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The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The Duo-Flow Side x Side Double Lumen Catheter is a non-implanted hemodialysis catheter with two lumens. The red adapter connects to the proximal lumen for "arterial" outflow, and the blue adapter connects to the distal lumen for "venous" return. The catheter is available in various sizes and configurations (curved or straight extensions).

This document describes the premarket notification (510(k)) for the Medcomp® Duo-Flow® Side x Side Double Lumen Catheter. It outlines the device's characteristics, its intended use, and its substantial equivalence to a predicate device.

Key Point: The provided text does not describe an AI/ML medical device. It pertains to a physical medical device (a catheter) and therefore, the concepts of AI-specific acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone performance, and training sets for an AI model are not applicable.

The document primarily focuses on demonstrating the substantial equivalence of the Duo-Flow® Side x Side Double Lumen Catheter to a legally marketed predicate device (Mahurkar™ Acute Dual Lumen Catheter). This is a common pathway for medical device clearance in the US, where new devices are compared to existing ones that have already been cleared for marketing.

Instead of AI-specific performance metrics, the document details:

• Indications for Use: What the device is intended for (short-term central venous access for hemodialysis, apheresis, and infusion).
• Comparison to Predicate Device: A detailed table (Table 6.1) comparing various attributes of the subject device to the predicate device, including indications for use, definition, location of use, French size, catheter configuration, lengths, duration of use, sterilization method, number of lumens, patient population, insertion site, and kit type. The goal is to show that the new device is fundamentally similar to the predicate.
• Bench/Performance Data/Non-Clinical Testing: This section (Table 6.2) lists the applicable standards and performance testing conducted on the physical device to ensure its safety and effectiveness. These are primarily engineering and material tests, not clinical performance studies comparing diagnostic accuracy.
  • ISO 10555-1: Intravascular catheters (Air Leak, Liquid Leak, Peak Tensile Force, Gravity Flow)
  • ISO 11607-1 & -2: Packaging for terminally sterilized medical devices (Transit and Shelf Life testing)
  • ISTA 3A: Packaged products for parcel delivery system shipment (Transit Testing)
  • ISO 594-1 & -2: Conical fittings (Luer) for syringes, needles, etc. (Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking)
• Biocompatibility: Tests conducted according to ISO 10993 standards to ensure the device is safe for biological contact. These include cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, subacute toxicity, genotoxicity, implantation, and hemocompatibility.

Therefore, to directly answer your request based on the provided text, while acknowledging that it's not an AI device:

1. Table of acceptance criteria and the reported device performance:

Since this is a physical medical device and not an AI/ML diagnostic tool, the "acceptance criteria" are based on meeting established engineering and biocompatibility standards, and demonstrating substantial equivalence to a predicate device. Performance is measured by successful completion of these non-clinical tests.

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