(315 days)
The SunMed Foley Catheter is used to drain fluids to and from the urinary tract.
The catheters are comprised of a 2 lumen shaft with proximal funnel, inflation valve and distal retaining balloon. One lumen is for draining fuleds to and from the urinary tract. The second lumen is to inflate and deflate the balloon. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. The balloon fill volumes in ml and shaft size in French Gauge (Fr), Charriere (Ch) or millimeter (mm) are indicated on the funnel of each individual cathter and the distal tip type can be indicated on the individual pack label and / or outer carton. Sizes range from 6 to 30 Ch / Fr.
The provided text describes a 510(k) submission for the SunMed Foley Catheter, which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for clinical studies that establish acceptance criteria for an AI/algorithm-driven device.
Therefore, the input does not contain the information necessary to answer the questions about acceptance criteria and a study proving device performance as typically understood for AI/algorithm devices.
Specifically, the document discusses:
- Intended Use: Draining fluids to and from the urinary tract.
- Product Description: Two-lumen shaft with proximal funnel, inflation valve, and distal retaining balloon.
- Predicate Device: Rusch Silicon Coated Foley Catheter (K980870).
- Substantial Equivalence: Claimed due to equivalent intended use, manufacturing materials, operating principles, and physical, operational, and biological specifications.
There is no mention of an AI/algorithm, performance metrics, acceptance criteria, test sets, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.
In summary, the provided document relates to a traditional medical device (Foley catheter) and does not include the details required to answer your specific questions, which are geared towards the evaluation of AI/algorithm-driven medical devices.
§ 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.