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510(k) Data Aggregation

    K Number
    K083013
    Device Name
    PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
    Manufacturer
    GYRUS ACMI, INC.
    Date Cleared
    2008-12-09

    (61 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K034004,K012488,K973499
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PK® Diego® System is intended for cutting, coagulation and removal of bone and tissue in general ENT, Head & Neck, Otoneurologic and various spinal surgical procedures.

    Device Description

    The PK Diego System is identical to the device cleared under K034004. The system includes the same power console, footswitch, reusable handpiece and various single use, interchangeable burs and bipolar blades. The sole purpose of this submission is to expand the existing indications to include various spinal surgical procedures.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the PK® Diego® System:

    This 510(k) submission primarily focuses on expanding the indications for use of an already cleared device, the Diego RF Powered Dissector & Drill System (K034004), to include "various spinal surgical procedures." As such, the submission emphasizes substantial equivalence to predicate devices rather than entirely new performance testing.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (What was measured)Reported Device Performance (How the device performed)
    Bipolar cutting performance"Testing demonstrated that the performance requirements were met, and that the PK Diego System exhibited comparable performance characteristics to both predicates."
    Bipolar coagulation performance"Testing demonstrated that the performance requirements were met, and that the PK Diego System exhibited comparable performance characteristics to both predicates."
    Material biocompatibility (patient-contacting materials)"The PK Diego System uses patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI."
    Dimensional similarity (blade shaft and tip diameters)"The Diego bipolar blades are dimensionally similar to the predicate XPS (MDS) StraightShot Microdebrider System cleared under K973499, having similar blade shaft and tip diameters."
    Utilization of existing technology (electrosurgical energy)"The PK Diego System utilizes the same bipolar electrosurgical energy to cut and coagulate tissue as that used in the predicate Diego RF Dissector and Drill System..."
    Connectivity to existing generator/console"The PK Diego powered handpiece, burs and bipolar blades connect to the same electrosurgical generator/console, as the predicate and currently marketed Diego RF Dissector and Drill System..."

    2. Sample Size Used for the Test Set and Data Provenance:

    The document does not specify a numerical sample size for the performance testing. It generally refers to "Testing" and "comparable performance characteristics."

    The data provenance is retrospective, as it compares the PK Diego System's performance and characteristics to legally marketed predicate devices that have prior clearance. There is no indication of prospective clinical or lab studies specifically for this 510(k) submission.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

    The document does not mention the involvement of experts for establishing ground truth in terms of clinical or pathological evaluation for the performance testing. The comparison is against the known performance characteristics of existing predicate devices.

    4. Adjudication Method for the Test Set:

    No adjudication method is mentioned as there's no indication of multiple expert assessments or a need for dispute resolution in the context of this substantial equivalence submission.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    No MRMC comparative effectiveness study was done. This 510(k) is for a surgical device, not an imaging or diagnostic aid that would typically involve human readers.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

    This question is not applicable to the device described. The PK® Diego® System is a surgical instrument operated by a human surgeon, not an algorithm.

    7. Type of Ground Truth Used:

    The "ground truth" used for this submission is based on the established performance characteristics and safety profiles of the legally marketed predicate devices. This includes:

    • Known tissue debridement performance (XPS (MDS) StraightShot Microdebrider System)
    • Known tissue coagulation performance (Endius Bipolar Sheath)
    • Existing biocompatibility of materials (predicate devices and other Gyrus ACMI devices)
    • Established function of the shared power console and electrosurgical energy.

    8. Sample Size for the Training Set:

    The concept of a "training set" is not applicable here as the device is a mechanical/electrical surgical instrument, not an AI or machine learning model that requires training data.

    9. How the Ground Truth for the Training Set Was Established:

    This question is not applicable for the reasons stated in point 8.

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