Cleared Special

AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector

K222543 · Steris · General Hospital

Aug 2022

Decision

Days

Class 2

Risk

About This 510(k) Submission

K222543 is an FDA 510(k) clearance for the AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector, a Washer, Cleaner, Automated, Endoscope (Class II — Special Controls, product code NVE), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on August 25, 2022, 3 days after receiving the submission on August 22, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K222543 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 2022
Decision Date	August 25, 2022
Days to Decision	3 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	NVE — Washer, Cleaner, Automated, Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	This Automated Device Is Intended To Be Used To Clean Endoscopes. Endoscopes That Are Intended To Be Cleaned By The Automated Cleaner System Should Have Been Pre-cleaned And Tested For Leaks And Lumen Obstructions According To The Instrument Manufacturer's Instructions And Current Professional Practices Prior To Processing In The System. The System Includes A Chemical Dispensing System That Meters Out A Predetermined Volume Of Detergent During The Appropriate Cleaning Cycle. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). The Instrument Is Placed In A Tray With Each Lumen End Positioned In Opposite Sides Of The Tray To Allow Enough Detergent And Rinsing Water Pass Through The Lumens Of The Endoscopes.