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510(k) Data Aggregation

    K Number
    K113300
    Manufacturer
    Date Cleared
    2011-12-09

    (30 days)

    Product Code
    Regulation Number
    870.1250
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ATB ADVANCE PTA DILATATION CATHETER

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

    For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents.

    Device Description

    The ATB Advance® PTA Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The ATB Advance® PTA Dilatation Catheter is also intended for post dilatation of balloon-expandable peripheral vascular stents. The 6 Fr balloon catheter will be compatible with a 0.035 inch wire guide and an 8 Fr sheath. It will be supplied sterile, intended for one-time use.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the ATB Advance® PTA Dilatation Catheter:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Balloon Minimum Burst Strength: Burst at or above the minimum rated burst pressure.Testing shows the balloons will burst at or above the minimum rated burst pressure, with all failure modes being linear tears. Predetermined acceptance criteria met.
    Balloon Compliance: Meet labeled diameter within tolerance at the nominal pressure under simulated body temperature conditions.Testing shows that, under simulated body temperature conditions, each balloon will meet its labeled diameter within tolerance at the nominal pressure. Predetermined acceptance criteria met.
    Balloon Profile: Compatible with an 8 Fr sheath (
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    K Number
    K052036
    Manufacturer
    Date Cleared
    2005-08-25

    (28 days)

    Product Code
    Regulation Number
    870.1250
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATB ADVANCE PTA DILATATION CATHETER

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

    For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Intended to treat because is also intended for post-dilatation of balloonexpandable peripheral vascular stents.

    Device Description

    The ATB™ Advance PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac. renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 or 6.0 French nylon tubing compatible with an 0.035-inch quidewire. It will be supplied sterile, intended for one-time use.

    AI/ML Overview

    The provided text describes a 510(k) Pre-market Notification for the ATB™ Advance PTA Dilatation Catheter. It outlines the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria from an AI/ML perspective.

    The "Test Data" section lists various in-vitro tests conducted on the device, inherently mechanical in nature. These are standard engineering tests for medical devices, not studies of an AI's performance.

    Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, statistical performance metrics, sample sizes for AI training/testing, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not present in the provided document.

    The document describes a traditional medical device submission for a physical catheter, not an AI or software as a medical device.

    What the document does provide in relation to "tests":

    The ATB™ Advance PTA Dilatation Catheter was subjected to the following physical/mechanical tests to assure reliable design and performance:

    • Tensile tests
    • Balloon inflation/deflation tests
    • Balloon burst tests
    • Balloon compliance
    • Balloon fatigue tests
    • Balloon profile
    • Balloon burst within a stent
    • Balloon fatigue within a stent

    The document states: "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter." However, specific numerical acceptance criteria for each of these tests and their corresponding reported performance values are not detailed in the provided text.

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