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The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring, and for power injection of contrast media.

The NMI IC has an open ended lumen with proximally located luer lock adapters(s), extension tube(s) with clamp(s) and suture wing for catheter securement; available in single and multi-lumen with burnif(s) and the reverse tapered shaft to aid in staunching bleeding at the insertion site. The comingulations, when a revelod with depth indicators along its length. The lumens are differentiated by proximally located colored clamps and luer adapter(s) marked with lumen size. Maximum power injection flow rates are indicated on the clamp(s). The proposed NMI IC will be offered in kits with other legally marketed products.

The provided document is a 510(k) premarket notification for a medical device (NMI Intravascular Catheter). It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing detailed study results for a new device's performance.

Therefore, the document does not contain the information requested to describe acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• Information on MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Details on ground truth for test and training sets, or training set sample size.

The performance data section (H) only lists the FDA guidance documents and international standards that the NMI IC was assessed in accordance with, such as:

• EN ISO 10555-1:1996, AMD 1: 1999, AMD 2: 2004, Sterile, Single use intravascular catheters - Part 1: General Requirements
• EN ISO 10555-3:1997 COR 2002, Sterile, Single-Use Intravascular Catheters Part 3: Central Venous Catheters
• FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995"
• IEC 60601-2-34:2000-10 - Medical Electrical Equipment Part 2-34: Particular Requirements for Invasive Blood Pressure Monitoring Equipment
• AAMI TIR 9: 1992 - Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
• AAMI/ANSI/ISO 10993-1: 2003, Biological evaluation of medical devices Part 1: Evaluation and testing

These standards outline general requirements and testing methodologies for intravascular catheters and medical devices, but the document does not provide the specific acceptance criteria derived from these standards or the detailed results of the studies conducted to meet them. The conclusion states that the device is "substantially equivalent to the predicate devices" based on responses to FDA's 510(k) Decision Making Tree, implying that its performance is considered acceptable if it is comparable to already approved devices.

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