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510(k) Data Aggregation
(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.
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(141 days)
VitalCare's Urethral Catheter Red Rubber is intended to be inserted through the urethra to the bladder and utilized for passage of fluid from the urinary tract.
Urethral Catheter Red Rubber
The provided text describes a 510(k) submission for a medical device, the "VitalCare Urethral Catheter Red Rubber." However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).
The document is primarily a notification of substantial equivalence to a predicate device (Kendall Dover Red Rubber Robinson Catheter) and outlines the intended use and technological features comparison. The FDA's response confirms the substantial equivalence determination, classifying the device and permitting its market entry based on this comparison.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study particulars, as these details are not present in the provided text.
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