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510(k) Data Aggregation

    K Number
    K032684
    Device Name
    RAYCELL
    Manufacturer
    MDS NORDION
    Date Cleared
    2003-09-26

    (28 days)

    Product Code
    MOT
    Regulation Number
    N/A
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K974210
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Raycell™ Shielded Cabinet X-ray System is intended for the irradiation of blood and blood products packaged in transfusion bags when irradiation to reduce the risk of Graft versus Host Disease is indicated, and is used 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).

    Device Description

    The Raycell Shielded Cabinet X-ray System consists of a sample holder (canister) between the two (2) x-ray tubes, dual power supplies, radiation shielding, control electronics, cooling assemblies and operator controls. The radiation source of the Raycell™ Shielded Cabinet X-ray System includes of two vertically opposed xray tubes contained in a shielded enclosure. It is identical to the predicate device with the exception of labeling changes to reflect the new product name and identify MDS Nordion as the manufacturer.

    AI/ML Overview

    The provided document describes a 510(k) submission for the Raycell™ Shielded Cabinet X-ray System. This submission is for a medical device that irradiates blood and blood products. It is a declaration of substantial equivalence to an existing predicate device, the RS 3000 Shielded Cabinet X-Ray Blood Irradiator (K974210).

    The document does not contain information about studies to prove device performance against acceptance criteria in the context of AI/ML or diagnostic performance. Instead, the "acceptance criteria" here refers to the device's technological characteristics remaining the same as the predicate device, which is the basis for claiming substantial equivalence.

    Therefore, many of the requested fields are not applicable to this type of regulatory submission.

    Here's an attempt to fill out the information based on the provided text, with clarifications where the requested information is not available or relevant:

    Acceptance Criteria and Study Details for Raycell™ Shielded Cabinet X-ray System

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Technological Characteristics)Reported Device Performance (Raycell™)
    Source: 160 kVdc x-raysSame (160 kVdc x-rays)
    Beam filtration: 0.38 mm copperSame (0.38 mm copper)
    Single beam HVL, water: Approximately 4 mmSame (Approximately 4 mm)
    Dose rate: 3 Gy min⁻¹Same (3 Gy min⁻¹)
    Max/min dose ratio: <1.3Same (<1.3)
    Sample holder: Fixed, presents maximum width, minimum depthSame (Fixed, presents maximum width, minimum depth)
    Radiation Safety: Pb shielding, interlocksSame (Pb shielding, interlocks)

    Notes on Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are the technological characteristics of the predicate device (RS 3000). The "study" proving the device meets these criteria is essentially the declaration by MDS Nordion that the Raycell™ is "identical to the predicate device with the exception of labeling changes" and has "the same" technological characteristics. There is no performance study against these criteria described, as the claim is identity or sameness regarding these technical specifications.

    2. Sample size used for the test set and the data provenance:

    • Not applicable. This submission is for a blood irradiator, not an AI/ML or diagnostic device that would involve a "test set" of data or images. The "test" for substantial equivalence relies on comparing the device specifications to those of a predicate device.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. No ground truth establishment for a test set is described, as the device is not a diagnostic AI/ML tool.

    4. Adjudication method for the test set:

    • Not applicable. No test set or human adjudication is described.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This device is a blood irradiator, not an AI-assisted diagnostic tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This device is a blood irradiator. It does not involve an algorithm with standalone performance.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable for diagnostic ground truth. The "ground truth" for this submission is the established technical specifications and safe operation of the legally marketed predicate device (RS 3000), which the Raycell™ is stated to be identical to, except for labeling and manufacturer name. The intended use also refers to existing recommendations for gamma irradiation of blood products.

    8. The sample size for the training set:

    • Not applicable. This device is a blood irradiator, not an AI/ML model that requires a training set.

    9. How the ground truth for the training set was established:

    • Not applicable. As above, no training set is relevant to this device's regulatory submission.
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