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510(k) Data Aggregation

    K Number
    K082921
    Device Name
    RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
    Manufacturer
    RAD SOURCE TECHNOLOGIES, INC.
    Date Cleared
    2009-02-17

    (139 days)

    Product Code
    MOT
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K974210
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAD SOURCE TECHNOLOGIES, INC.

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

    Intended for the irradiation of blood or blood products packaged in transfusion bags in accordance with "Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products" (22 July 1993 memorandum from Acting Director Office of Blood Research and Review, Center of Biologics Evaluation and Research, FDA to all registered blood establishments) when irradiation to reduce the risk of Graft Versus Host Disease is indicated.

    Device Description

    The RS 3400 Rad Source X-ray Blood Irradiator consists of a shielded enclosure containing one x-ray tube capable of emitting radiation in a 360 degree output around its cylindrical design, a power supply and controller. A carousel capable of holding 5 cylindrical containers rotates those cylinders around the cylindrical x-ray tube radiation source causing the blood products contained therein to be irradiated.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided document:

    The document describes a 510(k) premarket notification for the RS 3400 Rad Source X-ray Blood Irradiator, seeking substantial equivalence to a predicate device, the RS 3000 Shielded Cabinet X-ray Radiation Source (K974210). Since this is a submission for an X-ray irradiation device, not an AI/ML medical device, many of the standard questions regarding AI/ML acceptance criteria, reader studies, and ground truth establishment for diagnostic performance are not applicable.

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this device are based on demonstrating substantial equivalence to its predicate for safety and effectiveness in irradiating blood products. This is primarily evaluated through measurable technical characteristics and the ability to achieve the required radiation dose.

    CharacteristicAcceptance Criteria (from Predicate Device)Reported Device Performance (Submitted Device)
    Source160kVdc x-rays, .38 mm Cu filter, hvl app. 4 cm H2O150kVdc x-rays, .45 mm Cu filter, hvl app. H₂O cooled
    Dose Rate3 Gy/minute>5 Gy/minute
    Max/Min dose ratio:
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