(132 days)
All Silicone Foley Catheter intended for urological use only. Foley Catheter 2-way: for routine drainage of the urinary bladder. Foley Catheter 3-way: for drainage of the urinary bladder and bladder irrigation. Foley Catheter with Temperature Sensor: for drainage of the urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Urinary Foley catheter
This document is a 510(k) premarket notification approval letter for a Foley Catheter. It discusses the regulatory approval, but it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.
Therefore, I cannot fulfill your request based on the provided text. The document is about a traditional medical device (a catheter), not a device that relies on AI/ML.
§ 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.