(58 days)
The Bardex I. C. Pediatric Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
The Bardex I. C. Pediatric Foley Catheter is a two-way latex Foley catheter with silver and hydrogel coatings.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Bardex I.C. Pediatric Foley Catheter), which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria.
The "Performance Data Summary" section explicitly states: "The Bardex I.C. Pediatric Foley Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those Foley catheters currently manufactured. Performance and functional testing standards are based on the FDA draft 'Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters'' dated September 12, 1994."
This indicates that the submission relies on adherence to existing standards and specifications, implying that specific, new performance studies with acceptance criteria were not part of this 510(k) filing for demonstrating equivalence to predicate devices. Therefore, I cannot provide the requested information from the given text.
§ 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.