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510(k) Data Aggregation

    K Number
    K211395
    Device Name
    NIO-I
    Manufacturer
    Date Cleared
    2021-07-28

    (84 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Einstein Works LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NIO-I is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
    Device Description
    The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age. The NIO-I provides haptic feedback via the steppedneedle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.
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