(87 days)
The Rüsch Brillant Two Way Silicone Foley is used to drain fluids to and from the urinary tract.
The Rüsch Brillant Three Way Silicone Foley is used to drain fluids to and from the urinary tract, and to flush and irrigate the urinary tract.
The Rusch Brillant Silicone catherer is of the balloon retention type, commonly called a Foley catheter. The device is single use, disposable, and sterile. The central lumen is for draining fluids to and from the urinary tract. The second lumcn is to inflate and deflate the balloon with sterile water. On models with a third lumen (commonly called a Threeway Catheter), it is used in conjunction with the central lumen for flushing or irrigating the urinary tract.
The distal end has eye holes, which are for drainage. On the opposing end of the shaft, are a connecting funnel (for a drainage bag, purchased separately) and a Luer activated valve.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) summary for a Foley catheter, primarily focusing on establishing substantial equivalence to previously marketed devices. It describes the device, its intended use, and its technological characteristics, but it does not detail any performance studies, acceptance criteria, or specific metrics.
Therefore, I cannot extract the requested information from the given text.
§ 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.