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).

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), Enflurane (ENF), Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), 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).

AI/ML Overview

The document provided is a 510(k) premarket notification for the IRadimed Corporation's 3880 MRI Patient Monitoring System, specifically for the addition of Invasive Blood Pressure (IBP) monitoring. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with clinical studies. As such, much of the requested information (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not explicitly provided in the context of proving performance against numerical acceptance criteria using clinical data for the IBP feature.

However, the document does contain information about performance testing against recognized consensus standards. Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not present specific numerical acceptance criteria for IBP performance (e.g., accuracy +/- X mmHg) directly within a table. Instead, it indicates compliance with recognized consensus standards. For IBP, the relevant standard mentioned is:

Acceptance Criteria (Standard)	Reported Device Performance
IEC/ Medical Electrical Equipment - Part 2-34: Particular Requirements For The Basic Safety, Including Essential Performance, Of Invasive Blood Pressure Monitoring Equipment (Edition 3.0 2011)	Pass

This implies that the device met all the requirements outlined in this standard for invasive blood pressure monitoring. The detailed numerical specifications within this standard would constitute the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "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." Therefore, no sample size for a clinical test set is provided, nor is data provenance from such a study. The performance evaluation relied on non-clinical (laboratory/engineering) testing against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical study with expert-established ground truth was performed for the IBP addition.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study requiring adjudication was performed for the IBP addition.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a patient vital signs monitor, not an AI diagnostic tool used by human readers. Its function is to display vital signs, not to interpret images or aid human decision-making in a way that an MRMC study would assess.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance of the IBP monitoring functionality was assessed in a "standalone" fashion in the sense that the device's ability to measure and display IBP was evaluated against engineering standards without requiring human interpretation as part of the primary performance evaluation. The "Pass" result for IEC 60601-2-34 indicates it met the specified performance requirements of this standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance evaluation, the "ground truth" would be the reference measurements or established benchmarks against which the device's IBP readings were compared in a controlled laboratory setting, as mandated by the IEC 60601-2-34 standard. This standard specifies methods for testing the accuracy and performance of invasive blood pressure monitors.

8. The sample size for the training set

Not applicable. The device is a monitoring system, not an AI algorithm that undergoes a training phase with a dataset.

9. How the ground truth for the training set was established

Not applicable, as no training set was used for an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

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 DriveWinter 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:

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.

TechnologicalCharacteristic	Primary Predicate Device:IRadimed Corporation's3880 MRI Patient Monitoring System(K172200)	Proposed Device:IRadimed Corporation's3880 MRI Patient Monitoring System(Pending 510(k))	Comparison
MONITOR
Intended Use/Indication for Use	The IRadimed Corporation's 3880 MRIPatient Monitoring System is intended tomonitor a single patient's vital signs forpatients undergoing Magnetic ResonanceImaging (MRI) procedures.The 3880 MRI Patient Monitoring System isintended for use by healthcare professionals.The 3880 MRI Patient Monitoring System isintended for use in Adult and Pediatric,including Neonatal populations, formonitoring of Electrocardiogram (ECG),Non-Invasive Blood Pressure (NIBP) andTemperature.The 3880 MRI Patient Monitoring System isalso intended for use in Adult and Pediatric,not including Neonatal populations, formonitoring of Pulse Oximetry (SpO2),Anesthetic Agents, Respiration, Capnography(CO2) and Oxygen (O2).The 3880 MRI Patient Monitoring Systemprovides monitoring for three distinct patienttypes as defined below (Note: Pediatric groupexcludes Neonates):Patient Types/Ages:1_Adult/ Greater than 22 years2_Pediatric/ (Includes: Infant, Child andAdolescent)- Adolescent/ aged 12 through 21 (up to butnot including the 22nd birthday)- Child/ 2 years to less than 12 years- Infant/ 29 days to less than 2 years3_Neonate/ from birth through the first 28	The IRadimed Corporation's 3880 MRIPatient Monitoring System is intended tomonitor a single patient's vital signs forpatients undergoing Magnetic ResonanceImaging (MRI) procedures.The 3880 MRI Patient Monitoring System isintended for use by healthcare professionals.The 3880 MRI Patient Monitoring System isintended for use in Adult and Pediatric,including Neonatal populations, formonitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), InvasiveBlood Pressure (IBP) and Temperature.The 3880 MRI Patient Monitoring System isalso intended for use in Adult and Pediatric,not including Neonatal populations, formonitoring of Pulse Oximetry (SpO2),Anesthetic Agents, Respiration, Capnography(CO2) and Oxygen (O2).The 3880 MRI Patient Monitoring Systemprovides monitoring for three distinct patienttypes as defined below (Note: Pediatric groupexcludes Neonates):Patient Types/Ages:1_Adult/ Greater than 22 years2_Pediatric/ (Includes: Infant, Child andAdolescent)- Adolescent/ aged 12 through 21 (up to butnot including the 22nd birthday)- Child/ 2 years to less than 12 years- Infant/ 29 days to less than 2 years3_Neonate/ from birth through the first 28	SameSameSubstantiallyEquivalentSameSameSame

	Table 5-1, Technological Characteristics Comparison Table of Primary Predicate:

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Table 5-2, Technological Characteristics Comparison Table of Invasive Blood Pressure Predicate Device:

TechnologicalCharacteristic	IBP Predicate Device:	Proposed Device:	Comparison
	Invivo Corporation (Philips)Expression MR400 MRI Patient MonitoringSystem (K152330)	IRadimed Corporation3880 MRI Patient Monitoring System(Pending 510(k))
Intended Use/Indication for Use	The Expression MR400 MRI Patient MonitoringSystem (Model MR400) is intended to monitorvital signs for patients undergoing MRI proceduresand to provide signals for synchronization for theMRI scanner.The Expression MR400 MRI Patient MonitoringSystem (Model MR400) is intended for use byhealthcare professionals.The Expression MR400 MRI Patient MonitoringSystem (Model MR400) provides monitoring forthe following vital sign parameters: ECG, pulseoximetry (SpO2), non-invasive blood pressure(NIBP), and optionally, invasive blood pressure(IBP), carbon dioxide (CO2) and respiration rate,anesthetic agents, nitrous oxide (N2O), oxygen(O2), and/or temperature.	The IRadimed Corporation's 3880 MRI PatientMonitoring System is intended to monitor a singlepatient's vital signs for patients undergoingMagnetic Resonance Imaging (MRI) procedures.The 3880 MRI Patient Monitoring System isintended for use by healthcare professionals.The 3880 MRI Patient Monitoring System isintended for use in Adult and Pediatric, includingNeonatal populations, for monitoring ofElectrocardiogram (ECG), Non-Invasive BloodPressure (NIBP), Invasive Blood Pressure (IBP)and Temperature.The 3880 MRI Patient Monitoring System is alsointended for use in Adult and Pediatric, notincluding Neonatal populations, for monitoring ofPulse Oximetry (SpO2), Anesthetic Agents,Respiration, Capnography (CO2) and Oxygen(O2).The 3880 MRI Patient Monitoring Systemprovides monitoring for three distinct patient typesas defined below (Note: Pediatric group excludesNeonates):Patient Type /Age1 Adult/ greater than 22 years2 Pediatric (Includes: Infant, Child andAdolescent)-Adolescent / aged 12 through 21 (up to but notincluding the 22nd birthday)-Child/ 2 years to less than 12 years-Infant/ 29 days to less than 2 years3 Neonate/ from birth through the first 28 days oflife	Substantiallyequivalent
Operating Principle	Conversion of intra-arterial bloodpressure measurements into electricalsignals (via transducer)	Conversion of intra-arterial bloodpressure measurements into electricalsignals (via transducer)	Same
Materials	IBP signal processing board housed inMR400 Cart with connection ports forP1 or P2 channels.	IBP signal processing board housed in3883 ipPOD with connection ports forP1 and P2 channels.	Substantiallyequivalent
IBP InformationDisplayed	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:

FDARecognition#	Standard #	Standard Development Organization /Title of Standard	Revision/Year	Results
19-4	60601-1*	IEC/ Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and Essential Performance	Edition 3.1 2005/(R)2012And A1:2012	Pass
19-5	60601-1-2*	IEC/ Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Compatibility -Requirements and Tests	Edition 4: 2015	Pass
5-76	60601-1-8	IEC/ Medical Electrical Equipment - Part 1-8: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: General Requirements, Tests AndGuidance For Alarm Systems In Medical ElectricalEquipment And Medical Electrical Systems	Edition 2.1 2012	Pass
3-126	60601-2-27	IEC/ Medical Electrical Equipment - Part 2-27: ParticularRequirements For The Basic Safety And EssentialPerformance Of Electrocardiographic Monitoring Equipment[Including: Corrigendum 1 (2012)]	Edition 3.0 2011	Pass
3-115	60601-2-34*	IEC/ Medical Electrical Equipment - Part 2-34: ParticularRequirements For The Basic Safety, Including EssentialPerformance, Of Invasive Blood Pressure MonitoringEquipment	Edition 3.0 2011	Pass

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

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FDARecognition#	Standard #	Standard Development Organization /Title of Standard	Revision/Year	Results
3-123	80601-2-30	ISO/ Medical Electrical Equipment - Part 2-30: ParticularRequirements For The Basic Safety And EssentialPerformance Of Automated Non-InvasiveSphygmomanometers	Edition 1.1 2013	Pass
1-96	80601-2-55	ISO/ Medical Electrical Equipment - Part 2-55: ParticularRequirements For The Basic Safety And EssentialPerformance Of Respiratory Gas Monitors	Edition 1.0 2011	Pass
6-232	80601-2-56	ISO/ Medical Electrical Equipment - Part 2-56: ParticularRequirements For Basic Safety And Essential PerformanceOf Clinical Thermometers For Body TemperatureMeasurement	Edition 1.0 2009	Pass
1-85	80601-2-61	ISO/ Medical Electrical Equipment - Part 2-61: ParticularRequirements For Basic Safety And Essential PerformanceOf Pulse Oximeter Equipment	Edition 1.0 2011	Pass
5-40	14971*	ISO/ Medical Devices - Application Of Risk ManagementTo Medical Devices	Edition 2.0 2007	Pass
2-220	10993-1	ISO/ Biological Evaluation Of Medical Devices - Part 1: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:Tests For In Vitro Cytotoxicity	Edition 3.0 2009	Pass
2-174	10993-10	ISO/ Biological Evaluation Of Medical Devices - Part 10:Tests For Irritation And Skin Sensitization	Edition 3.0 2010	Pass
8-422	F2052-15*	ASTM/ Standard Test Method for Measurement ofMagnetically Induced Displacement Force on MedicalDevice in MR Environment	2015	Pass
8-128	F2213-11*	ASTM/ Standard Test Method For Measurement OfMagnetically Induced Torque On Medical Devices In TheMagnetic Resonance Environment	2011	Pass
19-13	62133	IEC/ Secondary Cells And Batteries Containing Alkaline OrOther Non-Acid Electrolytes - Safety Requirements ForPortable Sealed Secondary Cells, And For Batteries MadeFrom Them, For Use In Portable Applications [Including:Corrigendum 1 (2013)]	Edition 2.0 2012	Pass
5-114	62366	IEC/ Medical Devices - Part 1: Application Of UsabilityEngineering To Medical Devices [IncludingCORRIGENDUM 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).

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).

TechnologicalCharacteristic	Primary Predicate Device:IRadimed Corporation's3880 MRI Patient Monitoring System(K172200)	Proposed Device:IRadimed Corporation's3880 MRI Patient Monitoring System(Pending 510(k))	Comparison
Monitor Materials	Housing mainly coated aluminum,antimagnetic stainless steel, plastics	Housing mainly coated aluminum,antimagnetic stainless steel, plastics	Same
Display	No cart required, (optional mountingaccessory for attachment to wheeledstand or patient bed), Touchscreen	No cart required, (optional mountingaccessory for attachment to wheeled standor patient bed), Touchscreen	Same
Remote Monitoringcapabilities(optional for both)	Remote Monitoring Tablet (3885T),operates on battery power, can be dockedfor charging and desktop use in the BaseStation (3885B) which is plugged intoAC mains power	Remote Monitoring Tablet (3885T),operates on battery power, can be dockedfor charging and desktop use in the BaseStation (3885B) which is plugged intoAC mains power	Same
MRI Conditions ofUse	Monitor: $< 30,000$ gaussWireless PODS: $< 30,000$ gaussMulti-Gas Unit: $< 600$ gaussSecondary Display (two pieces):Tablet $< 15,000$ gauss, exceptduring the course of an MRIscan Base Station: MR Unsafe	Monitor: $< 30,000$ gaussWireless PODS: $< 30,000$ gaussMulti-Gas Unit: $< 600$ gaussSecondary Display (two pieces):Tablet $< 15,000$ gauss, exceptduring the course of an MRIscan Base Station: MR Unsafe	Same
Printer	Integrated into secondary display- BaseStation (3885B)	Integrated into secondary display- BaseStation (3885B)	Same
Energy Source	External power supply connected to ACmains power or lithium polymer internalbattery power	External power supply connected to ACmains power or lithium polymer internalbattery power	Same
WirelessCommunication	Via 2.4 GHz wireless radios	Via 2.4 GHz wireless radios	Same
Alarms Capability	Audible and Visual Alarms on monitorand remote display, Compliant to IEC60601-1-8	Audible and Visual Alarms on monitorand remote display, Compliant to IEC60601-1-8	Same
Biocompatibility	Complies with ISO 10993-1, 10993-5,10993-10	Complies with ISO 10993-1, 10993-5,10993-10	Same
Sterility	Not Applicable	Not Applicable	Same
ECG
Wireless ECGMaterials	Plastic housing with enclosed battery,ECG Lead Wires and Electrodes	Plastic housing with enclosed battery,ECG Lead Wires and Electrodes	Same
Module EnergySource	Lithium polymer battery	Lithium polymer battery	Same
ECG InformationDisplayed	Waveform and Numeric	Waveform and Numeric	Same
ECG Accuracyduring MRI Scan	May be Affected by MRI gradients	May be Affected by MRI gradients	Same
SpO2
Wireless SpO2Materials	Module is enclosed in a plastic housingwith enclosed battery, SpO2 sensor cableand grip(s)	Module is enclosed in a plastic housingwith enclosed battery, SpO2 sensor cableand grip(s)	Same
Operating Principle	Red & Infrared Light Absorption	Red & Infrared Light Absorption	Same
TechnologicalCharacteristic	Primary Predicate Device:IRadimed Corporation's3880 MRI Patient Monitoring System(K172200)	Proposed Device:IRadimed Corporation's3880 MRI Patient Monitoring System(Pending 510(k))	Comparison
Module EnergySource	Lithium ion battery	Lithium ion battery	Same
SPO2 InformationDisplayed	Waveform and Numeric	Waveform and Numeric	Same
NIBP
NIBP Materials	NIBP Hose- Medical Grade, Class IVPVC (non-latex)NIBP Cuffs for Adults and pediatricpatients- medical grade urethaneNIBP Cuffs for neonatal patients-medical grade soft fabric	NIBP Hose- Medical Grade, Class IVPVC (non-latex)NIBP Cuffs for Adults and pediatricpatients- medical grade urethaneNIBP Cuffs for neonatal patients- medicalgrade soft fabric	Same
Operating Principle	Oscillometric technology (with aninflatable cuff) determines systolic anddiastolic pressures	Oscillometric technology (with aninflatable cuff) determines systolic anddiastolic pressures	Same
NIBP InformationDisplayed	Numeric	Numeric	Same
CO2
Materials	Various sized nasal and oral cannulas fordifferent patient types- Medical GradeCo-extruded PVC	Various sized nasal and oral cannulas fordifferent patient types- Medical GradeCo-extruded PVC	Same
Operating Principle	Side stream, NDIR (non-dispersiveinfrared absorption) technique	Side stream, NDIR (non-dispersiveinfrared absorption) technique	Same
CO2 InformationDisplayed	Waveform and Numeric	Waveform and Numeric	Same
ANESTHETIC AGENTS, O2
Materials	Scavenge Hose- Medical Grade PVCO2 Oxygen Cell- ParamagneticCo-Extruded Sample Line	Scavenge Hose- Medical Grade PVCO2 Oxygen Cell- ParamagneticCo-Extruded Sample Line	Same
Operating Principle	Side Stream, non-dispersive infrared(NDIR) absorption technique	Side Stream, non-dispersive infrared(NDIR) absorption technique	Same
Anesthetic AgentsMonitored	Desflurane (DES)Enflurane (ENF)Halothane (HAL)Isoflurane (ISO)Sevoflurane (SEV)Nitrous Oxide (N2O)	Desflurane (DES)Enflurane (ENF)Halothane (HAL)Isoflurane (ISO)Sevoflurane (SEV)Nitrous Oxide (N2O)	Same
Anesthetic AgentsInformationDisplayed	Waveform and Numeric	Waveform and Numeric	Same
TEMP
Materials	Fiber-optic Temperature Sensor, MedicalGrade PVC	Fiber-optic Temperature Sensor, MedicalGrade PVC	Same
TechnologicalCharacteristic	Primary Predicate Device:IRadimed Corporation's3880 MRI Patient Monitoring System(K172200)	Proposed Device:IRadimed Corporation's3880 MRI Patient Monitoring System(Pending 510(k))	Comparison
Operating Principle	Fiber-optic Technology	Fiber-optic Technology	Same
TEMP InformationDisplayed	Numeric, Celsius (°C) or Fahrenheit (°F)	Numeric, Celsius (°C) or Fahrenheit (°F)	Same