(307 days)
This intermittent catheter is a flexible tubular device that is inserted through the urethra by female pediatic patients who need to drain urine from the bladder.
The Female IC (not finalized) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Female IC is inserted into the urethra to drain urine from the bladder. This directly hydrated catheter is packaged in a polypropylene/polyethylene case which was designed to be easy to open, close and dispose of, with a discrete consumer design. A "first use label" on the case indicates to the end user if the product was previously opened.
The provided document is a 510(k) summary for a medical device (Female IC intermittent catheter) and primarily discusses its substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It does not include information about AI/ML algorithm performance, clinical studies involving human readers, or specific performance metrics like sensitivity, specificity, and AUC that would be expected for an AI/ML medical device.
Therefore, I cannot fulfill the request for information related to acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional medical device (catheter) and its regulatory clearance process based on substantial equivalence, not AI/ML performance.
If you have a document describing an AI/ML medical device, please provide that, and I will be happy to 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.