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The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60 (Flexible and Lumen cycle) - - -STERIS V-Pro s2 (Flexible and Lumen cycle) - STERIS V-Pro maX 2 (Lumen, Non-Lumen and Flexible cycle) - - -STERIS V-Pro maX (Lumen, Non-Lumen and Flexible cycle) - STERRAD 100NX ALLCLEAR (Standard, Flexible,DUO and Express cycle) - - -Sterizone VP4 (Cycle 1) Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads. The following table (Table 1) identifies the validated lumen claims of the SteriTite container with MediTray parts in low temperature and pre-vacuum steam sterilizers: Table 1. SteriTite Container System with MediTray Parts Lumen Claims: | Sterilizer | Cycle | Lumen Sterilization Claims (I.D. x Length) | |--------------------|----------|---------------------------------------------------------------------------| | STERIS V-Pro 60 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) | | STERIS V-Pro 60 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERIS V-Pro s2 | Flexible | ≥1mm x ≤990mm (Single or Dual Lumen) | | STERIS V-Pro s2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERIS V-Pro maX 2 | Flexible | ≥1mm x ≤1050mm (Single Lumen) | | STERIS V-Pro maX 2 | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERIS V-Pro maX | Flexible | ≥1mm x ≤1050mm (Single Lumen) | | STERIS V-Pro maX | Lumen | ≥0.77mm x ≤527mm (Dual Channel) | | STERRAD 100NX | DUO | ≥1mm x ≤875mm (Single Lumen) | | Sterizone VP4 | Cycle 1 | ≥1.2mm x ≤1955mm (Flexible Lumens) | | Sterizone VP4 | Cycle 1 | ≥1.45mm x ≤3500mm (Flexible Lumens) | | Steam | Pre-Vac | ≥2mm x ≤400mm (Stainless Steel Lumen)<br>≥1.2mm x ≤400mm (Flexible Lumen) |

The SteriTite® Universal Container is a rigid, reusable, sealed sterilization packaging system that is compatible with steam, hydrogen peroxide, ethylene oxide, and ozone sterilizers. The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite® container as previously cleared is available with solid or perforated base. The container is made of anodized aluminum with passivated stainless-steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

The SteriTite container and MediTray products are a reusable sterilization container system to be used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. It is intended to allow sterilization of the enclosed devices and maintain sterility of the enclosed device until it is used. This container system is compatible for use with the following low temperature sterilizers and cycles identified below: - STERIS V-Pro 60 (Flexible and Lumen cycle) - STERIS V-Pro s2 (Flexible and Lumen cycle) - STERIS V-Pro maX 2 (Lumen and Flexible cycle) - STERIS V-Pro maX (Lumen and Flexible cycle) - STERRAD 100NX (ALLCLEAR-DUO cycle) - Sterizone VP4 (Cycle 1) Refer to the specific Sterilizer user manual and vendor provided information regarding of appropriate devices and device type. See the following pages for tables of compatible devices and description of the validated loads.

The SteriTite container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The SteriTite container as previously cleared is available with solid or perforated base. The container is made of anodized aluminum with passivated stainless-steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates in lid and base are interchangeable for universal use. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions, and racks provide instrument protection and secure devices for sterilization within the container.

The SteriTite® container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The container consists of a solid or perforated base and perforated lid with filter retention plates, and disposable polypropylene filters. The Case Medical's SteriTite® container system and MediTray products are compatible with the TSO3 Inc.'s STERIZONE® VP4 Cycle 1 sterilization system for blades, lumened devices and flexible endoscopes.

The SteriTite® container system consists of a family of rigid reusable containers and inserts that provide an effective reusable sterilization packaging system for operating room instruments. The Sterillite® container for use in STERIZONE® VP4(Cycle 1) is available with solid and perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate with gaskets and off set vent pattern secures a disposable filter for bacterial barrier filtration. Filter retention plates and lids and base are interchangeable for universal design. A recessed gasket contributes to a knife edge fit between lid and base. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.

The SteriTite Universal Container System, with MediTray products, is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The container consists of a perforated base and lid, with filter retention plates, and disposable polypropylene filters. The SteriTite container system is compatible for use with AMSCO V-PRO 1 Plus low temperature Sterilization System, Lumen and Non-lumen Cycle, and AMSCO V-PRO maX low temperature Sterilization System Lumen, Non-lumen and Flexible Cycle. The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts, including brackets, posts and partitions. The SteriTite container may be used for sterilization of medical devices, including full instrument sets and mixed loads. - 30 days of real time shelf-life testing with handling events has been conducted for SteriTite . containers after sterilization in Amsco V-PRO sterilization lumen cycle. - Reuse testing: Material Compatibility was assessed after 100 cycles of AMSCO V-PRO 1 lumen ● cycles. SteriTite Universal Container System is recommended for use in: V-PRO 1 Plus sterilizer in: 1. - Non-lumen cycles to sterilize non-luments, including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors. - Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of ● forceps and scissors, and medical devices, including rigid endoscopes, with a single stainless steel lumen, with an inside diameter of 3mm or larger and a length of 400mm or shorter for a maximum of 20 lumens per load. - 2. V-PRO maX sterilizer in: - Non-lumen cycles to sterilize non-luments including non-lumened rigid endoscopes . and non-lumened hinged instruments, such as forceps or scissors. - Lumen cycles to sterilize instruments with diffusion restricted areas, such as the hinged portion of . forceps and scissors, and medical devices, including rigid endoscopes with a single stainless steel lumen with an inside diameter of 3mm or larger, and a length of 400mm or shorter for a maximum of 20 lumens per load. - Flexible cvcles to sterilize single or dual lumen surgical flexible endoscopes in either of two load . configurations (per sterilizer manufacturer instruction): - Two flexible endoscopes and no additional load, each having either: a. - a single lumen with an inside diameter of 1mm or larger, and a length of . 1050mm or shorter, or - two lumens, with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter, and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter. - One flexible endoscope and load, each having either: b. - a single lumen with an inside diameter of 1mm or larger and a length of . 1050mm or shorter, or - two lumens with one having an inside diameter of 1mm or larger and a . length of 998mm or shorter and the second one an inside diameter of 1 mm or larger and a length of 850mm or shorter. The SteriTite Universal Container System is recommended to be used for the sterilization of surfaces and rigid or flexible lumens: | | Table 1: SteriTite Universal Container System in AMSCO V-PRO sterilization. | | | | | |--|-----------------------------------------------------------------------------|--|--|--|--| |--|-----------------------------------------------------------------------------|--|--|--|--| | Sterilizer | Cycle | Rigid lumens 3mm<br>dia. or larger and<br>400 mm long or<br>shorter | Flexible lumens 1 mm<br>dia. or larger and<br>1050mm long or<br>shorter | Surfaces | |-----------------------|-----------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|----------| | Amsco V-PRO<br>1 Plus | Lumen cycle | X | | | | | Non-lumen cycle | | | X | | Amsco V-PRO<br>Max | Lumen cycle | X | | | | | Non-lumen cycle | | | X | | | Flexible cycle | | X | | Note: Lumen cycle parameters are the same for both sterilizer models referred to in the current submission. Non-Lumen cycle parameters are the same for both sterilizer models referred to in the current submission.

The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for use in Amsco V-PRO 1 Plus and V-PRO 1 Max non-lumen and flexible cycle has a perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.

The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices and instrumentation to be sterilized, transported and stored by health care providers. The container consists of a perforated base and lid with filter retention plates, and disposable polypropylene filters. The SteriTite universal container system is compatible for use with STERRAD 100NX Sterilization (Standard and Flex cycles). The SteriTite container has been validated with stainless steel and porous lumens, inoculated product, insert boxes, multilevel tray systems and various inserts including brackets, posts and partitions. The container may be used for sterilization of medical devices including full instrument sets and mixed loads. SteriTite universal container system is recommended to be used for sterilization of surfaces and lumens: - In STERRAD 100NX Standard cycle, process stainless steel lumens instruments of 0.7 mm diameter or larger and up to 500 mm in length. - In STERRAD 100NX Flexible cycle, process flexible endoscopes, PE/PTFE Lumen instruments of ≥1.2 mm x ≤835 mm. 120 days of real time Shelf life testing with handling events has been conducted for SteriTite containers after STERRAD 100NX Sterilization. Reuse testing was performed after 501 STERRAD 100NX Standard cycles.

The SteriTite universal container system consists of a family of rigid reusable containers and Inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container for STERRAD 100NX has perforated base. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts including insert boxes, brackets, posts, partitions and racks provide instrument protection and secure devices for sterilization within the container.

The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in Steris Amsco V-PRO 1 low temperature Sterilization System Lumen Cycle. SteriTite Sealed Container system is recommended for surface and stainless steel lumens (process up to 20 stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm or shorter).

The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. Stainless steel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamper evident seals. A filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts are available for instrument management. The lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.

The SteriTite universal container system with MediTray products is a reusable sterilization container system intended to be used to enclose other medical devices (blades and lumens), which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in STERRAD 200. STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for pre-vacuum steam flash sterilization (270°F for 4 minutes). The SteriTite perforated bottom container with disposable polypropylene filters (Polypro) must be used for STERRAD Sterilization. The paper filter is recommended for prevacuum steam flash sterilization. For ozone sterilization, either disposable naper or polypropylene filters can be used. The SteriTite universal container system with MediTray products is a reusable sterilization container system used to enclose other medical devices, which are to be sterilized, transported and stored by a health care provider. The SteriTite container system is intended for use in STERRAD 200, STERRAD NX and Ozone 125L sterilizers, as well as the sealed containers are intended for prevacuum steam flash sterilization (270°F for 4 minutes). The container may be used for sterilization of medical devices including full instrument sets and mixed loads. SteriTite Sealed Container system is recommended for surface and lumens: -In STERRAD® 200 Sterilization, process only stainless steel lumened instruments of 3mm diameter or larger and a length up to 400 mm. -In STERRAD NX standard cycle, process stainless steel lumened instruments of 2mm diameter or larger and up to 400 mm in length. -In STERRAD NX advanced cycle, process stainless steel lumened instruments of 1mm diameter or larger and up to 500 mm in length and porous lumens (flexible endoscope) of 1mm diameter or larger and up to 850 mm in length. -In Pre-vacuum Steam Flash Sterilization, process stainless steel lumened instruments of 2mm diameter or larger and a length of up to 400 mm as well as porous lumens of 3mm diameter or larger and a length up to 400 mm. -In Ozone 125L Sterilization, process stainless steel lumened instruments of 3mm diameter or larger and a length up to 470 mm. The attached tables identify which products with disposable filter may be sterilized in the respective sterilization cycles.

The SteriTite universal container system consists of a family of rigid reusable containers and inserts that provide an effective sterilization packaging method for operating room instruments. The SteriTite® container has both solid and perforated base containers. The container is made out of anodized aluminum with passivated stainless steel hardware and silicone gaskets. A stainless steel latching mechanism with handles on both ends secures the lid to the base and provide a method to incorporate tamper proof disposable locks. Each filter retention plate secures a disposable filter for bacterial barrier filtration. Various instrument trays as well as stacked baskets and inserts provide instrument protection and secure devices for sterilization within the container. The lids and bases as well as retention plates of the same model and size are compatible and interchangeable throughout its useful life. Vent holes are offset to prevent strike through. All components may be easily disassembled for cleaning.

The SteriTite® containers with FlashIlite® valve plate(s) are intended to be used in conjunction with MediTray basic tray for the flash sterilization of one instrument or instrument set. The SteriTite container system with MediTray product are intended to be used to contain medical devices for steam sterilization. The full line of MediTray product is intended for complex customization in prevacuum steam sterilization. MediTray basic trays are intended to be used in the sealed container for sterilization in steam pre-vacuum and gravity sterilization. MediTray products may be used scoarately for sterilization when wrapped in FDA cleared medical grade wrappers. The MediTray products include case/trays with lid and base, insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, partitions.

The SteriTite® container system consists of the SteriTite line of rigid reusable containers with an additional option of a FlashTite valve plate(s). The line features an assortment of container designs and sizes. The MediTray product line includes instrument baskets, trays, and case/trays (incorporating a lid and base), organizing insert boxes, cassettes, trays, baskets, instrument racks, silicone mats, brackets, posts, and partitions designed to contain medical devices within sealed containers or to be wrapped. SteriTite Containers with FlashTite valve plate(s) and MediTray products may be stacked.

The SteriTite® container system is designed for use in hospitals and health care facilities to contain medical devices for sterilization, storage, transportation, and aseptic presentation of contents. It is intended to be used to sterilize medical devices including surfaces and lumens in steam, gas (EO) and gas plasma (STERRAD Sterilization). The SteriTite container is designed to maintain sterility of the contents until it is used. The SteriTite container system and MediTray product is intended to be used to contain medical devices for sterilization, storage, transportation and aseptic presentation of contents in health care facilization of surfaces and lumented dev in EO. Metal lumens 2.2mm diameter or larger and length up to 45.7 cm and porous (silicone) lumened devices 3 mm diameter or larger and length up to 40 cm were validated. The SterTite container is designed to maintain sterility of the contents until it is used

The SteriTite container system consists of a family of rigid reusable scaled containers that provide an effective sterilization packaging method for medical devices. Cases and lids are interchangeable. A part number and lot number identify each component of the container, including lid, base, retaincr/valve plate and insert basket or tray. The SteriTite system is designed for sterilant penetration through vents/perforations in the lid and in perforated bottom models in the base of SteriTite sealed containers as well. MedifFray case trays, baskets and insert boxes may be placed within sealed containers or wrapped.

The perforated base containers are part of a line of the SteriTite @ Reusable Rigid Sterilization Container system. The SteriTite® perforated base containers have been validated for use in STERRAD 100S Sterilization under the following conditions. They are intended to be used for the sterilization of surgical instruments and devices in STERRAD 100S Sterilization for a hospital or other health care facilities. Review the sterilizer manufacturer's Instructions for Use for specific information as to the limitations of instrumentation specifications and material compatibility. Review the Steril'ite® labeling as to the limitations in regard to using a sealed container system in STERRAD 100S Sterilization. - Caution: In STERRAD 100S Stcrilization use only perforated bottom SteriTite® ● containers. - Caution: In STERRAD 100S Sterilization use only nonwoven polypropylene . disposable filters. - Caution: In STERRAD 100S Sterilization do not use materials made of cellulose . (paper filters and cotton) with SteriTite® perforated bottom containers. - Caution: In STERRAD 100S Sterilization use only luments of 3mm or . larger and a length of up to 400 mm. The SteriTite® perforated base containers using polypropylene nonwoven Disposable Filter # SCF02 may be used for the sterilization of surgical instruments in STERRAD 100S Sterilization for a hospital or other health care facilities. - After each sterilization cycle the filters must be discarded. - - Before each sterilization cycle use new filters. -

The SteriTite® Rigid Container System consists of a family of rigid containers that provide an effective stcrilization packaging method for operating room instruments. The SteriTite® perforated base containers include a vented base and a vented lid with filter retention plates. The SteriTite® unit consists of an anodized aluminum sealed case with a microbial barrier filltration system that allows effective penetration by the sterilant. The SteriTite® perforated base containers with baskets have been validated for surfaces and lumens in STERRAD 100S Sterilization. For STERRAD 100 and 100S Sterilization each stainless stccl filter retention plate secures a disposable round non-woven polypropylene disposable bacterial filter. Silicone gaskets are permanently attached to the filter retention plates and lid with silicone adhesive. A stainless stcel latching mechanism with handles on both ends secures the lid to the base and provides a method to incorporate tamperproof disposable locks. The disposable filter # SCF02 is a nonwoven polypropylene material.