| Device |
automated endoscope channel cleaner |
| Definition |
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. |
| Physical State |
The device may be supplied with accessories used in the cleaning process. The device may include hardware and software to allow for data collection and review. The device does not include software that outputs any clinical interpretation of the data. |
| Technical Method |
Cleans endoscope channels using a cleaning agent which mixes with water to form a slurry. The slurry shots travel through the endoscope channels and the physical action created through friction of slurry particles and the inner surface of the lumen, is what removes soil from the endoscope. |
| Target Area |
Gastrointestinal tract |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | SEW |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control Devices
(DHT4C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6994
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
