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:

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.
Useful in the following delivery routes: arterial, intravenous, spinal, subcutaneous, and enteral.
Useful in the following delivery modes: continuous, intermittent and bolus.
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.
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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Inferred from Regulatory Standards and Equivalence Claims)	Reported Device Performance (Summary from Text)
MRI Compatibility:
- Operates to full specification in magnetic fields up to 10,000 gauss-line of 3.0 Tesla MR Scanner.	- "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." - 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.

Summary

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Ko50 30

MAR 2 4 2005

(P. 1 of 3)

510(k) Summary of Safety and Effectiveness

Submitter Information:

Iradimed Corporation 7457 Aloma Ave. Suite 201 Winter Park, FL 32792

Phone: 407-677-8020 407-677-5037 Fax: Contact: Mr. Francis Casey

Date Prepared: January 31, 2005

Product Name:

Trade Name:	MRidium™ 3850 Infusion Pump System
Common Name:	Infusion Pump and Infusion Sets.
Classification Name & Class:	Infusion Pump - Class II (see 21 CFR - 880.5725)

Predicate Devices:

The predicate device(s) are: the Medrad Continuum Infusion Pump System (510(k) numbers K032771 and K021988); Alaris PC-1 Infusion Pump System (510(k) number K012383); and their respective infusion sets. These predicate devices have similar performance specifications as the MRidium 3850 Infusion Pump System.

Device Description:

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 Tcsla 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 MR1 bore opening. The magnetic content of the device is minimal so as to avoid any hazard of magnetic attraction.

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.

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K454341(42 or 43)

needle-free access ports, and fluid bottle/bag insertion devices required for safe and effective fluid delivery.

Intended Uses:

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 geduction nooplar of enous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile resomation . 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.

Technological Comparison to Predicate Device(s):

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 (and their respective infusion sets) which are currently being marketed.

They are functionally equivalent in the following areas:

1. Fluid Overpressure Limit System 1. Patient Infusion Sets
1. AC/Battery Power Systems
1. Alarm Detection System 7. Keypad/ Information Display System
1. Pump Drive and Control System

Air Bubble Detection System

1. Communication System
  The only notable difference in the technology is the use of a piezo-electric/ultrasonic motor, which is functionally identical to the commonly-used drive motors, but possesses inherent MRI-compatibility due to its immunity to the influence of magnetic fields.

The Iradimed Corporation MRIDIUM 3850 Infusion Pump System uses similar types of technology that are found in the predicate devices listed above. A detailed comparison of these similarities and differences has been performed, and demonstrates equivalence with the predicate devices.

Summary of Performance Testing:

The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System (including the MRidium 1000 Series Infusion Sets) 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.

The results of these non-clinical tests allow Iradimed Corporation to conclude that the MRidium™ 3850 MRI Infusion Pump System is substantially equivalent to the Medrad Continuum MRI-Compatible System and Alaris PC-1 Infusion System which are currently being marketed, and that they are as safe and effective as these devices in providing infusion therapy.

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Additionally, tests demonstrating consideration and mitigation of the identified potential Auditionally, tests demonstrating completed, along with the design reviews, product hazards for this device au vo oting performed prior to product release.

・・

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

Iradimed Corporation C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K050301

K020201
Trade/Device Name: MRidium 3850 Series MRI Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 7, 2005 Received: February 8, 2005

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becarer bed the device is substantially equivalent (for the referenced above and nave acternillioure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate conmisere prior to fray ave been reclassified in accordance with the provisions of Amendinents, or to devroes and Cosmetic Act (Act) that do not require approval of a premarket the rederal I vod, Drug, and Ocomens , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the rior ston, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mr), it may be subject to Back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the be announcements concerning your device in the Federal Register.

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Page 2 - Mr. Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA s issualled of a busefalles with other requirements
mean that FDA has made a determination that your device Federal accepaires mean that FDA has made a decommanent until Jose administered by other Federal agencies. of the Act of ally rederal statutes and regaranents, including, but not limited to: registration You must comply with an the Act 3 requirements) at 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bart 800); and and listing (21 CFR Pat 607), laceming (21 CFR Pat 820) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820 requirements as set form in the quality of storms (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailering , bastantial equivalence of your device to a premarket notification. The PDA midml of basilinal of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation please contact the Office of Occipitalism premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general micrimational and Consumer Assistance at its toll-free Division of Birman (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Quitte Michie MD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Unknown

Device Name: Iradimed Corporation MRidium 3850 series MRI Infusion Pump

Indications For Use:

The Iradimed Corporation's MRIDIUM 3850 Infusion Pump System is intended for The Iradimed Corporation's MKU/LDM 3830 Inniston I tis required to interest it is required to infuse
general hospital or clinical use by medical fluid-hefore, during or after general hospital or cimical use by incores protested, during, or after Magnetic patients with intra-venous of mucharing while either in a stationary or mobile
Resonance Imaging (MR) scans, functioning while either in a stationary of mobile Resonance Imaging (MKI) Scans, Iunchoning MRI offision Pump System (including the
position. The specific MRidium 2850 Series MRI Infinitions for as follows: position. The specific MRusion 5650 Series Mr. 4.
MRidium 1000 Series of Infusion Sets) indications for use are as follows:

1. Useful in the administration of fluids requiring precisely controlled infusions and Useful in the administration of nulus requiring proclession.
  including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
other therapeutic nulus.

Useful in the following delivery routes: arterial, intravenous, spinal,

subcutaneous, and enteral. subcutaneous, and enteral.

Useful in the following delivery modes: continuous, intermittent and bolus.

1. Useful in the following denvely modes. Somators, this product can be useful in

Although specifically intended for use in the MRI, this product of the liberare

Although specifically intended for use in are headlications or other healthcare
critical care, anesthesia, neonatal and pediatric applications or other healthcared or critical care, anesthesia, neonatur and pourines of promp can be monitored or supervised by a clinician.
supervised by a cimician.

Used inside the MRI room mounted outside the 10,000 Gauss line and with Osta misto magnets of field strength of 3.0 Tesla or less.

The MRidium 1000 Series Infusion Sets are intended as accessories to the The MKidlum 1000 Senes Infusion Bow are more 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 Membrane Oxygenation (ECMO) systems where and result in uncontrolled fluid flow.

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(Please do not write below this line-continue on another PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1 --

A.K. m

mi Diro-Oli) ring of Anashesiology, General Hospital, Control. Control. Dental Devices

My Number: K9542341

PACE 11/21 RCVD AT 1/31/2005 7:17:17 PM [Eastern Standard Time] - CSID:407677607 * DURATION (mm-s):08-10

Regulation Number and Section

§ 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).