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510(k) Data Aggregation

    K Number
    K030884
    Device Name
    APTUS BLUE
    Manufacturer
    ACADENTAL
    Date Cleared
    2003-05-27

    (68 days)

    Product Code
    KJJ
    Regulation Number
    N/A
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K972234
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K972234

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

    Aptus Blue is used in the cleansing of the root canal preparation during endodontic therapy.

    Device Description

    Aptus Blue is a 3cc endodontic syringe containing EDTA solution. Aptus Blue allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic tissue from the root canal. It is designed to be used with endodontic irrigation solutions and sodium hypochlorite solutions.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device (Aptus Blue) rather than a study with acceptance criteria and performance data in the typical sense of a clinical trial for software or diagnostic devices.

    The "acceptance criteria" here refer to the regulatory pathway for demonstrating substantial equivalence to a predicate device. The "study" proving it meets these criteria is the comparison to the predicate device and the assessment of its technological characteristics.

    Here's the breakdown of the requested information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Note: For this type of submission, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics, rather than specific performance metrics like sensitivity/specificity.

    Acceptance Criterion (Regulatory)Reported Device Performance/Characteristics
    Intended Use Equivalence: Does the device share the same intended use as a legally marketed predicate device?Aptus Blue: Used in the cleansing of the root canal preparation during endodontic therapy.
    Predicate Device (RCT Gel K972234 / RC Prep Pro-1976): Implied equivalent use (root canal cleansing).
    Technological Characteristics Equivalence: Are the technological characteristics substantially equivalent to the predicate device, or do any differences not raise new questions of safety and effectiveness?Aptus Blue: 3cc endodontic syringe containing EDTA solution. Designed to be used with endodontic irrigation solutions and sodium hypochlorite solutions. All components used in predicate medical devices or found safe for dental use.
    Predicate Device (RCT Gel K972234 / RC Prep Pro-1976): Implied similar composition (EDTA solution for root canal cleansing). The document states "identical concentrations of active ingredients" with the predicate.
    Safety and Effectiveness: Does the device demonstrate safety and effectiveness for its intended use? (Often inferred from equivalence to a safe and effective predicate).Aptus Blue: "We believe that, due to the long established safe and effective use of the predicate device and the identical concentrations of active ingredients, limited contact time within the oral cavity, decomposition, and thorough removal of the product from the canal space, the use of Aptus Blue does not require additional biocompatibility testing and that the device is safe and effective for the intended uses."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not applicable. This submission relies on a comparison of device characteristics and intended use to a predicate, not a test set of data.
    • Data Provenance: Not applicable.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Not applicable. There was no "test set" in the context of clinical data for which experts establish ground truth.

    4. Adjudication Method for the Test Set

    • Not applicable.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • No, a MRMC comparative effectiveness study was not done.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Not applicable. This is a physical device (EDTA solution in a syringe), not an algorithm or software.

    7. The Type of Ground Truth Used

    • In the context of this 510(k), the "ground truth" for demonstrating safety and effectiveness relies on the established safe and effective use of the predicate device (RC Prep Pro-1976) and the identical active ingredient concentrations and similar technological characteristics of the new device (Aptus Blue).

    8. The Sample Size for the Training Set

    • Not applicable. This is a physical device, not a machine learning model.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable.
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