(267 days)
Greene Renal Transplant Stent Set is used to establish temporary internal drainage from the ureteropelvic junction to the bladder. It is indicated for use following renal transplant.
The Greene Renal Transplant Stent Set is sterile, single-use device. The Greene Renal Transplant Stent Set is comprised of a double pigtail multi-length silicone stent, a radiopaque polyurethane ureteral catheter, a vinyl stent positioner and a stainless steel wire guide. The stent is available in sizes, 6.0 and 7.0 Fr with multi-length 8 to 20 centimeters. The stents are constructed of radiopaque silicone elastomer. Sideports extend along the body of the stent as well as on the curled pigtail loops (pigtail) to provide drainage. The stents are secured in the urinary tract with pigtail loops on the proximal and distal ends. There are black ink markings at the proximal and distal ends, and grey ink marks on the stent body which provide visualization during stent advancement and placement. The Greene Renal Transplant Stent is labeled for a 3-month indwell time.
The set will be supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with three-year shelf life.
This document is a 510(k) premarket notification for the Greene Renal Transplant Stent Set. It describes the device, its intended use, and comparative testing against a predicate device to demonstrate substantial equivalence. However, this document does not contain the detailed acceptance criteria and study proving device performance as typically expected for an AI/ML medical device submission.
This 510(k) is for a physical medical device (a ureteral stent), not a software or AI/ML product. The "Performance Data" section lists various physical and chemical tests conducted on the stent set (e.g., sterility, packaging, biocompatibility, stent radiopacity, curl retention, kink radius, flow rate, MRI compatibility). These are standard tests for physical medical devices to ensure their safety and functionality.
Therefore, I cannot extract the information required by your prompt, as it pertains to AI/ML device validation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance), which is not relevant to this type of device.
The document states: "The results of these tests provide reasonable assurance that the Greene Renal Transplant Ureteral Stent Set met the design input requirements based on the intended use. The subject device does not raise new questions of safety or effectiveness as compared to the predicate." This is the general conclusion of substantial equivalence for a physical device, based on the non-AI/ML specific performance tests listed.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).