Disposable ureteral stent

The Disposable ureteral stent is a sterile, single-use polyurethane device inserted endoscopically into the ureter to provide temporary drainage from the kidney to the bladder in patients with benign, malignant, or post-traumatic ureteral obstructions, stones, strictures, or trauma. It is available in sizes 4–12 French diameter and 12–30 cm lengths, with maximum indwell time of 30 days, and a 4 Fr pediatric model is available for infants, children, and adolescents.

The subject device differs from the predicate (RELIEF stent) in several technological characteristics: it offers more diameter options (4–8 Fr vs. 6 Fr only), more length options (12–30 cm vs. 24–26 cm), uses different guidewire sizes by diameter (0.028–0.035 inch depending on stent size vs. 0.035–0.038 inch), lacks a radiopaque tip on the push tube (predicate has one), and has no pigtail straightener (predicate includes one). Both are single-use, EtO-sterilized polyurethane stents with pigtail loops at proximal and distal ends.

Bench testing per FDA's 1993 'Guidance for the Content of Premarket Notification for Ureteral Stents'; biocompatibility testing per FDA guidance 'Use of International Standard ISO 10993-1' (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, subacute/subchronic toxicity, implantation); sterilization validation per ISO 11135:2014 (Ethylene Oxide Gas to SAL 10−6); shelf-life and accelerated aging studies demonstrating 3-year performance maintenance.

Although the subject and predicate devices have different technological characteristics (diameter/length range, guidewire sizes, push tube design, and accessories), both have identical indications for use, identical 30-day maximum indwell time, same material (polyurethane), same sterilization method, and same single-use classification. Performance testing data demonstrated that the technological differences do not raise different questions of safety or effectiveness compared to the predicate device, establishing substantial equivalence despite these design variations.