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510(k) Data Aggregation

    K Number
    K134031
    Device Name
    THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2014-07-21

    (202 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K130391,K102725,K111295,K083127
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.

    The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of quidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.

    The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.

    Device Description

    The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a semi-compliant balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter (1.2 mm) and length (12 mm) at recommended pressures. The Threader™ Micro-Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There is a single radiopaque marker band located in the center of the balloon body to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information for the Threader™ Micro-Dilatation Catheter, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Test/RequirementReported Device Performance
    BiocompatibilityCytotoxicity Hemolysis (Direct Contact & Extract)Tests completed; no new safety issues raised.
    SensitizationTests completed; no new safety issues raised.
    Complement ActivationTests completed; no new safety issues raised.
    Intracutaneous ReactivityTests completed; no new safety issues raised.
    CoagulationTests completed; no new safety issues raised.
    Acute Systemic ToxicityTests completed; no new safety issues raised.
    In Vitro HemocompatibilityTests completed; no new safety issues raised.
    Materials Mediated PyrogenicityTests completed; no new safety issues raised.
    USP PhysicochemicalTests completed; no new safety issues raised.
    In-Vitro PerformanceEffective LengthTests completed; no new performance issues raised.
    Catheter Bond StrengthTests completed; no new performance issues raised.
    Shaft Inner and Outer DiameterTests completed; no new performance issues raised.
    Tip Pull TestTests completed; no new performance issues raised.
    Balloon Crossing ProfileTests completed; no new performance issues raised.
    Flexibility and KinkTests completed; no new performance issues raised.
    Balloon Preparation, Deployment, and RetractionTests completed; no new performance issues raised.
    Torque StrengthTests completed; no new performance issues raised.
    Withdrawal into a Guide CatheterTests completed; no new performance issues raised.
    RadiopacityTests completed; no new performance issues raised.
    Balloon Rated Burst PressureTests completed; no new performance issues raised.
    Coating IntegrityTests completed; no new performance issues raised.
    Balloon Fatigue (Repeat Inflations)Tests completed; no new performance issues raised.
    Particulate EvaluationTests completed; no new performance issues raised.
    Balloon ComplianceTests completed; no new performance issues raised.
    Catheter Body Burst PressureTests completed; no new performance issues raised.
    Balloon Inflation/Deflation TimeTests completed; no new performance issues raised.
    Contrast Media Flow RateTests completed; no new performance issues raised.
    Overall EquivalenceConformance to regulatory guidanceThe device was subjected to testing according to the requirements of "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." The results provide reasonable assurance of conformance and substantial equivalence to predicate devices.

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

    The provided 510(k) summary does not specify the sample sizes used for the biocompatibility or in-vitro performance tests. It only states that these tests were "completed."

    The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin. Given the nature of these tests (bench testing and biocompatibility), they are typically conducted in a controlled laboratory environment.

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

    This information is not applicable and therefore not provided in the 510(k) summary. The ground truth for device performance in this context is established through objective physical and chemical testing against engineering specifications and regulatory guidance, not expert consensus on medical images or patient outcomes.

    4. Adjudication Method for the Test Set

    This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., medical images) requires consensus. The tests described are objective, physical, and chemical measurements.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI with human readers, which is not relevant for this device.

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

    No, a standalone algorithm performance study was not done. This device is a physical medical device (catheter), not a software algorithm.

    7. The Type of Ground Truth Used

    The ground truth used for evaluating the Threader™ Micro-Dilatation Catheter is based on:

    • Engineering Specifications: The device's design parameters (e.g., balloon diameter, length, bond strength) are inherent to its design and manufacturing.
    • Regulatory Guidance: The "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" provides the established benchmarks and acceptance criteria for these types of devices.
    • Predicate Device Performance: The device is compared to legally marketed predicate devices, implying that their established performance serves as a benchmark for substantial equivalence.

    8. The Sample Size for the Training Set

    This information is not applicable and therefore not provided. "Training set" refers to data used to train AI algorithms, which is not relevant for this physical medical device.

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

    This information is not applicable for the same reasons as above.

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