(62 days)
Infusion of physician-specified agents in the peripheral vasculature including but not limited to the renal arteries.
The FlowMedica Introducer Sheath is intended to facilitate the entry of interventional and diagnostic devices into the human vasculature.
The FlowMedica Bifurcated Infusion System consists of the FlowMedica Bifurcated Infusion Catheter and the FlowMedica Introducer Sheath.
The FlowMedica Bifurcated Infusion System consists of the Bifurcated Infusion Catheter and the Introducer Sheath. It is intended for single-use only and is sterilized using ethylene oxide gas.
The Bifurcated Infusion Catheter functions by selectively delivering physician-specified agents directly to the peripheral vasculature. The Bifurcated Infusion Catheter contains a 77cm working length shaft/infusion lumen. It is bifurcated at the distal end, which is comprised of two identical metal-supported and braided polymer branches.
The Introducer Sheath provides for the introduction of two interventional devices through a single vessel access site, allowing for the introduction of the Bifurcated Infusion Catheter and the introduction of a standard coronary guiding or diagnostic catheter as may be required for a catheterization procedure. The Introducer Sheath, available in four lengths, is a polymer and metal coil reinforced sheath with two insertion ports in its integral Y hub assembly. The ports contain a hemostasis valve, designed for a 6Fr diagnostic or guiding catheter, and Touhy Borst valve used for the Bifurcated Infusion Catheter. A vessel diffator is supplied with the Introducer Sheath.
The FlowMedica Bifurcated Infusion Catheter is designed for use only with the FlowMedica Introducer Sheath. Each component is packaged separately and may be ordered and shipped separately; however, the Instructions for Use included with the Bifurcated Infusion Catheter specify exclusive usage with the FlowMedica Introducer Sheath.
The provided document is a 510(k) summary for the FlowMedica Bifurcated Infusion System and its associated FDA clearance letter. It describes the device, its intended use, predicate devices, and testing conducted to support substantial equivalence.
However, the document does not contain information related to acceptance criteria, specific device performance metrics, or details of a clinical study with human subjects that would typically involve a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance.
The "Testing in Support of Substantial Equivalence Determination" section only lists categories of testing:
- Design Verification Testing
- Biocompatibility Testing
- Animal Testing
- Predicate Device Comparative Testing
It explicitly states: "Comparative bench testing demonstrates that the performance and safety of the FlowMedica Bifurcated Infusion Catheter is equivalent to that of the predicate devices." This indicates that the primary evidence for substantial equivalence came from bench (laboratory) and animal testing, not a clinical study involving a test set of human cases with expert-established ground truth.
Therefore, I cannot provide the requested information from the provided text. The device in question is a medical device (catheter and introducer sheath), and its clearance was based on substantial equivalence to existing predicate devices, supported by non-clinical testing.
The following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: No such table is present. The document generally states equivalence based on bench and animal testing.
- Sample size used for the test set and the data provenance: No clinical test set involving human data is described. Animal testing is mentioned, but details on sample size or data provenance for that are not provided beyond the category.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with expert-established ground truth is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical device, not an AI or image-based diagnostic tool that would typically involve human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: For the non-clinical testing (bench, animal), the "ground truth" would be established by direct measurement of device properties or observed physiological effects in animals, compared against predicate device performance. No human clinical ground truth (e.g., pathology, outcomes data) is mentioned for a test set.
- The sample size for the training set: Not applicable; this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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).