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    K Number
    K243549
    Device Name
    JETi Hydrodynamic Thrombectomy System
    Manufacturer
    Abbott Medical
    Date Cleared
    2025-04-04

    (140 days)

    Product Code
    QEZ,FOX,KDQ
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K232458,K202218
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K232458

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

    The JETi™ Hydrodynamic Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, including deep vein thrombosis (DVT), and to sub-selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.

    Device Description

    The JETi™ Hydrodynamic Thrombectomy System (JETi HTS) is a hydro-mechanical aspiration system intended for the removal of intravascular thrombus. The system is comprised of the JETi™ Catheter, JETi™ Pump Set, JETi™ Saline Drive Unit (SDU), JETi™ Accessory Cart, JETi™ Suction Tubing, and JETi™ Non-sterile Canister Set. The JETi Hydrodynamic Thrombectomy System is designed to continuously aspirate thrombotic material into the JETi Catheter, where a high-pressure stream of saline within the catheter tip macerates the thrombus as it is aspirated.

    AI/ML Overview

    Here's an analysis of the provided text, focusing on acceptance criteria and the supporting study, structured as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Criterion TypeAcceptance CriteriaReported Device Performance
    Primary EffectivenessAt least 75% reduction in modified Marder Score from pre-JETi venogram to final venogram (per core laboratory assessment), with a one-sided 97.5% lower confidence limit comparing to a performance goal of 64%.Achieved in 84.5% (93/110) limbs, with a one-sided 97.5% lower confidence limit of 76.4%, which compares favorably to the performance goal of 64% (p value < 0.0001). The primary effectiveness endpoint was met.
    Primary SafetyComposite of JETi-related major adverse events up to 30 days post-JETi (per CEC adjudication) should be less than 10%.1.7% (2/116) (95% CI, 0.21%, 6.09%). This rate is less than the acceptance criterion of 10%. The primary safety endpoint was met.
    Secondary Outcomes (Implied)Improved treated vessel patency and compressibility, Villalta post-thrombotic syndrome score, leg pain, and quality of life at 30 days. (While not explicitly stated as "acceptance criteria," these are reported as positive outcomes that support the device's effectiveness.)All were improved at 30 days.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size (Clinical Testing - JETi Registry):
      • Total registered subjects in the registry: 260
      • Subjects treated for lower extremity (LE) DVT (analysis population for effectiveness and safety): 116
      • Limbs evaluated for the primary effectiveness endpoint: 110
      • Subjects evaluated for the primary safety endpoint: 116
    • Data Provenance: Prospective, multi-center study conducted in the United States (US) and Europe.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • The document mentions "core laboratory assessment" for the primary effectiveness endpoint (Marder Score reduction) and "CEC adjudication" (Clinical Events Committee adjudication) for the primary safety endpoint (major adverse events).
    • The number and specific qualifications of the experts within the core laboratory and CEC are not specified in the provided text.

    4. Adjudication Method for the Test Set

    • Effectiveness Endpoint: "core laboratory assessment"
    • Safety Endpoint: "CEC adjudication"
    • The specific adjudication method (e.g., 2+1, 3+1, none) used by the core laboratory or CEC is not detailed in the provided text.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

    • No, an MRMC comparative effectiveness study was NOT done. The clinical study described (JETi Registry) is a "prospective, single-arm, multicenter study" focused on the performance of the JETi HTS alone. It does not compare the device's performance with and without AI assistance or against human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • The JETi™ Hydrodynamic Thrombectomy System is a physical medical device (a thrombectomy system). It does not appear to be an AI/algorithm-based device, so the concept of "standalone algorithm performance" is not applicable here. The study assesses the performance of the device in treating thrombosis.

    7. The Type of Ground Truth Used

    • Effectiveness Endpoint: Modified Marder Score from pre-JETi venogram to final venogram, assessed by a core laboratory. This suggests a standardized, expert-driven assessment of imaging data.
    • Safety Endpoint: JETi-related major adverse events, adjudicated by a Clinical Events Committee (CEC). This indicates expert consensus based on clinical event reporting.

    8. The Sample Size for the Training Set

    • Not applicable. The provided document describes a clinical study for a physical medical device (JETi™ Hydrodynamic Thrombectomy System), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. As mentioned above, this is a physical medical device, not an AI algorithm.
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