(117 days)
This device is used for stenting the urethra during hypospadias repair and to allow postoperative drainage of the bladder in infants (29 days to less than 2 years old) and children (2 years old to less than 12 years old).
The Firlit-Kluge Urethral Stent is constructed out of silicone tubing and a silicone ball. The stent tubing comes in both 8 French (Fr) and 10 French (Fr). The ball is located between the distal and proximal end of the stent tubing. The 8 Fr stent comes in lengths of 31, 40, and 50 cm. The 10 Fr stent comes in lengths of 31 and 50 cm. The Firlit-Kluge Urethral Stent has one variation with additional sideports. This catalogue number has 8 Fr tubing and a length of 31cm. There are a total of 40 sideports.
The Koyle Diaper Stent is constructed of C-Flex tubing and C-Flex suture funnel. The tubing is 50 cm in length and is available in diameters of 6 and 10 Fr. The tubing has four or eight distal sideports. The distal tip is open and rounded smooth; the proximal end is open. The suture funnel is bonded in between the distal and proximal tip. One version of the 6 Fr stent has ink marks from the distal tip to the suture funnel.
The Zaontz Urethral Stent is constructed from C-Flex tubing. The stent has two drainage sideports placed opposite of each other at the distal tip. The stent's proximal tip is flared and has four sideports. The stent is available in 6, 8, and 10 Fr diameter sizes and the length is 12 cm.
The devices will be supplied sterile and are intended for one-time use. The subject devices are packaged in a peel-open pouch with a three-year shelf life.
Due to the nature of the provided document, which is a 510(k) summary for medical device clearance, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report with quantitative performance metrics. The document lists the types of performance data collected but does not specify acceptance criteria or the reported device performance in a statistical manner.
Specifically, the document states:
"The following testing was performed in order to demonstrate that the Firlit-Kluge Urethral Stent, Koyle Diaper Stent, and Zaontz Urethral Stent met applicable design and performance requirements." It then lists the types of tests conducted:
- Biocompatibility
- Sterilization Testing
- Packaging Testing
- Dimensional Verification Testing
- Tensile Testing
- Flow Rate Testing
- Accelerated Age Testing
The conclusion drawn is: "The results of these tests provide reasonable assurance that the Firlit-Kluge Urethral Stent, Koyle Diaper Stent, and Zaontz Urethral Stent will function as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices."
Based on the provided text, I cannot extract specific acceptance criteria or reported device performance in a table format, nor can I provide details about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information is typically found in the full study reports, which are not part of this 510(k) summary.
Therefore, I am unable to fulfill the request with the specific details regarding acceptance criteria and study particulars, as this information is not available in the provided document.
§ 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.