(82 days)
This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.
The Rüsch SympaCath Hydrogel Coated Foley Catheter is a standard foley catheter, which has been coated with a coating known as hydrogel. The purpose of the coating is to make the catheter slippery on insertion, post activation with water.
The provided text is a 510(k) summary for a medical device (Rüsch SympaCath™ Hydrogel Coated Foley Catheter) and, as such, does not contain information about acceptance criteria, device performance studies with sample sizes, expert ground truth establishment, or clinical study methodologies like MRMC or standalone performance.
This document focuses on:
- Device identification: Submitter, device name (Rüsch SympaCath™ Hydrogel Coated Foley Catheter), common name (Foley Catheter), and classification.
- Equivalence to existing devices: Stating its equivalence to "Bard Biocath and Lubricath or the Curity Kendall Ultramer coated catheters."
- Description of the device: A standard Foley catheter with a hydrogel coating designed to be slippery upon activation with water.
- Intended use: A urological catheter inserted through the urethra to pass fluids.
- Summary of technological characteristics: Emphasizing the coating's function and the similarity of design, materials, and operating principles to competitors.
Therefore, I cannot provide the requested information regarding acceptance criteria and detailed study parameters because it is not present in the given text.
§ 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.