(184 days)
Two-way and Three-way Disposable Silicone Foley Catheters are indicated for urethral catheterization for bladder drainage for urological use only. The Two-way Disposable Silicone Foley Catheters have an indwell time of no more than 30 days and are indicated for adult use only.
This product is a Foley Balloon Catheter. It is a 'prescription only' device. It consists of a Manifold part and Shaft parts. The Manifold Part is equipped with a non-return valve for inflating the balloon and a band to fix the non-return valve and identify the catheter's size by its color. The Shaft parts have an x-ray opaque line for checking the position of the catheter by X-ray and a balloon to place the catheter in the bladder. After the catheter is inserted, distilled water or saline is injected to expand the balloon and fix the catheter in place. The shaft also contains drainage eyes for urine drainage, and a rounded tip to aid insertion of the catheter. This Foley Balloon Catheter will be provided in Two and Three-Way configurations. The Three-Way configuration contains an 'Irrigation Manifold' for washing the bladder with saline solution. The shaft and balloon of the catheter are made of silicone and zinc oxide. The tip and the manifold are made of silicone only. The proposed device is supplied in French sizes ranging from 12 to 24. It is available in 337(±15) mm and 345(±15) mm lengths with various balloon sizes. The devices for adults only.
The provided text describes a 510(k) premarket notification for disposable silicone Foley catheters, not an AI/ML-based medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in the document.
The document focuses on demonstrating substantial equivalence to a predicate device, which involves comparing technological characteristics and presenting performance testing related to biocompatibility, sterilization, shelf-life, and functional testing per ASTM F623.
Since the prompt specifically asks about the study proving an AI/ML device meets acceptance criteria, and the document is about a physical medical device (Foley catheter) with no mention of AI/ML, I cannot extract the requested information.
§ 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.