(123 days)
The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.
The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection between the catheter and the urinary bag is accomplished by using a standard non- interconnector. Catheterization is accomplished by inserting the catheter through the urethra. Drainage can also be accomplished by suprapubic placement or nephrostomy tract placement of the catheter.
The provided text is an FDA 510(k) clearance letter for a medical device: the "2-Way 100% Silicone Cleartract Catheter." This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and study results for software-based medical devices (like AI algorithms).
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance for a software component.
- Sample sizes used for a test set or training set, or their provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for the training set was established.
The document states that "performance testing was conducted on the subject device," and "All pre-determined acceptance criteria were met" for various bench performance tests related to the physical catheter (flow rate, balloon integrity, etc.). These are physical and mechanical tests for the catheter itself, not a study evaluating software or AI performance.
In summary, this document describes the clearance of a physical medical device (a catheter) and not a software/AI-driven device, thus the specific information requested about acceptance criteria and study details for an AI/software component 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.