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510(k) Data Aggregation

    K Number
    K031906
    Device Name
    APEEL CS CATHETER DELIVERY SYSTEM
    Manufacturer
    ST. JUDE MEDICAL
    Date Cleared
    2003-07-18

    (28 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    APEEL CS CATHETER DELIVERY SYSTEM

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

    The Apeel CS Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.

    Device Description

    The Apeel™ CS Catheter Delivery System includes a Peelable Introducer Sheath, Dilator, Cannulator, Detachable Hemostasis Valve with Side Port, Guidewire, Syringe and Needle. The introducer kits are provided sterile, and are intended for single-use only.

    AI/ML Overview

    The provided text is a 510(K) summary for the Apeel™ CS Catheter Delivery System, a medical device. This type of document is for regulatory submission and focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed performance studies with acceptance criteria in the manner one might find for a diagnostic or AI-powered device.

    Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted from this document. The document explicitly states:

    • "All technological characteristics of the Apeel™ CS Catheter Delivery System are substantially equivalent to the predicate devices including product design, packaging, sterilization, and labeling."
    • "St. Jude Medical, Daig Division considers the Apeel CS Catheter Delivery System to be substantially equivalent to the predicate devices."

    This indicates that the primary "proof" of the device's acceptability is its similarity to already approved devices, not necessarily a standalone performance study against specific, quantified acceptance criteria.

    However, I can provide a table summarizing what might be considered "acceptance criteria" based on the substantial equivalence claim, and state why the other requested information is not available in this document.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria Category (Implied by Substantial Equivalence)Reported Device Performance (Implied by Substantial Equivalence)
    Intended UseIntended to provide vascular access (including coronary sinus) and serve as a conduit for other devices, minimizing blood loss. (Matches predicate devices' intended use).
    Technological CharacteristicsSubstantially equivalent to predicate devices (Seal-Away CS Introducer Kit, Seal-Away Hemostasis Adapter, and Alliance Catheter Delivery System) in product design, packaging, sterilization, and labeling.
    Safety and EffectivenessDeemed safe and effective based on substantial equivalence to predicate devices, which are legally marketed.
    ClassificationClass II (Percutaneous Catheter Introducer, per 21 CFR 870.1340). (Matches predicate device classification).
    SterilityProvided sterile. (Implies adherence to predicate device's sterility methods and successful sterilization).
    Single-UseIntended for single-use only. (Matches predicate device usage).

    Information Not Available in the Provided Document:

    The provided 510(K) summary does not contain the following details, as it focuses on substantial equivalence rather than a de novo performance study with specific quantifiable metrics. This kind of information is typically found in clinical study reports or detailed engineering verification/validation reports, which are not usually part of the public 510(K) summary.

    • 2. Sample size used for the test set and the data provenance: Not applicable/not provided for this type of submission. There is no "test set" in the context of a performance study described here.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Ground truth is not established in this context.
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided.
    • 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an introducer sheath, not an AI or diagnostic imaging device.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided.
    • 8. The sample size for the training set: Not applicable/not provided.
    • 9. How the ground truth for the training set was established: Not applicable/not provided.
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