(258 days)
No.
The document describes basic pump functionalities, a dose rate calculator, and a drug library with limits, none of which indicate the presence of an AI model for decision-making or learning. The text specifically mentions that drug library inputs are created/modified by an in-house clinical team, implying manual, pre-defined rules rather than adaptive AI algorithms.
No.
This device delivers fluids and medication but does not directly treat or diagnose a medical condition.
No
Explanation: The device is an infusion pump system designed to deliver intravenous fluids and medications. Its primary function is to administer fluids at precisely controlled rates, not to diagnose medical conditions. While it can be used during MRI procedures, it does not analyze or interpret patient data for diagnostic purposes.
No
The device is a physical infusion pump system ("MRidium 3870 MRI Infusion Pump System") that delivers intravenous fluids. It includes hardware components verified through various tests (e.g., flow rate accuracy, electrical safety, mechanical testing, biocompatibility testing, MRI environment testing). While it contains software for control and features like a Dose Rate Calculator and Drug Library, it is fundamentally a hardware device with integrated software, not a software-only medical device.
No.
The device is an infusion pump used to deliver fluids and medication to patients, not to perform in vitro diagnostic testing on specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line.
The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode.
The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours.
The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight).
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.
Product codes (comma separated list FDA assigned to the subject device)
FRN, FOX, LHI
Device Description
The MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion Pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system allowing placement as close as physically possible to the MRI scanner without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The magnetic content of the Pump is such that there is no hazard of magnetic attraction, up to 3T (30,000 gauss).
The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. The integral infusion set mounting channel is horizontally oriented in the front of the pump with position detection sensors and graphical user feedback to aid the user in the correct infusion set loading process. The main assembly of the pump unit contains the controls, display, power supply, battery, and processor/memory functions suitable to meet all system requirements.
A remote display (3875) is also available as an option for independent viewing and control from the adjacent MRI Control Room area (Zone III).
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 with soft and hard limits for each drug. These Drug Library inputs can only be created or modified by the Iradimed in-house clinical team based on input and validation from the healthcare facility. Once programmed, the library is digitally signed requiring proper verification by a software 'key' within the 3870 MR IV pump upon loading. Loading of the drug library requires access to the Password protected Service Menu.
The Dose Error Reduction System (DERS) feature allows user-facilities to provide input to custom names, and doses, with hard and soft limits for use in the Drug Library. The Drug Library supports care area specific infusion protocols for primary, bolus, loading dose, and KVO delivery modes, retrievable by drug/protocol name. The library, as prescribed by the healthcare facility, is programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum allowable) and soft limits (high and low limits that require a user confirmation to exceed) for Dose, Concentration, Time and Patient Weight can be programmed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and Pediatric patients, including Neonates.
Intended User / Care Setting
General hospital or clinical use by medical professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence between the subject and predicate device the following non-clinical tests were performed:
-
Safety Assurance Case
A safety assurance case for the MRidium 3870 Infusion Pump System was provided in accordance with the FDA Guidance document, Infusion Pumps Total Product Life Cycle issued December 2, 2014. The stated purpose of the safety assurance case is: "The MRidium 3870 Infusion Pump System is safe for its intended use".
The Safety Assurance Case is used to make a convincing argument, together with supporting evidence, that the 3870 System is adequately safe for its intended use. The top-level argument is supported by three lower-level claims that argue –- The residual risk of using the 3870 System is acceptable.
- The 3870 System meets clinically valid essential performance specifications.
- The 3870 System's design is reliable.
Evidence is referenced within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate device.
-
Verification Testing of Product Requirements:
Verification testing of product requirements is provided for the following:- Verification of flow rate accuracy per AAMI TIR101
- Essential Performance Testing
- Reliability Testing
- Air-in-line Performance Testing
- Occlusion Performance Testing
- Alarms Testing
- Software Verification and Validation Testing
- Cybersecurity Testing
- Battery Testing
- EMC/EMI Testing
- Environmental Storage and Operating Conditions Testing
- Shock and Vibration Testing
- Electrical Safety Testing
- Mechanical Testing
- Biocompatibility Testing
- Ingress Protection Testing
- Wireless Co-existence Testing
- Standards Testing (IEC 60601 Series Certification (IEC 60601-1, IEC 60601-1-8, IEC 60601-1-6, IEC 62304, IEC 62366-1)
-
Human Factors Validation Testing:
Iradimed Corporation's MRidium 3870 MRI Infusion Pump System complies with the applicable FDA Recognized Consensus Standards.- AAMI/ANSI HE75, Human factors engineering – Design of medical devices
- ANSI/AAMI/IEC 62366, Medical devices – Application of usability engineering to medical devices
- ANSI/AAMI/ISO 14971, Medical devices – Application of risk management to medical devices
- IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-
MRI Environment Conditions of Use Testing:
Iradimed Corporation's MRidium 3870 MRI Infusion Pump System was tested in its environment of use to ensure that it is safe and effective while operating in the MRI environment, including during MRI scanning sequences. Testing performed in the MRI environment included:- Magnetic Displacement Force, Static Spatial Gradients and Torque Verification
- Spurious Emissions Verification (Image Artifact)
- Verification of Essential Performance During MRI Scans
- Flow Accuracy
- Alarms
- Unintended Bolus
- Wireless Communication
Evidence of conformity with the MRI Environment Conditions of Use can be found in the bench testing section of this Submission and confirms that the 3870 System is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - MRidium 3870 MRI Infusion Pump System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 28, 2025
Iradimed Corporation
Daniel Bennett
Regulatory Affairs Director
1025 Willa Springs Drive
Winter Springs, Florida 32708
Re: K242752
Trade/Device Name: MRidium 3870 MRI Infusion Pump System (3870)
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion pump
Regulatory Class: Class II
Product Code: FRN, FOX, LHI
Dated: April 22, 2025
Received: April 25, 2025
Dear Daniel Bennett:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices, and
Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242752
Device Name: MRidium 3870 MRI Infusion Pump System
Indications for Use (Describe)
The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line.
The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode.
The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours.
The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight).
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.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 5
Iradimed Corporation MRidium® 3870 MRI Infusion Pump System
1025 Willa Springs Drive
Winter Springs, FL 32708
PH: 407-677-8022
FX: 407-677-5037
SUBMITTER INFORMATION:
Establishment Name: Iradimed Corporation
Establishment Address: 1025 Willa Springs Drive
Winter Springs, FL 32708
Contact Name: Mr. Daniel L. Bennett
Contact E-mail: dbennett@iradimed.com
Contact Phone: 407-677-8022 x143
Contact Fax: 407-677-5037
Date Prepared: April 22, 2025
DEVICE IDENTIFICATION:
Trade name: MRidium®3870 MRI Infusion Pump System
Common name: Infusion Pump
Classification name: Pump, Infusion
Regulation number: 21 CFR 880.5725
Regulatory class: II
Product code: FRN
PRIMARY PREDICATE DEVICE TO WHICH EQUIVALENCE CLAIMED:
Predicate Device: MRidium 3860+ MRI Infusion Pump/Monitoring System
Manufacturer: Iradimed Corporation
510(k) #: K143369
Clearance date: 12/15/2016
DEVICE DESCRIPTION:
The MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion Pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system allowing placement as close as physically possible to the MRI scanner without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The magnetic content of the Pump is such that there is no hazard of magnetic attraction, up to 3T (30,000 gauss).
The pump unit is designed with an integral single peristaltic pump channel utilizing an ultrasonic (non-magnetic) motor. The integral infusion set mounting channel is horizontally oriented in the front of the pump with position detection sensors and graphical user feedback to aid the user in the correct infusion set loading process. The main assembly of the pump unit contains the controls, display, power supply, battery, and processor/memory functions suitable to meet all system requirements.
Page 6
A remote display (3875) is also available as an option for independent viewing and control from the adjacent MRI Control Room area (Zone III).
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 with soft and hard limits for each drug. These Drug Library inputs can only be created or modified by the Iradimed in-house clinical team based on input and validation from the healthcare facility. Once programmed, the library is digitally signed requiring proper verification by a software 'key' within the 3870 MR IV pump upon loading. Loading of the drug library requires access to the Password protected Service Menu.
The Dose Error Reduction System (DERS) feature allows user-facilities to provide input to custom names, and doses, with hard and soft limits for use in the Drug Library. The Drug Library supports care area specific infusion protocols for primary, bolus, loading dose, and KVO delivery modes, retrievable by drug/protocol name. The library, as prescribed by the healthcare facility, is programmed with nominal starting values for: Dose, Concentration, and Time. Also, hard limits (maximum and minimum allowable) and soft limits (high and low limits that require a user confirmation to exceed) for Dose, Concentration, Time and Patient Weight can be programmed.
INTENDED USE / INDICATIONS FOR USE:
The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line.
The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode.
The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours.
The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regard to neonatal subpopulations (i.e., low and extremely low birth weight).
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.
Page 7
SUMMARY OF SUBSTANTIAL EQUIVALENCE COMPARISON WITH PREDICATE DEVICE:
A side-by-side comparison of the Intended Use and Technological Characteristics of the predicate device and proposed device is provided in Table-1, below, which includes a summary of the technological characteristics of the device compared to the predicate device and why any differences do not impact substantial equivalence.
Table-1: Summary of the Technological Characteristics of the Device Compared to the Predicate Device
| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| 1.1.1 Classification Information | |||
| Common Name | MRI Infusion Pump System | MRI Infusion Pump System | Same |
| Classification Name | Pump, Infusion | Pump, Infusion | Same |
| Regulation | 21 CFR 880.5725 | 21 CFR 880.5725 | Same |
| Class | II | II | Same |
| Product Code | FRN | FRN | Same |
| High Level Device Description | Volumetric Infusion Pump for use in the MRI environment. Used to deliver fluids into a patient's body in a controlled manner. | Volumetric Infusion Pump for use in the MRI environment. Used to deliver fluids into a patient's body in a controlled manner. | Same |
Page 8
| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| 1.1.2 Intended Use / Indications for Use | |||
| Intended Use / Indications for Use | The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode. The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours. The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regards to neonatal and neonatal subpopulations (i.e.: low and extremely low birth weight). 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. | 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. | Different: The proposed device is capable of safely operating up to 15,000 (1.5T) Gauss field line in up to a 3T (3 Tesla) MRI system, which is an improvement over the predicate device which operates at up to the 10,000 Gauss (1T) field line in MRI systems up to 3T. The proposed device is indicated for only intravenous routes of administration, whereas the predicate is indicated for subcutaneous, intra-venous or intra-arterial fluids routes of administration. The proposed device route of administration is subset of the predicate device routes of administration and is consistent with the predicate use. In addition to infusion therapy, the predicate device also provided a pulse oximeter for monitoring the SpO2 vital sign. The proposed device does not include an SpO2 monitoring function, only providing infusion therapy. It is not necessary for an infusion pump to provide vital sign monitoring, as this can be achieved with a patient monitoring system, such as Iradimed's multi-parameter 3880 MRI Patient Monitoring System. |
| Contraindications for Use | 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 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. | Same |
Page 9
| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| 1.1.2 Intended Use / Indications for Use | |||
| Intended Use / Indications for Use | The Iradimed Corporation's MRidium 3870 MRI Infusion Pump System is indicated for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intravenous fluids where a large magnetic field could be present such as Magnetic Resonance Imaging (MRI). The MRidium 3870 MRI Infusion pump can also be used during transport within the clinical environment as part of the periprocedural care before or after the MRI exam. The MRidium 3870 MRI Infusion Pump can be used with up to a 3.0 Tesla MRI system when placed as close as clinically possible to the MR system, without being placed within the magnet's bore, up to a 15,000 Gauss magnetic field line. The pump and infusion sets are designed to deliver saline and IV medication. The system is useful in the administration of fluids requiring precisely controlled infusion rates. The system can operate in primary, loading, bolus, or KVO delivery mode. The dedicated Iradimed 1056, 1058, and 1059 Infusion Sets for the MRidium 3870 MRI Infusion Pump are intended for single patient use up to 6 hours. The device is intended for Adult and Pediatric patients, including Neonates. Careful clinical considerations involving drug and dosing should always be applied especially with regards to neonatal and neonatal subpopulations (i.e.: low and extremely low birth weight). 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. | 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. | Different: The proposed device is capable of safely operating up to 15,000 (1.5T) Gauss field line in up to a 3T (3 Tesla) MRI system, which is an improvement over the predicate device which operates at up to the 10,000 Gauss (1T) field line in MRI systems up to 3T. The proposed device is indicated for only intravenous routes of administration, whereas the predicate is indicated for subcutaneous, intra-venous or intra-arterial fluids routes of administration. The proposed device route of administration is subset of the predicate device routes of administration and is consistent with the predicate use. In addition to infusion therapy, the predicate device also provided a pulse oximeter for monitoring the SpO2 vital sign. The proposed device does not include an SpO2 monitoring function, only providing infusion therapy. It is not necessary for an infusion pump to provide vital sign monitoring, as this can be achieved with a patient monitoring system, such as Iradimed's multi-parameter 3880 MRI Patient Monitoring System. |
| Contraindications for Use | 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 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. | Same |
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| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| 1.1.3 Operating Principle | |||
| Operating Principle | Non-magnetic ultrasonic motor driven linear peristaltic pump drive mechanism facilitates positive movement of fluids through an infusion line in a controlled manner. | Non-magnetic ultrasonic motor driven linear peristaltic pump drive mechanism facilitates positive movement of fluids through an infusion line in a controlled manner. | Same |
| 1.1.4 Configurations and Accessories | |||
| Number of Infusion Channels | 1 | 1 (up to 2 with optional 3861 SideCar Pump attachment) | Different: The proposed device is a single channel infusion pump, whereas the predicate device could be configured with an optional secondary infusion channel which shared the same programming controls as the primary infusion channel. The proposed device can be configured with up to four infusion channels on an IV pole mount, each with their own controls. The proposed device provides an improvement over the predicate device in that it eliminates the need to share the controls and display while operating two infusion channels. The differences in the configurations of the proposed device do not raise any new questions of safety or effectiveness and are substantially equivalent to the predicate device |
| Max Infusion Channels Per IV Pole | 4 | 4 | Same |
| Remote Display Provided | Yes, optional 3875 | Yes, optional 3865 | Different: The predicate device (3860+) had an optional remote (3865) that can display and control a single system with up to 2 infusion channels. It used a wireless radio to communicate from the MRI scan room (Zone IV) to the control area (Zone III). The subject device (MRidium 3870 MRI Infusion Pump) has an optional remote (3875 Remote) that can display and control up to 4 infusion pumps at the same time. It uses the same proprietary point to point wireless radio to communicate from the MRI scan room (Zone IV) to the control area (Zone III). To improve security, the wireless point to point radio used with the 3875 Remote utilizes encryption, whereas the predicate device was not encrypted. The differences in the proposed device do not raise any new questions of safety or effectiveness and therefore it is substantially equivalent to the predicate device. |
| Range of wireless Remote communications | From MRI exam scan room to MR control room | From MRI exam scan room to MR control room | Same |
| IV Set Compatibility | 1000 Series IV Sets (Iradimed Proprietary Design) | 1000 Series IV Sets (Iradimed Proprietary Design) | Same |
| Non-magnetic IV Pole Provided | Yes, optional | Yes, optional | Same |
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| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| Drug Library | Included Feature | Optional Feature | Different: The predicate device (3860+) had an optional drug library (DERS) available but also operated in a rate/volume mode if no drug was selected, or if the drug library DERS option was not purchased. The subject device (MRidium 3870 MRI Infusion Pump) will only operate with the built in DERS drug library. Like the predicate, the drug library will be configured by the healthcare facility, but will be programmed at Iradimed before verification by the facility. Since the DERS drug library is no longer an option, including it on each pump should improve overall safety of the device. Therefore, the differences in the proposed device do not raise new questions of safety or effectiveness, and it is substantially equivalent to the predicate device. |
| 1.1.5 Vital Signs Monitored | |||
| Vital Signs Monitored | N/A | SpO2 | Different: In addition to infusion therapy, the predicate device also provided a pulse oximeter for monitoring the SpO2 vital sign. The proposed device does not include an SpO2 monitoring function, only providing infusion therapy. It is not necessary for an infusion pump to provide vital sign monitoring, as this can be achieved with a patient monitoring system, such as Iradimed's multi-parameter 3880 MRI Patient Monitoring System. The difference in the proposed device does not raise any questions of safety or effectiveness regarding infusion therapy and therefore it is substantially equivalent to the predicate device. |
| 1.1.6 Target Population Specification | |||
| Target Population | Patients undergoing MRI procedures: • Adult • Pediatric, including Neonates | Patients undergoing MRI procedures: • Adult • Pediatric, including Neonates | Same |
| 1.1.7 MRI System Range Specifications | |||
| MRI Scanner Types | 0.2 to 3.0 Tesla MRI Systems | 0.2 to 3.0 Tesla MRI Systems | Same |
| Pump MRI Conditions: B0 Field / Gauss-Line Limit, full operation | 3870 IV Pump: ≤ 15,000 gauss | 3860+ IV Pump: ≤ 10,000 gauss | Different: The proposed device is capable of safely operating up to 15,000 (1.5T) Gauss field line in up to a 3T (3 Tesla) MRI system, which is an improvement over the predicate device which operates at up to the 10,000 Gauss (1T) field line in MRI |
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| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| systems up to 3T. Therefore, the difference in the MR conditions of use does not affect the safety or effectiveness of the device and are substantially equivalent to the predicate device. | |||
| Power Supply MRI Conditions: B0 Field / Gauss-Line Limit | 1120-19 Power Supply 8 Hours at 125 mL/hr Rate | > 12 Hours at 125 mL/hr Rate | Different: The predicate device specifies Pump Battery Operating Time of >12 Hours at 125 mL/hr Rate, whereas the proposed device specifies Pump Battery Operating Time of > 8 Hours at 125 mL/hr Rate. The Pump Battery Operating Time is provided in the labeling and does not raise any new questions of safety or |
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| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| effectiveness as the battery has enough capacity. The system can also be operated while AC power is plugged in if the battery were to run low. Like the predicate device, the proposed device also provides alarms when "low" battery conditions exist. Therefore, the proposed device is substantially equivalent to the predicate device. | |||
| Pump Battery Charge Time | 100 uL (+20%) | > 100 uL (+20%) | Same |
| Fluid Container Source Height Limits | +60 to -60 cm (+24 to -24 in) relative to pump center | +60 to -60 cm (+24 to -24 in) relative to pump center | Same |
| Audible Alarm Range Pump (at 1 Meter) | Minimum: 65 dBA Maximum: > 85 dBA @1 meter | Minimum: 65 dBA Maximum: > 85 dBA @ 1 Meter | Same |
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| Characteristic | Proposed Device: Iradimed Corporation's MRidium 3870 MRI Infusion Pump System (Pending 510(k)) | Predicate Device: Iradimed Corporation's MRidium 3860+ MRI Infusion Pump System (K143369) | Comparison |
|---|---|---|---|
| User Event Log | Non-volatile memory retains each operating step and alarm - up to 5000 entries | Non-volatile memory retains each operating step and alarm - up to 5000 entries | Same |
| 1.1.13 Alarms | |||
| Alarms | Possible Free Flow Alarm Pump Failure Alarm Door Opened Alarm Bubble Detection Fault Alarm Bubble Detection Alarm Downstream (Patient) Occlusion Alarm Upstream (Inlet) Occlusion Alarm Low Battery Alarm Dead Battery Alarm Pump Key Stuck Alarm Depleted Battery Alarm AC Power Required Alarm Depleting Battery Alarm Defective Battery Alarm No Battery Detected Alarm Exceeded Battery Life Alarm Infusion Complete Alarm KVO Started Alarm End of Infusion Alarm Cannot Start - Service Required Alarm Cannot Start - IV Set Alarm Cannot Start - Cycle Door Alarm Cannot Start - Door Open Alarm Cannot Start - Dosing Parameters Alarm Cannot Start - Wrong Screen Alarm Patient Identifier Conflict Alarm No Action Alarm IV Set Expired Alarm Near End of Infusion Alarm IV Set Expiring Soon Alarm Battery Life Exceeded Alarm Software Mismatch Alarm Wrong Link Password Alarm Speaker Fault Alarm Battery Near End-of-Life Alarm VI Cleared Alarm Communication Lost (Remote Only) | Air-in-line Battery low Battery depleted Bolus complete Infusion complete Infusion not started Occlusion (upstream or downstream) Dose limits exceeded Service Error Code Communication Loss (Remote Only) KVO Alert | Different: Although some of the alarms have different names, all of the predicate Alarms are still represented in the proposed device. There are also additional new state-of-the-art alarms intended to increase awareness and reduce errors. The Alarms provided in the proposed device do not introduce new questions of safety or effectiveness and are substantially equivalent to the predicate device. |
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SUMMARY OF PERFORMANCE TESTING (NON-CLINICAL):
To demonstrate substantial equivalence between the subject and predicate device the following non-clinical tests were performed:
- Safety Assurance Case
- Verification Testing of Product Requirements
- Human Factors Validation Testing
- MRI Environment Conditions of Use Testing
1) Safety Assurance Case:
A safety assurance case for the MRidium 3870 Infusion Pump System was provided in accordance with the FDA Guidance document, Infusion Pumps Total Product Life Cycle issued December 2, 2014. The stated purpose of the safety assurance case is: "The MRidium 3870 Infusion Pump System is safe for its intended use".
The Safety Assurance Case is used to make a convincing argument, together with supporting evidence, that the 3870 System is adequately safe for its intended use. The top-level argument is supported by three lower-level claims that argue –
- The residual risk of using the 3870 System is acceptable.
- The 3870 System meets clinically valid essential performance specifications.
- The 3870 System's design is reliable.
Evidence is referenced within the assurance case to demonstrate that the subject device is verified and validated for its intended use and to demonstrate substantial equivalence to the predicate device.
2) Verification Testing of Product Requirements:
Verification testing of product requirements is provided for the following:
- Verification of flow rate accuracy per AAMI TIR101
- Essential Performance Testing
- Reliability Testing
- Air-in-line Performance Testing
- Occlusion Performance Testing
- Alarms Testing
- Software Verification and Validation Testing
- Cybersecurity Testing
- Battery Testing
- EMC/EMI Testing
- Environmental Storage and Operating Conditions Testing
- Shock and Vibration Testing
- Electrical Safety Testing
- Mechanical Testing
- Biocompatibility Testing
- Ingress Protection Testing
- Wireless Co-existence Testing
- Standards Testing (IEC 60601 Series Certification (IEC 60601-1, IEC 60601-1-8, IEC 60601-1-6, IEC 62304, IEC 62366-1)
3) Human Factors Validation Testing:
Iradimed Corporation's MRidium 3870 MRI Infusion Pump System complies with the applicable FDA Recognized Consensus Standards.
- AAMI/ANSI HE75, Human factors engineering – Design of medical devices
- ANSI/AAMI/IEC 62366, Medical devices – Application of usability engineering to medical devices
- ANSI/AAMI/ISO 14971, Medical devices – Application of risk management to medical devices
- IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
- IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
4) MRI Environment Conditions of Use Testing:
Iradimed Corporation's MRidium 3870 MRI Infusion Pump System was tested in its environment of use to ensure that it is safe and effective while operating in the MRI environment, including during MRI scanning sequences. Testing performed in the MRI environment included:
- Magnetic Displacement Force, Static Spatial Gradients and Torque Verification
- Spurious Emissions Verification (Image Artifact)
- Verification of Essential Performance During MRI Scans
- Flow Accuracy
- Alarms
- Unintended Bolus
- Wireless Communication
Evidence of conformity with the MRI Environment Conditions of Use can be found in the bench testing section of this Submission and confirms that the 3870 System is as safe, as effective, and performs as well as or better than the predicate device.
CONCLUSION AND STATEMENT OF SUBSTANTIAL EQUIVALENCE:
The performance testing demonstrates that Iradimed Corporation's MRidium 3870 MRI Infusion Pump System described in this submission is substantially equivalent to the predicate device (K143369) MRidium 3860+ MRI Infusion Pump / Monitoring System.