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510(k) Data Aggregation

    K Number
    DEN050001
    Device Name
    DECAPINOL ORAL RINSE
    Manufacturer
    SINCLAIR PHARMACEUTICALS LIMITED
    Date Cleared
    2005-04-18

    (84 days)

    Product Code
    NTO
    Regulation Number
    872.5580
    Type
    Post-NSE
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K993147
    Device Name
    DECAP
    Manufacturer
    THE KIPP GROUP
    Date Cleared
    1999-11-02

    (42 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DECap™ is a non-vented cap that is intended to seal male or female luer locks that are part of typical medical devices such as manifolds, stopcocks or sets.

    Device Description

    The DECap™ is a non-vented cap.

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a medical device called "DECap™". It primarily focuses on the regulatory approval for marketing the device based on its substantial equivalence to a legally marketed predicate device.

    Unfortunately, this document does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specifics of a study proving the device meets those criteria.

    The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...".

    This means the device was cleared because it was shown to be substantially equivalent to an existing device, not necessarily through a new study with explicit acceptance criteria for its performance. The 510(k) pathway often relies on demonstrating that a new device is as safe and effective as a predicate device, which can involve performance data but doesn't always require a comprehensive study against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might.

    Therefore, I cannot provide the requested information from this document. The document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size, data provenance, or details of a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information about a standalone algorithm performance study.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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