MRIDIUM 3850 MRI PUMP SYSTEM

K050301 · Iradimed Corporation · FRN · Mar 24, 2005 · General Hospital

Device Facts

• Record ID: K050301
• Device Name: MRIDIUM 3850 MRI PUMP SYSTEM
• Applicant: Iradimed Corporation
• Product Code: FRN · General Hospital
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

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 intravenous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans, functioning while either in a stationary or mobile position. 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.

Device Story

MRidium 3850 is an MRI-compatible IV infusion pump for use in MR scan rooms. It utilizes an ultrasonic (piezo-electric) motor to ensure operation within magnetic fields up to 3.0 Tesla without magnetic attraction or interference with image signal-to-noise ratios. The system consists of a main pump unit with display, controls, and battery, with an optional second peristaltic channel. It uses custom MRidium 1000 Series infusion sets with medical-grade PVC tubing and silicone pumping segments. Operated by clinicians in hospital settings, the device provides precisely controlled fluid delivery. Output is monitored via the integrated display. The device benefits patients by allowing continuous, controlled infusion therapy during MRI procedures, eliminating the need to disconnect or pause critical therapy when moving patients into the scan environment.

Clinical Evidence

Bench testing only. Conformance to international safety standards for infusion therapy, electrical safety, and electromagnetic compatibility (IEC 60601-1-1, IEC 60601-1-2, AAMI/ANSI ID26, IEC 60601-2-24, UL2601) was established. No clinical data provided.

Technological Characteristics

MRI-compatible infusion pump; piezo-electric/ultrasonic motor drive; medical-grade PVC/silicone infusion sets; AC/battery power; peristaltic pumping mechanism; standalone operation with integrated display/controls; electromagnetic compatibility for 3.0 Tesla environments; conforms to IEC 60601-1-1, IEC 60601-1-2, AAMI/ANSI ID26, IEC 60601-2-24, and UL2601.

Indications for Use

Indicated for hospital/clinical use by medical professionals for infusion of fluids (blood, lipids, drugs, antibiotics, enteral solutions) via arterial, intravenous, spinal, subcutaneous, or enteral routes. Suitable for continuous, intermittent, or bolus delivery in MRI, critical care, anesthesia, neonatal, and pediatric settings. Contraindicated for use on the inlet side of ECMO systems where negative pressure > 100 mmHg may cause uncontrolled flow. Used in MRI environments up to 3.0 Tesla, outside the 10,000 Gauss line.

Regulatory Classification

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.

Predicate Devices

• Medrad Continuum Infusion Pump System (K032771, K021988)
• Alaris PC-1 Infusion Pump System (K012383)

Submission Summary (Full Text)

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Ko50 30

# MAR 2 4 2005

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### 510(k) Summary of Safety and Effectiveness

#### Submitter Information:

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

Phone: [phone] 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 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,

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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:

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

4. Air Bubble Detection System

- 8. 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 [phone]. 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 [phone] 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.
2. Useful in the following delivery routes: arterial, intravenous, spinal,
- subcutaneous, and enteral. subcutaneous, and enteral.
3. Useful in the following delivery modes: continuous, intermittent and bolus.
- 3. Useful in the following denvely modes. Somators, this product can be useful in
4. 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.
5. 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)

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AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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