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510(k) Data Aggregation

    K Number
    K052228
    Device Name
    SMIT SLEEVE
    Manufacturer
    NUCLETRON CORPORATION
    Date Cleared
    2005-11-09

    (85 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K953946
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smit Sleeve is intended for Intracavitary Brachytherapy procedures involving Nucletron remote afterloading equipment.
    The Smit Sleeve (189.660 to 189.667) is an accessory to the GYN Applicators and the CT/MR Smit Sleeve (189.565) is an accessory to the CT/MR GYN Applicators.

    Device Description

    The Nucletron Smit Sleeve as described in this submission is designed as an accessory to the Nucletron remote afterioading equipment and is intended for Intracavitary Brachytherapy procedures.
    The Smit Sleeve has a Flange, which is sutured against the cervix. The Smit Sleeve prevents that the Intrauterine Tube of the Gynaecological Applicator is inserted to deep in the Uterus.
    The Smit Sleeve is left in the patient between fractions. Between fractions the Intrauterine The of the Gynaecological Applicator can be inserted into the endometrium multiple times without dilating the Cervix. After the treatment the Smit Sleeve is removed.
    The device uses similar (implantable) materials as in the legally marketed predicate device cited the Intracavitary Mould. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set.
    The Smit Sleeve is used as an accessory to the Nucletron microSelectron.

    AI/ML Overview

    This document is not a study that proves a device meets acceptance criteria. It is a 510(k) summary for a medical device (Nucletron Smit Sleeve) where the manufacturer asserts substantial equivalence to a legally marketed predicate device.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as these are not components of a 510(k) summary for substantial equivalence.

    The document primarily focuses on:

    • Describing the device.
    • Stating its intended use.
    • Identifying a legally marketed predicate device.
    • Asserting that the modified device (Smit Sleeve) is substantially equivalent to the predicate device based on similar materials, implant techniques, and intended use.
    • The FDA's letter confirming this substantial equivalence.
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