Defendo Fujifilm 700 Single Use Cleaning Adapter

The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single-use, non-sterile disposable valve that attaches to the air/water cylinder of Fujifilm endoscopes to allow air and water to be flushed through the endoscope's air/water channels after a procedure to remove debris. It is not intended for use during patient procedures and comes with a warning tag to communicate this restriction.

The modified device is identical to the predicate in construction, materials, dimensions (1.800 × 0.748 inches), operating principle (manual actuation), and applicable endoscopes (Fujifilm). The key differences are: the modified device is non-sterile and unsterilized (versus EtO-sterilized predicate with 10⁻⁶ SAL), and packaging changes from PETG tray with Tyvek lid to poly bag.

ASTM D4169 (shipping test) is the only consensus standard explicitly cited in the non-clinical testing summary.

Because the device is non-sterile and not exposed to patient contact—it operates only on the endoscope exterior post-procedure—removal of sterilization does not compromise safety or effectiveness. All non-clinical performance testing (water/air flow rates, button cycling, cap strength, backpressure hold, attachment force, and shipping durability) met acceptance criteria identically to the predicate. The technological characteristics, materials, dimensions, and intended use remain substantially the same, supporting equivalence despite the sterilization status change.