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510(k) Data Aggregation

    K Number
    K082518
    Device Name
    DUAL NEEDLE SUTURE PASSER SYSTEM
    Manufacturer
    CAYENNE MEDICAL, INC.
    Date Cleared
    2009-01-16

    (136 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K063778,K041894,K023388,K062307,K072322
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dual Needle Suture Passer System is intended for approximation of soft tissue in procedures such as meniscal repair

    Device Description

    The Dual Needle Suture Passer System is a sterile hand-held, manually operated single procedure suture placement system for soft tissue approximation procedures.

    AI/ML Overview

    The provided text describes the 510(k) summary for the Dual Needle Suture Passer System. The study conducted to demonstrate equivalence is a mechanical test rather than a clinical study involving human or animal subjects that would typically have the detailed information requested.

    Here's the information extracted and filled in to the best of what's available in the text:

    Device: Dual Needle Suture Passer System

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Suture knot pull-out strength significantly higher than a predicate deviceSuture knot pull-out strength is significantly higher than that of a predicate device.
    Meet knot pull-out strength requirements in animal tissueThe proposed device was tested in animal tissue and meets the knot pull-out strength requirements.
    Meet USP requirements for non-absorbable suturesThe proposed device meets USP requirements for non-absorbable sutures.

    Study Details:

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

      • The document implies a test set was used for mechanical testing of suture knot pull-out force in "animal tissue." No specific number of samples or animal subjects is provided.
      • Data provenance: "animal tissue" is mentioned, not a specific country. The study appears to be a laboratory/benchtop test rather than a clinical study. It is a retrospective comparison against a predicate device.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not applicable. This was a mechanical engineering/biomedical performance test, not a study requiring expert consensus for ground truth.

    3. Adjudication method for the test set:

      • Not applicable, as there was no expert review or human assessment of ground truth. The acceptance criteria were based on quantitative mechanical measurements.

    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:

      • No, an MRMC study was not done. This device is a surgical instrument, not an AI diagnostic tool.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This device is a surgical instrument, not an algorithm.

    6. The type of ground truth used:

      • The "ground truth" for this study was defined by established mechanical engineering standards (e.g., USP requirements) and direct comparison to a predicate device's performance through quantitative mechanical testing (suture knot pull-out force).

    7. The sample size for the training set:

      • Not applicable. This was a mechanical performance study, not a machine learning study involving training data.

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

      • Not applicable. This was a mechanical performance study, not a machine learning study involving training data.
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