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    K Number
    K063468
    Device Name
    THE FUGO BLADE FOR DENTISTRY
    Manufacturer
    MEDISURG LTD.
    Date Cleared
    2007-04-18

    (153 days)

    Product Code
    EKZ
    Regulation Number
    872.4920
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K050933,K000768,K001498,K041019
    Why did this record match?
    Device Name :

    THE FUGO BLADE FOR DENTISTRY

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

    The Fugo Blade system is intended for incision, excision, ablation, vaporization and hemostasis of oral soft tissue e.g. excisional and incisional biopsies; exposure of unerupted teeth; fibroma removal; frenectomy and frenotomy; gingival troughing for crown impressions; gingiyoplasty: gingivectomy; gingival incision and excision; hemostasis; implant recovery; incision and drainage of abscess; leukoplakia; operculectomy; oral papillectomies; pulpotomy; pulpotomy as an adjunct to root canal therapy; reduction of gingival hypertrophy; soft tissue crown lengthening; secular debridement; treatment of aphthous ulcers; vestibuloplasty; biopsy incision and excision; and lesion (tumor) removal.

    Device Description

    The Fugo Blade for dentistry is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9.8+/- 2.0 x 106 Hz) and focused on a thin blunt cutting filament. Moreover, the EM energy from flashlight size (C cell) batteries is fed into a proprietary electronic network system which is activated by the surgeon with an on/off switch. This electronic system is fed EM energy from the battery energy supply source, then conditions it in a proprietary fashion and transfers it to the surgeon cutting filament. This column of EM energy is capable of reacting with tissue. This column of EM energy causes the molecular bonds in the tissue which come in contact with the EM field to ionize and thereby break apart, a condition that plasma physicists refer to as "plasma formation". In this way, the molecular lattice of the tissue is broken into micro-fragments, thereby creating an incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.

    AI/ML Overview

    The provided 510(k) summary for the "Fugo Blade for Dentistry" is a pre-market notification to establish substantial equivalence to a predicate device, not a report on a study proving the device meets specific acceptance criteria in the manner typically seen for novel efficacy claims. This document primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device (Wallach Quantum 500 electrosurgical generator for surgery, K000768) and other previously cleared Fugo Blade products (K001498, K041019, K050933) for ophthalmic use.

    Therefore, the acceptance criteria and study details are interpreted in the context of demonstrating substantial equivalence rather than novel performance claims against predefined metrics.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Since this is a substantial equivalence submission, specific acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy) for the dental application are not explicitly stated in this document. Instead, the "acceptance criteria" are implied to be the established safety and efficacy of the predicate devices. The "reported device performance" refers to the demonstration that the Fugo Blade for Dentistry shares the same technological characteristics and clinical effects as these predicate devices.

    Acceptance Criteria (Implied)Reported Device Performance
    Technological Equivalence: Same electronic system as previously FDA cleared Fugo Blade devices (K001498, K041019, K050933).The Fugo Blade for Dentistry uses the "same electronic system" as the technologic predicates. It conditions, tunes (9.8+/- 2.0 x 106 Hz), and focuses EM energy from C-cell batteries to create a plasma field for tissue interaction. UL approval, CSA compliant, and compliance with ANSI/AAMI HF18:2001 (thermal safety, high frequency leakage current).
    Safety and Efficacy Equivalence (General Electrosurgery): As safe and effective as the Wallach Quantum 500 system (K000768) for dentistry.Preclinical Data: The Fugo Blade uses EM energy to create a plasma field, substantiated by proprietary studies at Swarthmore College Plasma Lab. This mechanism is compared to "arcs" (plasma clouds) generated by other electrosurgical units like the Wallach Quantum 500.
    Clinical Data (Referenced from Prior Submissions):
     - [K001498](https://510k.innolitics.com/search/K001498): Statistical significance for safety and efficacy in incision/ablation/vaporization of highly delicate tissue (human lens capsule,
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