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510(k) Data Aggregation

    K Number
    K160900
    Device Name
    CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
    Manufacturer
    C.R. BARD INC.
    Date Cleared
    2016-05-31

    (60 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K142808
    Why did this record match?
    Reference Devices :

    K142808

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

    The CapSure ™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

    Device Description

    The CapSure™ Permanent Fixation System is a sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft. The shaft of the CapSure™ Permanent Fixation System is 37 cm in length. The fasteners are designed with a 316L Stainless steel helical coil and polyetheretherketone (PEEK) cap on the proximal end to support mesh or tissue.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the CapSure™ Permanent Fixation System. It focuses on demonstrating substantial equivalence to a predicate device (K142808 CapSure™ Permanent Fixation System) rather than presenting a study for initial market approval. Therefore, the information typically requested for a device's initial acceptance criteria and its demonstration through a study (especially regarding algorithm performance, ground truth establishment, sample sizes for training/test sets, and expert involvement for AI/diagnostic devices) is largely not applicable in this context.

    This submission is about minor changes to an already cleared device, asserting that no technological characteristics have changed and that updated instructions for use are supported by adequate performance data from the previous 510(k).

    However, I can extract the information related to performance data and acceptance criteria as presented for the original clearance (K142808) and affirmed for this submission.

    Here's a breakdown based on the document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test CategorySpecific TestAcceptance CriteriaReported Device Performance
    BiocompatibilityCytotoxicity(Implicit: Meet ISO 10993 standards for non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, etc. for materials in contact duration categories)All samples tested met the acceptance criteria. (Deployment device: tissue contacting
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