresponding performance results. Instead, it states that "Test results demonstrated that all acceptance criteria were met." The acceptance criteria would be derived from the product specifications for each test listed.
| Test Performed (Proposed Device) | Reported Device Performance |
|---|---|
| Visual and Dimensional Inspection | Met all acceptance criteria |
| ClotTriever Sheath Compatibility | Met all acceptance criteria |
| Deployment/Retraction Force | Met all acceptance criteria |
| Kink Radius | Met all acceptance criteria |
| Fluid Leakage, Sheath | Met all acceptance criteria |
| Vacuum Leakage, Sheath | Met all acceptance criteria |
| Simulated Use, Track & Tensile | Met all acceptance criteria |
Tests leveraged from predicate device (K210689) also met their respective acceptance criteria, implying the performance was acceptable for those aspects as well.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any of the non-clinical tests.
The data provenance is non-clinical testing, performed to verify compliance with product specifications. It's a regulatory submission and not a clinical study involving human patients.
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 this is a non-clinical device verification study, not a study requiring expert clinical adjudication or ground truth establishment in the traditional sense of medical image analysis or diagnostic performance. 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 same reasons as above. There is no clinical test set 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, a multi-reader, multi-case comparative effectiveness study was not done. This device is a mechanical thrombectomy system, not an AI-powered diagnostic tool, and the submission is for a device modification, focusing on non-clinical performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm or AI system. It's a physical medical device.
7. The type of ground truth used
The "ground truth" for this device's performance is established by engineering specifications and performance standards for medical devices. This includes mechanical properties, material compatibility, and functional performance in simulated environments.
8. The sample size for the training set
This information is not applicable as this is a physical medical device and not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established
This information is 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).