(77 days)
The CystoSure® Plus catheter provides access and visualization for the female urinary bladder.
The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time
The CystoSure® and CystoSure® Plus catheters are intended for use in the diagnostic visualization of the female bladder with a port to allow for the insertion of an endoscope. They are made from silicone and they are used in both surgical and diagnostic procedures for draining the bladder and enabling the visualization of internal bladder surfaces.
The provided text is a 510(k) summary for the CystoSure® Plus Catheter. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device performance study.
The document states: "The CystoSure Plus catheter meets all performance criteria of the predicate CystoSure catheter." However, it does not elaborate on what these performance criteria are, nor does it present data from a specific study demonstrating compliance with these criteria for the CystoSure Plus device itself. Instead, the submission relies on the concept of "substantial equivalence" to a legally marketed predicate device (K142194 CystoSure Urinary Access System) and modifications for improved patient comfort and ease of insertion.
Therefore, I cannot provide the requested information. The text does not describe an AI/ML device, nor does it include a study with acceptance criteria specific to the performance of such a device.
§ 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.