3880 MRI Patient Monitoring System

K172200 · Iradimed Corporation · MWI · Oct 25, 2017 · Cardiovascular

Device Facts

• Record ID: K172200
• Device Name: 3880 MRI Patient Monitoring System
• Applicant: Iradimed Corporation
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended 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), 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).

Device Story

Multi-parameter vital signs monitor for MRI environment; processes/displays ECG, NIBP, SpO2, CO2, O2, anesthetic agents, temperature, respiration. Inputs: wireless ECG/SpO2 PODs, NIBP cuffs, temperature sensors, gas sampling lines. Operation: AC or internal battery; portable for intra-department transport; mounts to cart/bed. Output: touchscreen display of waveforms/numerics; audible/visual alarms. Used by healthcare professionals in MRI suites. Remote monitoring via 3885-T tablet. Output informs clinical decisions during MRI procedures; benefits include continuous patient monitoring in high-magnetic field environments.

Clinical Evidence

Clinical validation for NIBP performance provided per ISO 81060-2:2013. No other clinical data reported. Device safety and effectiveness supported by extensive non-clinical bench testing, including electromagnetic compatibility, alarm system compliance, and MR-environment safety (displacement force/torque).

Technological Characteristics

Materials: coated aluminum, antimagnetic stainless steel, medical-grade PVC/urethane. Sensing: NDIR (CO2/agents), oscillometric (NIBP), fiber-optic (Temp), red/IR absorption (SpO2). Connectivity: 2.4 GHz wireless PODs. Power: AC or internal lithium polymer battery. Standards: IEC 60601-1, 60601-1-2, 60601-1-8, 60601-2-27, 80601-2-30, 80601-2-55, 80601-2-56, 80601-2-61, ISO 10993, ASTM F2052, F2503, F2213.

Indications for Use

Indicated for monitoring vital signs in patients undergoing MRI procedures. Patient populations include adults, pediatric (infants, children, adolescents), and neonates (ECG, NIBP, Temp only). SpO2, anesthetic agents, respiration, CO2, and O2 monitoring indicated for adults and pediatric patients (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

• Tesla M3 MRI Patient Monitoring System (K142032)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

October 25, 2017

Iradimed Corporation Francis Casey Vice-President, QA & Regulatory Affairs 1025 Willa Springs Drive Winter Springs, Florida 32708

### Re: K172200

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: September 26, 2017 Received: September 27, 2017

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M. A. Wilhelm

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) K172200

Device Name 3880 MRI Patient Monitoring System

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 Neonations, for monitoring of Electrocardiogram (ECG). Non-Invasive Blood Pressure (NIBP), 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 (02).

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 |

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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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 K172200.

1025 Willa Springs Drive Winter Springs, FL 32708 PH: 407-677-9022 FX: 407-677-5037

#### 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: | [e-mail] |
| Contact Phone: | 407-677-8022 x106 |
| Contact Fax: | 407-677-5037 |

September 25th, 2017 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:

| Predicate device: | Tesla M3 MRI Patient Monitoring System |
|-------------------|-----------------------------------------------------|
| Manufacturer: | MIPM (Mammendorfer Institut für Physik und Medizin) |
| 510(k) #: | K142032 |
| Clearance date: | May 7th, 2015 |

#### 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 (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 patient bed. The 3880 provides monitoring for the following parameters:

- Electrocardiogram (ECG)
- Heart rate (HR- ECG, SpO2, and NIBP derived)

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- Blood oxygen saturation/pulse oximetry (SpO2) ●
- Non-invasive blood pressure (NIBP)
- End-tidal and fractional inspired CO2 (EtCO2 and FiCO2)
- Anesthetic agents (AGENT) (requires 3886 Multi-Gas Unit) ●
- o Desflurane (DES)
- Enflurane (ENF) O
- Halothane (HAL) O
- o Isoflurane (ISO)
- 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 |

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 ●
- Cannulas
- Remote monitoring tablet (3885-T) ●
- Remote monitoring tablet docking base, including printer (3885-B) ●
- Multi-Gas Unit (3886)
- Mounting hardware and stand

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## 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), 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 |

## TECHNOLOGICAL CHARACTERISTICS:

IRadimed Corporation's 3880 MRI Patient Monitoring System is equivalent to its primary predicate, MIPM Tesla M3, in both functionality and technology. See table 5-1 below for details:

Table 5-1, Technological Characteristics Comparison Table:

| Technological<br>Characteristic | Predicate Device: | Proposed Device: | Comparison |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | MIPM's | IRadimed Corporation's | (see Section 12 for<br>detailed discussion of<br>Substantial Equivalence) |
| | Tesla M3 MRI Patient Monitoring System | 3880 MRI Patient Monitoring System | |
| | (K142032) | (Pending 510(k)) | |
| MONITOR | | | |
| Intended Use | The MRI Patient Monitoring System<br>Tesla M3 is intended for monitoring of<br>vital signs during MRI examinations<br>(MRI procedures) of patients.<br><br>The Tesla M3 is intended for use in the | 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<br>Resonance Imaging (MRI) procedures. | Substantially<br>equivalent |
| | Predicate Device: | Proposed Device: | Comparison |
| Technological<br>Characteristic | MIPM's<br>Tesla M3 MRI Patient Monitoring System<br>(K142032) | IRadimed Corporation's<br>3880 MRI Patient Monitoring System<br>(Pending 510(k)) | (see Section 12 for<br>detailed discussion of<br>Substantial Equivalence) |
| | Adult, Pediatric and Neonatal<br>populations for the continuous<br>monitoring of Electrocardiogram (ECG),<br>Non-Invasive Blood Pressure (NIBP),<br>Invasive Blood Pressure (IBP),<br>Temperature, Respiration, Capnography<br>(etCO2), Oxygen and Anesthetic Agents. | 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<br>Resonance Imaging (MRI) procedures. | |
| | The Tesla M3 is intended for use in the<br>Adult and Pediatric populations for the<br>continuous monitoring of Pulse<br>Oximetry (SpO2). | The 3880 MRI Patient Monitoring<br>System is intended for use by healthcare<br>professionals. | |
| | The Tesla M3 is intended for use by<br>health care professionals. | The 3880 MRI Patient Monitoring<br>System is intended for use in Adult and<br>Pediatric, including Neonatal<br>populations, for monitoring of<br>Electrocardiogram (ECG), Non-Invasive<br>Blood Pressure (NIBP), and<br>Temperature. | |
| | | The 3880 MRI Patient Monitoring<br>System is also intended for use in Adult<br>and Pediatric, not including Neonatal<br>populations, for monitoring of Pulse<br>Oximetry (SpO2), Anesthetic Agents,<br>Respiration, Capnography (CO2), and<br>Oxygen (O2). | |
| | | The 3880 MRI Patient Monitoring<br>System provides monitoring for three<br>distinct patient types as defined below<br>(Note: Pediatric group excludes<br>Neonates): | |
| | | Patient Types/Ages:<br>1_Adult/ Greater than 22 years<br>2_Pediatric/ (Includes: Infant, Child and<br>Adolescent)<br>- Adolescent/ aged 12 through 21 (up to<br>but 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<br>28 days of life | |
| Monitor Materials | Housing mainly coated aluminum,<br>antimagnetic stainless steel, plastics | Housing mainly coated aluminum,<br>antimagnetic stainless steel, plastics | Substantially<br>equivalent |
| Display | Permanently installed on wheeled cart,<br>Touchscreen | No cart required, (optional mounting<br>accessory for attachment to wheeled<br>stand or patient bed), Touchscreen | Substantially<br>equivalent |
| | Predicate Device: | Proposed Device: | Comparison |
| | MIPM's | IRadimed Corporation's | (see Section 12 for |
| Technological | Tesla M3 MRI Patient Monitoring System | 3880 MRI Patient Monitoring System | detailed discussion of |
| Characteristic | (K142032) | (Pending 510(k)) | Substantial Equivalence) |
| Remote | Desktop use only, must be plugged into<br>AC mains power | Remote Monitoring Tablet (3885-T),<br>operates on battery power, can be<br>docked for charging and desktop use in<br>the Base Station (3885-B) which is<br>plugged into AC mains power | Substantially<br>equivalent |
| Monitoring<br>capabilities<br>(optional for both) | | | |
| MRI Conditions<br>of Use | Monitor: < 200 gauss<br>Wireless modules: < 30,000 gauss<br>Multi-Gas Module: < 200 gauss<br>Secondary Display (single piece):<br>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 | Substantially<br>equivalent |
| Printer | Integrated into secondary display | Integrated into secondary display- Base<br>Station (3885-B) | Substantially<br>equivalent |
| Energy Source | External power supply connected to AC<br>mains power or lithium ion internal<br>battery power | External power supply connected to AC<br>mains power or lithium polymer internal<br>battery power | Substantially<br>equivalent |
| Wireless<br>Communication | ECG and SpO2 patient modules link to<br>the Monitor via wireless 2.4 GHz link. | ECG and SpO2 patient PODS link to the<br>Monitor via wireless 2.4 GHz link. | Substantially<br>equivalent |
| 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 | Substantially<br>equivalent |
| Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1, 10993-5,<br>10993-10 | Substantially<br>equivalent |
| Sterility | Not Applicable | Not Applicable | Substantially<br>equivalent |
| 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 | Substantially<br>equivalent |
| Module Energy<br>Source | Lithium ion battery | Lithium polymer battery | Substantially<br>equivalent |
| ECG Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Substantially<br>equivalent |
| ECG Accuracy<br>during MRI Scan | Affected by MRI gradients | Affected by MRI gradients | Substantially<br>equivalent |
| SpO2 | | | |
| Wireless SpO2<br>Materials | Module is enclosed in a plastic housing<br>with enclosed battery, SpO2 sensor<br>cable and grip(s) | Module is enclosed in a plastic housing<br>with enclosed battery, SpO2 sensor cable<br>and grip(s) | Substantially<br>equivalent |
| Operating<br>Principle | Red & Infrared Light Absorption | Red & Infrared Light Absorption | Substantially<br>equivalent |
| Module Energy<br>Source | Lithium ion battery | Lithium polymer battery | Substantially<br>equivalent |
| SPO2 Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Substantially<br>equivalent |
| | Predicate Device: | Proposed Device: | Comparison |
| | MIPM's | IRadimed Corporation's | (see Section 12 for |
| Technological<br>Characteristic | Tesla M3 MRI Patient Monitoring System<br>(K142032) | 3880 MRI Patient Monitoring System<br>(Pending 510(k)) | detailed discussion of<br>Substantial Equivalence) |
| NIBP | | | |
| NIBP Materials | NIBP Hose- Medical Grade, Class IV<br>PVC (non-latex) | NIBP Hose- Medical Grade, Class IV<br>PVC (non-latex) | Substantially<br>equivalent |
| | 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<br>Principle | Oscillometric technology (with an<br>inflatable cuff) determines systolic,<br>diastolic and mean arterial pressures | Oscillometric technology (with an<br>inflatable cuff) determines systolic, and<br>diastolic pressures | Substantially<br>equivalent |
| NIBP Information<br>Displayed | Numeric | Numeric | Substantially<br>equivalent |
| CO2 | | | |
| Materials | Various sized nasal and oral cannulas for<br>different patient types- Medical Grade<br>PVC | Various sized nasal and oral cannulas for<br>different patient types- Medical Grade<br>PVC | Substantially<br>equivalent |
| Operating<br>Principle | Side stream, NDIR (non-dispersive<br>infrared absorption) technique. | Side stream, NDIR (non-dispersive<br>infrared absorption) technique. | Substantially<br>equivalent |
| CO2 Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Substantially<br>equivalent |
| ANESTHETIC AGENTS, O2 | | | |
| Materials | Scavenge Hose- Medical Grade PVC | Scavenge Hose- Medical Grade PVC | Substantially<br>equivalent |
| | O2 Oxygen Cell- Paramagnetic | O2 Oxygen Cell- Paramagnetic | |
| | Co-Extruded Sample Line | Co-Extruded Sample Line | |
| Operating<br>Principle | Side Stream, non-dispersive infrared<br>(NDIR) absorption technique | Side Stream, non-dispersive infrared<br>(NDIR) absorption technique | Substantially<br>equivalent |
| Anesthetic Agents<br>Monitored | Desflurane (DES) | Desflurane (DES) | Substantially<br>equivalent |
| | Enflurane (ENF) | Enflurane (ENF) | |
| | Halothane (HAL) | Halothane (HAL) | |
| | Isoflurane (ISO) | Isoflurane (ISO) | |
| | Sevoflurane (SEV) | Sevoflurane (SEV) | |
| | Nitrous Oxide (N2O) | Nitrous Oxide (N2O) | |
| Anesthetic Agents<br>Information<br>Displayed | Waveform and Numeric | Waveform and Numeric | Substantially<br>equivalent |
| TEMP | | | |
| Materials | Fiber-optic Temperature Sensor,<br>Medical Grade PVC | Fiber-optic Temperature Sensor,<br>Medical Grade PVC | Substantially<br>equivalent |
| Operating<br>Principle | Fiber-optic Technology | Fiber-optic Technology | Substantially<br>equivalent |
| TEMP<br>Information<br>Displayed | Numeric, Celsius (°C) only | Numeric, Celsius (°C) or Fahrenheit (°F) | Substantially<br>equivalent |

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## SUMMARY OF NON-CLINICAL PERFORMANCE DATA:

Verification, validation, and testing activities establish the performance, functionality, usability and reliability characteristics of the device with respect to the predicate. Testing involved system level tests, biocompatibility, performance, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and the specifications of the 3880 MRI Patient Monitoring System as well as the requirements from FDA Recognized Consensus Standards (see Table 5-2 below for a list of the FDA Recognized Consensus Standards the device claims conformance to including a summary of the results of testing). Section 18 of this submission includes a complete list of all testing performed to demonstrate substantial equivalence to the predicate device). Results of the non-clinical testing demonstrate that the device operates as intended within its performance specifications and is substantially equivalent to the predicate device. The results do not raise issues regarding the safety and effectiveness of the device.

| FDA<br>Recognition<br># | Standard # | Title of Standard | Revision/Year | Results |
|-------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------|
| 19-4 | 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety<br>and Essential Performance | Edition 3.1<br>2005/(R)2012<br>And A1:2012 | Pass |
| 19-5 | 60601-1-2 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety<br>and Essential Performance - Collateral Standard: Electromagnetic Compatibility<br>- Requirements and Tests | Edition 3: 2007 | Pass |
| 5-76 | 60601-1-8 | Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety<br>And Essential Performance - Collateral Standard: General Requirements, Tests<br>And Guidance For Alarm Systems In Medical Electrical Equipment And Medical<br>Electrical Systems | Edition 2.1 2012 | Pass |
| 3-126 | 60601-2-27 | Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic<br>Safety And Essential Performance Of Electrocardiographic Monitoring<br>Equipment [Including: Corrigendum 1 (2012)] | Edition 3.0 2011 | Pass |
| 3-123 | 80601-2-30 | Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic<br>Safety And Essential Performance Of Automated Non-Invasive<br>Sphygmomanometers | Edition 1.1 2013 | Pass |
| 1-96 | 80601-2-55 | Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic<br>Safety And Essential Performance Of Respiratory Gas Monitors | Edition 1.0 2011 | Pass |
| 6-232 | 80601-2-56 | Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic<br>Safety And Essential Performance Of Clinical Thermometers For Body<br>Temperature Measurement | Edition 1.0 2009 | Pass |
| 1-85 | 80601-2-61 | Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic<br>Safety And Essential Performance Of Pulse Oximeter Equipment | Edition 1.0 2011 | Pass |
| 5-40 | 14971 | Medical Devices – Application Of Risk Management To Medical Devices | Edition 2.0 2007 | Pass |
| 2-220 | 10993-1 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing<br>Within A Risk Management Process | Edition 4.0 2009 | Pass |
| 2-245 | 10993-5 | Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro<br>Cytotoxicity | Edition 3.0 2009 | Pass |
| 2-174 | 10993-10 | Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation And<br>Skin Sensitization | Edition 3.0 2010 | Pass |
| 8-422 | F2052-15 | Standard Test Method for Measurement of Magnetically Induced Displacement<br>Force on Medical Device in MR Environment | 2015 | Pass |
| 3-349 | F2503-13 | Standard Practice for Marking Medical Devices and Other Items for Safety in the<br>Magnetic Resonance Environment | 2013 | Pass |
| 8-128 | F2213-11 | Standard Test Method For Measurement Of Magnetically Induced Torque On<br>Medical Devices In The Magnetic Resonance Environment | 2011 | Pass |
| 19-13 | 62133 | Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid<br>Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For<br>Batteries Made From Them, For Use In Portable Applications [Including:<br>Corrigendum 1 (2013)] | Edition 2.0 2012 | Pass |

Table 5-2, FDA Recognized Consensus Standards Summary Table:

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## SUMMARY OF CLINICAL PERFORMANCE DATA:

Non-invasive Blood Pressure (NIBP) clinical performance data provided in Section 20 demonstrates that the device meets the requirements of ISO 81060-2 (2013) "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type", operates as intended within the performance specifications and is safe and effective for clinical use. The results do not raise issues regarding the safety and effectiveness of the device.

## STATEMENT OF SUBSTANTIAL EQUIVALENCE:

IRadimed Corporation's 3880 MRI Patient Monitoring System, described in this submission is substantially equivalent to the cleared device, the Tesla M3 MRI Patient Monitoring System (K142032).