XTJF-160AF Duodenoscope

• • Terminated Z-1845-2016 FDA Class II ·initiated 15 Mar 2016

  New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.

Full name

Xtjf-160AF Duodenovideoscope

510(k) Number

K024033 ↗

FDA Product Code

FDT

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the XTJF-160AF Duodenoscope used for in clinical practice?

  The XTJF-160AF Duodenoscope is designed for endoscopic examination of the duodenum and upper gastrointestinal tract, enabling visualization and intervention in the biliary and pancreatic ducts. It supports diagnostic and therapeutic procedures such as biopsy, dilation, and stone removal, making it essential for gastroenterology and urology specialties.

• Is the XTJF-160AF Duodenoscope single-use or reusable?

  The XTJF-160AF Duodenoscope is a reusable medical device. Between patient uses, it requires thorough cleaning, disinfection, and sterilization to ensure safety and maintain functionality. Proper handling and maintenance are critical to prevent cross-contamination and preserve device integrity.

• What storage and handling guidelines must be followed for the XTJF-160AF Duodenoscope?

  The device must be stored and handled according to Olympus Optical Co., Ltd.’s manufacturer guidelines to ensure its integrity and patient safety. Since it is not MRI-safe, it must only be used in non-MRI environments. Proper storage conditions help prevent damage and contamination, extending the device’s lifespan and reliability.

• Can the XTJF-160AF Duodenoscope be used in MRI environments?

  No, the XTJF-160AF Duodenoscope is explicitly not MRI-safe. It must only be used in non-MRI environments to avoid potential risks to both the device and the patient during imaging procedures.

• What regulatory clearance does the XTJF-160AF Duodenoscope hold?

  The XTJF-160AF Duodenoscope holds FDA 510(k) clearance under the classification of Class II (product code 876.1500). This clearance confirms its substantial equivalence to a predicate device and ensures it meets regulatory standards for safety and effectiveness in its intended use.