Disposable Distal Attachment D-201 Series

The Disposable Distal Attachment D-201 Series is a set of seven sterile, single-use transparent plastic tubes of varying diameters that attach to an endoscope's distal end. Most models include a drainage side hole to allow fluid egress. The device is designed to maintain proper viewing depth and field of view during gastrointestinal endoscopic procedures.

The subject device is a straight transparent tube attached via medical tape, offered in outer diameters of 11.35–15.7 mm. Key differences from the predicate are: the subject is sterile and single-use (versus non-sterile and reusable), pre-sterilized with EtO (versus user autoclave), and most models include drainage holes (versus none in the predicate). The subject device is also shorter in length from the endoscope distal end than the predicate.

ISO 10993-1:2018 (biocompatibility and cytotoxicity, sensitization, irritation, acute systemic toxicity), ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-11:2017, USP <51> (pyrogenicity), ISO 11135:2014 (sterilization validation), ISO 10993-7:2008 (ethylene oxide residuals), ISO 11607-1:2019 and ASTM F1980-21 (packaging and shelf life).

The subject device performs the identical intended function—maintaining endoscope viewing depth in the gastrointestinal tract—as the predicate device using the same attachment method (medical tape) and similar outer diameters. The addition of drainage holes and pre-sterilization in single-use format are design enhancements that do not alter the fundamental mechanism or safety profile. Non-clinical biocompatibility, sterilization, and shelf-life testing demonstrate the subject device performs as safely and effectively as the predicate.