(213 days)
The Allwin Ureteral Catheters are used for drainage of urine from the ureter and they allow the delivery of contrast media.
Not Found
This document is an FDA 510(k) clearance letter for a medical device (Allwin Ureteral Catheters), not a study report or clinical trial summary. Therefore, it does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It doesn't detail the performance validation methods or results for the device itself.
To answer your request, you would need access to the actual 510(k) premarket notification submission (K220730) which would contain the data from performance testing, if such data was required and submitted for this type of device. However, for a Class II device like a ureteral catheter (product code KOD), performance testing might focus on physical properties, biocompatibility, and sterilization rather than image analysis performance metrics.
In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria and study data for device performance.
§ 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.