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510(k) Data Aggregation

    K Number
    K071269
    Device Name
    HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2007-08-01

    (86 days)

    Product Code
    CBT
    Regulation Number
    868.1100
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Ohio 43016

    Re: K071269

    Trade/Device Name: HemoDraw™ Arterial Blood Sampling Set Regulation Number: 868.1100

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

    The HemoDraw™ Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided context does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for the HemoDraw™ Arterial Blood Sampling Set, indicating that the device has been found substantially equivalent to a predicate device. It defines the indications for use of the device but does not include any performance data or study design details.

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    K Number
    K070340
    Device Name
    SECURE ARTERIAL BLOOD SAMPLING SYSTEM
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Date Cleared
    2007-03-15

    (37 days)

    Product Code
    CBT
    Regulation Number
    868.1100
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    MAR 1 5 2007

    Re: K070340

    Trade/Device Name: SECURE® Arterial Blood Sampling Set Regulation Number: 868.1100

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

    The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system designed to allow easy withdrawal of blood samples from an arterial pressure monitoring line while maintaining a completely closed system.

    Device Description

    The SECURE® Arterial Blood Sampling Set is a hemodynamic pressure monitoring and blood gas sampling system.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.

    The document is an FDA 510(k) clearance letter for the "SECURE® Arterial Blood Sampling Set." This letter primarily:

    • Acknowledges the review of the premarket notification.
    • States that the device is substantially equivalent to legally marketed predicate devices.
    • Outlines general regulatory requirements and responsibilities for the manufacturer.
    • Includes the "Indications for Use" statement for the device.

    It does not contain:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes for test or training sets.
    • Information about experts used for ground truth or adjudication methods.
    • Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used or how it was established.

    Therefore, I cannot provide the requested information.

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