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510(k) Data Aggregation

    K Number
    K973070
    Device Name
    CONVEEN EASICATH SET
    Manufacturer
    COLOPLAST CORP.
    Date Cleared
    1997-11-06

    (80 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K896729,K910022
    Why did this record match?
    Reference Devices :

    K896729

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

    The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of bladder drainage.

    Device Description

    The Conveen® EasiCath Set is a single use, disposable system that consists of a sterile polyvinylchloride intermittent catheter, coated with polyvinvlovrrolidone, and a sterile saline solution ampoule all sealed in a urine collection bag. The user twists open the saline ampoule inside the bag and soaks the catheter for 30 seconds. Once wet, the polyvinylpyrrolidone layer binds water molecules to the surface of the catheter creating a smooth lubricating film. The bag is opened and the catheter is inserted into the patent's urethra. The catheter itself is the same design and materials as our current non-coated Conveen® Intermittent Catheters, K896729.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Conveen® EasiCath Set, derived from the provided 510(k) summary:

    This device appears to be primarily a catheter system and the "acceptance criteria" and "studies" are focused on biocompatibility and safety of its components, rather than a performance study measuring clinical outcomes or diagnostic accuracy which would typically involve human readers or ground truth as seen in AI/imaging devices.

    Therefore, many of the requested fields regarding AI/human reader performance, ground truth establishment, and sample sizes for training/test sets are not applicable to this type of device and its submission.

    Acceptance Criteria and Reported Device Performance

    Test/CriteriaAcceptance Criteria (Implied by USB XXII Requirements)Reported Device Performance
    Intracutaneous TestNo significant difference in skin reaction between extract and control solutions.Conclusion: "No difference in skin reaction was observed at the injection sites of the extracts or the control solutions. Passed the Intracutaneous Test according to USP XXII requirements."
    Systemic Injection TestNo signs of toxicity in treated animals compared to controls.Conclusion: "No signs of toxicity were observed in the mice treated with the extract or the control solution. Passed the Systemic Injection Test according to USP XXII requirements."
    Mutagenicity Ames TestNo increase in the number of revertants compared to controls, indicating no mutagenic activity.Conclusion: "The extracts induced no increase in the number of revertants as compared to the controls. Thus, no detectable mutagenic activity was found of the extracts in the Ames test."
    Sensitization Guinea Pig Maximization TestNo evidence of delayed contact hypersensitivity.Conclusion: "No evidence of delayed contact hypersensitivity was seen after treatment with the extract or the control solution."
    Cytotoxicity Elution Test (L 929 cells)Cytotoxicity grade
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