(63 days)
The AMSure 100% Silicone Foley Catheter is intended for use in the drainage of fluids to, and from, the urinary tract
AMSure 100% Silicone Foley Catheter
The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AmSure 100% Silicone Foley Catheter. This document is a regulatory approval letter and an "Indications for Use Statement". It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document confirms the device's substantial equivalence to legally marketed predicate devices and is a regulatory clearance, not a technical report detailing the device's validation study.
§ 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.