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The EOGas 4 Ethylene Oxide Gas Sterilize is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below: Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters | EO Exposure Time | Total Cycle Time | EO Amount | Temperature | Relative Humidity | |------------------|------------------|-----------------|----------------|-------------------| | 3 hours | 3.5 hours | 17.6 g $\pm$ 5% | 50°C $\pm$ 3°C | 35-70% | | 6 hours | 7 hours | | | | The differences between the two options are the length of EO gas exposure and the length of mandatory ventilation after gas exposure; the gas exposure is chosen based on the devices to be sterilized. The appropriate purge probe and process challenge device (PCD) must be used: EOGas 4 SteriTest for a 3-hour gas exposure, EOGas 4 Endo-SteriTest for a 6-hour gas exposure. The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes with working length shorter than 1100 mm as specified in the labeling. The EOGas 4 SteriTest PCD is used with the 3-hour gas exposure. The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the labeling. The EOGas 4 Endo-SteriTest PCD is used with the 6-hour gas exposure.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.60 (115V) or AN4000.61 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag.

The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The 12 hour cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces.

The Anprolene AN75 Ethylene Oxide Gas Sterilizers, model numbers AN75i (AN75.64 and AN75.65), AN75iX (AN75.84 and AN75.85), and AN75J (AN75.74 and AN75.75), are intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN87 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7508.14 Anprolene SteriTest) that is integrated into the sterilizer.

The EOGas 4 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The 3 hour cycle at 50°C in the EOGas 4 Ethylene Oxide sterilization of medical devices as well as for the sterilization of single-lumen flexible endoscopes.

The EOGas 4 Ethylene Oxide Gas Sterilizer, model AN4000.01 (115V) or AN4000.11 (230V), is intended to sterilize moisture, temperature, chemical corrosion, or radiation-sensitive reusable medical devices in healthcare facilities. The sterilant is a unit dose of 100% ethylene oxide contained in a cartridge, and the sterilization chamber is a gas-impervious flexible sterilization bag. Each sterilization cycle is monitored using cumulative gas exposure measurement (AN1087 Dosimeter), as well as a Bacillus atrophaeus biological indicator (AN2203) inserted into a process challenge device (AN7408.14 Andersen EOGas 4 Steritest) that is integrated into the sterilizer.

The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles: | Model | Cycle | Gas Expose Time (min.) | Temperature (deg C) | EO Concentration (mg/L) | Relative Humidity (%) | |-------|-------|------------------------|---------------------|-------------------------|-----------------------| | GS5 | Cool | 270 | 38 | 736 | 40-80 | | GS5 | Warm | 60 | 55 | 736 | 40-80 | | GS8 | Cool | 270 | 38 | 759 | 40-80 | | GS8 | Warm | 60 | 55 | 759 | 40-80 | Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instructions. The load per cycle should not exceed 20 lumens.

The 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 models are traditional ethylene oxide (EO) sterilizers that use 100% EO cartridges in a vacuum vessel. The sterilizers use fully automated controls for cycle processing and error handling.

TSO3 125L Ozone Sterilizer is intended for use in the sterilization processing of reusable medical devices in health care facilities. TSO 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. TSO3 125L Ozone Sterilizer has the ability to sterilize successfully packaged rigid and flexible lumen medical devices, including single and multi channel flexible endoscopes such as fiberoptic and video endoscopes.

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned. The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.). It requires USP grade oxygen, water and electricity. TSO3 Sterilizer could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor. Model 125L is equipped with a unique factory-programmed control system. Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized. OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance. TSO3 Chemical Indicators are available for this process. No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

The TSO3 Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in health care facilities. The TSO3 Ozone Sterilizer, Movol 1252. is designed for sterilization of both metal and non-metal medical devices at low temperatires. The sterilization cycle operates at very low pressure and low temperature, consequently it is suitable for processing medical devices sensitive to heat and moisture. The TSO3 Ozone Sterilizer, Model 125L, is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and sciators.

TSO3 Ozone Sterilizer, model 125L is intended to sterilize medical devices that has been previously cleaned. The sterilization chamber has a capacity of 125 liters (4.3 cu. ft.). It requires USP grade oxygen, water and electricity. Model 125L could be installed as a free standing unit or recessed behind the wall. No exhaust gas ventilation duct is required as long as the room is adequately ventilated. By-products are oxygen and low humidity water vapor. Model 125L is equipped with a unique factory-programmed control system. Non-woven wrapping material or pouches and anodized aluminum containers are used as packaging for medical devices to be sterilized. OZO-TEST® self-contained Biological Indicators (B. stearothermophilus) are recommended for use in evaluating cycle performance. TSO3 Chemical Indicators are available for this process. No aeration is needed following the sterilization cycle. The sterilized items are cool to the touch and can be removed immediately and used, or stored for future use.

The TSO1-Model 125L is an Ozone Sterilizer intended for use in the sterilization processing of reusable medical devices in Health Care Facilities. The TSO3 Model 125L Ozone Sterilizer is designed for sterilization of both metal and non-metal medical devices at low temperatures. The sterilization cycle operates at very low pressure and low temperatures, consequently it is suitable for processing medical devices sensitive to heat and moisture. The TSO-125L Ocone Sterilizer is designed to sterilize instruments and devices with diffusion-restricted spaces, such as the hinged portion of forceps and scissors. The TSO--125L Ozone Sterilizer is also designed to process medical devices having a single stainless steel lumen with: - an inside diameter of 2 mm or larger and a length of 250 mm or shorter; - an inside diameter of 3 min or larger and a length of 470 mm or shorter; - an inside diameter of 4 mm or larger and a length of 600 mm or shorter. Note: Testing conducted employing half cycle with a SAL of 10 with no survivors. The packaging compatible with the TSO3-Model 125L Ozone Sterilizer are TSO3 sterilization pouch and rigid anodized aluminum containers using disposable cellulose filter paper.

TSO model 125L Ozone Sterilizer is intended to sterilize reusable medical devices that have been previously cleaned. Ozone is generated within the sterilizer to provide an efficient sterilant without the concerns for transporting, handling and disposing of toxic chemicals. The sterilization chamber has a capacity of 125 liters (4 cu. ft.). It requires medical grade oxygen, water and clectricity. The Model 125L is equipped with a unique factory-programmed control system for processing reusable medical devices. Processed medical instruments requires no aeration time at the end of the sterilization cycle. The TSO3 sterilization pouch and anodized aluminum sterilization containers are used as packaging for medical devices to be sterilized. The TSO3 OZO-TEST™ self-contained Biological Indicator (B. stearothermophilus) is recommended for use in evaluating cycle performance. TSO3 Chemical Indicator is recommended for use to differentiate between processed and unprocessed loads and to indicate that the load has been exposed to the sterilization process. Model 125L could be installed as a free standing unit or recessed behind a wall. No exhaust gas ventilation duct is required in a room that is adequately ventilated.

The H & W Hospital Ethylene Oxide Sterilizer Control System is an accessory in the form of an electronic control system for the retrofit of existing sterilizers to provide operator and information monitoring capabilities of a personal computer (PC) together with the functional reliability, safety, and dependability of control obtained through the use of a programmable logic controller (PLC). The H & W Hospital Ethylene Oxide Sterilizer Control System is intended to retrofit existing Steris (Amsco) Eagle Model 2000 & 3000 series and Getinge (Castle) Model M/C 3500, 3600 or 4200 series Hospital EO Sterilizers only. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard ANSI/AAMI ST-24.

This device is an accessory to an electronic ethylene oxide sterilizer control system. This control system is a modern, programmable logic controller (PLC)-based system with Personal Computer (PC) user interface. This accessory control system uses a PLC and a Visual Basic/Windows user interface. These two features, a PLC for control and a Windows -based user interface provide multiple advantages. First being the inherent safety and reliability of the PLC and second the operator's ease of use of the Windows "based user interface. This accessory control system kit is intended for the retrofit of existing sterilizers or for use on sterilizers remanufactured by original equipment manufacturers, third party remanufacturers or their licensees.

This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations: - An inside diameter of 1 mm or larger and a length of 125 mm or shorter - An inside diameter of 2 mm or larger and a length of 250 mm or shorter . The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with radio frequency (RF) electrical energy. The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.