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510(k) Data Aggregation

    K Number
    K070845
    Device Name
    SOUNMED COLOPOSCOPE COLPO-99/99PLUS
    Manufacturer
    SOUNMED, INC.
    Date Cleared
    2007-10-12

    (199 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K021854
    Why did this record match?
    Device Name :

    SOUNMED COLOPOSCOPE COLPO-99/99PLUS

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

    The Sounmed Colposcope COLPO-99 is intended to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy.

    Device Description

    The ColposcopeS COLPO-99 / 99 PLUS is a precise optical instrument designed specially for the gynecologic examination. The Sounmed colposcope can be used to view vaginal en cervical tissues using stereoscopic optics. The COLPO-99/ 99 PLUS Colposcope has detailed features that include a wide field of view, long focal length, uniform illumination, adjustable brightness, ease operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows: Eyepiece Magnification: 12.5X with diopter adjustment. Focal Length: 300mm. Green filter light. Easy replacement of halogen light bulb. Ball joint gives you 360 degree easy motion for gross focus.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Sounmed Colposcopes COLPO-99/99 PLUS. It states that no clinical tests were performed as it was deemed "Not Applicable." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

    The document discusses non-clinical tests performed to demonstrate substantial equivalence, which primarily involved compliance with certain standards:

    • EN 60601-1-1
    • EN 60601-1-2
    • ISO 14971:2000

    Since no clinical study was performed, the following information cannot be provided from this document:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established
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