(372 days)
The AMSure Red Rubber Urethral Catheter is intended for use in the drainage of fluid from the urinary tract
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "AMSure™ Red Rubber Urethral Catheter." It is NOT a study report or clinical trial documentation, and therefore, it does not contain the information requested in your prompt.
Specifically, it lacks:
- Acceptance criteria and reported device performance: This document only states that the device is "substantially equivalent" to a legally marketed predicate device. It does not provide any specific performance metrics or acceptance criteria.
- Study details: There is no mention of any specific study (clinical or otherwise) conducted to prove the device meets acceptance criteria.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The purpose of a 510(k) clearance is to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance data from a new study meeting specific acceptance criteria as would be found in a clinical trial report.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.