Steritec Containers System & Meditray Products

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:

1. V-PRO 1 Plus sterilizer in:

* Non-lumen cycles to sterilize non-lumened instruments, 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-lumened instruments 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 cycles to sterilize single or dual lumen surgical flexible endoscopes in either of two load configurations (per sterilizer manufacturer instruction):

a. Two flexible endoscopes and no additional load, each having either:

* 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 1mm or larger and a length of 850mm or shorter.

b. One flexible endoscope and load, each having either:

* 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 1mm 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 dia. or larger and 400 mm long or shorter | Flexible lumens 1mm dia. or larger and 1050mm long or shorter | Surfaces

Amsco V-PRO 1 Plus | Lumen cycle | X | |

Amsco V-PRO 1 Plus | Non-lumen cycle | | | X

Amsco V-PRO Max | Lumen cycle | X | |

Amsco V-PRO Max | Non-lumen cycle | | | X

Amsco V-PRO Max | 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.