LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K161848
    Device Name
    Family of Steam sterilizers B17 B22 Series
    Manufacturer
    CEFLA S.C.
    Date Cleared
    2017-02-23

    (233 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K151597
    Why did this record match?
    Device Name :

    Family of Steam sterilizers B17 B22 Series

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

    B CLASSIC-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

    B CLASSIC-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

    B FUTURA-17 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

    B FUTURA-22 is a steam sterilizer that is intended for use by a heath care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

    Device Description

    The Family of steam sterilizers B17 B22 series includes table-top steam sterilizers that use saturated steam at high pressures and temperatures to kill infectious bio-organisms. The Classic and B Futura models differ only for some minor characteristics such as color touchscreen, optional Wi-FI connection, illumination of the working area and Ethernet connection. The steam is generated by a steam generator connected to the sterilization chamber without disconnecting devices. An electric heating element surrounds the chamber for preheating of the chamber and maintaining the temperature. The subject family is characterized by a fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by a final vacuum drying phase able to eliminate any trace of condensation from the load.

    AI/ML Overview

    This document pertains to the FDA 510(k) premarket notification for a new family of steam sterilizers (B17 B22 Series) and compares them to a legally marketed predicate device (Family of Steam sterilizers B28 series, K151597). The information provided focuses on the physical and performance characteristics of mechanical steam sterilizers, not on AI/ML-driven diagnostic devices. Therefore, a direct response to the requested information regarding AI/ML device acceptance criteria and study details (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth, etc.) cannot be extracted from this document.

    However, I can extract the acceptance criteria for the steam sterilizer's performance and the reported device performance based on the provided text, as these are the "study" and "acceptance criteria" applicable to this specific type of medical device.

    Key Findings for Steam Sterilizer Device Performance and Acceptance:

    The document demonstrates substantial equivalence to a predicate device (CEFLA S.C. Family of Steam sterilizers B28 series, K151597) by meeting the requirements of ANSI/AAMI ST55:2010 for table-top steam sterilizers.

    Here's a table of acceptance criteria and reported device performance for this steam sterilizer:

    Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (from ANSI/AAMI ST55:2010, as implied by compliance statements)Reported Device Performance (from "2.6. Performance Data")
    Biological Performance (Sterility Assurance Level - SAL)
    SAL of 10⁻⁶ reduction (no growth at half cycle with validation loads)Textile PCD: All biological indicators resulted sterile, ensuring a SAL of 10⁻⁹.
    Wrapped instruments and lumen devices (double package): All biological indicators resulted sterile, ensuring a SAL of 10⁻⁶.
    Dental handpieces (double package): All biological indicators resulted sterile, ensuring a SAL of 10⁻⁶.
    Chamber Temperature Control
    Chamber temperatures always between -0°C and +3°C of the sterilization temperature set point during sterilization holding time.Chamber temperatures always between -0°C and +3°C of the sterilization temperature set point during sterilization holding time. (In compliance with acceptance criteria defined).
    Bowie-Dick Test
    Uniform color change on a FDA cleared Bowie-Dick test pack.Uniform color change on a FDA cleared Bowie-Dick test pack.
    Air Leak Test
    Average leak rate
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1