(175 days)
To pass fluid to and from the urinary bladder after prostatectomy.
Fortune Medical Instruments Corp. All Silicone 2-Way/3-Way Hematuria Catheters Models 4861, 4862, 4863, 4864 and 4865.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for a device based on the provided text. The document is a 510(k) clearance letter from the FDA, which confirms that a medical device (Fortune All-Silicone 2-Way and 3-Way Hematuria Catheter Models) is substantially equivalent to a legally marketed predicate device.
This type of letter does not include information about specific acceptance criteria or an analytical study with performance metrics, sample sizes, expert qualifications, or ground truth methods. It simply states that the FDA has reviewed the premarket notification and determined substantial equivalence, allowing the device to be marketed.
Therefore, the requested information (such as a table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, or training set details) is 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.