(71 days)
The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for the GuardianCatheter™-Infant Urinary Collection Kit. This type of document confirms that a device is substantially equivalent to a predicate device already on the market.
It is important to note that 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, and often do not involve extensive new clinical studies with detailed acceptance criteria and performance metrics as might be seen for novel, high-risk devices or those requiring a PMA (Premarket Approval).
Based on the provided text, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. The letter primarily confirms regulatory clearance and substantial equivalence.
Therefore, I cannot populate the table or answer the specific questions about performance metrics and study details from the text provided. The document outlines the device's indications for use and confirms its regulatory classification, but does not present the type of clinical study data you are asking for.
§ 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.