(83 days)
The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.
The MTP Uropump Disposable Tubing Set is intended to be utilized with the Karl Storz Uropump Irrigation/Suction System for the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.
The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
This document is a 510(k) summary for the MTP Uropump Disposable Tubing Set. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
The document details the device's identification, indication for use, device description, and claims substantial equivalence to a predicate device. It also includes the FDA's clearance letter.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance from the provided 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.