(25 days)
The Renegade STC TM 18 Microcatheter is intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
The Renegade™ STC-18 Microcatheter is a sterile, single-use catheter and is available in lengths of 105 cm, 130 cm, and 150cm.
The provided text describes a Special 510(k) for the Renegade™ STC-18 Microcatheter, focusing on its intended use, classification, and biocompatibility. However, it does not contain a study that details specific acceptance criteria and reported device performance in a quantitative manner. The document asserts "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised," but it does not present the specific data, metrics, or studies used to reach this conclusion beyond biocompatibility testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone (algorithm only) performance results
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on the regulatory submission and FDA's determination of substantial equivalence, not on the detailed technical data from specific performance studies that would typically define acceptance criteria and device performance metrics. The Biocompatibility section mentions testing per ISO 10993, but does not provide specific acceptance criteria or quantitative results.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).