Image courtesy Pentax Medical

FDA clears Pentax Medical Video ED34-i10T2 duodenoscope

The US Food and Drug Administration cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses.

The Pentax Medical Video ED34-i10T2 model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

The FDA has previously issued communications to health care facilities about following appropriate steps for cleaning and disinfecting these devices between use. In August, the FDA released a safety communication recommending that duodenoscope manufacturers and health care facilities transition to duodenoscopes with disposable components. Disposable designs can simplify or eliminate the need for reprocessing of certain components, which may reduce between-patient duodenoscope contamination.

The FDA has previously cleared duodenoscopes with removable endcap components. This most recent clearance is the first device with a disposable elevator component — a part that has been traditionally difficult to clean and reprocess. The elevator part of the duodenoscope facilitates access to the bile and pancreatic ducts, and is used to position endoscopic instruments during the procedure.

The Pentax Medical Video Duodenoscope ED34-i10T2 is intended to be used with endoscopic devices, introduced in the patient’s mouth, to provide visualization via a video monitor of and therapeutic access to the biliary tract (liver, gall bladder and bile ducts) through the upper gastrointestinal tract. Risks of using the Pentax Medical Video Duodenoscope ED34-i10T2 include the potential for injuries, including, but not limited to, burns, electric shock, perforation, infection and bleeding.

The Pentax Medical Video Duodenoscope ED34-i10T2 was reviewed through the premarket clearance (510(k)) pathway. A 510(k) notification is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As part of the premarket clearance review, the manufacturer submitted evidence to the FDA demonstrating that the device is substantially equivalent to a predicate device.

The FDA granted clearance of the ED34-i10T2 to Pentax of America.