Disposable Percutaneous Nephrostomy Dilatation Kit

The Disposable Percutaneous Nephrostomy Dilators are sterile, single-use devices composed of a dilator tube and tearing sheath. They are used to prepare tracts and serve as splittable working sheaths to protect kidney tissue (parenchyma) during percutaneous nephrostomy procedures in adult patients. The devices are sterilized with ethylene oxide and have a 3-year shelf life.

The subject device offers dilator sizes from 8–24 Fr (compared to predicate's 6–14 Fr), a specified length of 195±10 mm, and uses different materials: PTFE and ABS for the sheath assembly, and polypropylene for the dilator tube. The predicate uses PEBA for simple dilators and HDPE/PTFE for the splittable sheath variant. All other structural and functional features—including sterility, intended use, and basic design as a dilator with splittable sheath—remain the same.

ISO 11070:2014 (intravascular introducers and dilators); ISO 10993-5, -10, -23, -11 (biocompatibility); ISO 11135:2014 and ISO 11737-1:2018, -2:2019 (sterilization and sterility); ISO 10993-7:2008 (ethylene oxide residuals); ASTM F1980-2016, D3078-02-2021, F1929-15, F88/F88M-15, F1886-16 (aging, packaging integrity, and seal testing); FDA guidance on sterile device submissions.

The subject device is substantially equivalent because it has the same indications for use, product code (EZN), and fundamental design (dilator tube with tearing sheath) as the predicate. Dimensional, material, and design differences (larger Fr range, different polymers, specified length) are within the range of legally marketed similar devices and do not raise new safety or effectiveness questions. Comprehensive biocompatibility testing per ISO 10993-1, sterility and shelf-life validation, and performance testing per applicable ISO standards demonstrate the subject device is as safe and effective as the predicate.