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510(k) Data Aggregation

    K Number
    K082191
    Device Name
    CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
    Manufacturer
    CARDIOMEMS INC
    Date Cleared
    2008-08-19

    (15 days)

    Product Code
    NQH
    Regulation Number
    870.2855
    Type
    Abbreviated
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.

    Device Description

    The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System includes:

    • The CardioMEMS EndoSure™ s2 Sensor with radio-opaque markings -(implant)
    • A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ s2 Sensor)
    • CardioMEMS EndoSure™ Electronics System
    AI/ML Overview

    The provided text is a 510(k) Summary for the CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System. It describes the device, its intended use, and technological characteristics. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

    The "Performance Data" section in {1} states: "Testing has shown the EndoSure Sensor with Delivery System to be biocompatible and compatible with MRI, ultrasound, pacemakers and external defibrillators. Bench testing confirms that the device functions per its specifications."

    This statement confirms that testing was done and the device functions to its specifications, but it does not provide the acceptance criteria, the reported device performance in a table, or details about the specific studies (sample sizes, ground truth, experts, adjudication, etc.) that would allow for a complete answer to your request.

    Therefore, I cannot fulfill your request for detailed acceptance criteria and study information based solely on the provided text. The document is primarily a regulatory submission summary, not a comprehensive technical study report.

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