(23 days)
The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
This document is a 510(k) premarket notification for a Pediatric Urinary Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information cannot be directly extracted or is not applicable in the context of this type of regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study endpoint. Instead, the comparison to the predicate device serves as the primary means of demonstrating safety and effectiveness. The "Proposed device" column acts as the "reported device performance" in this context, showing that its attributes match or are equivalent to the predicate.
| Attribute | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Intended use | ||
| Placed into urethra for urine drainage | Yes | Yes |
| Single patient use |
§ 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.