(118 days)
Aseptic Intermittent Self-Catheterization.
The Rüsch FloNeil (coated, with Water Pack) / Rüsch Flocath IntroGel (uncoated, without Water Pack) - consists of a tubular PVC catheter, a split introducer, a silicone introducer tip. introducer cap, lubrication jelly and a pack of 15ml saline (for FloNeil -coated product) inside a closed urine collection bag.
The provided text is a 510(k) Summary for a medical device (urinary catheters) and the subsequent FDA clearance letter. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, not a performance study in the sense of accuracy, sensitivity, or specificity.
Therefore, I cannot fulfill your request for the detailed information because the source document does not provide it.
Here's a breakdown of what the document does include:
- Device Name: Rüsch FloNeil (coated, with Water Pack) and Rüsch FloCath IntroGel (uncoated, without Water Pack)
- Intended Use: Aseptic Intermittent Self-Catheterization
- Predicate Device: Rüsch MMG/O'Neil Catheter Set and the MMG O'Neil Urinary Catheter
- Substantial Equivalence: Claimed equivalence in materials, design, and use to the predicate.
- Classification: Class II medical device, 78 KOD, 21CFR 876.5130
To address your query regarding acceptance criteria and a study, these would typically be found in a performance study report, clinical trial summary, or a specific section of a 510(k) submission dedicated to performance testing (if non-clinical or clinical data were required to demonstrate substantial equivalence beyond material and design comparison). This document is a high-level summary.
§ 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.