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510(k) Data Aggregation

    K Number
    K122235
    Device Name
    RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
    Manufacturer
    Teleflex Medical, Inc.
    Date Cleared
    2013-09-06

    (407 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K964056
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Rusch TracFlex Plus Tracheostomy Tube Set is used in airway management of tracheostomized patients

    Device Description

    The Rusch TracFlex Plus Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 7-11mm in 1 mm increments, with accessories which may be included in a set or sold separately. The device is used to provide an artificial airway, in order to provide access to the patient's airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device, the Rusch TracFlex Plus Tracheostomy Tube Set. This type of submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than conducting a full clinical study to prove efficacy and safety from scratch.

    Therefore, the "study that proves the device meets the acceptance criteria" is primarily a non-clinical comparative performance testing study, designed to show that the new device performs equivalently to the predicate device. This is not a human clinical trial with outcomes data or a statistical analysis of diagnostic accuracy.

    Here's an analysis based on your request, highlighting the differences in a 510(k) submission:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria in this context are established by engineering and performance standards (like ISO standards) and internal requirements to ensure the device performs comparably to the predicate and safely. The "reported device performance" indicates that the new device met these criteria.

    TestAcceptance CriteriaReported Device Performance
    Connector bonding strengthComply with ISO 5366-1 Section 6.1: The attachment of the connector to the tracheostomy tube must withstand an axial separation force.Met (implied by "pass/fail criteria has been met")
    Flange (neck-plate) bonding strengthComply with ISO 5366-1 Section 6.2: The attachment of the neck-plate to the tracheostomy tube must withstand an axial separation force.Met (implied by "pass/fail criteria has been met")
    Cuff resting diameterComply with ISO 5366-1 Section 6.4.3: Cuff diameter measured under specified inflation pressure to remove creases without excessive stretching.Met (implied by "pass/fail criteria has been met")
    Tube collapseComply with ISO 5361 section 4.5 (for cuff tests): Patency of the ET tube airway lumen tested by passing a steel ball through it with the cuff inflated within a transparent tube.Met (implied by "pass/fail criteria has been met")
    Cuff herniationComply with ISO 5361 section 4.5 (for cuff tests): Tendency of the cuff to herniate beyond a perpendicular plane at the bevel edge tested under axial force with the cuff inflated within a transparent tube, ensuring no excessive protrusion that could occlude the orifice.Met (implied by "pass/fail criteria has been met")
    Cuff Burst EvaluationEnsure the cuff does not burst or rupture when inflated inside the trachea (no specific standard cited, likely internal specification).Met (implied by "pass/fail criteria has been met")
    Cuff Bond StrengthEvaluate the strength needed to separate the cuff from the tube (no specific standard cited, likely internal specification).Met (implied by "pass/fail criteria has been met")
    Side arm bonding strengthEvaluate the retention force of the inflation line connection to the Tracheostomy tube (no specific standard cited, likely internal specification).Met (implied by "pass/fail criteria has been met")
    Ink adhesion (Tracheostomy tube)Ensure printing remains legible after aging, sterilization, and wiping with a solvent (no specific standard cited, likely internal specification).Met (implied by "pass/fail criteria has been met")
    DEHP testingComply with ISO 10993-17 and 10993-18: Determine the content of DEHP in the total device, demonstrating
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