Endoscopic Distal Attachment (AF-D series)

The Endoscopic Distal Attachment (AF-D series) is a single-use device made of TPU that attaches to the distal end of compatible endoscopes. It maintains the endoscopic field of view during procedures such as mucosal resection by providing an attaching portion, a tapered distal portion, and optional drain holes to prevent fluid accumulation on the endoscope surface.

The subject device has six models varying in surface design (flat or inclined), presence or absence of drain holes, and inclusion or exclusion of measurement scales. Outer diameters range from 11.7–16.4 mm and compatible endoscope diameters from 13.7–18.4 mm. The predicate (FUJIFILM Hood DH-28GR/29CR/30CR) has three fixed models with outer diameters of 11.8–14.8 mm and narrower compatible ranges. Both use TPU material, ethylene oxide sterilization, and single-use design; differences in dimensions accommodate different endoscope manufacturers and specifications.

ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 (biocompatibility); ISO 11135:2014+A1:2018, ISO 11737-2:2019, ISO 10993-7:2008+A1:2019 (sterilization); ASTM F1980-21, ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1929-15, ASTM D3078-02, DIN 58593-6, ASTM F88/F88M-15, ASTM D4169-22 (shelf life and packaging); ISO 8600-1:2015, ISO 8600-4:2023 (operational performance).

The subject and predicate devices share identical principles of operation, indications for use, regulatory classification, and material composition. Although the subject device has expanded dimensional ranges and additional model variants to support multiple endoscope manufacturers, these differences reflect design accommodation rather than fundamental changes. Bench testing confirmed mechanical and chemical performance equivalence between the subject and predicate devices. Safety concerns—tissue damage, connection reliability, endoscope compatibility—were addressed through performance testing, demonstrating no new safety or effectiveness issues arise from the dimensional variations.