Search Results

The MC3 Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

The MC3 Jugular Dual Lumen Catheters are bi-caval dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous surgical methods (Seldinger type approach). The introducer is designed to follow a prepositioned standard 0.038" (0.97 mm) or 0.035" (0.89 mm) guide wire (not included). The introducer hub provides an area for grasping the introducer during insertion and when fully seated, indicates that the introducer is fully inserted. The catheter is wire reinforced for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. The catheters remain intact throughout the duration of use and withstand the forces associated with insertion, securement, connection to perfusion line, clamping, blood pressures, and removal.

This document describes the premarket notification for a medical device and provides information on its performance evaluations, but it does not contain acceptance criteria or a study proving the device meets those criteria in the context of diagnostic or AI-driven performance.

The document is a 510(k) summary for the MC3 Jugular Dual Lumen Catheter, which is a physical medical device (a catheter) used for Veno-Venous Extracorporeal Membrane Oxygenation (ECMO). The "performance evaluations" mentioned are for the physical characteristics and safety of the catheter itself (e.g., durability, flow, kink resistance, biocompatibility, sterility), not for a diagnostic algorithm or AI system's output.

Therefore, I cannot provide the requested information from the provided text, as it pertains to a different type of device and different evaluation criteria than what your questions imply (e.g., questions about ground truth, expert consensus, MRMC studies, standalone algorithm performance, training/test sets are relevant for AI/diagnostic devices, not for a physical catheter's mechanical performance).

If you have a document related to an AI/diagnostic device, please provide that.

Ask a specific question about this device

The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.

The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14, 18, 22 and 26 Fr. outer diameter. There are two distinct kits, one intended for insertion of cannula smaller than 26 Fr. which includes the 14, 18, and 22 Fr. dilators and one intended for the insertion of cannula larger than 26 Fr. which also includes the 26 Fr. dilator. The Dilators are designed to accept a standard 0.038 inch guidewire. The Protek Venous Dilator Sets are intended as a single patient, single use, sterile device.

Each dilator consists of a tube with a hub. The dilators fit over a guidewire during insertion. The dilators are used to prepare the target vessel for the safe introduction of a large bore cannula. The dilator body is constructed from radiopaque material for visualization under nuoroscopy.

The provided document is a 510(k) premarket notification letter and supporting documentation for the Protek Venous Dilator Sets. It focuses on demonstrating substantial equivalence to a predicate device for a medical dilator. This type of document does not include information related to acceptance criteria, study details, expert involvement, or statistical analysis typically found in an FDA submission for AI/ML-driven devices or diagnostic tools.

Therefore, I cannot provide the requested information for this specific document because it describes a physical medical device (dilator) and not a device that relies on AI/ML or requires a complex validation study with acceptance criteria related to diagnostic performance.

The document details non-clinical testing for the dilator, such as:

• Tensile Strength: "Pull test with objective acceptance criteria." Conclusion: "All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application."
• Deflection Test: "Compliance measurement with side-by-side comparison to similar sized predicate devices." Conclusion: "The Protek Venous Dilators are all more compliant than similarly sized predicate devices, as designed."
• Biocompatibility: "Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours." Conclusion: "All tests passed."

This is the extent of the "acceptance criteria" and "study" information available in this document. It does not fit the format of an AI/ML-driven diagnostic study.

Ask a specific question about this device