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510(k) Data Aggregation

    K Number
    K992714
    Device Name
    MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010
    Manufacturer
    HYSTERX, INC.
    Date Cleared
    1999-10-05

    (54 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K922802
    Why did this record match?
    Device Name :

    MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010

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

    The MicroGRASP Monopolar Coagulator is indicated for use in the grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures.

    Device Description

    The MicroGRASP Monopolar Coagulator is an instrument designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device.

    AI/ML Overview

    The provided document describes a premarket notification for the "MicroGRASP Monopolar Coagulator," a device designed for grasping and coagulation of soft tissue and blood vessels during surgical procedures. The document aims to demonstrate substantial equivalence to a predicate device, the "Microsurge Front-End Grasping Devices."

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in a quantitative sense with corresponding performance metrics for the new device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The primary "acceptance criteria" appear to be meeting applicable standards and not raising new safety/effectiveness issues compared to the predicate.

    Acceptance Criteria (Implied)Reported Device Performance
    Compliance with applicable standards (e.g., for electrical safety, performance)"The MicroGRASP Monopolar Coagulator has been designed and tested to applicable standards (ANSI/AAMI HF-18/1993)."
    No new issues of safety, effectiveness, or performance compared to predicate."The MicroGRASP Monopolar Coagulator does not raise any new issues of safety, effectiveness, or performance of the product."
    Similar intended use to predicate.Intended Use for MicroGRASP is "For grasping and coagulation of soft tissue and blood vessels up to 3 mm during open and guidance-assisted surgical procedures," which is analogous to the predicate's "To remove tissue or control bleeding during general surgical endoscopic or laparoscopic procedures."
    Similar operating principle to predicate (Monopolar Electrosurgical handpiece).MicroGRASP: "Electrosurgical handpiece for coagulation." Predicate: "Electrosurgical handpiece for coagulation; electro-cautery." Both are Monopolar.
    Similar materials and design to predicate."The MicroGRASP Monopolar Coagulator contains materials similar to those used in the predicate device, is of similar design and has the same operating principle as the predicate device." Specific material comparisons are provided in the table.

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

    The document does not mention a "test set" in the context of clinical or performance data from a sample of cases or patients. The evaluation appears to be based on bench testing and comparison of technical characteristics. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature is not provided.

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

    This information is not provided as the submission relies on bench testing and comparison to standards, not human expert evaluation of a test set in the traditional medical device study sense.

    4. Adjudication Method for the Test Set

    This information is not provided as there is no described test set that would require adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

    This is not applicable. The device is a mon-AI surgical instrument (Monopolar Coagulator), not an AI diagnostic or assistance tool. Therefore, an MRMC study related to AI assistance for human readers was not performed or mentioned.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

    This is not applicable. The device is a physical surgical instrument, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for the device's acceptable performance appears to be:

    • Compliance with published standards: Specifically, ANSI/AAMI HF-18/1993 for electrosurgical devices.
    • Demonstration of substantial equivalence to a legally marketed predicate device (Microsurge Front-End Grasping Devices) in terms of intended use, operating principle, and technical characteristics.

    8. The Sample Size for the Training Set

    This is not applicable. The device is a physical surgical instrument, and there is no mention of a "training set" in the context of machine learning or AI development.

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

    This is not applicable for the same reason as above.

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