NVE · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500
Classification
FDA Product Code
NVE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.1500
Review panel
HO
Medical specialty
Gastroenterology, Urology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.