(133 days)
The Dfiner is indicated for catheterization of the male urethra for the introduction of contrast materials.
The Dfiner Urological Catheter is a dual lumen flexible co-axial catheter. The main lumen contains a flexable sheath which houses is a solid flexible rod. Attached to the distal end of the rod is an array of wires. The wire bundle can be advanced and deployed in the bladder to assist with anatomical imaging. Contrast material is introduced through the main lumen. The catheter has a rigid "Y" connector at the proximal end that allows the wire bundle/sheath to be deployed/retracted and access to the main lumen.
The provided text is a 510(k) Summary for the Dfiner Urological Catheter. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML medical devices.
The document describes a traditional medical device (a catheter) and references a "comparison of technological characteristics" to predicate devices, rather than a clinical performance study with acceptance criteria, sample sizes, ground truth, or expert involvement.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to already legally marketed devices based on design, intended use, and materials of manufacture, not on the performance of an AI 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.