Disposable Distal Cap

The Disposable Distal Cap is a single-use device that attaches to the distal end of an endoscope to maintain an appropriate endoscopic field of view during procedures. It is supplied sterile and comes in 3 types with multiple diameter specifications (ranging from 11.35 to 15.7 mm) to accommodate different endoscope sizes.

The proposed device matches the predicate in product code (FDS), regulation (21 CFR 876.1500), and Class II classification. Both use EO sterilization to achieve 10⁻⁶ SAL, have single-structure design, are single-use, and are compatible with various endoscope diameters. The proposed device uses silicone + ink materials versus TPES in the predicate, and has a one-year shelf life versus three years for the predicate—both described as similar rather than substantially equivalent.

ISO 10993-1:2009 (biocompatibility evaluation including cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogenicity); ASTM F1980-21 (accelerated aging of sterile barriers); ISO 11607-1:2019 and ISO 11607-2:2019 (packaging for sterilized devices); ISO 11135:2014+A1:2018 (ethylene oxide sterilization validation). Functional tests included dimension, endoscope compatibility, endoscopic field of view, and connection force testing.

The device is substantially equivalent because it shares the same intended use (maintaining endoscopic field of view), identical regulatory classification and product code, equivalent sterilization method and SAL, identical single-use design and configuration, and compatible diameter specifications with the predicate Disposable Distal Attachment (K984358). Performance testing and biocompatibility evaluation conducted per ISO 10993-1 and sterilization validation per ISO 11135 confirm safety and effectiveness comparable to the predicate. Minor differences in material (silicone + ink versus TPES) and shelf life (one versus three years) do not affect the fundamental intended use or safety profile.