(226 days)
The Urinary Catheter is indicated for use to facilitate access to the urinary tract through a retrograde route for the delivery of gels or fluids into the urinary tract.
The Urinary Catheter is a single use 12 Fr or 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long. The catheter tube is made of Polyvinylchloride (PVC) and the Luer lock hub is made of Polycarbonate. The catheter is uncoated. The device is designed to assist in access to the urinary bladder using standard technique for drainage and delivery of gels or fluids. The catheter is indicated for use by healthcare professionals for facilitating access to the urinary tract through a retrograde route, for the delivery of gels or fluids into the urinary tract. The catheter is supplied sterile in a Tyvek pouch. The catheter is inserted into the body for a typical duration of less than 1 hour.
I cannot fulfill your request to describe the acceptance criteria and study proving device performance as the provided text is a 510(k) summary for a urinary catheter, which is a physical medical device, not an AI/ML-driven device.
The questions you've asked (e.g., number of experts, ground truth, MRMC study, training data) are relevant to the evaluation of AI/ML-powered medical devices, specifically those that analyze data (like images) to provide diagnostic or prognostic information. The provided document describes the regulatory clearance for a physical urinary catheter based on its substantial equivalence to predicate devices and bench testing for physical characteristics like flow rate, kink resistance, and tensile force.
Therefore, the information required to answer your questions (acceptance criteria for AI performance, clinical study results for AI, ground truth establishment, training set details) is not present in this document.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.