(62 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 system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists 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 a clot reservoir, a funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters 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 ClotTriever Thrombectomy System underwent non-clinical testing to demonstrate substantial equivalence to its predicate device, specifically ClotTriever Thrombectomy System (K173470). The device is used for the non-surgical removal of soft thrombi and emboli from blood vessels and for the injection/aspiration of fluids in the peripheral vasculature.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text lists numerous tests conducted to ensure the device's performance meets established specifications. For each test, the "reported device performance" is a blanket statement indicating that: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."
Without specific numerical or qualitative results for each individual test, a detailed table with specific acceptance criteria and performance metrics cannot be generated. However, the types of tests conducted serve as proxies for the acceptance criteria for various aspects of the device's functionality and safety.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Packaging & Sterility | Pouch Seal Inspection | Seal integrity adequate to maintain sterility | All acceptance criteria met |
| Dye Penetration Inspection | No dye penetration, indicating seal integrity | All acceptance criteria met | |
| Pouch Peel Test | Appropriate peel strength for safe opening | All acceptance criteria met | |
| Physical & Dimensional | Visual & Dimensional Inspections (Sheath, Dilator, Clot Reservoir, Loading Tool) | Conformance to design specifications and tolerances | All acceptance criteria met |
| Functional - Insertion & Retraction | Guidewire Compatibility Verification | Smooth passage and compatibility with guidewires | All acceptance criteria met |
| Insertion Force - ClotTriever Dilator Handle into Sheath Hub | Within specified force limits for user ease | All acceptance criteria met | |
| Retraction Force - Dilator Handle from Sheath Hub | Within specified force limits for user ease | All acceptance criteria met | |
| Deployment Force - ClotTriever Sheath from Dilator | Within specified force limits for reliable deployment | All acceptance criteria met | |
| Engagement Force - Dilator Handle | Secure engagement | All acceptance criteria met | |
| Retraction Force - Dilator Thru ClotTriever Sheath | Within specified force limits for smooth retraction | All acceptance criteria met | |
| Retraction Force - Dilator Handle | Within specified force limits for user ease | All acceptance criteria met | |
| Insertion Verification ClotTriever Delivery Catheter thru Sheath | Smooth and unobstructed passage | All acceptance criteria met | |
| Retraction of the ClotTriever Catheter Thru ClotTriever Sheath | Smooth and unobstructed retraction | All acceptance criteria met | |
| Mechanical Integrity | Kink Resistance/Radius Verification ClotTriever Sheath & Dilator | Resistance to kinking at specified radii | All acceptance criteria met |
| Leakage Verification (ClotTriever Sheath, Dilator, Clot Reservoir) | No fluid leakage | All acceptance criteria met | |
| Air Leakage, ClotTriever Sheath | No air leakage | All acceptance criteria met | |
| Clot Reservoir Check Valve Cracking Pressure | Within specified pressure range for proper function | All acceptance criteria met | |
| Vacuum Testing (ClotTriever Sheath, Clot Reservoir) | Ability to maintain specified vacuum levels | All acceptance criteria met | |
| Push-Button Force Testing Garrote Valve | Within specified force limits for user operation | All acceptance criteria met | |
| Fluid Test Thru ClotTriever Sheath/Dilator | Unobstructed fluid flow | All acceptance criteria met | |
| Corrosion Resistance | No corrosion observed | All acceptance criteria met | |
| ClotTriever Dilator Retraction in Clot Analog | Effective retraction in a simulated clot environment | All acceptance criteria met | |
| Simulated Use, Track and Tensile (ClotTriever Dilator, Sheath) | Mechanical integrity and tracking performance in simulated use | All acceptance criteria met | |
| Simulated Use, Tensile – ClotTriever Clot Reservoir | Mechanical integrity under tensile stress | All acceptance criteria met | |
| Simulated Use Track and Turn-to-Failure, ClotTriever Sheath | Durability and functionality in simulated extreme use | All acceptance criteria met | |
| Torque Testing (Dilator, Garrote Valve, Flushing Stopcock) | Resistance to breakage or failure under torque | All acceptance criteria met | |
| Burst Testing (Garrote Valve, Flushing Stopcock) | Resistance to bursting at specified pressures | All acceptance criteria met | |
| Particulate Evaluation | Within acceptable limits for biocompatibility | All acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
The provided information focuses on non-clinical testing (e.g., bench testing, mechanical tests). There is no information provided regarding a "test set" in the context of patient data.
- Sample Size: Not applicable for a clinical test set as no clinical testing was performed for this submission. For the non-clinical tests, specific sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were used to meet the verification and validation requirements.
- Data Provenance: Not applicable for a clinical test set. For the non-clinical tests, the data provenance is from the manufacturer's (Inari Medical) internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no clinical ground truth was established by experts for a test set in this context.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring expert adjudication was utilized.
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
An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for the determination of substantial equivalence." This implies no human-in-the-loop performance evaluation or comparison with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The ClotTriever Thrombectomy System is a physical medical device (catheter system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The Type of Ground Truth Used
For the non-clinical testing conducted, the "ground truth" used was established product specifications, engineering standards, and the performance of the predicate device (K173470). In other words, the device's performance was compared against predetermined acceptance criteria derived from its design requirements and the known characteristics of equivalent devices.
8. The Sample Size for the Training Set
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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).