(18 days)
Used for female intermittent self-catheterization of the bladder. Curved design permits easier insertion and makes the catheter easier for patients to manipulate.
Not Found
I'm sorry, but this document does not contain the information requested. This document is a 510(k) premarket notification decision letter from the FDA for a urological catheter. It confirms that the device is substantially equivalent to a legally marketed predicate device.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, or details about test sets.
- Details about expert involvement in establishing ground truth.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone algorithm performance study.
- The type of ground truth used.
- Information about the training set or how its ground truth was established.
The content focuses on regulatory approval based on substantial equivalence to an existing device, rather than detailed performance study results against specific acceptance criteria.
§ 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.