Search Results

Mais central venous catheters are indicated to provide short-term access (

Mais Central Venous Catheter is a radio opaque catheter, which is placed mainly in the subclavian, or jugular veins down to the right auricle as a short-term channeling access to the central venous system for central administration of drugs and central infusion of fluids and transfusion of blood.

The device provides pre-operative access to infuse anesthesia drugs and quick central access in emergencies as cardiac standstill, shock, etc.

Measuring the central venous pressure can be achieved by connecting the central lumen to the measuring device tube.

Central venous (CV) catheters can be used in anesthesia, critical care, and emergency medicine.

The correct positioning of the central venous catheter is of key significance for therapeutic success.

For most applications, placement in the superior vena cava approximately 2cm before the opening into the right atrium is viewed as the optimal position for the catheter tip.

The CV Catheter is needle punctured and surgically inserted into the superior vena cava (a large vein) of a patient. It can be planted inside for one-month maximum.

Mais Catheters are made from soft polyurethane material and have double, triple or quadruple lumens, and the length is variable. The Mais catheter consists of a white radio opaque multi lumen tube which is tipped with a soft polyurethane material and has many side holes relevant to each lumen. There are markings along the effective length to indicate each centimeter. There is a connector which connects the catheter lumen(s) to a lumen of a transparent polyurethane extension tube so each catheter lumen is connected to a specific extension line. The connector is polyurethane and nearly triangular shaped. Each extension tube is marked to indicate which catheter lumen is attached to it. Distal lumen is used for the CVP monitoring. A flat clamp is put over each extension tube. The flat clamp is colored differently for a given multi lumen catheter.

This looks like a medical device submission, specifically a 510(k) summary for a "Mais Central Venous Catheter." The document describes the device, its intended use, and compares it to a legally marketed predicate device (BD Acute Central Line, K190855).

However, the provided text does not contain acceptance criteria related to device performance in a study involving human readers or AI assistance. Instead, the performance testing section (8. Performance Testing) focuses on the device's physical and biological characteristics, conforming to recognized standards like ISO 10555-1, ISO 10555-3, and ISO 10993-1. These are engineering and biocompatibility tests, not clinical performance studies with diagnostic outputs.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to human readers, AI assistance, effect size, standalone performance, ground truth, or training set specifics.

There is no mention of:

• Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy).
• Any study involving AI or human interpretation of medical images/data.
• Sample size for test sets or training sets in the context of diagnostic performance.
• Experts establishing ground truth for diagnostic purposes.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth (e.g., pathology, outcomes data) for diagnostic tasks.

The document is about the physical and material safety and performance of an intravascular catheter, not about a diagnostic device or a device that uses AI for interpretation.

Ask a specific question about this device