(54 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 the ClotTriever Catheter, ClotTriever BOLD Catheter, ClotTriever 13 Fr and 16 Fr Sheaths, and Protrieve Sheath, each packaged separately.
The ClotTriever BOLD Catheter is 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 Catheter, ClotTriever BOLD Catheter, ClotTriever Sheaths, and Protrieve Sheath have radiopaque distal tips.
The provided text is a 510(k) summary for the ClotTriever BOLD® Catheter, describing modifications to an existing device and demonstrating substantial equivalence to its predicate. The assessment focuses on non-clinical testing, as no clinical testing was required.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests performed to ensure the modified device meets specified requirements, asserting that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, specific numerical acceptance criteria (e.g., minimum force, maximum leakage) and the quantitative reported performance values are not explicitly detailed in this summary. Instead, it provides a list of tests and a general statement of compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant product specifications | All acceptance criteria were met. |
| Optimal Packaging Usability | Tested, and criteria met. |
| Acceptable Visual and dimensional inspections | Tested, and criteria met. |
| Effective Deairing/Flushing | Tested, and criteria met. |
| Adequate Radial force | Tested, and criteria met. |
| Acceptable Deployment force of ClotTriever BOLD from delivery catheter | Tested, and criteria met. |
| Adequate Retraction force of handle | Tested, and criteria met. |
| Acceptable Retraction force of ClotTriever BOLD into delivery catheter | Tested, and criteria met. |
| No/Minimal Leakage (ClotTriever BOLD Catheter) | Tested, and criteria met. |
| Sufficient Corrosion resistance | Tested, and criteria met. |
| Satisfactory Simulated use, track and tensile (ClotTriever BOLD Catheter) | Tested, and criteria met. |
| Adequate Torque testing (ClotTriever BOLD handle) | Tested, and criteria met. |
| Acceptable Particulate matter levels | Tested, and criteria met. |
| Effective Performance (Clot removal from collection bag) | Tested, and criteria met. |
| Successful Narrow occlusion test | Tested, and criteria met. |
| Pouch seal integrity (visual inspection, dye penetration, peel and seal strength, bubble leak) | Leveraged from predicate, deemed met. |
| Visual and dimensional inspections post-simulated use | Leveraged from predicate, deemed met. |
| Guidewire compatibility | Leveraged from predicate, deemed met. |
| Conical fitting with 6% luer taper | Leveraged from predicate, deemed met. |
| Proper Insertion/Retraction through ClotTriever Sheath | Leveraged from predicate, deemed met. |
| ClotTriever BOLD Catheter kink radius | Leveraged from predicate, deemed met. |
| Leakage/Air leakage/Vacuum testing (ClotTriever Sheath) | Leveraged from predicate, deemed met. |
| Simulated use, track, and rotation/tensile (non-affected components) | Leveraged from predicate, deemed met. |
| ClotTriever BOLD Catheter radiopacity | Leveraged from predicate, deemed met. |
| Compatibility with Protrieve Sheath (insertion, retraction, leakage, air leakage, vacuum) | Leveraged from Protrieve Sheath (K220415), deemed met. |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility) | Leveraged from predicate (no new materials), deemed met. |
| Sterilization validation (SAL 10-6, EO) | Leveraged from predicate (no greater challenge), deemed met. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes (number of devices or tests performed) for the non-clinical tests. It only lists the types of tests conducted.
The data provenance is from non-clinical (bench and in-vitro) laboratory testing performed by the manufacturer, Inari Medical, Inc. The document does not specify a country of origin for the data beyond the manufacturer's location in Irvine, California, USA. All testing appears to be prospective in the sense that it was conducted specifically for this submission to verify the modified device's performance.
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 evaluation relies solely on non-clinical, objective engineering and materials testing. There's no "ground truth" in the clinical sense established by human experts, but rather adherence to predefined engineering specifications and standards.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as above. Non-clinical tests typically involve objective measurement against predetermined pass/fail criteria, rather than subjective adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device (ClotTriever BOLD® Catheter) is a mechanical medical device for thrombectomy and does not involve AI or human "readers" in its operation or assessment as described in this 510(k) summary. No MRMC study was mentioned or performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm or AI system. Its performance is assessed through its physical characteristics and mechanical functionality.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on engineering specifications, performance standards, and established biocompatibility and sterilization requirements. For comparative purposes, the predicate device (ClotTriever BOLD® Catheter, K212632) serves as a benchmark for equivalence, and its performance data established the precedent for acceptable parameters.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of this mechanical device submission. The device is not learning from data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
§ 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).