(173 days)
The Hemedex Fixation Device is intended to be used on the patient's skin to secure the percutaneous placement of the QFlow Perfusion Probe.
The Hemedex Fixation Device is a compact soft silicone disk with a securing clamp and adhesive dressing for securing a probe or catheter to the patients skin. The clear pressure sensitive adhesive dressing allows for easy visual inspection of catheter entry site.
I am sorry, but based on the provided text, there is no detailed information available regarding acceptance criteria, device performance metrics, or the actual study results that would allow me to populate the requested table and answer questions 2 through 9.
The document is a 510(k) premarket notification letter from the FDA to Hemedex, Inc. for their Fixation Device. It primarily states that the device has been found substantially equivalent to a predicate device (UreSil Fixation Device K914699).
Here's what the document does state in relation to performance testing:
- Section 7. Performance Testing: "Bench testing was conducted to demonstrate that this device meets the requirements of its intended use and meets the specified performance criteria."
However, this statement provides no specifics about:
- What those "specified performance criteria" were.
- The actual results of the "bench testing."
- The methodology, sample sizes, or ground truth establishment for any such testing.
Therefore, I cannot provide the requested information. The document only confirms that some bench testing was done to demonstrate the device meets its intended use and performance criteria, but it does not elaborate on these aspects in any way that fulfills the detailed questions asked.
§ 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.