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510(k) Data Aggregation

    K Number
    K022861
    Device Name
    SAFETOUCH
    Manufacturer
    RUSIN MEDICAL DEVICES
    Date Cleared
    2002-11-26

    (90 days)

    Product Code
    NHM
    Regulation Number
    884.2990
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SafeTouch sheet and marking pen are used to mark the location of breast lumps that a woman may find while doing her monthly breast selfexamination.

    Device Description

    SafeTouch® Breast Exam Recording Sheet

    AI/ML Overview

    The provided FDA 510(k) summary for the "SafeTouch® Breast Exam Recording Sheet"does not contain information about acceptance criteria or a study proving device performance against such criteria.

    This document is a letter from the FDA determining substantial equivalence for marketing the device. It typically does not include detailed performance studies, which are usually found in the original 510(k) submission itself or in separate technical documentation.

    Therefore, I cannot extract the requested information from the provided text.

    To answer your questions, I would need access to the actual 510(k) submission document, which would detail any performance testing conducted for the SafeTouch® device.

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