(211 days)
The ENVOY Guiding Catheters are intended for the intravascular introduction of interventional/diagnostic devices in the peripheral, coronary and neurovasculature systems.
The 7F, 8F and 9F ENVOY Guiding Catheters are designed for the intravascular introduction of interventional/diagnostic devices into the peripheral, coronary and neurovascular systems.
I am sorry, but the provided text does not contain information about specific acceptance criteria, a study that proves a device meets those criteria, or details regarding sample sizes, expert qualifications, or ground truth establishment.
The document is a US FDA 510(k) premarket notification letter for the ENVOY Guiding Catheter, indicating that the device has been found substantially equivalent to previously marketed devices. It confirms the intended use, classification, and states that biocompatibility tests were successfully performed. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study to prove acceptance criteria.
- Sample sizes for test or training sets.
- Information on data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request for this specific information based on the text provided.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).