(30 days)
The ClotTriever Thrombectomy System consists of the 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 reinforced 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 Large Bore 60 cc syringe. The ClotTriever Catheter consists of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.
The provided text describes a 510(k) premarket notification for the ClotTriever Thrombectomy System, focusing on device modifications and non-clinical testing. It explicitly states that "Clinical testing was not required for the determination of substantial equivalence." This means that the information requested regarding acceptance criteria, study details, human reader performance, ground truth establishment for a training set, and sample sizes for training and test sets in a clinical context is not applicable to this submission, as no human clinical study was performed.
The document primarily details non-clinical testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document broadly states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."
While a specific table of acceptance criteria with numerical performance values is not provided, the following list represents the types of non-clinical tests conducted to meet internal specifications:
| Acceptance Criteria (Test Type) | Reported Device Performance (Implied) |
|---|---|
| Pouch Seal Inspection | Met |
| Dye Penetration Inspection | Met |
| Visual & Dimensional Inspections ClotTriever Sheath | Met |
| Visual & Dimensional Inspections ClotTriever Dilator | Met |
| Visual & Dimensional Inspections Loading Tool | Met |
| Guidewire Compatibility Verification, ClotTriever Dilator | Met |
| Deployment Force ClotTriever Sheath from Dilator | Met |
| Retraction Force Dilator Thru ClotTriever Sheath | Met |
| Insertion Verification ClotTriever Delivery Catheter thru Sheath | Met |
| Retraction of the ClotTriever Catheter Thru ClotTriever Sheath | Met |
| Kink Resistance/Radius Verification ClotTriever Sheath & Dilator | Met |
| Leakage Verification, ClotTriever Sheath | Met |
| Leakage Verification, ClotTriever Dilator | Met |
| Fluid Test Thru ClotTriever Sheath/Dilator | Met |
| ClotTriever Dilator Retraction in Clot Analog | Met |
| Simulated Use, Track and Rotation ClotTriever Sheath | Met |
| Simulated Use, Track and Tensile ClotTriever Dilator | Met |
| Simulated Use, Track and Tensile ClotTriever Sheath | Met |
| Insertion and Placement Resistance | Met |
| Corrosion Resistance | Met |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a clinical context as no human clinical study was performed. The non-clinical tests would have used physical samples of the device components. The document does not specify the number of samples for each non-clinical test or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no human clinical study was conducted, and therefore no ground truth was established by medical experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human clinical study was conducted.
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
Not applicable. The device is a medical instrument (thrombectomy system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be the established engineering and performance specifications for each test (e.g., a specific force for deployment, a tolerance for dimensions, absence of leakage). These are defined internally by the manufacturer during device development.
8. The sample size for the training set
Not applicable, as no algorithm or human reader training set was required for this device's regulatory submission based on non-clinical testing.
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).