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510(k) Data Aggregation

    K Number
    K042258
    Device Name
    BP-SPECT V1.O
    Manufacturer
    SYNTERMED, INC.
    Date Cleared
    2004-10-04

    (45 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K020300
    Why did this record match?
    Device Name :

    BP-SPECT V1.O

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

    The BP-SPECT™ software program should be used for the display of wall motion and quantification of left and right ventricular function parameters from gated Tc99m blood pool SPECT studies.

    Device Description

    The BP-SPECT™ is used to display gated wall motion and for quantifying parameters of left and right ventricular from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

    AI/ML Overview

    The provided text describes the Syntermed, Inc. BP-SPECT™ software program, which is used for displaying wall motion and quantifying left and right ventricular function parameters from gated Tc99m blood pool SPECT studies. However, the document does not provide specific acceptance criteria or a detailed study methodology with the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, ground truth details, etc.).

    The document states:

    • "The expected accuracy of the program can be found in Item H. Testing & Validation"
    • "Specific details and results concerning the validation of the . BP-SPECT™ program are listed in Item H, Testing & Validation."

    Unfortunately, Item H. Testing & Validation is not included in the provided text. Therefore, I cannot extract the detailed information requested regarding the acceptance criteria and the study that proves the device meets them.

    The text does make general statements about validation:

    • "The effectiveness of the program has been established in in-house testing and clinical validation studies."
    • "We contend that the method employed for the development and the final in-house validation results of this medical display software program, . BP-SPECT™ program, have proven its safety and effectiveness."

    Without access to "Item H. Testing & Validation," the specific details of the acceptance criteria and the study proving compliance cannot be provided.

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