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510(k) Data Aggregation

    K Number
    K980177
    Device Name
    SUGITRON MODEL: IEC
    Manufacturer
    ELLMAN INTL., INC.
    Date Cleared
    1998-07-07

    (168 days)

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

    SUGITRON MODEL: IEC

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

    is idendical to the Surgitron as a preammendment device such as:

    • Cutting Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

    • Blended Cutting and Coagulation Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

      • Hemostasis Control of Bleeding, Epilation, Telangiectasia
      • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
      • Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the "Surgitron Model: IEC" device, indicating that it has been found substantially equivalent to a pre-amendment device.

    Specifically, the text includes:

    • FDA 510(k) clearance letter: This letter confirms that the device can be marketed in the US.
    • Indications for Use: A list of medical procedures for which the Surgitron device is intended, such as various cutting, blended cutting and coagulation, hemostasis, fulguration, and bipolar procedures.

    There is no mention of:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance, or details about test sets.
    • The number or qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • The type of ground truth used.
    • Training set sample sizes or how ground truth for the training set was established.

    Therefore, I cannot fulfill your request for these specific details based on the provided document.

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