(64 days)
This urological catheter is intended for the infusion of Sterile solution into the b ladder to irrigate, cleanse, or drain thecontents of the bladder during surgical procedures.
Both the device in this submission and the predicate device are used to irrigate and drain the bladder. Both devices use an inflation balloon to retain the Catheter in the bladder. Both devices are 3-way foley Catheters.
The provided text describes a 510(k) premarket notification for a medical device called "MRI's All Silicone Irrigation 3-Way Foley Catheter." However, it does not contain any information about acceptance criteria, device performance testing, study design, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.
The documents are a 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than a detailed performance study with acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The provided information is insufficient to answer your prompt.
§ 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.