Percutaneous Endoscopic Gastrostomy (PEG) Kit

The Degania Silicone Percutaneous Endoscopic Gastrostomy (PEG) Kit is a single-use, sterile, disposable kit for placing a feeding tube directly into the stomach via minimally invasive endoscopy. It provides enteral nutrition and medication delivery to adult patients unable to maintain adequate oral intake, and includes a silicone feeding catheter, two-way ENFit connector, external retention device, and placement tools.

The device is silicone-based, sterile, and single-use, designed for Push or Pull placement methods in two French sizes (20 Fr and 24 Fr). Key differences from the predicate are: an ENFit-only connector compliant with ISO 80369-3 (instead of optional non-ENFit connectors), and a simplified external retention device design with silicone bolster and clamp instead of a twist-lock and cable tie. The device shares the same principle of operation, materials, dimensions, and method of insertion as the predicate.

ISO 14971 (risk management), ISO 10993-1 and FDA guidance (biocompatibility including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, implantation, genotoxicity), ISO 11135 and ISO 10993-7 (sterilization and residuals), ISO 11607-1 and 11607-2 (packaging validation), ASTM D4169, F1886, F88/F88M, F1929, F2098 (transportation and distribution), ASTM F640 (X-ray detectability), ISO 20695 (enteral feeding systems), ISO 80369-3 and ISO 18250-3 (ENFit connectors), and ASTM F2503-20 (MRI safety).

The Degania Silicone PEG Kit is substantially equivalent to the Entuit PEG predicate (K213356) because both are silicone-based, sterile, single-use systems for percutaneous endoscopic gastrostomy using Push or Pull techniques, with identical fundamental technological characteristics, materials, dimensions, and principle of operation. The minor technological differences (ENFit-only connector and simplified external retention design) align with current international safety standards and do not raise new safety or effectiveness questions. Nonclinical testing demonstrates the device meets all applicable consensus standards and performs equivalently to the predicate.