(141 days)
VitalCare's Urethral Catheter Red Rubber is intended to be inserted through the urethra to the bladder and utilized for passage of fluid from the urinary tract.
Urethral Catheter Red Rubber
The provided text describes a 510(k) submission for a medical device, the "VitalCare Urethral Catheter Red Rubber." However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).
The document is primarily a notification of substantial equivalence to a predicate device (Kendall Dover Red Rubber Robinson Catheter) and outlines the intended use and technological features comparison. The FDA's response confirms the substantial equivalence determination, classifying the device and permitting its market entry based on this comparison.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study particulars, as these details are not present in 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.