(55 days)
The O'Neil Sterile Field Intermittent Urinary Catheter is a pre-lubricated urinary catheter with a specially designed silicone tip which is used to facilitate the urethral introduction of the catheter.
The O'Neil Sterile Field Intermittent Urinary Catheter is a pre-lubricated urinary catheter with a specially designed silicone tip.
I am sorry, but the provided text from the FDA 510(k) K993651 letter and the "Indications For Use" form do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a clearance letter from the FDA stating that the O'Neil Sterile Field Intermittent Urinary Catheter is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, experts, adjudication, or MRMC studies from the provided 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.