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510(k) Data Aggregation

    K Number
    K070644
    Date Cleared
    2007-04-02

    (25 days)

    Product Code
    Regulation Number
    878.3300
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GORE SEAMGUARD® Staple Line Reinforcement Material for circular staplers is indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.

    Device Description

    This 510(k) is being submitted for a minor modification to the product configuration made to the SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material for use with circular staplers cleared under K053200. The proposed modification that is subject of this 510(k) submission is to include a polymer introducer sleeve as an accessory within the current packaging configuration for use as a tool to facilitate the delivery of the CBSG product through the abdominal wall to bariatric anastomotic sites during laparoscopic procedures. No other changes are being made to the SEAMGUARD device or its packaging as cleared under K053200.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device modification, specifically for the GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with acceptance criteria and performance metrics as might be found in a Premarket Approval (PMA) application or a de novo submission.

    Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance, or training set details).

    The core of this 510(k) is to demonstrate that a minor modification (the inclusion of a polymer introducer sleeve) to an already cleared device does not raise new questions of safety or effectiveness. It relies on the substantial equivalence principle and states that "A variety of tests, assessments, and comparisons demonstrate that the SEAMGUARD® Staple Line Reinforcement Material with optional introducer sleeve for Circular Staplers is substantially equivalent to its predicate in terms of design, intended use, principle of operation, and performance attributes." However, these "tests, assessments, and comparisons" are not detailed in the provided text.

    In summary, based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, device performance, and study methodology because this information is not present in a 510(k) summary for a minor device modification.

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