Search Results

The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the right side of the heart.

The TriClip Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The distal shaft is steered using a handle and knobs.

The TriClip Steerable Guide Catheter is compatible with devices (e.g., catheters) with a maximum diameter of 5.2 mm (0.204"), and the Dilator is compatible with devices (e.g., needles or guidewires) with a maximum diameter of 0.9 mm (0.035").

The TriClip Steerable Guide Catheter consists of materials including nylon, stainless steel, polycarbonate, PVP coating, silicone, urethane, PVC, and Pebax. The distal shaft has a hydrophilic coating to provide a lubricated surface for ease of insertion.

The TriClip Steerable Guide Catheter is provided EO sterile and for single use only.

The provided text is a 510(k) summary for the TriClip Steerable Guide Catheter, a medical device. It does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Therefore, I cannot extract the information required to answer your questions as they pertain to such a study (e.g., acceptance criteria for an AI, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, standalone performance, etc.).

The document describes the device, its intended use, comparison to predicate devices, and the bench testing performed to demonstrate its safety and effectiveness. This testing includes:

• Biocompatibility: In accordance with ISO 10993-1, covering cytotoxicity, hemocompatibility, sensitization, irritation, acute systemic toxicity, and materials-mediated pyrogenicity.
• Design Verification (Bench Testing): Visual inspection, catheter dimensions, curves and steering performance, tensile strengths, torsional strengths, hemostasis, particulate evaluation, and shelf-life verification.
• Sterilization: EO sterilization to achieve a SAL of 10-6 per ISO 11135, and EO/ECH residuals assessment per ISO 10993-7.
• Packaging: Verification studies in compliance with ISO 11607-1 and ISO 11607-2.

Since the provided text does not contain the information requested about an AI/Machine Learning diagnostic device, I will state that the information is not present in the document.

Ask a specific question about this device