Search Results

The BioGuard Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The BioGuard Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.

The BioGuard Air/Water Valve and the BioGuard Suction Valve are accessories to an endoscope. The Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel and also controls water used to wash the lens of the endoscope. The Suction valve allows the user to control suction through the scope's accessory channel. The valves are sterile, single-use, disposable devices. The Air/Water valve consists of a snap cap, stem, gaskets, spring and valve base (skirt and endcap). The Suction valve consists of a stem, spring and valve base (skirt and endcap).

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. * The extensive treatment of EPA potable water consists of: - 1. Pre-filtration through two pre-filters: - · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. - · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron. ## 2. UV Irradiation: - During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water. - 3. 0.1 micron filtration: - · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron. The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities. The SYSTEM 1 endo Processor automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C and rinses the load with 0.2 micron filtered water. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Seven Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for a proprietary component of S40 Sterilant Concentrate. The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels. The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible semi-critical heat-sensitive medical devices and their accessories. The system consists of the SYSTEM 1 endo Processor and S40 Sterilant Concentrate, interchangeable Processing Trays/Containers, and Quick Connects. The current submission is provided to describe the addition of a second supplier for of a proprietary component of S40 Sterilant Concentrate. The SYSTEM 1 endo Processor is an automated, self-contained device that uses S40 Sterilant Concentrate to create and maintain the conditions necessary for liquid chemical sterilization in 6 minutes. After LCS processing, the liquid chemically sterilized articles are rinsed with 0.2 micron filtered potable water and are ready for use or may be prepared for storage. The SYSTEM 1 endo Processor uses only S40 Sterilant Concentrate. Upon loading the single-use cup, the active ingredient in S40 - peracetic acid - is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. The interchangeable processing trays/containers are made to accommodate a variety of semi-critical instrument types and models. Each container is designed to maintain instruments in position while specific SYSTEM 1 endo Quick Connects, if required, facilitate delivery of the sterilant use-solution and rinse water to internal channels.

The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the: · Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or · Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology. A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the: · Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or • Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the: - . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or - Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology. A version of the Celerity™ HP Chemical Indicator may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the: - Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle . of a V-PRO® Low Temperature Sterilization System, or - Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology The CI is composed of the following components: - Substrate ● - Indicator Ink The PI is composed of the following components - Substrate - Indicator Ink - Adhesive ● - Backing Paper

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles: · Lumen, Non Lumen, Flexible, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers · STERRAD® 100S Sterilizer (default cycle) • STERRAD® 200 Sterilizer (default cycle) · Standard and Advanced Cycles of the STERRAD® NX Sterilizers with All Clear Technology · Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizers with All Clear technology The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V PRO s 2 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The challenge pack is not intended for routine of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer. The user places the VERIFY V24 SCBI into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid. The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included. The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time. VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization a biological indicator, integrating indicator or both a biological and integrating indicator from the following list. - · 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company - · 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company - Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc. - · Celerity 20 Steam Biological Indicator - · VERIFY STEAM Integrating Indicator - · VERIFY SixCess MF4 STEAM Emulating Indicator VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator. The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°P/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack. The VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10minute 270°F/132°C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

The VERIFY All-in-One STEAM Reusable Test Pack consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity Xtend 10 Assembly containing the Celerity 20 STEAM Biological Indicator and the Celerity 10 STEAM Chemical Indicator. The Celerity Xtend 10 Assembly consists of a tube and cap design, comprised of one (1) polypropylene tube and one (1) silicone rubber cap containing one (1) Celerity 20 STEAM Biological Indicator and one (1) Celerity 10 STEAM Chemical Indicator and can only be used with the VERIFY A11-in-One STEAM Reusable Test Pack. The Celerity Xtend 10 Assembly has a tamper evident seal that will be broken once the assembly has been opened after use. A broken tamper evident seal will indicate to the user that it cannot be reused. The Celerity Xtend 10 Assembly is a single use device used for routine monitoring of 10-minute 270°F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack. The Celerity 20 STEAM Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity STEAM Incubator, in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 STEAM Biological Indicator has been cleared under K173634 and K181429 and the Incubator has been cleared under K173670. The Celerity 10 STEAM Chemical Indicator is a single-use device used to monitor a 10-minute 270°F/132°C dynamic air removal steam sterilization cycle and is subject of a concurrent premarket notification.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities. The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use. The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices. * The extensive treatment of EPA potable water consists of: - 1. Pre-filtration through two pre-filters: - · Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. - · Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron. - 2. UV Irradiation: - · During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered to the water. - 3.0.1 micron filtration: · The water prepared by pre-filtration is filtered through redundant, 0.1-micron (absolute rated) membranes to remove bacteria, fungi and protozoa > 0.1 micron.

The SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heat sensitive, flexible and rigid endoscopes and their accessories, and microsurgical instruments. The system consists of the SYSTEM 1E Processor and the S40 Sterilant Concentrate, interchangeable processing trays/containers and Quick Connects. The device was originally cleared under K090036. Six Special 510(k)s were cleared that subsequently made minor modifications to hardware, software, specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying the Indications for Use. The current submission is provided to describe the addition of a second supplier for bacterial retentive water filter, referred to in labeling as the MaxPure filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule. The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6 minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1micron filter membranes. The processor, which is computer controlled and continually monitored, provides printed documentation of each cycle. S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40 Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials. The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemical sterilant use dilution and rinse water to internal channels.

The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles: - · Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterilizers - · Standard Cycle of the STERRAD® 100S Sterilizer - · Standard and Advanced Cycles of the STERRAD® NX Sterilizer - · Express, Flex Scope and Standard Cycles of the STERRAD® 100 NX Sterilizer The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer. The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid. The VERIFY V24 Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included. The user places the VERIFY V24 Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.