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510(k) Data Aggregation

    K Number
    K213070
    Device Name
    MD-320W Ultrasound Biomicroscope
    Manufacturer
    Meda Co., LTD
    Date Cleared
    2021-11-18

    (56 days)

    Product Code
    IYO,ITX
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K152318,K140199
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K152318

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

    MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.

    The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation.

    It is not allowed to use UBM on patients with eye trauma, inflammation or infection.

    Device Description

    MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable and two user-selectable APPs:

    MD3XUBM.AP1-C V1.0 APP (included in MD3XUBM-C V1.0) runs on the windows operating system of the PC and allows the user to control probe scanning, image acquisition and display via the PC user interface.

    MD3XUBM.AP1-S V1.0 APP (included in MD3XUBM-S V1.0) runs on the operating system of the legally marketed MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) and allows the user to control probe scanning, image acquisition and display via the MD-2300S user interface.

    Under the excitation of electric pulse, the 50MHz ultrasound transducer emits ultrasonic pulse into eye and receives reflective echo from the surfaces of different tissue, thus forming real-time two-dimensional image of eye tissue.

    AI/ML Overview

    This FDA 510(k) summary for the MD-320W Ultrasound Biomicroscope details its substantial equivalence to a predicate device but does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The provided text focuses on comparing the new device's technological characteristics and intended use to a predicate device (VuPad Ophthalmic Ultrasound System), highlighting non-clinical testing for safety, EMC, and acoustic output.

    Therefore, the following information cannot be extracted from the provided text:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set and data provenance.
    • Number of experts used to establish ground truth and their qualifications.
    • Adjudication method for the test set.
    • Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Whether a standalone performance study was done.
    • The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance study.
    • The sample size for the training set.
    • How the ground truth for the training set was established.

    The document only states that "The software and essential performance have passed verification and validation, and the results comply with the related requirements as per the FDA Guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in June 27, 2019." This is a general statement about compliance with guidance and does not provide specific performance metrics or study details.

    In summary, the provided text describes regulatory approval based on substantial equivalence to a predicate device, focusing on technical specifications and general safety/EMC testing, rather than detailed performance study data against specific acceptance criteria.

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