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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
    Predicate For
    N/A
    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 The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.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 Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter.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 (<24 hrs) Contact Duration device" (patient exposure <1 hr), classified as an "External Communicating Device – Tissue/Bone/Dentin."
    Overall Performance for Intended UsePerformance standards for intravascular catheter introducers (ISO 11070:2014)Results of testing demonstrate that the proposed device performs similarly to the predicate device and can be used according to its intended use. Overall, the device is found substantially equivalent to the predicate device based on the testing performed. No clinical testing was performed.

    Study Details (Non-Clinical Bench Testing)

    As this is a physical medical device and the clearance is based on substantial equivalence through non-clinical testing, the following points are not applicable (N/A) in the context of an AI/ML device approval. However, I can state what is available in the document.

    1. Sample size used for the test set and the data provenance:

      • Sample Size: Not explicitly stated as "sample size" in the context of a test set for an AI/ML model. The document indicates that various non-clinical bench tests were performed to evaluate the device's characteristics and performance. The number of units tested for each specific test is not detailed.
      • Data Provenance: N/A for AI/ML data provenance. The "data" here refers to physical test results obtained from the manufactured devices. The manufacturer is B. Braun Medical Inc., located in Allentown, Pennsylvania, USA. The testing would have been conducted by or for B. Braun.
      • Retrospective or Prospective: N/A. This is bench testing of physical devices.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • N/A. Ground truth for an AI/ML model does not apply here. The "ground truth" for a physical device is its adherence to specified physical and functional performance metrics, typically measured by engineering and quality control professionals using calibrated equipment and standard test methods.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • N/A. This is not an image classification or diagnostic device. Adjudication methods are relevant for human interpretation of data, typically in AI/ML performance evaluation studies.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • No MRMC study was done. The document explicitly states: "No clinical testing was performed, as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device." MRMC studies are for AI/ML devices involving human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • N/A. This is not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • N/A for AI/ML "ground truth". The ground truth for this device is based on engineering specifications, compliance with international standards (ISO), and direct physical measurements/tests to ensure the device performs as intended and is safe and effective when compared to a legally marketed predicate device.

    7. The sample size for the training set:

      • N/A. There is no AI/ML training set. The "training" for such a device involves manufacturing processes and quality control to meet design specifications.

    8. How the ground truth for the training set was established:

      • N/A. No AI/ML training set exists for this device.
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