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The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue. The STERRAD 100NX Sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer STANDARD cycle: - Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle. Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer FLEX Scope cycle: - Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 1065 mm or shorter. A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load. Note: With the exception of the 1 x 1065 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 1065 mm flexible endoscopes were validated without any additional load. The STERRAD 100NX EXPRESS Cycle is designed for surface sterilization of both metal and nonmetal medical devices at low temperatures. - It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors - It can sterilize rigid and semi-rigid endoscopes without lumens. Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs on the bottom shelf. The STERRAD 100NX DUO Cycle is designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions: - Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter - Accessory devices that are normally connected to a flexible endoscope during use - Flexible endoscopes without lumens Note 1: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs. - One Dual channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter. Note 2: The validation studies for DUO Cycle was performed using a validation load consisting of 1 dual channel endoscope with 1 mm diameter x 885 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens and 1 dual channel endoscope with ≥1 mm diameter x ≤670 mm long and ≥2.2 mm diameter x ≤845 mm long PTFE/PE lumens The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following: - Medical devices, including multi-channel endoscopes (including duodenoscopes), with no more than 4 channels, with lumen dimensions of ≥1mm x ≤1500mm in length, and ≥2mm x ≤1630mm in length. - One flexible endoscope per tray, and no more than two flexible endoscopes per cycle Note1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf. Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD User Guide "STERRAD Sterilizer Cycle Selection table" for ULTRA GI compatible duodenoscopes.

The STERRAD 100NX Sterilization System with ALLClear Technology is a self-contained stand-alone system 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 where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to achieve sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, biological indicator, chemical indicator products and sterilant cassettes. The STERRAD 100NX Sterilizer has five cleared sterilization cycles: STANDARD, FLEX, EXPRESS, DUO and ULTRA GI Cycles. The STERRAD 100NX Sterilizer with ALLClear Technology described within this submission expands the indications of the DUO Cycle of the STERRAD 100NX Sterilizer to include one dual-channel flexible endoscope with two polyethylene and Teflon (polytetrafluoroethylene) lumens that each have an inside diameter of 1 mm or larger and a length of 885 mm or shorter and with the weight of 3.4 kg (7.4 lbs). There are no other changes to the indications for use for the DUO cycle.

The LOWTEM Crystal 120 Sterilizer System is indicated to sterilize pre-cleaned and dried reusable medical devices with nonabsorbable materials. The Crystal 120 sterilizer's Standard cycle can sterilize: - Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors, - Medical devices with single stainless-steel lumen with: An inside diameter of 1mm or larger and a length of 125mm or shorter An inside diameter of 2mm or larger and a length of 250mm or shorter An inside diameter of 3mm or larger and a length of 400mm or shorter * The validation testing for this lumen size was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. - Contra-indication: It is contraindicated to sterilize single usable medical devices made up with absorbable materials such as cellulose or wood. - Intended user: trained nurse level or higher level of healthcare providers The validated maximum load conditions Total weight: The validation performances were conducted using a validation load consisting of two instrument trays containing a total weight of 8.9kg(19.6lbs). Usage of sterilization pouch: The medical devices to be sterilized are packaged in Tyvek sterilization pouch and sealed. The pouched medical devices are placed at the trays.

The LOWTEM Crystal 120 low-temperature vaporized hydrogen peroxide sterilizer is a selfcontained stand-alone device, using vaporized hydrogen peroxide as the sterilant. The LOWTEM Crystal 120 includes the LCD touch monitor, Hydrogen Peroxide Supply (HPS) Unit, Sterilization Chamber Door, and Printer on the front of the Sterilizer.

The STERRAD 100NX Sterilizer with ALLClear Technology is designed for sterilization of both metal medical devices at low temperatures. The STERRAD sterilization process is a multiphase sterlization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to safely sterilize medical instruments and materials without leaving toxic residue. The STERRAD 100NX Sterilize can sterilize instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Medical devices with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer STANDARD cycle: · Single channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length of 500 mm or shorter. A maximum of ten single channel stainless steel lumens, five per tray per sterilization cycle. Medical devices, including most flexible endoscopes, with the following materials and dimensions can be processed in the STERRAD 100NX Sterilizer FLEX Scope cycle: • Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and length of 1065 mm or shorter. A maximum of two flexible endoscopes, one per tray per sterilization cycle. No additional load. Note: With the exception of the 1 x 1065 mm flexible endoscopes, the validation studies were performed using a validation load consisting of two instrument trays each weighing 10.7 lbs. The 1 x 1065 mm flexible endoscopes were validated without any additional load. The STERRAD 100NX EXPRESS Cycle is an additional optional cycle designed for surface sterilization of both metal and nonmetal medical devices at low temperatures. • It can sterilize instrument surfaces and instruments having diffusion-restricted spaces, such as the hinged portion of forceps and scissors · It can sterilize rigid and semi-rigid endoscopes without lumens. Note: The validation studies for EXPRESS Cycle were performed using a validation load consisting of a single instrument tray weighing 10.7 lbs placed on the bottom shelf. The STERRAD 100NX DUO Cycle is an additional optional cycle designed for sterilization of medical devices including most flexible endoscopes, with the following materials and dimensions: • Single channel polyethylene and Teflon (polytetrafluoroethylene) flexible endoscopes with an inside diameter of 1 mm or larger and a length of 875 mm or shorter · Accessory devices that are normally connected to a flexible endoscope during use • Flexible endoscopes without lumens Note: The validation studies for DUO Cycle were performed using a validation load consisting of two flexible endoscopes with their accessory devices weighing a total of 13.2 lbs. The STERRAD 100NX Sterilizer ULTRA GI Cycle is designed for sterilization of the following: • Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length. · One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle Notel : The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf. Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD User Guide "STERRAD Sterilizer Cycle Selection table" for ULTRA GI Cycle compatible duodenoscopes. The APTIMAX™ Tray for ULTRA GI™ Cycle is designed to encase surgical instruments for sterilization in STERRAD™ 100NX Sterilization System with ALLCLEAR™ Technology: • ULTRA GI™ Cycle

The STERRAD 100NX Sterilization System with ALLClear Technology is a self-contained stand-alone system 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 where the solution is heated and vaporized, introducing the vapor into the chamber under sub-ambient pressure and transforming the vapor into a gas plasma using electrical energy. The sterilization process is a multiphase process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to achieve sterilization. The hardware for the STERRAD 100NX Sterilizer consists of a sterilizer chamber and a variety of instruments and components which are housed in a covered frame. The sterilizer also uses accessories such as reusable instrument trays, biological indicator products and sterilant cassettes. The STERRAD 100NX Sterilizer has four cleared sterilization cycles: STANDARD, FLEX, EXPRESS, and DUO Cycles. The STERRAD 100NX Sterilizer described within this submission introduces the new ULTRA GI Cycle along with the new APTIMAX Instrument Tray for ULTRA GI Cycle. The STERRAD 100NX Sterilizer ULTRA GI Cycle is an additional cycle designed for sterilization of the following: - Hydrogen peroxide compatible flexible multi-channel duodenoscopes, with no more ● than 4 channels, with lumen dimensions having an inside diameter (ID) of ≥1mm x ≤1500mm in length, or ≥2mm ID x ≤1630mm in length. - . One flexible duodenoscope per tray, and no more than two flexible duodenoscope per cycle Note 1: The STERRAD 100NX Sterilizer ULTRA GI Cycle was validated using a load weight of 15.4 lbs (2 x 7.7 lbs), one endoscope per shelf. Note 2: Only duodenoscopes that have been cleared as compatible with vaporized hydrogen peroxide are acceptable. Check STERRAD Sterilizer Cycle Selection table for ULTRA GI Cycle compatible duodenoscopes. The APTIMAX Instrument Tray for ULTRA GI Cycle is designed to encase surgical instruments for sterilization in STERRAD 100NX Sterilization System with ALLClear Technology: - ULTRA GI Cycle . This cycle is designed to run on STERRAD 100NX System with ALLClear Technology with the DUO Module enabled. ALLClear Technology features of Load Check, System Check, and Load Conditioning are integrated into the ULTRA GI cycle.

The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of: - ID of 1.0 mm or larger and a length of 3580 mm or shorter and . - ID of 1.2 mm or larger and a length of 4095 mm or shorter .

The SteroScope® Sterilization Technology System is a vaporized hydrogen peroxide based (VHP) sterilizer for the terminal sterilization of flexible endoscopes with the following characteristics: Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of: · ID of 1.0 mm or larger and a length of 3580 mm or shorter and · ID of 1.2 mm or larger and a length of 4095 mm or shorter. The SteroScope® Sterilization Technology System is a Gas Plasma VHP sterilization system designed specifically for flexible endoscope terminal sterilization, not for general surgical instrument loads. It is a self-contained stand-alone system of hardware and software system that uses technology to rapidly diffuse VHP into all the channels of the flexible endoscope to facilitate the sterilization of inner device surfaces, while being occupationally and environmentally safe to use. To enable the terminal sterilization of long multi-lumen endoscopes, while minimizing oxidation damage, the SteroScope® Sterilization Technology System incorporates a proprietary gas diffusion technology which creates a pressure differential in each internal endoscope lumen channel to actively pull hydrogen peroxide vapor from the chamber of the VHP sterilizer through the distal end of each endoscope channel, while the endoscope is in a sterile container. Utilizing a separate mechanism for the rapid diffusion of VHP from the chamber into the individual SteroScope® Sterilization Technology System allows the entire endoscope to be sterilized with less overall peroxide dose exposure.

The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. The Non Lumen Cycle can sterilize: † Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes. t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). The Fast Non Lumen Cycle can sterilize: * Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg). The Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two load configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are > 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope accessories, mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length • Additional instruments may include non-lumened or lumened medical devices with the following configurations: o Single, dual or triple channel stainless steel lumen that is · ≥ 0.48 mm ID and ≤ 100 mm in length ** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg). The Lumen Cycle can sterilize: † Medical devices with the following configurations: · Single, dual or triple channeled stainless steel lumen that are: • ≥ 0.77 mm ID and ≤ 527 mm in length • ≥ 0.8 mm ID and ≤ 542 mm in length - ≥ 0.48 mm ID and ≤ 100 mm in length - · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length - Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: - ≥ 3 mm ID and ≤ 298 mm in length - ≥ 4 mm ID and < 424 mm in length * Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). The Specialty Cycle can sterilize: Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures .* or Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes. ** 3D Printed Devices constructed of the following materials, and lumen if present, must be sterilized in the Specialty Cycle identified | Material | Manufacturer | Specialty Cycle | Lumens | |--------------------------|--------------|-----------------|---------------------| | Surgical Guide Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L | | BioMed Amber Resin | Formlabs | F | ≥3 mm ID x ≤30 mm L | | Dental LT Clear V2 Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L | | BioMed Clear Resin | Formlabs | D | ≥3 mm ID x ≤30 mm L | | MED615RGD | Stratasys | E | ≥3 mm ID x ≤20 mm L | | MED620 | Stratasys | E | ≥3 mm ID x ≤20 mm L | | MED610 | Stratasys | E | ≥3 mm ID x ≤20 mm L | * The validation studies were conducted using a validation load consisting of single-pouched guide(s) (with or without tray) with a total weight of 5 lbs. (2.3 kg) of 3D printed material. ** The validation studies were conducted using a validation load consisting of pouched devices (with or without tray) for a total weight of 11 lbs. (5 kg).

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities. The five pre-programmed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle. VAPROX HC Sterilant is a 59% hydrogen peroxide sterilant used only the V-PRO Low Temperature Sterilization Systems (V-PRO). It was originally cleared for use in K062297 and the cup was modified in K112813. It has also been cleared as part of the various V-PRO Sterilizer models. The most recent Premarket Notifications for each model are identified in Table 1. This Premarket Notification is only for a proposed modification to VAPROX HC; there are no modifications to any of the V-PRO Low Temperature Sterilization Systems listed below: - V-PRO 1 - V-PRO 1 Plus ● - V-PRO maX ● - V-PRO maX 2 ● - V-PRO 60 - V-PRO s2 ●

The V-PRO maX 2 Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. The Non Lumen Cycle can sterilize: † Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). The Fast Non Lumen Cycle can sterilize: * Non-lumened instruments including non-luments. non-luments. non-lumened rigid, semi-rigid and flexible endoscopes. * The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg). The Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length Additional instruments may include non-lumened or lumened medical devices with the following configurations: Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length ++ The validation studies were conducted with a flexible endoscope in a tray with endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg). The Lumen Cycle can sterilize: † Medical devices with the following configurations: · Single, dual or triple channeled stainless steel lumen that are: - > 0.77 mm ID and < 527 mm in length - ≥ 0.8 mm ID and ≤ 542 mm in length - ≥ 0.48 mm ID and ≤ 100 mm in length · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: - ≥ 3 mm ID and ≤ 298 mm in length - ≥ 4 mm ID and < 424 mm in length † Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs (8.9 kg). The Specialty Cycle can sterilize: Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid and flexible endoscopes. * * The validation studies were conducted using a validation load consisting of one pouched instrument tray or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 lbs (5 kg). or Patient-specific surgical guides (e.g. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures. ** ** The validation studies were conducted using a validation load consisting of pouched guide(s) (with or without tray) for a total weight of 5 lbs (2.3 kg) 3D printed material. Devices used in validation studies were prepared in accordance with printer manufacturers' instructions for use, to include printing, curing, removal of support material and cleaning.

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities. The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The five preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.

The STERLINK Plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK Plus can sterilize *: - · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - · Medical devices with a single stainless steel lumen with: - o An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter *The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 3 .97 lbs. Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization. The materials compatibility for use in the Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, are as follows: Aluminum 6061, Stainless Steel 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50). The maximum load weight that can be placed in the Tyvek® roll is: - · 3.97 pounds (1.8kg) for CHAMBER mode of FPS-15s Plus - 3.97 pounds (1.8kg) for CHAMBER mode of STERLINK plus sterilizer - 1.54 pounds (0.7kg) for CHAMBER mode of STERLINK mini sterilizer The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140-1 :2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK sterilizer. The Tyvek® Roll with CI for STERLINK Sterilizer is offered in the follow 1 type: · Sterilization roll. Flat Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C. Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals. Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met. Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterlization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide. The self-contained biological indicator and chemical processing indicators are intended for use with. - · CHAMBER mode of FPS-15s Plus sterilizer - · CHAMBER mode of STERLink plus sterilizer - · CHAMBER mode of STERLINK mini sterilizer

The STERLINK plus sterilizer with STERLOAD™ cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method. This system consists of a main device connected pump module and cassette which are called the STERLINK plus and STERLOAD™ cassette, respectively. The STERLOAD™ cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (HzO2) which is utilized as the sterilant. Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization. The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer. The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2). Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or Mini-Bio Auto-Readers Incubators. Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper, and plastic.

The STERLINK™ FPS-15s Plus sterilizer is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal medical devices used in healthcare facilities. A preprogrammed sterilization lumen cycle operates at low pressure and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK™ FPS-15s Plus can sterilize*: - Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - Medical devices with a single stainless steel lumen with: - STERPACK™ plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter - STERLOAD™: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter *The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1 1b and 3.97 lbs with STERPACK™ plus and STERLOAD™, respectively,

The STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This system consists of a main device and cassettes which are called the STERLINK™ FPS-15s Plus and STERPACK™ plus or STERLOAD™, respectively. The STERPACK™ plus and STERLOAD™ cassette contain 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK mini can sterilize *: - · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - · Medical devices with a single stainless-steel lumen with: - o An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter *The validation testing was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1.54 lbs. Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization. The materials compatible for use in the Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in Chamber mode, are as follows: Aluminum 5052, Aluminum 6061, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HDPE), Polypropylene (PP), Polytetrafluoroethylene (PTFE) and Silicone (Hardness 50). The maximum load weight that can be placed in the Tyvek® roll is: - · 3.97 pounds (1.8 kg) for CHAMBER mode of FPS-15s Plus sterilizer - · 1.54 pounds (0.7 kg) for CHAMBER mode of STERLINK mini sterilizer The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140 1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer. The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type: · Sterilization roll, Flat Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C. Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals. Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met. Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide. The self-contained biological indicator and chemical processing indicators are intended for use with: - · CHAMBER mode of FPS-15s Plus sterilizer - · CHAMBER mode of STERLINK mini sterilizer

The STERLINK mini sterilizer with STERLOAD™ mini cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This system consists of a main device connected pump module and cassette which are called the STERLINK mini and STERLOAD™ mini cassette, respectively. The STERLOAD™ mini cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant. Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed medical devices for up to 1 month post sterilization. The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer. The Tyvek® Roll with CI for STERLINKIM Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2). Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or MiniBio Auto-Readers Incubators. Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.

The V-PRO maX Low Temperature Sterilization System using VAPROX HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and temperature, suitable for processing medical devices without leaving toxic residues. Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. The V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t Non-lumened instruments including non-luments, non-luments, non-lumened rigid, semi-rigid, semi-rigid and flexible endoscopes. t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg). The V-PRO maX Sterilizer's Flexible Cycle can sterilize: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two configurations: 1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. * The flexible endoscopes may contain single or dual channel lumens that are ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length. * The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope accessories and mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are ≥ 1 mm ID and ≤ 1050 mm in length Additional instruments may include non-lumened or lumened medical devices with the following configurations: Single, dual or triple channel stainless steel lumen that is ≥ 0.48 mm ID and ≤ 100 mm in length ** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments and silicone mat for a total weight of 24 lbs (11 kg). The V-PRO maX Sterilizers' Lumen Cycle can sterilize: * Medical devices with the following configurations: · Single, dual or triple channeled stainless steel lumen that are: - ≥ 0.77 mm ID and ≤ 527 mm in length - ≥ 0.8 mm ID and ≤ 542 mm in length - ≥ 0.48 mm ID and ≤ 100 mm in length - · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length - · Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: - ≥ 3 mm ID and ≤ 298 mm in length - · ≥ 4 mm ID and < 424 mm in length * Validation testing for all lumen sizes was conducted using a maximum of 20 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two trays with silicone mats for a total weight of 19.65 lbs (8.9 kg).

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers. The sterilizers have three or more of the following pre-programmed cycles (the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, and the Fast Non Lumen Cycle). The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged reusable surgical instruments used in healthcare facilities. The V-PRO Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The four preprogrammed cycles all use a conditioning phase, a sterilize phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle, no cool down or aeration period is required following completion of the cycle.