Gastro Concepts Air Assist

The Gastro Concepts Air Assist is a single-use, disposable device that slides over the outer surface of an endoscope to help maintain air/CO2 insufflation during colonoscopy. It comprises a cylindrical body with a conical-shaped tip and an open channel for endoscope insertion. Positioned against the anus (not inserted into the rectum), it forms a temporary seal to maintain adequate colonic distension for improved visualization.

The Air Assist uses a physical barrier mechanism to impede pressure loss and maintain insufflation, enabling better operative space. It is made of silicone rubber, is non-sterile, single-use, and has a 6-month shelf life. It is compatible with endoscopes 11.5–13 mm in diameter. Unlike the predicate GelPOINT Path (which is inserted into the anus and is sterile), the Air Assist is positioned externally, making it less invasive.

ISO 10993-1 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process' was cited for biocompatibility assessment.

The Air Assist achieves substantially equivalent function to the predicate GelPOINT Path because both devices provide an improved field of view by maintaining proper insufflation during endoscopic procedures and facilitate therapeutic access. Although device placement differs (external vs. inserted) and sterilization status differs (non-sterile vs. sterile), both work through a physical barrier mechanism to impede pressure loss. Bench testing demonstrated the Air Assist can withstand clinically relevant mechanical forces and successfully reduces air leak during simulated colonic insufflation, meeting the same regulatory classification (Class II, 21 CFR 876.1500) and product code (FER) without raising new safety or effectiveness questions.