3880 MRI Patient Monitoring System
Device Facts
| Record ID | K180903 |
|---|---|
| Device Name | 3880 MRI Patient Monitoring System |
| Applicant | Iradimed Corporation |
| Product Code | MWI · Cardiovascular |
| Decision Date | Mar 29, 2019 |
| 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), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).
Device Story
3880 MRI Patient Monitoring System monitors vital signs during MRI procedures; used by healthcare professionals in MRI suites. Inputs: ECG (via wireless ePOD), SpO2 (via wireless oPOD), NIBP (oscillometric), temperature (fiber-optic), and respiratory gases (via 3886 Multi-Gas Unit/ISA OR+ module). Device processes signals to display waveforms and numeric values on a touchscreen; includes audible/visual alarms per IEC 60601-1-8. Powered by AC or internal battery; portable for intra-department transport. Remote monitoring available via 3885T tablet. Output allows clinicians to track patient status in real-time, facilitating clinical decision-making during MRI scans. Benefits include continuous patient safety monitoring in high-magnetic-field environments.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by non-clinical bench testing and performance data from predicate devices. SpO2 performance verified via bench testing comparing subject device to Masimo SET Rad-8 technology per ISO 80601-2-61.
Technological Characteristics
Multi-parameter monitor; housing: coated aluminum, stainless steel, plastics. Sensing: ECG (wireless), SpO2 (red/IR absorption), NIBP (oscillometric), CO2/Agents (side-stream NDIR), Temperature (fiber-optic). Connectivity: 2.4 GHz wireless link for modules. Power: AC/internal lithium polymer battery. Biocompatibility: ISO 10993-1, -5, -10. MRI compatibility: tested per ASTM F2052, F2503, F2213.
Indications for Use
Indicated for monitoring vital signs in adult, pediatric, and neonatal patients undergoing MRI procedures. Parameters include ECG, SpO2, NIBP, temperature, anesthetic agents, respiration, capnography (CO2), and oxygen (O2).
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)
- 3160 Precess MRI Patient Monitoring System (K050399)
- MASIMO SET® RAD-8 PULSE OXIMETER (K053269)
- Root Monitoring System and Accessories (ISA OR+ & Nomoline Accessories) (K171121)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2019
Iradimed Corporation Francis Casey Vice President, QA & Regulatory Affairs 1025 Willa Springs Dr. Winter Springs, Florida 32708
Re: K180903
Trade/Device Name: 3880 MRI Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: February 15, 2019 Received: February 19, 2019
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. 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 801 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
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as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
# Shawn W. Forrest -S 2019.03.29 11:11:31 -04'00'
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) K180903
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 Pediatric, including Neonatal populations, for monitoring of Electrocardiogram (ECG), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/0 description: The image shows the logo for IRADIMED CORPORATION. The logo is purple and has the company name in all caps. To the right of the logo is the number K180903.
1025 Willa Springs Drive Winter Springs, FL 32708 PH: 407-677-9022 FX: 407-677-5037
#### 510(k) Summary 002
### 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 |
Date Prepared: March 21, 2019
#### 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 25th, 2017 |
### OTHER LEGALLY MARKETED PREDICATE DEVICES TO WHICH EQUIVALENCE CLAIMED:
| SpO2 Predicate Device: | 3160 Precess MRI Patient Monitoring System |
|------------------------|--------------------------------------------|
| Manufacturer: | Invivo Corporation |
| 510(k) #: | K050399 |
| Clearance date: | August 25th, 2005 |
| | |
| SpO2 Reference Device: | MASIMO SET® RAD-8 PULSE OXIMETER |
|------------------------|----------------------------------|
| Manufacturer: | Masimo Corporation |
| 510(k) #: | K053269 |
| Clearance date: | December 21st, 2005 |
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| CO2/AGENTS Predicate Device: | Root Monitoring System and Accessories (ISA OR+ & Nomoline Accessories) |
|------------------------------|-------------------------------------------------------------------------|
| Manufacturer: | Masimo Corporation |
| 510(k) #: | K171121 |
| Clearance date: | November 11th, 2017 |
### DEVICE DESCRIPTION:
The 3880 MRI Patient Monitoring System, also referred to as the 3880, cleared October 25th, 2017, is a multi-parameter vital signs monitor designed for use in the Magnetic Resonance (MR) 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, and NIBP derived) ●
- Blood oxygen saturation/pulse oximetry (SpO2) ●
- Non-invasive blood pressure (NIBP)
- 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 FiN2O) ● (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 Configuration (Requires 3880 and 3886):
| | 3886 Multi-Gas Unit | | |
|---------------|---------------------|-----|----|
| Configuration | AGENTS | CO2 | O2 |
| 3886 | X | X | 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
- Operation 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 ●
- Temperature sensor
- Nomoline: Adapters, Cannulas, Airway Adapter 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), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).
### TECHNOLOGICAL CHARACTERISTICS:
IRadimed Corporation's 3880 MRI Patient Monitoring System is equivalent to the predicate devices identified: the 3880 MRI Patient Monitoring System (K172200), the 3160 Precess MRI Patient Monitoring System (K050399), the Masimo SET® Rad-8 Pulse Oximeter (K053629) and the Masimo Root Monitoring System and Accessories (K171121) in both functionality and technology. The purpose of this submission is to add neonatal indications for use for the pulse oximeter (SpO2), capnography (CO2) and Anesthetic Agents (AGENTS) vital sign monitoring parameters to the primary predicate 3880 MRI Patient Monitoring System, cleared October 25th, 2017. See Tables 5-1, 5-2 and 5-3 below for comparisons of the technological characteristics between the proposed and predicate devices:
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| Table 5-1, Technological Characteristic | Comparison Table of Primary Predicate: | | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | 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,<br>Capnography (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<br>group excludes Neonates):<br><br><b>Patient Types/Ages:</b><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<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>3_Neonate/ from birth through the first 28<br>days of life | 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>Pulse Oximetry (SpO2), Non-Invasive Blood<br>Pressure (NIBP), Temperature, Anesthetic<br>Agents, Respiration, Capnography (CO2),<br>and Oxygen (O2). | Same<br><br>Same<br><br>Substantially<br>Equivalent |
| 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<br>stand or patient bed), Touchscreen | Same |
| Remote Monitoring<br>capabilities<br>(optional for both) | Remote Monitoring Tablet (3885T),<br>operates on battery power, can be<br>docked for charging and desktop use in<br>the Base Station (3885B) which is<br>plugged into AC mains power | Remote Monitoring Tablet (3885T),<br>operates on battery power, can be<br>docked for charging and desktop use in<br>the Base Station (3885B) which is<br>plugged into AC mains power | Same |
| | Primary Predicate Device: | Proposed Device: | |
| | IRadimed Corporation's | IRadimed Corporation's | |
| Technological<br>Characteristic | 3880 MRI Patient Monitoring System<br>(K172200) | 3880 MRI Patient Monitoring System<br>(Pending 510(k)) | Comparison |
| 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<br>• 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<br>• 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 | ECG, SpO2 and CO2/AGENTS modules<br>link to the Monitor via wireless 2.4 GHz<br>link. | ECG, SpO2 and CO2/AGENTS modules<br>link to the Monitor via wireless 2.4 GHz<br>link. | 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 | Affected by MRI gradients | Affected by MRI gradients | Same |
| NIBP | | | |
| NIBP Materials | NIBP Hose- Medical Grade, Class IV<br>PVC (non-latex) | NIBP Hose- Medical Grade, Class IV<br>PVC (non-latex) | Same |
| | NIBP Cuffs for Adults and pediatric<br>patients- medical grade urethane | NIBP Cuffs for Adults and pediatric<br>patients- medical grade urethane | |
| | NIBP Cuffs for neonatal patients-<br>medical grade soft fabric | NIBP Cuffs for neonatal patients-<br>medical grade soft fabric | |
| 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 |
| | Primary Predicate Device: | Proposed Device: | |
| | IRadimed Corporation's | IRadimed Corporation's | |
| Technological | 3880 MRI Patient Monitoring System | 3880 MRI Patient Monitoring System…
