3880 MRI Patient Monitoring System
Device Facts
| Record ID | K182900 |
|---|---|
| Device Name | 3880 MRI Patient Monitoring System |
| Applicant | Iradimed Corporation |
| Product Code | MWI · Cardiovascular |
| Decision Date | Dec 14, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) and Temperature. The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric, not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2) and Oxygen (O2). The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates): 1 - Adult (greater than 22 years). 2 - Pediatric (Infant 29 days - 2 years), Child (2 - 12 years), Adolescent (12 - 21 years), 3 - Neonate (28 days).
Device Story
Multi-parameter vital signs monitor for MRI environment; processes/displays waveforms, numerics, and alarms. Inputs: ECG (via wireless ePOD), SpO2 (via wireless oPOD), NIBP, IBP (via 3883 ipPOD), CO2, O2, Anesthetic Agents (via 3886 Multi-Gas Unit), and Temperature. Operates on AC or internal battery. Used by healthcare professionals in MRI suites; portable for intra-department transport. Output: Real-time vital sign data on touchscreen monitor or remote tablet (3885T). Assists clinicians in patient assessment during MRI. Benefits: Enables continuous monitoring of critical patients within high-field MRI environments.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, verification, and validation activities, including compliance with IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, 60601-2-34, ISO 80601-2-30, 80601-2-55, 80601-2-56, 80601-2-61, and biocompatibility standards (ISO 10993).
Technological Characteristics
Housing: coated aluminum, antimagnetic stainless steel, plastics. Sensing: Fiber-optic (Temp), NDIR (CO2/Agents), Oscillometric (NIBP), Transducer (IBP). Connectivity: 2.4 GHz wireless radios for PODs. Power: AC or internal lithium polymer battery. Standards: IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-34, ISO 10993, ISO 14971.
Indications for Use
Indicated for monitoring vital signs in patients undergoing MRI procedures. Populations: Adults (>22y), Pediatric (Infants 29d-2y, Children 2-12y, Adolescents 12-21y), and Neonates (birth-28d). ECG, NIBP, IBP, and Temperature monitoring for all populations. SpO2, Anesthetic Agents, Respiration, CO2, and O2 monitoring for Adult and Pediatric populations (excluding Neonates).
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Predicate Devices
- 3880 MRI Patient Monitoring System (K172200)
- Expression MR400 MRI Patient Monitoring System (K152330)
Submission Summary (Full Text)
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December 14, 2018
Iradimed Corporation Francis Casey Vice-President, QA & Regulatory Affairs 1025 Willa Springs Drive Winter Springs, Florida 32708
Re: K182900
Trade/Device Name: 3880 MRI Patient Monitoring System Regulation Number: 21 CFR 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alar) Regulatory Class: Class II Product Code: MWI Dated: October 12, 2018 Received: October 16, 2018
Dear Francis Casey:
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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Stephen C. Browning -S5
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K182900
Device Name 3880 MRI Patient Monitoring System
#### Indications for Use (Describe)
The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures. The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals. The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatic, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) and Temperature. The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric, not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2) and Oxygen (O2). The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates):
#### 1 - Adult (greater than 22 years).
2 - Pediatric (Infant 29 days - 2 years), Child (2 - 12 years), Adolescent (12 - 21 years),
3 - Neonate (28 days).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 05 | 510(k) Summary
#### SUBMITTER INFORMATION:
| Establishment Name: | IRadimed Corporation |
|------------------------|------------------------------------------------------|
| Establishment Address: | 1025 Willa Springs Drive<br>Winter Springs, FL 32708 |
| Contact Name: | Mr. Francis Casey |
| Contact E-mail: | fcasey@iradimed.com |
| Contact Phone: | 407-677-8022 x106 |
| Contact Fax: | 407-677-5037 |
October 12, 2018 Date Prepared:
#### DEVICE IDENTIFICATION:
| Trade name: | 3880 MRI Patient Monitoring System |
|----------------------|--------------------------------------------------------------------------|
| Common name: | MRI multi-parameter patient monitoring system |
| Classification name: | Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) |
| Regulation number: | 21 CFR 870.2300 |
| Regulatory class: | 2 |
| Product code: | MWI |
## PRIMARY LEGALLY MARKETED PREDICATE DEVICE TO WHICH EQUIVALENCE CLAIMED:
| Primary Predicate Device: | 3880 MRI Patient Monitoring System |
|---------------------------|------------------------------------|
| Manufacturer: | IRadimed Corporation |
| 510(k) #: | K172200 |
| Clearance date: | October 25, 2017 |
## OTHER LEGALLY MARKETED PREDICATE DEVICES TO WHICH EQUIVALENCE CLAIMED:
| IBP Predicate Device: | Expression MR400 MRI Patient Monitoring System |
|-----------------------|-----------------------------------------------------|
| Manufacturer: | Invivo Corp., a division of Philips Medical Systems |
| 510(k) #: | K152330 |
| Clearance date: | December 23, 2015 |
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## DEVICE DESCRIPTION:
The 3880 MRI Patient Monitoring System, also referred to as the 3880, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance Imaging (MRI) environment by trained healthcare professionals. The 3880 processes and displays multiple parameters, waveforms, measurement numeric values and alarms. The device is powered by either AC line power or its internal battery. It is light weight making it a practical intra-department patient transportation monitor for use within the MRI suite. The device can be carried by its handle, mounted to a wheeled cart/stand, or attached to a patient bed. The 3880 provides monitoring for the following parameters:
- Electrocardiogram (ECG)
- Heart rate (HR- ECG, SpO2, IBP and NIBP derived) ●
- Blood oxygen saturation/pulse oximetry (SpO2)
- Non-invasive blood pressure (NIBP)
- Invasive blood pressure (IBP) ●
- End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) ●
- . Anesthetic agents (AGENTS) (requires 3886 Multi-Gas Unit)
- Desflurane (DES) O
- Enflurane (ENF) O
- Halothane (HAL) O
- Isoflurane (ISO) O
- Sevoflurane (SEV) O
- Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O and FiNzO) . (requires 3886 Multi-Gas Unit)
- Temperature (TEMP) ●
- Respiration rate (CO2-derived)
The 3880 MRI Patient Monitoring System can be ordered with the following configurations:
#### Standard Configuration:
| | 3880 MRI Patient Monitor | | | | |
|---------------|--------------------------|------|------|-----|------|
| Configuration | ECG | SpO2 | NIBP | CO2 | Temp |
| 3880 | X | X | X | X | X |
#### Optional Configurations:
Anesthetic Agents (Requires 3880 Monitor and 3886 Multi-Gas Unit):
| | 3886 Multi-Gas Unit | | |
|------------------------|---------------------|-----|----|
| Optional Configuration | AGENTS | CO2 | O2 |
| 3886 | X | X | X |
Invasive Blood Pressure (IBP) (Requires 3880 Monitor and 3883 ipPOD):
| | 3883 ipPOD |
|------------------------|------------|
| Optional Configuration | IBP |
| 3883 | X |
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The 3880 consists of the following key components:
- Patient monitor with buttons and touch screen display ●
- Wireless ECG POD, "ePOD" ●
- Wireless SpO2 POD, "oPOD" ●
- Battery for patient monitor .
- Power supply and cables
- Operations Manual .
Accessories to the 3880 are offered to accommodate various patient sizes. Key standard and optional accessories include:
- ECG cables and electrodes
- SpO2 sensors and grips ●
- NIBP cuffs and hoses
- Invasive blood pressure ipPOD (3883) ●
- Invasive blood pressure cable adapters (transducers sold separately) ●
- Temperature sensor
- Cannulas and Sample Lines ●
- . Remote monitoring tablet (3885T)
- Remote monitoring tablet docking base, including printer (3885B) .
- Multi-Gas Unit (3886) ●
- Mounting hardware and stand
## INDICATIONS FOR USE:
The IRadimed Corporation's 3880 MRI Patient Monitoring System is intended to monitor a single patient's vital signs for patients undergoing Magnetic Resonance Imaging (MRI) procedures.
The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.
The 3880 MRI Patient Monitoring System is intended for use in Adult and Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) and Temperature.
The 3880 MRI Patient Monitoring System is also intended for use in Adult and Pediatric, not including Neonatal populations, for monitoring of Pulse Oximetry (SpO2), Anesthetic Agents, Respiration, Capnography (CO2) and Oxygen (O2).
The 3880 MRI Patient Monitoring System provides monitoring for three distinct patient types as defined below (Note: Pediatric group excludes Neonates):
| Patient Type | Age |
|------------------------------------------------------|----------------------------------------------------------------|
| 1 Adult | greater than 22 years |
| 2 Pediatric (Includes: Infant, Child and Adolescent) | |
| -Adolescent | aged 12 through 21 (up to but not including the 22nd birthday) |
| -Child | 2 years to less than 12 years |
| -Infant | 29 days to less than 2 years |
| 3 Neonate | from birth through the first 28 days of life |
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# TECHNOLOGICAL CHARACTERISTICS:
IRadimed Corporation's 3880 MRI Patient Monitoring System is equivalent to the following predicate devices: the 3880 MRI Patient Monitoring System (K172200) and the Expression MR400 MRI Patient Monitoring System (K152330). The purpose of this submission is to add the Invasive Blood Pressure (IBP) vital sign monitoring parameter to the 3880 MRI Patient Monitoring System. The technological characteristics of the proposed device are compared to both the primary predicate device (K172200) and the IBP parameter-specific predicate device (K152330) in Tables 5-1 and 5-2, respectively.
| Technological<br>Characteristic | Primary Predicate Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(K172200) | Proposed Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(Pending 510(k)) | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| MONITOR | | | |
| Intended Use/<br>Indication for Use | The IRadimed Corporation's 3880 MRI<br>Patient Monitoring System is intended to<br>monitor a single patient's vital signs for<br>patients undergoing Magnetic Resonance<br>Imaging (MRI) procedures.<br><br>The 3880 MRI Patient Monitoring System is<br>intended for use by healthcare professionals.<br><br>The 3880 MRI Patient Monitoring System is<br>intended for use in Adult and Pediatric,<br>including Neonatal populations, for<br>monitoring of Electrocardiogram (ECG),<br>Non-Invasive Blood Pressure (NIBP) and<br>Temperature.<br><br>The 3880 MRI Patient Monitoring System is<br>also intended for use in Adult and Pediatric,<br>not including Neonatal populations, for<br>monitoring of Pulse Oximetry (SpO2),<br>Anesthetic Agents, Respiration, Capnography<br>(CO2) and Oxygen (O2).<br><br>The 3880 MRI Patient Monitoring System<br>provides monitoring for three distinct patient<br>types as defined below (Note: Pediatric group<br>excludes Neonates):<br><br><b>Patient Types/Ages:</b><br><b>1_Adult/</b> Greater than 22 years<br><b>2_Pediatric/</b> (Includes: Infant, Child and<br>Adolescent)<br>- Adolescent/ aged 12 through 21 (up to but<br>not including the 22nd birthday)<br>- Child/ 2 years to less than 12 years<br>- Infant/ 29 days to less than 2 years<br><b>3_Neonate/</b> from birth through the first 28 | The IRadimed Corporation's 3880 MRI<br>Patient Monitoring System is intended to<br>monitor a single patient's vital signs for<br>patients undergoing Magnetic Resonance<br>Imaging (MRI) procedures.<br><br>The 3880 MRI Patient Monitoring System is<br>intended for use by healthcare professionals.<br><br>The 3880 MRI Patient Monitoring System is<br>intended for use in Adult and Pediatric,<br>including Neonatal populations, for<br>monitoring of Electrocardiogram (ECG), Non-<br>Invasive Blood Pressure (NIBP), Invasive<br>Blood Pressure (IBP) and Temperature.<br><br>The 3880 MRI Patient Monitoring System is<br>also intended for use in Adult and Pediatric,<br>not including Neonatal populations, for<br>monitoring of Pulse Oximetry (SpO2),<br>Anesthetic Agents, Respiration, Capnography<br>(CO2) and Oxygen (O2).<br><br>The 3880 MRI Patient Monitoring System<br>provides monitoring for three distinct patient<br>types as defined below (Note: Pediatric group<br>excludes Neonates):<br><br><b>Patient Types/Ages:</b><br><b>1_Adult/</b> Greater than 22 years<br><b>2_Pediatric/</b> (Includes: Infant, Child and<br>Adolescent)<br>- Adolescent/ aged 12 through 21 (up to but<br>not including the 22nd birthday)<br>- Child/ 2 years to less than 12 years<br>- Infant/ 29 days to less than 2 years<br><b>3_Neonate/</b> from birth through the first 28 | Same<br><br>Same<br><br>Substantially<br>Equivalent<br><br>Same<br><br>Same<br><br>Same |
| | Table 5-1, Technological Characteristics Comparison Table of Primary Predicate: | | |
|--|---------------------------------------------------------------------------------|--|--|
| | | | |
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| Technological<br>Characteristic | Primary Predicate Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(K172200) | Proposed Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(Pending 510(k)) | Comparison |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Monitor Materials | Housing mainly coated aluminum,<br>antimagnetic stainless steel, plastics | Housing mainly coated aluminum,<br>antimagnetic stainless steel, plastics | Same |
| Display | No cart required, (optional mounting<br>accessory for attachment to wheeled<br>stand or patient bed), Touchscreen | No cart required, (optional mounting<br>accessory for attachment to wheeled stand<br>or patient bed), Touchscreen | Same |
| Remote Monitoring<br>capabilities<br>(optional for both) | Remote Monitoring Tablet (3885T),<br>operates on battery power, can be docked<br>for charging and desktop use in the Base<br>Station (3885B) which is plugged into<br>AC mains power | Remote Monitoring Tablet (3885T),<br>operates on battery power, can be docked<br>for charging and desktop use in the Base<br>Station (3885B) which is plugged into<br>AC mains power | Same |
| MRI Conditions of<br>Use | Monitor: $< 30,000$ gauss<br>Wireless PODS: $< 30,000$ gauss<br>Multi-Gas Unit: $< 600$ gauss<br>Secondary Display (two pieces):<br>Tablet $< 15,000$ gauss, except<br>during the course of an MRI<br>scan Base Station: MR Unsafe | Monitor: $< 30,000$ gauss<br>Wireless PODS: $< 30,000$ gauss<br>Multi-Gas Unit: $< 600$ gauss<br>Secondary Display (two pieces):<br>Tablet $< 15,000$ gauss, except<br>during the course of an MRI<br>scan Base Station: MR Unsafe | Same |
| Printer | Integrated into secondary display- Base<br>Station (3885B) | Integrated into secondary display- Base<br>Station (3885B) | Same |
| Energy Source | External power supply connected to AC<br>mains power or lithium polymer internal<br>battery power | External power supply connected to AC<br>mains power or lithium polymer internal<br>battery power | Same |
| Wireless<br>Communication | Via 2.4 GHz wireless radios | Via 2.4 GHz wireless radios | Same |
| Alarms Capability | Audible and Visual Alarms on monitor<br>and remote display, Compliant to IEC<br>60601-1-8 | Audible and Visual Alarms on monitor<br>and remote display, Compliant to IEC<br>60601-1-8 | Same |
| Biocompatibility | Complies with ISO 10993-1, 10993-5,<br>10993-10 | Complies with ISO 10993-1, 10993-5,<br>10993-10 | Same |
| Sterility | Not Applicable | Not Applicable | Same |
| ECG | | | |
| Wireless ECG<br>Materials | Plastic housing with enclosed battery,<br>ECG Lead Wires and Electrodes | Plastic housing with enclosed battery,<br>ECG Lead Wires and Electrodes | Same |
| Module Energy<br>Source | Lithium polymer battery | Lithium polymer battery | Same |
| ECG Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Same |
| ECG Accuracy<br>during MRI Scan | May be Affected by MRI gradients | May be Affected by MRI gradients | Same |
| SpO2 | | | |
| Wireless SpO2<br>Materials | Module is enclosed in a plastic housing<br>with enclosed battery, SpO2 sensor cable<br>and grip(s) | Module is enclosed in a plastic housing<br>with enclosed battery, SpO2 sensor cable<br>and grip(s) | Same |
| Operating Principle | Red & Infrared Light Absorption | Red & Infrared Light Absorption | Same |
| Technological<br>Characteristic | Primary Predicate Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(K172200) | Proposed Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(Pending 510(k)) | Comparison |
| Module Energy<br>Source | Lithium ion battery | Lithium ion battery | Same |
| SPO2 Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Same |
| <b>NIBP</b> | | | |
| NIBP Materials | NIBP Hose- Medical Grade, Class IV<br>PVC (non-latex)<br><br>NIBP Cuffs for Adults and pediatric<br>patients- medical grade urethane<br><br>NIBP Cuffs for neonatal patients-<br>medical grade soft fabric | NIBP Hose- Medical Grade, Class IV<br>PVC (non-latex)<br><br>NIBP Cuffs for Adults and pediatric<br>patients- medical grade urethane<br><br>NIBP Cuffs for neonatal patients- medical<br>grade soft fabric | Same |
| Operating Principle | Oscillometric technology (with an<br>inflatable cuff) determines systolic and<br>diastolic pressures | Oscillometric technology (with an<br>inflatable cuff) determines systolic and<br>diastolic pressures | Same |
| NIBP Information<br>Displayed | Numeric | Numeric | Same |
| <b>CO2</b> | | | |
| Materials | Various sized nasal and oral cannulas for<br>different patient types- Medical Grade<br>Co-extruded PVC | Various sized nasal and oral cannulas for<br>different patient types- Medical Grade<br>Co-extruded PVC | Same |
| Operating Principle | Side stream, NDIR (non-dispersive<br>infrared absorption) technique | Side stream, NDIR (non-dispersive<br>infrared absorption) technique | Same |
| CO2 Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Same |
| <b>ANESTHETIC AGENTS, O2</b> | | | |
| Materials | Scavenge Hose- Medical Grade PVC<br><br>O2 Oxygen Cell- Paramagnetic<br><br>Co-Extruded Sample Line | Scavenge Hose- Medical Grade PVC<br><br>O2 Oxygen Cell- Paramagnetic<br><br>Co-Extruded Sample Line | Same |
| Operating Principle | Side Stream, non-dispersive infrared<br>(NDIR) absorption technique | Side Stream, non-dispersive infrared<br>(NDIR) absorption technique | Same |
| Anesthetic Agents<br>Monitored | Desflurane (DES)<br>Enflurane (ENF)<br>Halothane (HAL)<br>Isoflurane (ISO)<br>Sevoflurane (SEV)<br>Nitrous Oxide (N2O) | Desflurane (DES)<br>Enflurane (ENF)<br>Halothane (HAL)<br>Isoflurane (ISO)<br>Sevoflurane (SEV)<br>Nitrous Oxide (N2O) | Same |
| Anesthetic Agents<br>Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Same |
| <b>TEMP</b> | | | |
| Materials | Fiber-optic Temperature Sensor, Medical<br>Grade PVC | Fiber-optic Temperature Sensor, Medical<br>Grade PVC | Same |
| Technological<br>Characteristic | Primary Predicate Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(K172200) | Proposed Device:<br>IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(Pending 510(k)) | Comparison |
| Operating Principle | Fiber-optic Technology | Fiber-optic Technology | Same |
| TEMP Information<br>Displayed | Numeric, Celsius (°C) or Fahrenheit (°F) | Numeric, Celsius (°C) or Fahrenheit (°F) | Same |
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# Table 5-2, Technological Characteristics Comparison Table of Invasive Blood Pressure Predicate Device:
| Technological<br>Characteristic | IBP Predicate Device: | Proposed Device: | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | Invivo Corporation (Philips)<br>Expression MR400 MRI Patient Monitoring<br>System (K152330) | IRadimed Corporation<br>3880 MRI Patient Monitoring System<br>(Pending 510(k)) | |
| Intended Use/<br>Indication for Use | The Expression MR400 MRI Patient Monitoring<br>System (Model MR400) is intended to monitor<br>vital signs for patients undergoing MRI procedures<br>and to provide signals for synchronization for the<br>MRI scanner.<br><br>The Expression MR400 MRI Patient Monitoring<br>System (Model MR400) is intended for use by<br>healthcare professionals.<br><br>The Expression MR400 MRI Patient Monitoring<br>System (Model MR400) provides monitoring for<br>the following vital sign parameters: ECG, pulse<br>oximetry (SpO2), non-invasive blood pressure<br>(NIBP), and optionally, invasive blood pressure<br>(IBP), carbon dioxide (CO2) and respiration rate,<br>anesthetic agents, nitrous oxide (N2O), oxygen<br>(O2), and/or temperature. | The IRadimed Corporation's 3880 MRI Patient<br>Monitoring System is intended to monitor a single<br>patient's vital signs for patients undergoing<br>Magnetic Resonance Imaging (MRI) procedures.<br><br>The 3880 MRI Patient Monitoring System is<br>intended for use by healthcare professionals.<br><br>The 3880 MRI Patient Monitoring System is<br>intended for use in Adult and Pediatric, including<br>Neonatal populations, for monitoring of<br>Electrocardiogram (ECG), Non-Invasive Blood<br>Pressure (NIBP), Invasive Blood Pressure (IBP)<br>and Temperature.<br><br>The 3880 MRI Patient Monitoring System is also<br>intended for use in Adult and Pediatric, not<br>including Neonatal populations, for monitoring of<br>Pulse Oximetry (SpO2), Anesthetic Agents,<br>Respiration, Capnography (CO2) and Oxygen<br>(O2).<br><br>The 3880 MRI Patient Monitoring System<br>provides monitoring for three distinct patient types<br>as defined below (Note: Pediatric group excludes<br>Neonates):<br><br>Patient Type /Age<br>1 Adult/ greater than 22 years<br>2 Pediatric (Includes: Infant, Child and<br>Adolescent)<br>-Adolescent / aged 12 through 21 (up to but not<br>including the 22nd birthday)<br>-Child/ 2 years to less than 12 years<br>-Infant/ 29 days to less than 2 years<br>3 Neonate/ from birth through the first 28 days of<br>life | Substantially<br>equivalent |
| Operating Principle | Conversion of intra-arterial blood<br>pressure measurements into electrical<br>signals (via transducer) | Conversion of intra-arterial blood<br>pressure measurements into electrical<br>signals (via transducer) | Same |
| Materials | IBP signal processing board housed in<br>MR400 Cart with connection ports for<br>P1 or P2 channels. | IBP signal processing board housed in<br>3883 ipPOD with connection ports for<br>P1 and P2 channels. | Substantially<br>equivalent |
| IBP Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Same |
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## SIMILARITIES AND DIFFERENCES
The proposed device is the same as the primary predicate device (K172200) except for the addition of Invasive Blood Pressure (IBP) monitoring. The proposed device is the same or similar to the IBP parameter specific predicate device (K152330) in the following ways: it utilizes the same fundamental operating principle, it displays IBP vital sign information for up to two channels in waveform and numerics, and it is intended for the same population of Adults to Neonatal patients.
The proposed device differs from the primary predicate device in the following way: the software of the primary predicate device (K172200) has been modified to include monitoring of Invasive Blood Pressure. The proposed device differs from the IBP parameter specific predicate device (K152330) in the following ways: the proposed device utilizes a Wireless IBP Pod (module) to send data to the monitor for display whereas the IBP parameter specific device is hardwired to the monitor.
A detailed comparison of the differences is provided in Section 12, the Substantial Equivalence Discussion.
#### SUMMARY OF NON-CLINICAL PERFORMANCE DATA:
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the proposed device with respect to the predicates. Testing involved system level tests, performance tests, safety testing identified during hazard analysis and testing to the FDA Recognized Consensus Standards listed in Table 5-2 below. Results of the performance testing (see Section 18) demonstrate that the proposed device operates as intended within the performance specifications and is substantially equivalent to the predicate devices. The results do not raise issues regarding the safety and effectiveness of the proposed device. The proposed device is in compliance with the following standards:
| FDA<br>Recognition<br># | Standard # | Standard Development Organization /<br>Title of Standard | Revision/Year | Results |
|-------------------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------|
| 19-4 | 60601-1* | IEC/ Medical Electrical Equipment - Part 1: General<br>Requirements for Basic Safety and Essential Performance | Edition 3.1 2005/(R)2012<br>And A1:2012 | Pass |
| 19-5 | 60601-1-2* | IEC/ Medical Electrical Equipment - Part 1-2: General<br>Requirements for Basic Safety and Essential Performance -<br>Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests | Edition 4: 2015 | Pass |
| 5-76 | 60601-1-8 | IEC/ Medical Electrical Equipment - Part 1-8: General<br>Requirements For Basic Safety And Essential Performance -<br>Collateral Standard: General Requirements, Tests And<br>Guidance For Alarm Systems In Medical Electrical<br>Equipment And Medical Electrical Systems | Edition 2.1 2012 | Pass |
| 3-126 | 60601-2-27 | IEC/ Medical Electrical Equipment - Part 2-27: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of Electrocardiographic Monitoring Equipment<br>[Including: Corrigendum 1 (2012)] | Edition 3.0 2011 | Pass |
| 3-115 | 60601-2-34* | IEC/ Medical Electrical Equipment - Part 2-34: Particular<br>Requirements For The Basic Safety, Including Essential<br>Performance, Of Invasive Blood Pressure Monitoring<br>Equipment | Edition 3.0 2011 | Pass |
Table 5-2, FDA Recognized Consensus Standards Summary Table:
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| FDA<br>Recognition<br># | Standard # | Standard Development Organization /<br>Title of Standard | Revision/Year | Results |
|-------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|---------|
| 3-123 | 80601-2-30 | ISO/ Medical Electrical Equipment - Part 2-30: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of Automated Non-Invasive<br>Sphygmomanometers | Edition 1.1 2013 | Pass |
| 1-96 | 80601-2-55 | ISO/ Medical Electrical Equipment - Part 2-55: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of Respiratory Gas Monitors | Edition 1.0 2011 | Pass |
| 6-232 | 80601-2-56 | ISO/ Medical Electrical Equipment - Part 2-56: Particular<br>Requirements For Basic Safety And Essential Performance<br>Of Clinical Thermometers For Body Temperature<br>Measurement | Edition 1.0 2009 | Pass |
| 1-85 | 80601-2-61 | ISO/ Medical Electrical Equipment - Part 2-61: Particular<br>Requirements For Basic Safety And Essential Performance<br>Of Pulse Oximeter Equipment | Edition 1.0 2011 | Pass |
| 5-40 | 14971* | ISO/ Medical Devices - Application Of Risk Management<br>To Medical Devices | Edition 2.0 2007 | Pass |
| 2-220 | 10993-1 | ISO/ Biological Evaluation Of Medical Devices - Part 1:<br>Evaluation And Testing Within A Risk Management Process | Edition 4.0 2009 | Pass |
| 2-245 | 10993-5 | ISO/ Biological Evaluation Of Medical Devices - Part 5:<br>Tests For In Vitro Cytotoxicity | Edition 3.0 2009 | Pass |
| 2-174 | 10993-10 | ISO/ Biological Evaluation Of Medical Devices - Part 10:<br>Tests For Irritation And Skin Sensitization | Edition 3.0 2010 | Pass |
| 8-422 | F2052-15* | ASTM/ Standard Test Method for Measurement of<br>Magnetically Induced Displacement Force on Medical<br>Device in MR Environment | 2015 | Pass |
| 8-128 | F2213-11* | ASTM/ Standard Test Method For Measurement Of<br>Magnetically Induced Torque On Medical Devices In The<br>Magnetic Resonance Environment | 2011 | Pass |
| 19-13 | 62133 | IEC/ Secondary Cells And Batteries Containing Alkaline Or<br>Other Non-Acid Electrolytes - Safety Requirements For<br>Portable Sealed Secondary Cells, And For Batteries Made<br>From Them, For Use In Portable Applications [Including:<br>Corrigendum 1 (2013)] | Edition 2.0 2012 | Pass |
| 5-114 | 62366 | IEC/ Medical Devices - Part 1: Application Of Usability<br>Engineering To Medical Devices [Including<br>CORRIGENDUM 1 (2016)] | Edition 1.0 2015 | Pass |
* Standards identified with an asterisk in the table above have corresponding test reports supplied in Section 18 to support the addition of Invasive Blood Pressure monitoring with the 3880 MRI Patient Monitoring System. Compliance with all other applicable standards was provided and reviewed with the primary predicate device, which was cleared to market under K172200.
## SUMMARY OF CLINICAL PERFORMANCE DATA:
Clinical data is not required to substantiate claims of safety and effectiveness for the modification of the proposed device to include invasive blood pressure monitoring.
## STATEMENT OF SUBSTANTIAL EQUIVALENCE:
The proposed 3880 MRI Patient Monitoring System with the addition of invasive blood pressure monitoring capabilities utilizes the same fundamental scientific technology as the predicate devices on the market. It has passed all performance and verification/validation testing and complies with the applicable standards. Therefore, IRadimed Corporation's 3880 MRI Patient Monitoring System, as described in this submission, is substantially equivalent to the primary predicate devices, the Iradimed 3880 MRI Patient Monitoring System
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(K172200) and the IBP parameter-specific predicate device, Invivo's Expression MR400 MRI Patient Monitoring System (K152330).
