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    K Number
    K153243
    Device Name
    Fehling-Punches
    Manufacturer
    Fehling Instruments GmbH & Co. KG
    Date Cleared
    2016-08-04

    (269 days)

    Product Code
    HAE,DEV
    Regulation Number
    882.4840
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K150428,K092227
    Why did this record match?
    Device Name :

    Fehling-Punches

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

    Fehling rongeurs (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

    Device Description

    Fehling-Punches are reusable stainless steel instruments that are coated with CERAMO® that are sterilizable and packaged non-sterile. The instruments are offered in various sizes and with different features to accommodate the variations of patient anatomy and access. Instruments are available with the following features: 0.8-8 mm bite sizes; 9 – 19 mm jaw openings; 40° and 90° up/down cutting angles; up/down curved; reqular and thin profile footplates; standard and ejector tips; 110 - 400 mm shaft lengths; and various handle and shaft styles, detachable and non-detachable. Fehling-Punches are distributed under the following brand names: CERAMO® CONCEPT X, CERAMO® CONCEPT CLASSIC, CERAMO® CONCEPT APART, CERAMO® GENTLE, CERAMO® GENTLE "SINGER", CERAMO® TRADITION X, CERAMO® FIST. CERAMO® EJECTOR, CERAMO® SUBLAMINAR, CERAMO® APART, CERAMO® KERRISION. The instruments are made of stainless steel according to ASTM F899 and are coated with CERAMO®. CERAMO®is an AlTiN coating. A reusable screwdriver (item code TXW-9X) is offered with the Fehling Punches for the assembly and disassembly.

    AI/ML Overview

    The acceptance criteria table and device performance based on the provided document are as follows. Please note that the document does not describe a study involving an AI/algorithmic device. The device described is a manual surgical instrument (bone punches). Therefore, many of the requested categories related to AI/MRMC studies, ground truth methodology, and training/test set details are not applicable as they pertain to AI algorithms, not manual instruments.

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/CharacteristicAcceptance Criteria (Implied/Stated)Reported Device Performance
    Biocompatibility
    CytotoxicityNo cytotoxic potentialNo cytotoxic potential to L-929 mouse fibroblast cells.
    SensitizationNot considered a sensitizer (per ISO 10993-10)Not considered a sensitizer in the guinea pig maximization model.
    HemolysisNon-hemolyticDirect contact and extract were non-hemolytic (mean hemolytic index
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