LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160297
    Device Name
    Tuohy NRFit
    Manufacturer
    PAJUNK GmbH Medizintechnologie
    Date Cleared
    2016-10-28

    (268 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K040965
    Why did this record match?
    Device Name :

    Tuohy NRFit

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

    The Tuohy NRFit™ cannulas/ needles for anesthesia are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of an epidural catheter.

    The device is intended for adult and pediatric patients.

    Device Description

    The Tuohy NRFit™ anaesthesia conduction needles are available in different sizes (length and diameter). Optional Accessories are retaining plate and stylet made from plastic or stainless steel as it has been cleared in the predicate device's 510(k)s.

    The Tuohy NRFit™ anaesthesia conduction needles can be used for both, epidural anaesthesia and peripheral nerve blocks each equipped with appropriate labelling as the Tuohy needle in general is a commonly used needle with both clinical demands and techniques.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "Tuohy NRFit™" anesthesia conduction needles. The manufacturer, PAJUNK GmbH Medizintechnologie, is seeking to demonstrate substantial equivalence to a legally marketed predicate device (K040965, PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES).

    The key difference between the subject device and the predicate device is the design of the needle's hub: the predicate devices use a LUER taper connector, while the subject devices use an NRFit connector as described in ISO 80369-6 for neuroaxial devices. The submission argues that all other aspects, including clinical technique, indications for use, technical specifications, materials used, sterility, and biocompatibility, are identical or unaffected by the hub design change.

    The document focuses on demonstrating that the new hub design does not compromise the device's safety and effectiveness compared to the predicate.

    Here's an analysis of the acceptance criteria and the study presented:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Feature/TestAcceptance CriteriaReported Device PerformanceConclusion
    Sterilization EfficacySAL of 10^-6 for Ethylene Oxide sterilization. Compliance with ISO 11135-1 Overkill Approach. Residuals of EO and ECH within limits (25ppm). Pyroburden/endotoxin limit of 0.06 EU/ml and 2.15 EU/device.SAL: 10^-6
    Method: Validated according to ISO 11135-1 Overkill Approach (1 sublethal, 2 half, 1 full cycle).
    Residuals: Met limits of 25ppm for EO and ECH.
    Pyroburden: Met limits of 0.06 EU/ml and 2.15 EU/device.Compliant (Identical to predicate)
    Shelf LifeNo decrease in essential performance after 5 years. Sterility maintained after 5 years.Sterility tests performed on worst-case devices after 5 years showed devices were sterile. Performance of essential device elements (LUER/NRFit connection, bonding, catheter tensile strength, needle bending rigidity) showed no decrease after 5 years.Compliant (Identical to predicate)
    BiocompatibilityCompliance with ISO 10993-1, 2nd and 3rd edition. FDA-recommended tests completed for "External communicating device - Blood Path, indirect - Limited (
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1