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510(k) Data Aggregation

    K Number
    K180329
    Date Cleared
    2018-04-09

    (62 days)

    Product Code
    Regulation Number
    870.5150
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K173672, K143563, K163597

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 CategorySpecific TestAcceptance Criteria (Implied)Reported Device Performance
    Packaging & SterilityPouch Seal InspectionSeal integrity adequate to maintain sterilityAll acceptance criteria met
    Dye Penetration InspectionNo dye penetration, indicating seal integrityAll acceptance criteria met
    Pouch Peel TestAppropriate peel strength for safe openingAll acceptance criteria met
    Physical & DimensionalVisual & Dimensional Inspections (Sheath, Dilator, Clot Reservoir, Loading Tool)Conformance to design specifications and tolerancesAll acceptance criteria met
    Functional - Insertion & RetractionGuidewire Compatibility VerificationSmooth passage and compatibility with guidewiresAll acceptance criteria met
    Insertion Force - ClotTriever Dilator Handle into Sheath HubWithin specified force limits for user easeAll acceptance criteria met
    Retraction Force - Dilator Handle from Sheath HubWithin specified force limits for user easeAll acceptance criteria met
    Deployment Force - ClotTriever Sheath from DilatorWithin specified force limits for reliable deploymentAll acceptance criteria met
    Engagement Force - Dilator HandleSecure engagementAll acceptance criteria met
    Retraction Force - Dilator Thru ClotTriever SheathWithin specified force limits for smooth retractionAll acceptance criteria met
    Retraction Force - Dilator HandleWithin specified force limits for user easeAll acceptance criteria met
    Insertion Verification ClotTriever Delivery Catheter thru SheathSmooth and unobstructed passageAll acceptance criteria met
    Retraction of the ClotTriever Catheter Thru ClotTriever SheathSmooth and unobstructed retractionAll acceptance criteria met
    Mechanical IntegrityKink Resistance/Radius Verification ClotTriever Sheath & DilatorResistance to kinking at specified radiiAll acceptance criteria met
    Leakage Verification (ClotTriever Sheath, Dilator, Clot Reservoir)No fluid leakageAll acceptance criteria met
    Air Leakage, ClotTriever SheathNo air leakageAll acceptance criteria met
    Clot Reservoir Check Valve Cracking PressureWithin specified pressure range for proper functionAll acceptance criteria met
    Vacuum Testing (ClotTriever Sheath, Clot Reservoir)Ability to maintain specified vacuum levelsAll acceptance criteria met
    Push-Button Force Testing Garrote ValveWithin specified force limits for user operationAll acceptance criteria met
    Fluid Test Thru ClotTriever Sheath/DilatorUnobstructed fluid flowAll acceptance criteria met
    Corrosion ResistanceNo corrosion observedAll acceptance criteria met
    ClotTriever Dilator Retraction in Clot AnalogEffective retraction in a simulated clot environmentAll acceptance criteria met
    Simulated Use, Track and Tensile (ClotTriever Dilator, Sheath)Mechanical integrity and tracking performance in simulated useAll acceptance criteria met
    Simulated Use, Tensile – ClotTriever Clot ReservoirMechanical integrity under tensile stressAll acceptance criteria met
    Simulated Use Track and Turn-to-Failure, ClotTriever SheathDurability and functionality in simulated extreme useAll acceptance criteria met
    Torque Testing (Dilator, Garrote Valve, Flushing Stopcock)Resistance to breakage or failure under torqueAll acceptance criteria met
    Burst Testing (Garrote Valve, Flushing Stopcock)Resistance to bursting at specified pressuresAll acceptance criteria met
    Particulate EvaluationWithin acceptable limits for biocompatibilityAll 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.

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