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The Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System is intended for:

• General hospital or clinical use by medical professionals whenever it is required to infuse patients with subcutaneous, intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position.

• The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in either continuous, intermittent, or bolus delivery mode.

• The Infusion Pump can be used inside the MRI room mounted outside the 10,000 Gauss line (1 Tesla line), and with shielded magnets of field strength of 3.0 Tesla or less.

• This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

• The Pulse Oximeter is used to measure, display, and record functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing of the Oximeter was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot checking and/or continuous monitoring of patients who are well or poorly perfused in the MRI.

The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100 mmHg as the high negative pressures can result in uncontrolled fluid flow.

The MRidium 3860+ MRI Infusion Pump/Monitoring System with software version 3.5.3 is an MRI compatible IV pump intended for use within the MR Scan room. The device operates to full specification in magnetic fields of up to 10,000 Gauss and has RF emissions at Larmor frequencies up to and including 3.0 Tesla MR scanners (132 MHz) such that image signal to noise is not visibly affected with the pump within 1 foot from the MRI bore opening. The magnetic content of the device is such that there is no hazard of magnetic attraction.

The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (nonmagnetic) motor. This integral channel is vertically oriented to the right side of the main assembly of the pump unit shall contain the controls, display, power supply, battery, processor/memory functions suitable to meet the complete and expanded system requirements.

The left side of the unit is designed to accommodate attachment of an optional second peristaltic pump channel (Model 3861) which is controlled through the main pump assembly's display and controls. A remote display (Model 3865) is also available for independent viewing and control from the adjacent MRI Control areas.

The Dose Rate Calculator feature, allows the user to set up a patient's infusion rate based upon user selected parameters, including volume to be infused, dose, concentration, weight, and/or time.

The Dose Rate Calculator feature also provides a Drug Library, allowing the user to program a patient's infusion protocol from selected parameters, including volume to be infused, dose, concentration, weight and/or time.

The Drug Library includes a small drug library consisting of 5 drugs (four common medications most frequently infused during MRI procedures, and one customizable drug) and with the DERS library card, can hold up to 50 customizable drugs. The optional DERS library card also includes the ability of setting hard and soft limits for each drug. This Drug Library feature can only be activated/de-activated with a service-related, limited user access menu.

The Dose Error Reduction System (DERS) option (P/N 1145) to the Dose Rate Calculator feature allowing user facilities to program custom drug names, doses, and limits for use in the Dose Rate Calculator. A user programmable drug library memory card stores the specific infusion protocols established by the hospital facility. This library is accessed using the pump's Dose Rate Calculator Menu. The drug library card supports a number of separate user-programmed infusion protocols for either primary and/or primary/bolus infusions, retrievable by drug/protocol name. The library can be programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum) and soft limits (high and low limits that require a user confirmation to exceed) for: Dose, Concentration, Time and Patient Weight can be programmed. Programming the custom medications and limits is performed with the pump and a dedicated drug library SD Memory Card in the limited access service mode.

The Pulse Oximeter feature of the 3860+ MRI Infusion Pump/Monitoring System is used in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. It is indicated for continuous monitoring of patients in the MRI who are well or poorly perfused. The 3860+ System displays the patient's pulse rate and SpO2 values, as well as applicable alarm limits. The 3860+ System includes adjustable and visual pulse rate and oxygen saturation (SpO2) alarms. It also includes a variety of additional features, including low battery alarms, status indicators and sensor-related alarms. The 3860+ System only uses fiberoptic SpO2 sensors. These fiber optic sensors, cables, and associated finger wrap accessories contain no conductive components; they can be applied safely to the patient while inside an MR (magnetic resonance) environment. The 3860 model number is used for the same infusion device with no SpO2 module.

This document describes the Iradimed Corporation's MRidium 3860+ MRI Infusion Pump/Monitoring System, which is a medical device intended for infusing fluids to patients before, during, or after MRI scans, and for monitoring pulse oximetry. The submission is for a 510(k) premarket notification, claiming substantial equivalence to a predicate device (MRidium 3860 MRI Infusion Pump/Monitoring System, K090087).

Here's the information requested based on the provided text, focusing on the changes from the predicate device (software update and pulse oximeter):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of an AI/ML device. The testing described is verification and validation (V&V) for the infusion pump and pulse oximeter, and it focuses on the safety and performance of the device's functions, not on a diagnosis or prediction task from a specific dataset. Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) as typically understood for an AI/ML study is not applicable to this submission. The "test set" would typically refer to the data used to evaluate AI model performance, which isn't the primary focus here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As this is not an AI/ML device study involving ground truth establishment by experts on medical imaging or similar data, this information is not applicable. The ground truth for device performance would be established by validated test methods and reference measurements or standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as there is no mention of a human-adjudicated test set in the context of an AI/ML device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The submission is for a medical device (infusion pump/monitoring system) and does not involve AI assistance for human readers in diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This is not an AI algorithm being evaluated for standalone performance. The device itself (infusion pump and pulse oximeter) operates with software, and that software's performance is verified and validated as part of the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the specific performance testing detailed in this document:

• Software V&V: The ground truth is the design input and safety requirements for the software. This would be established through a rigorous software development lifecycle and adherence to recognized software engineering standards.
• Human Factors: The "ground truth" for human factors is compliance with the usability engineering guidance (FDA guidance). This would involve testing with representative users performing intended tasks.
• Risk Management: The "ground truth" for risk management is adherence to ISO 14971 and the FDA guidance for infusion pumps, ensuring identified risks are mitigated.
• Pulse Oximeter: The "ground truth" for the pulse oximeter's performance (SpO2 and pulse rate measurement accuracy) would be based on established physiological measurement standards and reference devices. The document states that performance specifications are "identical" to the predicate and that the OEM Masimo Set Technology (K053269) for pulse oximetry was previously cleared.

8. The Sample Size for the Training Set

This information is not applicable. The device is an infusion pump and monitoring system, not an AI/ML model that is "trained" on a dataset in the conventional sense. The software development process involves coding and internal testing, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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