(314 days)
VitalCare's Urethral Catheters are intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract.
Urological Urethral Catheter
The provided text describes a 510(k) premarket notification for a medical device called the "VitalCare Urethral Catheter." It focuses on the regulatory approval process and states that the device is substantially equivalent to a predicate device.
However, the document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in terms of performance metrics, clinical outcomes, or specific technical specifications with quantitative results.
The information provided only covers:
- Device Identification: VitalCare Urethral Catheter.
- Intended Use: "intended to be inserted through the urethra to the bladder and utilized for passage of fluid from/to the urinary tract."
- Predicate Device: Kendall Urethral Catheter.
- Comparison of Technical Features: States "The new device features and predicate features are similar. The pouch and contents of the pouch are similar."
- Regulatory Determination: Substantial Equivalence to the predicate device.
Therefore, I cannot provide the requested table or detailed information on acceptance criteria and a study to prove they are met because this information is not present in the provided text.
The document is a regulatory approval letter based on "substantial equivalence," meaning that the FDA found the new device to be as safe and effective as a legally marketed predicate device. This type of review often relies on demonstrating similarity in materials, design, intended use, and manufacturing processes, rather than presenting new clinical study data with specific performance metrics against pre-defined acceptance 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.