# K112813: Amsco V-Pro

- Pathway: 510(k) (Special)
- Applicant: Steris Corp
- Decided: Dec 1, 2011 after 65 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K020875 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062297: VHP 136 Low Temperature Sterilization System, STERIS Corporation (2007) Summary page 1.
- K083097: Amsco V-Pro 1 Low Temperature Sterilization System, STERIS Corporation (2009) Summary page 1.
- K102330: Amsco V-Pro Max Low Temperature Sterilization System, STERIS Corporation (2011) Summary page 1.

## Indications for use
The Amsco® V-PROTM MAX Low Temperature Sterilization System, with VAPROXTM 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 healthcarc 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 endloscopes, with a single stainless steel lumen with: o an inside diameter of I mm or larger and a length of 125 rum or shorter o an insider diameter of 2 mm, or larger and a length of 250 mum or shorter o an inside diameter of 3 mm or larger and a length of 400 mm or shorter aThe 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 Lumnen Cycle, cleared under K083097, can sterilize: Non-lumened instmuments including non-lumened rigid endloscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. bThe 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: 1. Two flexible endloscopes 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 I mim or larger and a length of 1050min or shorter * or two lumens with: * one lumen having an inside diameter of I tum or larger and a length of 998 mm or shorter * and the other lumen having an inside diameter of I nmm or larger and a length of 850 min or shorter The validation studies were conducted with two flexible endloscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). 2. One flexible endloscope with a light cord (if not integral to endoscope) and mat and additional non-Jumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endloscope can contain either: * a single lumen with an inside diameter of I 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 min or shorter * and the other lumen having an inside diameter of I mm or larger and a length of 850 mm or shorter d 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.

Source page: https://510kreport.com/device/K112813
Methodology: https://510kreport.com/methodology