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510(k) Data Aggregation

    K Number
    K212328
    Device Name
    DiscCath Needle Set
    Manufacturer
    DiscCath LLC
    Date Cleared
    2021-09-26

    (61 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K170112,K993967,K173155
    Why did this record match?
    Reference Devices :

    K170112, K993967

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

    The DiscCath Needle Set is intended to provide access into the intervertebral disc for discography and injection of fluids. The device is intended for adult patients.

    Device Description

    The DiscCath Needle Set is a single-use intradiscal injection needle comprised of a 17 gauge x 6" Introducer Needle and a 21 gauge x 10.2 inch (nominal) Injection Catheter. The Introducer Needle is comprised of a stainless-steel cannula and metal hub with a stainless-steel stylet with metal hub. The Introducer Needle has a cannula and stylet match ground bevel point at the distal tip which allows for penetration into the intervertebral disc. The Injection Catheter is comprised of a nitinol shape-set tube and a molded plastic hub. The injection catheter tubing is flexible with a curved tip welded closed at the distal end and includes a laser cut side-hole that allows for the injection of a fluid. When used as intended, the Introducer Needle and stylet are first inserted percutaneously and advanced adjacent to the target anatomy. After removing the Introducer Needle stylet, the curved catheter is then inserted through the Introducer Needle cannula and slowly advanced to the target anatomy. The DiscCath Needle Set is sterilized by ethylene oxide and intended for single use.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving that an AI/ML device meets acceptance criteria.

    The document is an FDA 510(k) clearance letter for a medical device called the "DiscCath Needle Set," which is an instrument, not an AI/ML software. The clearance is based on substantial equivalence to a predicate device, focusing on engineering specifications, material properties, sterilization, and biocompatibility, as opposed to performance metrics that would be associated with an AI/ML algorithm (e.g., sensitivity, specificity, AUC).

    Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving an AI/ML device meets them, as this information is not present in the provided text.

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