(78 days)
The AMSure Urethral Catherization Tray is intended for use in the drainage of urine from the bladder.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSure Urethral Catheterization Tray.
Based on the content, this document is a regulatory approval letter and does not contain the detailed information required to describe acceptance criteria and study results for device performance.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance. This document solely focuses on regulatory approval, not on the technical details of a study.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details about a standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The letter confirms the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a detailed technical performance evaluation that would typically involve acceptance criteria and study data as outlined in the request. The "Indications for Use Statement" on page 5 simply states the intended use of the device ("drainage of urine from the bladder") but does not provide performance metrics or acceptance criteria.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details based on 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.