(58 days)
These devices are intended for access and catheterization of the urinary tract, including the following applications:
- Delivery of contrast media
- Navigation of a tortuous ureter
- Access, advancement, or exchange of wire guides
The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters
This document, K181144, is a 510(k) premarket notification for the Angled Tip Ureteral Catheter from Cook Incorporated. It determines the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information regarding studies for AI/ML based medical devices or their acceptance criteria. It pertains to a physical medical device (catheter) and its substantial equivalence based on performance testing of the device itself. Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML test set or training set.
The performance data listed in the document (Biocompatibility, Sterilization, Dimensional and Compatibility, Radiopacity, Kink Radius, Tensile, Blockage and leakage) are standard engineering and material tests for a physical catheter, not typically applicable to the validation of an AI/ML algorithm.
§ 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.