(107 days)
The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.
Not Found
This looks like a 510(k) clearance letter from the FDA for a medical device called the "Nexus Irrigation Tubing Set." The letter is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its commercialization, but it does not detail the technical studies that would typically include acceptance criteria and performance data.
§ 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.