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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
    Predicate For
    K023254,K062444
    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 < 2.Conclusion: "Passed the Elution Test according to USP XXII requirements (cytotoxicity grade < 2)"

    Study Details

    1. Sample size used for the test set and the data provenance:

      • Test set sample size: Not explicitly stated in terms of number of subjects or samples. The tests described (Intracutaneous, Systemic Injection, Ames, Guinea Pig Maximization, Cytotoxicity) are laboratory-based biocompatibility tests that use standardized biological models (e.g., mice for systemic injection, guinea pigs for sensitization, L 929 cells for cytotoxicity, bacterial strains for Ames test).
      • Data provenance: Not specified in terms of country of origin. The tests are laboratory studies following recognized standards (USP XXII).
      • Retrospective or prospective: N/A (laboratory biocompatibility testing).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. The "ground truth" for these tests is defined by the objective results of the standardized biological assays as interpreted by the test protocols, not by expert consensus in a clinical sense.

    3. Adjudication method for the test set: N/A. The results of these laboratory tests are typically determined by protocol-driven observations and measurements, not by expert adjudication.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is not an AI/imaging device.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI algorithm.

    6. The type of ground truth used: The "ground truth" here is based on the biological response observed in standardized biocompatibility assays according to USP XXII requirements (e.g., absence of toxicity, absence of mutagenicity, absence of sensitization, low cytotoxicity).

    7. The sample size for the training set: N/A. This is not an AI device that requires a training set. The "training" for such devices involves ensuring the manufacturing process consistently produces safe materials.

    8. How the ground truth for the training set was established: N/A.

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