Author: Gustavo Romero-Velez, MD, David M. Pechman, MD, MBA
PENTAX Medical received FDA approval for DEC™ HD Partially Disposable Duodenoscope on November 15, 2019.
DEC™ is a high definition duodenoscope with some disposable components including a sterile cap and elevator lever. The device was developed as a response to the FDA and CDC’s call for advancement in duodenoscope design to increase patient safety. The disposable elements are intended to reduce the risk of endoscope-associated multi-drug resistant infections, while maintaining the imaging and therapeutic performance required to perform endoscopic retrograde cholangiopancreatography (ERCP) procedures. Once the cap is disposed, the duodenoscope is reprocessed in the standard fashion.
DEC™ has been available in other countries since 2017 and now it received FDA approval based on 510 K as it showed to be substantially equivalent to other devices in the market. The FDA has determined this device is substantially equivalent to the PENTAX ED‐3490TK Video Duodenoscope.
It is intended for optical visualization and therapeutic access of the biliary tract including ERCP, sphincterotomy, stent placement and removal.
The use of this device is contraindicated for other procedures not listed above. It should not be used if there is an absolute contraindication for endoscopy.
Obtained from https://www.pentaxmedical.com/pentax/en/99/2/PENTAX-MEDICAL-ANNOUNCES-USA-LAUNCH-OF-NEW-FDA-CLEARED-HD-ENDOBRONCHIAL-ULTRASOUND-SCOPE