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The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with 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 specific MRidium 3850 Series MRI Infusion Pump System (including the MRidium 1000 Series of Infusion Sets) indications for use are as follows:

1. Useful in the administration of fluids requiring precisely controlled infusions and including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
2. Useful in the following delivery routes: arterial, intravenous, spinal, subcutaneous, and enteral.
3. Useful in the following delivery modes: continuous, intermittent and bolus.
4. Although specifically intended for use in the MRI, this product can be useful in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the pump can be monitored or supervised by a clinician.
5. Used inside the MRI room mounted outside the 10,000 Gauss line and with MRI magnets of field strength of 3.0 Tesla or less.

The MRidium 1000 Series Infusion Sets are intended as accessories to the MRidium 3850 Series MRI Infusion Pump for use in the administration of fluids for precisely controlled infusion rates.

The infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -250 mmHg and could result in uncontrolled fluid flow.

The MRidium 3850 MRI Infusion Pump System is an MRI compatible IV pump intended for use within the MR Scan room. The device shall operate to full specification in magnetic fields of up to the 10.000 gauss-line of a 3.0 Tesla MR Scanner, and have RF emissions at the Larmor frequencies up to and including 3.0 Tesla MR scanners 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 minimal so as to avoid any hazard of magnetic attraction.

The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. This integral channel is vertically oriented to the right side of the unit. The main assembly of the pump unit shall contain the controls, display, power supply, battery, and 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 which is controlled through the main pump assembly's display and controls.

The MRidium 1000 Series Infusion Sets utilize medical-grade PVC tubing with a medical-grade silicone rubber pumping segment that fits into a custom housing within the Pump. These Infusion Sets also contain the necessary flow stop/prevention devices, needle-free access ports, and fluid bottle/bag insertion devices required for safe and effective fluid delivery.

The provided text describes a 510(k) premarket notification for the MRidium™ 3850 Infusion Pump System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute performance against established acceptance criteria for a novel technology. Therefore, many of the requested elements (like effect size of human readers with AI, adjudication methods for ground truth, or specific details of a comparative effectiveness study) are not applicable or directly derivable from this type of regulatory submission.

However, based on the provided text, here’s an interpretation of the available information:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly list "acceptance criteria" in a typical quantitative, pass/fail table format as would be seen for a new, unproven technology. Instead, it refers to conformity with national and international product safety standards and functional equivalence to predicate devices. The "performance" is primarily demonstrated through meeting these standards and showing that its technology is comparable.

• Uses a piezo-electric/ultrasonic motor, which possesses inherent MRI-compatibility due to its immunity to magnetic fields. |
  | - RF emissions at Larmor frequencies up to 3.0 Tesla MR scanners such that image signal-to-noise ratio is not visibly affected with the pump within 1 foot of the MR bore opening. | - "...and have RF emissions at the Larmor frequencies up to and including 3.0 Tesla MR scanners such that image signal to noise is not visibly affected with the pump within 1 foot from the MR bore opening." |
  | - Minimal magnetic content to avoid hazard of magnetic attraction. | - "The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction." |
  | Functional Equivalence to Predicates: | "The MRidium™ 3850 MRI Infusion Pump System (including the MRidium 1000 Series Infusion Sets) is functionally identical and substantially equivalent to the Medrad Continuum MRI-Compatible System and Alaris PC-1 Infusion System..."
• Similar in: Patient Infusion Sets, AC/Battery Power Systems, Pump Drive and Control System, Air Bubble Detection System, Fluid Overpressure Limit System, Alarm Detection System, Keypad/Information Display System, Communication System. |
  | Compliance with Safety Standards: | |
  | - Conforms to national and international product safety standards for infusion therapy, electrical safety, and electromagnetic compatibility. | - "conforms with national and available international product safety standards for infusion therapy, electrical safety, and electromagnetic compatibility. Nonclinical testing has been performed using these standards to establish the device's performance. These include: IEC 60601-1-1; IEC60601-1-2; AAMI/ANSI ID26 (1998); IEC 60601-2-24; and UL2601." |
  | - Mitigation of identified potential hazards. | - "Additionally, tests demonstrating consideration and mitigation of the identified potential hazards for this device were completed, along with the design reviews, prior to product release." |

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is non-clinical testing based on engineering standards. Therefore, concepts like country of origin for data or retrospective/prospective don't apply here. The "sample size" would refer to the number of devices or components tested according to the listed standards. This is not explicitly stated but implied by the successful completion of the tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided because the "ground truth" for this type of regulatory submission is typically defined by established engineering and medical device safety standards (e.g., IEC 60601 series, AAMI/ANSI ID26, UL2601), not by expert clinical consensus on a specific dataset.

4. Adjudication method for the test set

Not applicable. The testing described is non-clinical, hardware/software performance validation against standards, not clinical data adjudication.

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

Not applicable. This is not a study involving human readers or AI assistance. It's a 510(k) submission for an infusion pump, establishing substantial equivalence to existing predicate devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable. The device is an infusion pump, and its "standalone performance" is assessed by its ability to meet the specified engineering and safety standards, and to perform its intended function equivalently to predicate devices. There isn't an "algorithm only" component in the context of a diagnostic or AI-driven decision support system.

7. The type of ground truth used

The "ground truth" here is embodied in:

• Established engineering and medical device safety standards: (e.g., IEC 60601-1-1, IEC60601-1-2, AAMI/ANSI ID26 (1998), IEC 60601-2-24, and UL2601).
• Functional specifications of predicate devices: The functionality of the Medrad Continuum Infusion Pump System and Alaris PC-1 Infusion System serves as a benchmark for equivalence.
• Physical laws and principles related to MRI compatibility (magnetic fields, RF emissions).

8. The sample size for the training set

Not applicable. The device is an infusion pump, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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