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The Amsco® V-PRO™ MAX Low Temperature Sterilization System, with VAPROX™ HC Sterilant, 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. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. The Amsco V-PRO MAX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize: - Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors - Medical devices, including rigid endoscopes, with a single stainless steel lumen with: - an inside diameter of 1 mm or larger and a length of 125 mm or shorter - an insider diameter of 2 mm or larger and a length of 250 mm or shorter - an inside diameter of 3 mm or larger and a length of 400 mm or shorter The validation testing for all lumen sizes was conducted using a maximum of twenty (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. The Amsco V-PRO MAX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize: Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. The Amsco V-PRO MAX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations: - Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either: - a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter - or two lumens with: - one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter - and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter - 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). - One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endoscope can contain either: - a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter - or two lumens with: - one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter - and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter - The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

The Amsco V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilizers are self-contained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.