(26 days)
The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the uneticious barrier between the urethral tissue and the catheter or instrument.
Not Found
This document is a 510(k) premarket notification from the FDA for a device called the "Guardian Urethral Sheath." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've described for an AI/software-based medical device.
The information provided is a letter from the FDA to the manufacturer, Solace Therapeutics, stating that their device, the Guardian Urethral Sheath, has been found substantially equivalent to a legally marketed predicate device. This is a common regulatory pathway for medical devices that are similar to existing ones.
Therefore, I cannot extract the requested information from this document because it is not present. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria and studies demonstrating that a device (especially an AI-driven one) meets those criteria.
§ 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.