(35 days)
The FlowMedica Benephit™ △ Bifurcated Infusion Catheter is intended for the infusion of fluids into the peripheral vasculature including but not limited to the renal arteries.
The FlowMedica Benephit™ Δ 5Fr. Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.
Benephit™ Δ Infusion System (Benephit™ Δ Bifurcated Infusion Catheter & Benephit™ Δ 5Fr. Introducer Sheath)
This document is a 510(k) clearance letter from the FDA for a medical device called the "FlowMedica Bifurcated Infusion System." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.
Based on the provided text, there is no information available regarding acceptance criteria or the study that proves the device meets those criteria. The letter is an administrative notice of clearance, not a summary of testing or performance data.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for establishing ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
This type of information would typically be found in the 510(k) submission itself, not in the FDA's clearance letter.
§ 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).