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510(k) Data Aggregation

    K Number
    K180272
    Device Name
    Saniclave 250
    Manufacturer
    REVOLUTIONARY SCIENCE
    Date Cleared
    2018-07-26

    (176 days)

    Product Code
    FLE
    Regulation Number
    880.6880
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K112811
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Revolutionary Science Saniclave 250 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize wrapped heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.

    Device Description

    The Saniclave 250 by Revolutionary Science (model number RS-SC-250) is a 120 volt front loading autoclave. The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside. The Saniclave technology is based on the scientific concept that prolonged saturated pressurized steam at or over a temperature of 121degrees Celsius kills bacteria.

    AI/ML Overview

    The provided text describes the Saniclave 250, a steam sterilizer, and its comparison to a predicate device for 510(k) clearance. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Performance Objective)Reported Device Performance (Saniclave 250)
    Sterility Assurance Level (SAL): 10⁻⁶Achieved 10⁻⁶ SAL for all tested cycles and loads.
    Sterilization Temperature for all cycles121°C
    Sterilization Time for all cycles30 minutes
    Dry Time (Gravity, small load, wrapped)30 minutes
    Dry Time (Gravity, small load, unwrapped)N/A
    Dry Time (Gravity, large load, unwrapped)N/A
    Maximum Load (Gravity, small load, wrapped)1 tray, 4.5 lbs
    Maximum Load (Gravity, small load, unwrapped)1 tray, 4.5 lbs
    Maximum Load (Gravity, large load, unwrapped)3 trays, 8.0 lbs
    Compatibility with InstrumentsHeat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens > 3mm ID and
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