(267 days)
The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.
The Cook® Cystostomy Catheter Set is composed of a single-lumen silicone catheter available in 8 to 12 French with a working length of 54 centimeters, a trocar stylet with access sheath having an outer diameter of 10 to 14 French with a length of either 11 or 11.2 centimeters, a drainage adapter with stopcock available in 12 to 16 gauge and a soft low-profile silicone catheter support with pull tie. The set is supplied sterile, intended for one-time use only, and packaged in a peelopen pouch with a three-year shelf life.
This document is a 510(k) premarket notification for a medical device called the Cook® Cystostomy Catheter Set. It does not describe an AI/ML powered device, nor does it contain information about diagnostic study performance acceptance criteria or a study proving that an AI/ML powered device meets those criteria.
Therefore, I cannot provide the requested information, which is specific to AI/ML device performance studies, based on the provided text. The document details the substantial equivalence of a physical medical device (catheter set) to predicate devices through physical and biological testing, not through AI/ML model performance evaluation.
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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.