LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K241426
    Device Name
    GPS Advanced; 5 cc GPS Advanced Cannula
    Manufacturer
    Prosidyan, Inc.
    Date Cleared
    2024-07-10

    (51 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K170306,K222276,K201338
    Predicate For
    K251648
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

    Device Description

    GPS Advanced is a sterile, single use dispensing system for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The instrument system includes 1) a dispenser with a ratcheted plunger that advances with each squeeze of its handle and 2) two 5 cc GPS Advanced Cannulas which can be attached to the dispenser to deliver FIBERGRAFT™ BG Putty GPS. The 5 cc GPS Advanced Cannula (hereafter referred to as "GPS Advanced Cannula") is also available individually packaged. GPS Advanced and GPS Advanced Cannula are provided sterile via irradiation. GPS Advanced Cannulas are provided empty and need to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

    AI/ML Overview

    The provided document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as it relates to performance with AI.

    The document is a 510(k) premarket notification for a medical device called "GPS Advanced; 5 cc GPS Advanced Cannula," which is a dispensing system for a bone graft substitute. The review focuses on the substantial equivalence of this device to legally marketed predicate devices, primarily regarding its mechanical and material characteristics, sterility, usability, and packaging.

    The relevant section, "H. Performance Data," lists the following evaluations:

    • Biological Risk Assessment
    • Sterilization Validation
    • Usability Engineering Evaluation
    • Packaging and Shelf Life Testing, including functional evaluation

    These are standard engineering and safety tests for a medical device that does not involve AI.

    Therefore, I cannot provide the requested information regarding acceptance criteria for AI performance or a study demonstrating such performance.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1