(97 days)
The Rusch Silicone Foley is used to drain fluids to and from the urinary tract.
The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.
The Rusch Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Cylindrical, Coude and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes are available with the same configurations as the adult with the additional feature of a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr, smooth and profile shafts. Both shafts are available in coated form. Profile shafts provide drainage channels along the shaft length.
This document is a 510(k) summary for a medical device (Rüsch Silicone Foley Catheter) which primarily discusses its substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) notification process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness and the device is as safe and effective as the predicate device. This typically involves comparison to existing devices, rather than detailed performance studies with acceptance criteria in the way a clinical trial or performance study for a novel device would.
Therefore, for your request, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria for the Rüsch Silicone Foley Catheter beyond its intended use and technological equivalence.
- Sample size used for the test set and the data provenance: No test set or performance study data is included.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily states that the "Rusch Silicone catheter with silicone balloon, ported distal tip, and silicone funnel with and without coating, is equivalent to predicate devices" based on its technological characteristics. The performance is essentially inferred to be equivalent to the predicate devices (Bard, Bardex®, and Mentor, 4 Sure®).
§ 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.