(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 with tubing clamp, and a proximal hemostatic valve. An obturator is provided to aid insertion. Other provided accessories include a clot reservoir, a flush port adapter, an aspiration insert and a 60 ml syringe. The ClotTriever Catheter consists of three (3) pre-assembled polymeric coaxial catheters terminating in an expandable member and tissue collection net. At the proximal end of the catheter is a handle used to enable expansion of the expandable member and net. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the ClotTriever Sheath obturator and ClotTriever Catheter distal tips are radiopaque, and radiopaque marker bands are located on the intermediate shaft at the proximal end of the expandable member, and at the distal ends of the ClotTriever Sheath shaft and ClotTriever Catheter outer shaft.
The provided text is a 510(k) premarket notification summary for the ClotTriever Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and an animal study. It does not describe a study involving human subjects, AI assistance, or the establishment of ground truth by human experts for a test set in the way one would for an AI/ML medical device.
Therefore, most of the requested information regarding acceptance criteria and performance related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set details) is not applicable to this document.
However, based on the non-clinical testing described, I can infer the "acceptance criteria" were successful completion of various engineering and biocompatibility tests, and the "study that proves the device meets the acceptance criteria" refers to the results of these non-clinical tests and an animal study.
Here's how I can address the prompts based on the provided text, and where I must state "Not Applicable" due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document lists various tests performed to demonstrate safety and performance. The "acceptance criteria" are implied to be the successful completion of these tests to conform to standards and product specifications. The "reported device performance" is a general statement of success.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant standards (e.g., ISO 10555-1, ISO 594-1/2) | "This testing demonstrated compliance with relevant standards" |
| Conformance to product specifications | "Test results demonstrated that all acceptance criteria were met, and, therefore, the device conforms to established product specifications and intended use." |
| Successful pouch seal and dye penetration | Included in successful tests report. |
| Successful pouch peel, seal strength | Included in successful tests report. |
| Passed visual and dimensional inspections | Included in successful tests report. |
| Guidewire compatibility | Included in successful tests report. |
| Acceptable deployment force of ClotTriever Sheath from Dilator | Included in successful tests report. |
| Acceptable retraction force of Dilator through ClotTriever Sheath | Included in successful tests report. |
| Acceptable insertion of Delivery Catheter through ClotTriever Sheath | Included in successful tests report. |
| Acceptable deployment force of ClotTriever from Delivery Catheter | Included in successful tests report. |
| Acceptable retraction force of handle to Expand/Collapse ClotTriever | Included in successful tests report. |
| Acceptable retraction force of ClotTriever into Delivery Catheter | Included in successful tests report. |
| Acceptable retraction force of ClotTriever Catheter through ClotTriever Sheath | Included in successful tests report. |
| Acceptable ClotTriever Sheath/Dilator Kink Radius | Included in successful tests report. |
| Acceptable ClotTriever Device Kink Radius | Included in successful tests report. |
| Passed Leakage Testing (ClotTriever Sheath, Accessories, Flush Port, Hemostasis Valves) | Included in successful tests report. |
| Passed Air Leakage (ClotTriever Sheath) | Included in successful tests report. |
| Passed Leakage Testing (ID of ClotTriever Device w/Guidewire in Place) | Included in successful tests report. |
| Passed Vacuum Testing (ClotTriever Sheath) | Included in successful tests report. |
| Passed Test Conical Fittings with 6% Luer Taper, Dilator | Included in successful tests report. |
| Passed Flow Test Through ClotTriever Sheath/Dilator | Included in successful tests report. |
| Demonstrated Corrosion Resistance | Included in successful tests report. |
| Passed Simulated Use Track & Tensile (ClotTriever Sheath, Dilator, Clot Reservoir, ClotTriever Catheter) | Included in successful tests report. |
| Passed Simulated Use Track & Turn-to-Failure (ClotTriever Sheath and Accessories, ClotTriever Catheter) | Included in successful tests report. |
| Passed Torque Testing (ClotTriever Handle, Clot Reservoir Luer Activated Valve) | Included in successful tests report. |
| Minimal/Acceptable Particulate Matter | Included in successful tests report. |
| Biocompatibility (Cytotoxicity, Guinea pig maximization sensitization, Intracutaneous irritation, Acute systemic toxicity, Material mediated pyrogen, Bacterial mutagenicity, Hemolysis, Complement activation, Thromboresistance, USP Physicochemical) | "Biocompatibility testing in accordance with ISO 10993-1" was successfully performed. |
| Shelf life of 12 months (based on accelerated aging) | "Verification testing was conducted on sterilized (ethylene oxide), accelerated-aged devices to support the 12 months shelf life." |
| Package integrity testing (ISO 11607-1/2 guidelines) | Included in successful tests report. |
| Acute safety and performance in an animal model | "Acute evaluation of the safety and performance of the ClotTriever Thrombectomy System was successfully performed in a bovine model." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for engineering and biocompatibility testing of medical devices. For the animal study, it mentions "a bovine model," implying one or more bovine subjects, but no specific number is provided.
- Data Provenance: The tests were conducted by Inari Medical, Inc. (Irvine, CA, USA). The studies are non-clinical (laboratory tests and an animal study), not human clinical data, so terms like "retrospective" or "prospective" usually apply to human data collection. These would be considered prospective in the sense that the tests were designed and conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document is for a traditional medical device (thrombectomy system), not an AI/ML device that requires human expert-labeled ground truth for a test set. The "ground truth" for this device's performance is derived from physical measurements against engineering specifications and biological reactions in laboratory and animal models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this pertains to expert review of data, which is not relevant for this type of device submission.
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. This is a hardware medical device and does not involve human readers, AI assistance, or imaging interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or software component described that would have a "standalone" performance. The device is a physical thrombectomy system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is multi-faceted, based on:
- Engineering Specifications and Standards: Physical and performance characteristics measured against predetermined design requirements and compliance with international standards (e.g., ISO 10555-1, ISO 594-1/2, ISO 10993-1, ISO 11607-1/2).
- Biological Response: Results from biocompatibility tests (in vitro and in vivo models) and acute evaluation in a bovine model, indicating safety and performance in a living system.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set." The device itself is manufactured according to established processes and tested.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in this context. The "truth" about the device's design and manufacturing is based on its specifications, material properties, and manufacturing processes, which are validated through the non-clinical tests described.
§ 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).