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510(k) Data Aggregation

    K Number
    K974210
    Device Name
    SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
    Manufacturer
    RAD-SOURCE, INC.
    Date Cleared
    1998-03-30

    (140 days)

    Product Code
    MOT
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K865027
    Why did this record match?
    Reference Devices :

    K865027

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

    The RS 3000 Shielded Cabinet X-ray Radiation Source is 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 for 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 3000 Shielded Cabinet X-ray Radiation Source consists of A shielded enclosure containing 2 vertically opposed x-ray tubes with provision for a sample holder (canister) between them, a power supply and a controller.

    AI/ML Overview

    This document is a 510(k) premarket notification for the RS 3000 Shielded Cabinet X-ray Radiation Source, a blood irradiator. It focuses on demonstrating substantial equivalence to a predicate device (IBL 437C Blood Irradiator), rather than presenting a study with acceptance criteria and device performance in the typical sense of a diagnostic or therapeutic device that would involve a clinical study with human subjects.

    Therefore, many of the requested categories for a clinical study are not applicable to this type of submission. However, I can extract information related to the device's technical specifications and how they compare to the predicate, which serves as the "performance" data in this context for demonstrating substantial equivalence.

    Here's the breakdown of the information provided in the input, tailored to what's available for this specific type of device submission:

    1. Table of "Acceptance Criteria" (Predicate Device Specifications) and Reported Device Performance (RS 3000)

    In the context of a 510(k) for a blood irradiator, "acceptance criteria" are effectively the specifications and performance characteristics of the predicate device, which the new device (RS 3000) aims to meet or be substantially equivalent to.

    Criteria (Predicate: IBL 437C)RS 3000 Performance
    Source:160 kVdc x-rays, .38 mm Cu filter, hvl app. 4 cm H₂0
    Cs-137, 662 keV
    Dose rate:3 Gy min⁻¹
    > 4 Gy min⁻¹
    Max/min dose ratio:
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