SEW · Automated Endoscope Channel Cleaner

General Hospital · 21 CFR 880.6994 · Class 2

Overview

Identification

An automated endoscope channel cleaner is a device intended to replace all or a portion of manual cleaning of internal passages and ports of compatible, reusable flexible endoscopes. Cleaning is conducted using an agent that exerts physical force (e.g., friction) on single or multiple channels of compatible endoscopes for removal of soil. This device type is not intended to provide or replace high-level disinfection or sterilization.

Classification Rationale

Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated using general controls and the identified special controls.

Special Controls

In combination with the general controls of the FD&C Act, the automated endoscope channel cleaner is subject to the following special controls: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including that the device meets all design specifications and performance requirements: (i) Design verification testing must ensure the device meets its specifications. (ii) Simulated use testing must evaluate device cleaning efficacy under worst-case simulated use conditions. (iii) In-use testing must evaluate device performance under clinical use conditions. (iv) Evaluation of cleaning agent residues must include: (A) Quantitation of residues in compatible endoscope channels and ports; (B) Analysis of the impact of device use on subsequent reprocessing steps, such as high-level disinfection and sterilization; and (C) Evaluation of impact of device use on endoscope biocompatibility. (v) Compatibility testing of the device with compatible endoscope(s) must be conducted, to include a life cycle assessment study. The labeled life cycle must not exceed the endoscope manufacturer's life cycle specification. (vi) Cleaning agent shelf-life testing must demonstrate continued performance of the cleaning agent over its labeled shelf life. (2) Performance testing must demonstrate electromagnetic compatibility and electrical and mechanical safety of the device in the intended use environment. (3) Software verification, validation, and hazard analysis must be performed for any software components of the device. (4) Human factors testing must demonstrate that an intended user can correctly use the device for its intended use, based solely on its labeling and instructions for use. (5) Labeling must include the following: (i) A detailed summary of the device technical parameters, including any specifications; (ii) A statement regarding user adherence to the endoscope manufacturer's recommendations for use and cleaning of external/incompatible surfaces, as well as adherence to the manufacturer's validated microbicidal process for the entire device, drying and storage conditions; and (iii) Instructions for disinfection and maintenance of the automated endoscope channel cleaner.

Recent Cleared Devices (2 of 2)

Top Applicants

• Nanosonics Limited — 2 clearances