Disposable Distal End Tape Hood

The Disposable Distal End Tape Hood is a single-use endoscope accessory that attaches to colonoscope tips (9-14 mm diameter) to maintain a clear field of view during endoscopic procedures such as mucosal resection. It works by pushing away the mucosa and maintaining distance between the lens and tissue, available in transparent and opaque versions.

The proposed device is a strip-shaped hood with outer diameter 9-16 mm, total length 20 mm, inner distal diameter 7-16 mm, and distance from tip 2-5 mm. Key differences from predicate include: wrapping style design (no fixed attaching portion diameter), absence of drain holes, broader endoscope compatibility range (9-14 mm vs. predicate's three fixed sizes), and different dimensional specifications based on expanded endoscope compatibility.

ISO 10993 (biocompatibility of patient contact materials), sterilization process validation, and ethylene oxide (EO) residual testing. Performance testing included soak and water flow impact tests, pull-off tests, image quality testing, and reliability verification reports.

The proposed device has the same intended use as the FUJIFILM Hood predicate (maintaining field of view during endoscopic procedures). Dimensional and design differences do not raise new safety or effectiveness concerns; performance comparison and reliability tests demonstrate equivalence. The device is sterile, single-use, biocompatible, and functions similarly to the predicate despite design modifications.