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510(k) Data Aggregation

    K Number
    K232482
    Device Name
    MAGNETOM Viato.Mobile
    Manufacturer
    Siemens Medical Solutions USA, Inc.
    Date Cleared
    2023-09-06

    (21 days)

    Product Code
    LNH,LNI,MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K202014,K220151,K221733
    Why did this record match?
    Reference Devices :

    K202014, K220151

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

    The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

    The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

    Device Description

    MAGNETOM Viato.Mobile with software syngo MR XA51A includes minor modified hardware compared to the predicate device. MAGNETOM Sola Fit with software syngo MR XA51A. A high level summary of the modified hardware is provided below:

    Hardware
    Modified Hardware

    • Cover
      Other Modifications and / or Minor Changes
    • Adaptations for installation in a mobile trailer
    • MAGNETOM Viato.Mobile is a mobile MR system which enables the customers to relocate the MRI system to different locations and therefore provide imaging services where it is needed.
    AI/ML Overview

    The provided text describes the 510(k) summary for the MAGNETOM Viato.Mobile device, focusing on its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study specifically proving the device meets those criteria for software-driven performance aspects, nor does it include information about AI/ML models.

    The document states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device." It primarily focuses on hardware modifications and compliance with general medical device standards.

    Therefore, many of the requested details cannot be extracted from the provided text. Below is a summary of what can be inferred from the document and a clear indication of what information is missing.

    Acceptance Criteria and Reported Device Performance

    The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the context of an AI/ML model for diagnostic accuracy. Instead, the "performance" discussed relates to the device's adherence to general safety and operational standards as a Magnetic Resonance Diagnostic Device (MRDD).

    Table of Acceptance Criteria and Reported Device Performance (as inferred from the document regarding the device's overall functionality and safety):

    Acceptance Criteria CategorySpecific Criteria (Inferred from Standards)Reported Device Performance (Inferred from substantially equivalent claim)
    Magnetic Resonance Imaging FunctionalityProduction of transverse, sagittal, coronal, oblique images; spectroscopic images and/or spectra; display of internal structure/function of head, body, or extremities. Interpretation by trained physician assists in diagnosis.Performs as intended, equivalent to predicate device.
    Interventional ProceduresCompatibility with MR compatible devices (e.g., in-room displays, MR Safe biopsy needles) for imaging during interventional procedures.Performs as intended, equivalent to predicate device.
    Electrical SafetyCompliance with IEC 60601-1 (general requirements for basic safety and essential performance).Compliant with IEC 60601-1.
    Electromagnetic Compatibility (EMC)Compliance with IEC 60601-1-2 (electromagnetic disturbances requirements and tests).Compliant with IEC 60601-1-2.
    MR-Specific SafetyCompliance with IEC 60601-2-33 (particular requirements for basic safety and essential performance of magnetic resonance equipment).Compliant with IEC 60601-2-33.
    Software Life Cycle ProcessesCompliance with IEC 62304 (medical device software - software life cycle processes).Compliant with IEC 62304.
    Risk ManagementCompliance with ISO 14971 (application of risk management to medical devices).Compliant with ISO 14971.
    Usability EngineeringCompliance with IEC 62366-1 (application of usability engineering to medical devices).Compliant with IEC 62366-1.
    DICOM CompatibilityCompliance with NEMA DICOM standards (Digital Imaging and Communications in Medicine).Compliant with NEMA DICOM.
    Image Quality ParametersCompliance with NEMA standards for SNR, geometric distortion, image uniformity, slice thickness, acoustic noise, SAR.Compliant with relevant NEMA standards for image quality.
    Operational EnvironmentEquivalent to predicate device.Equivalent to predicate device.
    Programming LanguageEquivalent to predicate device.Equivalent to predicate device.
    Operating SystemEquivalent to predicate device.Equivalent to predicate device.

    Regarding the study that proves the device meets acceptance criteria:

    The document explicitly states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device."

    The assessment for substantial equivalence was based on:

    1. Bench testing of modified hardware: Performed according to "Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices."
    2. Verification and validation (V&V) of modified hardware: Performed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
    3. Electrical safety and electromagnetic compatibility (EMC) testing of the complete system: Performed per IEC 60601-1-2.

    The conclusion is that these non-clinical data demonstrate the device performs as intended and is substantially equivalent to the predicate device, the MAGNETOM Sola Fit (K221733).

    Missing Information (Not found in the provided text):

    1. Sample size used for the test set and the data provenance: Not applicable, as no performance study for diagnostic accuracy was conducted for an AI component. The tests were for hardware and system compliance.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no test set requiring expert ground truth for diagnostic accuracy.
    3. Adjudication method for the test set: Not applicable.
    4. 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. The device is a Magnetic Resonance Diagnostic Device, not an AI-assisted diagnostic tool.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
    7. The sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.

    This device is primarily an MR hardware system with software for operation and image generation, not a device incorporating AI/ML for diagnostic interpretation. The substantial equivalence relies on proving the modified hardware and mobile integration retain the fundamental safety and performance characteristics of the predicate device, as demonstrated through engineering tests and adherence to recognized standards.

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