(81 days)
The AMSure Foley Insertion Tray is intended for use in the drainage of urine from the bladder
Not Found
This is a 510(k) premarket notification for a medical device called the "AMSure™ Foley Insertion Tray", not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are specific to AI/ML device evaluations, are not applicable and cannot be extracted from this document.
The document focuses on the FDA's determination of substantial equivalence for a physical medical device (Foley Insertion Tray) to a legally marketed predicate device. The review process outlined here does not involve performance studies in the way an AI/ML algorithm would be evaluated. It addresses regulatory compliance, manufacturing practices, and the classification of the device and its components (including the drug component Povidone Iodine Swabsticks).
§ 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.