(87 days)
CES Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic and embolic agents into the peripheral, coronary and neurovasculatures.
CES Infusion Catheters are similar in its basic design, construction, indication for use and performance characteristics to other commercially available infusion catheters.
This document is a Premarket Notification 510(k) for a medical device called "CES Infusion Catheters." It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the provided text does not contain any information regarding acceptance criteria, study details (like sample sizes, ground truth, expert qualifications, or adjudication methods), or performance data for the CES Infusion Catheters themselves.
Therefore, I cannot fulfill your request for the specific information points you've listed. The document focuses on regulatory approval based on equivalence rather than detailed performance studies against defined acceptance criteria.
To elaborate on why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This document only states the intended use and general design. There are no performance metrics or acceptance criteria presented.
- Sample size used for the test set and the data provenance: No test sets or study data are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable as no study with a test set is described.
- MRMC comparative effectiveness study: Not mentioned. This type of study typically involves human readers and AI, which is not applicable to a physical catheter.
- Standalone performance study: Not mentioned.
- Type of ground truth used: Not applicable as no study with ground truth is described.
- Sample size for the training set: Not applicable as no training set for an algorithm is described. This device is a physical catheter, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).