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510(k) Data Aggregation

    K Number
    K171584
    Device Name
    B. Braun Tear-Away Introducer Needle
    Manufacturer
    B. Braun Medical Inc.
    Date Cleared
    2017-12-22

    (205 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K102460
    Why did this record match?
    Device Name :

    B. Braun Tear-Away Introducer Needle

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

    The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.

    Device Description

    The B. Braun Tear-Away Introducer Needle is a sterile, single-use, disposable device, that consists of a Stainless Steel Needle Hub. Tear-Away Sheath Hub. Tear-Away Sheath Shaft (tube) and a Protective Guard over the needle.

    The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.

    The plastic guard is removed and the B. Braun Tear-Away Introducer Needle is placed through the patient's skin with the bevel tip up. The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.

    The Tear-Away Introducer Needle Sheath remains in the patient to facilitate the placement of an introduction catheter. An introduction catheter is inserted thru the Tear-Away Introducer Needle Sheath and into the patient. Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter. The Tear-Away Introducer Needle Sheath is then split apart and peeled away from the catheter while holding the hub of the sheath at the T-handle. The Tear-Away Introducer Needle Sheath is then discarded.

    AI/ML Overview

    The provided text describes the B. Braun Tear-Away Introducer Needle and its substantial equivalence to a predicate device (Summit Medical Products, ambIT® Introducer) for FDA 510(k) clearance.

    Based on the document, this is not an AI/ML device. It is a physical medical device (an introducer needle). Therefore, many of the requested criteria related to AI/ML device testing (such as sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.

    However, I can extract and present the information provided regarding the device's acceptance criteria and the (non-clinical) study that proves it meets them.

    Device: B. Braun Tear-Away Introducer Needle

    Type of Device: Physical Medical Device (Catheter Introducer/Introducer Needle) - NOT AI/ML

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO standards.

    Acceptance Criteria CategorySpecific Test/StandardReported Device Performance (Summary)
    Physical and Dimensional CharacteristicsVisual InspectionVisual inspection was performed.
    Dimensional InspectionDimensional inspection was performed.
    Luer CompatibilityLuer Compatibility - Gauging (ISO 594-1:1986, ISO 80369-7:2016)Testing performed.
    Needle/Sheath Functionality & IntegrityNeedle Removal ForceTesting performed.
    OcclusionTesting performed.
    PressureTesting performed.
    Cannula Deflection (ISO 9626:2016)Testing performed.
    Cannula Breakage (ISO 9626:2016)Testing performed.
    Tensile StrengthTesting performed.
    Associated Device (likely compatibility/function with other devices)Testing performed.
    Stress CrackingTesting performed.
    Fluid Leakage by Pressure DecayTesting performed.
    Subatmospheric Pressure Air LeakageTesting performed.
    Resistance to Separation from UnscrewingTesting performed.
    Resistance to Separation from Axial LoadTesting performed.
    Resistance to OverridingTesting performed.
    Strength of Union (implied by separation/tensile tests)Testing performed.
    SterilitySterilization Method (Ethylene Oxide, SAL 10^-6)The device undergoes Ethylene Oxide sterilization to a Sterility Assurance Level (SAL) of 10^-6.
    BiocompatibilityBiocompatibility requirements per ISO 10993-1:2009 (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity, Rabbit Pyrogen)Materials meet biocompatibility requirements. The device is a "Limited (
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