(114 days)
Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.
The 3 Way Silicone Foley Balloon Catheter is composed of a silicone tube with an imbedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve. The tube has three lumens, one lumen for urinary drainage which is to be connected to urine collection container, one lumen with two-way valve for inflation/deflation of Foley balloon and one lumen for irrigation of bladder. Catheter is available in 16, 18, 20, 22, 24, 26 French with 30 cc balloon. Catheter is available in open or closed end. Open end allows for use of wire quide available separate). The 3 Way Silcone Foley Balloon Catheter is intended to be used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or Nephrostomy.
The devices are provided sterile and are intended for one time use.
The provided text is a 510(k) summary and FDA clearance letter for a medical device (3 Way Silicone Foley Balloon Catheter). It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, device performance metrics, or the study design typically found in a clinical trial or performance study report for AI-powered devices.
Therefore, I cannot provide the requested information in the format you specified. The information regarding sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not present in the provided text because this is a traditional medical device, not an AI device.
Here's what I can infer from the document:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly detailed in terms of quantitative metrics. The document broadly states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidances and recognized international standards." This indicates that the device met the established standards for these types of tests, but specific pass/fail criteria or numerical results are not provided.
- Study Type: The testing performed was likely focused on demonstrating the physical, chemical, and biological properties of the catheter, and its ability to function as intended (e.g., balloon inflation, fluid drainage/irrigation pathways). It was not a study to evaluate an AI algorithm.
- Ground Truth: For a traditional device like this, "ground truth" would be established by validated test methods and reference standards for material properties, sterility, and mechanical performance, not by expert consensus on clinical images or outcomes data in the context of an AI study.
In summary, the provided document does not support the detailed breakdown requested for an AI device 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.