(57 days)
The Self Cath® Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
The Self Cath Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector tubing (drain funnel) is attached to the opposite end of the PVC tube.
The provided text is a 510(k) summary for a urological catheter (Self Cath® Catheter) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Self Cath Plus). It does not contain information about acceptance criteria or specific studies detailing device performance against such criteria in the manner requested.
Therefore, I cannot provide a detailed answer to your request. The document describes the device, its intended use, and states that substantial equivalence is supported by a comparison of design, materials, and intended use, as well as "acceptable results from functional performance and biocompatibility testing." However, it does not specify what these "acceptable results" are, what acceptance criteria were used, or the details of the studies conducted. It also lacks information on sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies.
§ 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.