(357 days)
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).
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 provided text describes a 510(k) premarket notification for the Iradimed Corporation's 3880 MRI Patient Monitoring System. The purpose of this submission is to expand the indications for use to include neonatal populations for Pulse Oximetry (SpO2), Capnography (CO2), and Anesthetic Agents (AGENTS). The manufacturer claims substantial equivalence to previously cleared devices.
Based on the provided text, the device itself is a patient monitoring system, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical and potentially clinical testing performed to demonstrate substantial equivalence for the expanded indications.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by conformance to FDA-recognized consensus standards for medical electrical equipment. The "reported device performance" is indicated by a "Pass" for each standard.
| Acceptance Criteria (FDA Recognized Consensus Standard) | Standard ID | Reported Device Performance |
|---|---|---|
| Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | 60601-1 | Pass |
| Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests | 60601-1-2 | Pass |
| Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety And Essential Performance - Collateral Standard: General Requirements, Tests And Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems | 60601-1-8 | Pass |
| Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographic Monitoring Equipment | 60601-2-27 | Pass |
| Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers | 80601-2-30 | Pass |
| Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic Safety And Essential Performance Of Respiratory Gas Monitors | 80601-2-55* | Pass |
| Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement | 80601-2-56 | Pass |
| Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment | 80601-2-61* | Pass** |
| Medical Devices – Application Of Risk Management To Medical Devices | 14971 | Pass |
| Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process | 10993-1 | Pass |
| Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | 10993-5 | Pass |
| Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | 10993-10 | Pass |
| Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Device in MR Environment | F2052-15 | Pass |
| Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment | F2503-13 | Pass |
| Standard Test Method For Measurement Of Magnetically Induced Torque On Medical Devices In The Magnetic Resonance Environment | F2213-11 | Pass |
| Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications | 62133 | Pass |
Notes from the document:
- *All FDA Recognized Consensus Standards test reports listed above were provided and reviewed with the primary predicate device, which was cleared to market under K172200. The test reports provided in this submission, identified with asterisks in the table above, have been supplied in Section 18 to support substantial equivalence with the parameter specific predicates for the SpO2 and CO2/AGENTS parameters.
- ** Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted to demonstrate equivalence of the subject device which integrates Masimo MS Series Module and sensor technology. The testing demonstrated equivalence of both systems when configured for use in neonates.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The proposed modifications to the 3880 MRI Patient Monitoring Systems labeling does not require non-clinical performance testing. The non-clinical performance testing provided in K172200 has not changed since the submission and is still applicable to the modified device."
- Sample Size for Test Set: Not directly specified in the provided text for the current submission (K180903). The reliance is on prior testing from K172200 and the specified predicate devices (K050399, K053269, K171121). For the SpO2 performance, "The SpO2 volunteer blood study testing results using ISO 80601-2-61:2011 were submitted with K172200." This suggests human subject data for SpO2 accuracy, but the sample size is not stated here. "Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted" for neonatal SpO2, but again, the sample size (e.g., number of test points, subjects) is not provided.
- Data Provenance: The data is primarily from non-clinical performance testing (bench testing) and possibly a volunteer blood study. The origin (country, retrospective/prospective) of this data is not specified, but typically, premarket testing for FDA clearance is conducted under good laboratory practices (GLP) and may involve international standards but is intended for the US regulatory context. The nature of the submission (510(k) for an expanded indication) suggests this isn't a large-scale clinical trial with geographical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is typically relevant for studies involving subjective interpretations (e.g., image analysis for AI diagnostic devices). For a vital signs monitor, the "ground truth" would be established by validated reference measurement devices or controlled physiological conditions. The document does not describe the use of experts to establish ground truth in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable in the context of this submission. Adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers assess cases and their disagreements need to be resolved to establish a "ground truth" or reference standard. For a vital signs monitor, the performance is typically assessed against a known standard or reference measurement, not through human consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily for diagnostic medical devices (e.g., AI for radiology) to compare the performance of human readers with and without AI assistance. This submission is for a vital sign monitoring system, and the equivalence is established through conformance to performance standards and comparison to predicate devices, not improvement in human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
The device is a patient monitoring system, which intrinsically involves a human-in-the-loop (healthcare professional) for operation and interpretation. The "performance" refers to its accuracy and reliability in measuring physiological parameters, which is assessed against objective standards, not as a standalone AI algorithm independent of human use. The performance data is essentially "standalone" in the sense that the device's measurements are validated against reference measurements, assuming correct operation by a human, but it's not an AI algorithm in the typical sense of generating a diagnosis or recommendation.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on:
- Validated Reference Measurement Devices: For parameters like SpO2, NIBP, temperature, CO2, and anesthetic agents, the "ground truth" is typically obtained from highly accurate, calibrated reference instruments under controlled conditions (e.g., volunteer blood study for SpO2, calibrated pressure sources for NIBP, known gas concentrations for CO2/agents).
- Consensus Standards: Conformance to recognized international and national standards (e.g., ISO 80601 series) dictates the methods for validation and the acceptable ranges of error, effectively serving as the definition of acceptable "ground truth" performance.
8. The Sample Size for the Training Set
The provided document does not mention "training sets" in the context of machine learning or AI algorithms. This device is a physiological monitor, not an AI/ML-based diagnostic or prognostic tool. Therefore, there is no "training set" in the sense of data used to train an algorithm. The development of such devices relies on engineering design, validation against physical and physiological models, and adherence to established measurement principles, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI/ML training set, this question is not applicable.
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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) | |
|---|---|
| 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 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 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 |
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: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: Pediatricgroup excludes 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 28days of life | 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),Pulse Oximetry (SpO2), Non-Invasive BloodPressure (NIBP), Temperature, AnestheticAgents, Respiration, Capnography (CO2),and Oxygen (O2). | SameSameSubstantiallyEquivalent |
| 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 wheeledstand or patient bed), Touchscreen | Same |
| Remote Monitoringcapabilities(optional for both) | Remote Monitoring Tablet (3885T),operates on battery power, can bedocked for charging and desktop use inthe Base Station (3885B) which isplugged into AC mains power | Remote Monitoring Tablet (3885T),operates on battery power, can bedocked for charging and desktop use inthe Base Station (3885B) which isplugged into AC mains power | Same |
| Primary Predicate Device: | Proposed Device: | ||
| IRadimed Corporation's | IRadimed Corporation's | ||
| TechnologicalCharacteristic | 3880 MRI Patient Monitoring System(K172200) | 3880 MRI Patient Monitoring System(Pending 510(k)) | Comparison |
| 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 | ECG, SpO2 and CO2/AGENTS moduleslink to the Monitor via wireless 2.4 GHzlink. | ECG, SpO2 and CO2/AGENTS moduleslink to the Monitor via wireless 2.4 GHzlink. | 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 | Affected by MRI gradients | Affected by MRI gradients | Same |
| NIBP | |||
| NIBP Materials | NIBP Hose- Medical Grade, Class IVPVC (non-latex) | NIBP Hose- Medical Grade, Class IVPVC (non-latex) | Same |
| NIBP Cuffs for Adults and pediatricpatients- medical grade urethane | NIBP Cuffs for Adults and pediatricpatients- medical grade urethane | ||
| NIBP Cuffs for neonatal patients-medical grade soft fabric | NIBP Cuffs for neonatal patients-medical grade soft fabric | ||
| 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 |
| Primary Predicate Device: | Proposed Device: | ||
| IRadimed Corporation's | IRadimed Corporation's | ||
| Technological | 3880 MRI Patient Monitoring System | 3880 MRI Patient Monitoring System | |
| Characteristic | (K172200) | (Pending 510(k)) | Comparison |
| 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 |
| TEMP | |||
| Materials | Fiber-optic Temperature Sensor,Medical Grade PVC | Fiber-optic Temperature Sensor,Medical Grade PVC | Same |
| Operating Principle | Fiber-optic Technology | Fiber-optic Technology | Same |
| TEMP InformationDisplayed | Numeric, Celsius (°C) or Fahrenheit (°F) | Numeric, Celsius (°C) or Fahrenheit (°F) | Same |
Table 5-1, Technological Characteristics Comparison Table of Primary Predicate:
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Table 5-2, Technological Characteristics Comparison Table of SpO2 Specific Predicate Device:
| TechnologicalCharacteristic | SpO2 Predicate Devices: | Proposed Device: | Comparison |
|---|---|---|---|
| Invivo Corporation's | |||
| 3160 MRI Patient Monitoring System | IRadimed Corporation's | ||
| (K050399) and Masimo Corporation's | 3880 MRI Patient Monitoring System | ||
| Masimo SET® Rad-8 Pulse Oximeter (K053269) | (Pending 510(k)) | Substantiallyequivalent | |
| Indications for Use | The 3160 MRI Patient Monitoring System isintended to monitor vital signs for patientsundergoing MRI procedures and to provide signalsfor synchronization for the MRI scanner.The 3160 MRI Patient Monitoring System isintended for use by health care professionals. | 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), Temperature, Pulse Oximetry(SpO2), Anesthetic Agents, Respiration,Capnography (CO2), and Oxygen (O2). | |
| Wireless SpO2Module Materials | (Invivo) Dolphin SpO2 Module enclosedin plastic housing (K050399)(Masimo) Masimo SpO2 MS SeriesModule enclosed in plastic housing(K053269) | Masimo SpO2 MS Series Moduleenclosed in plastic housing | Substantiallyequivalent |
| Sensor Materials | (Invivo) fiber-optic glass SpO2 sensorcable | fiber-optic glass SpO2 sensor cable | Substantiallyequivalent |
| SpO2 ReusableAccessories | (Invivo) Silicone rubber grips withreceptacles for insertion of fiber-opticsensor heads from sensor cable. Varioussizes to accommodate all patient types | Silicone rubber grips with receptaclesfor insertion of fiber-optic sensor headsfrom sensor cable. Various sizes toaccommodate all patient types | Substantiallyequivalent |
| Operating Principle | Red & Infrared Light Absorption | Red & Infrared Light Absorption | Same |
| SpO2 InformationDisplayed | Waveform and Numeric | Waveform and Numeric | Same |
| TechnologicalCharacteristic | CO2/AGENTS Predicate Device:Masimo Root Monitoring System andAccessories (ISA OR+ Module andNomoline Accessories) (K171121) | Proposed Device:IRadimed Corporation's3880 MRI Patient Monitoring System(Pending 510(k)) | Comparison |
| Indications for Use | The Masimo Root Monitoring System andAccessories are indicated for use by healthcareprofessionals for the monitoring of multiplephysiological parameters in healthcareenvironments.The optional ISA product family consists ofsidestream gas analyzers (ISA OR+) andaccessories including Nomoline, intended to beconnected to other medical backboard devices formonitoring of breath rate [respiration] and thefollowing breathing gases[anesthetic agents]:ISA OR+: CO2, O2, N2O, Halothane, Enflurane,Sevoflurane and DesfluraneThe intended patient population is adult, pediatric,infant and neonatal patients.Note: the complete Indications for Use fromK171121 can be found in Section 21 "Other". Theexcised portion above is relevant to establishingsubstantial equivalence with the CO2/AGENTSparameters with the proposed device. | 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), Temperature, Pulse Oximetry(SpO2), Anesthetic Agents, Respiration,Capnography (CO2), and Oxygen (O2). | Substantiallyequivalent |
| Patient Population | Adult and Pediatric including Neonates | Adult and Pediatric including Neonates | Same |
| Multi-Gas ModuleMaterials | Masimo ISA OR+ Multi-Gas Analyzerw/Paramagnetic O2 Oxygen Cell | Masimo ISA OR+ Multi-Gas Analyzerw/Paramagnetic O2 Oxygen Cell | Same |
| EnclosureMaterials | Plastic Housing | Metal Housing | Substantiallyequivalent |
| AccessoryMaterials | Masimo Nomoline Accessories:• Sample line: Soft co-extruded PE/PVC• Cannula: Soft PVC• Airway adapters: Hard Plastic; methylmethacrylate-acrylonitrile-butadiene-styrene (MABS) | Masimo Nomoline Accessories:• Sample line: Soft co-extruded PE/PVC• Cannula: Soft PVC• Airway adapters: Hard Plastic; methylmethacrylate-acrylonitrile-butadiene-styrene (MABS) | Same |
| Operating Principle | Side Stream, non-dispersive infrared(NDIR) absorption technique | Side Stream, non-dispersive infrared(NDIR) absorption technique | Same |
| Anesthetic Agents/Gases Monitored | Desflurane (DES)Enflurane (ENF)Halothane (HAL)Isoflurane (ISO)Sevoflurane (SEV)Nitrous Oxide (N2O)Oxygen (O2)Capnography (CO2) | Desflurane (DES)Enflurane (ENF)Halothane (HAL)Isoflurane (ISO)Sevoflurane (SEV)Nitrous Oxide (N2O)Oxygen (O2)Capnography (CO2) | Same |
| Respiration Rate | CO2 derived | CO2 derived | Same |
| Information | Waveform and Numeric | Waveform and Numeric | Same |
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Table 5-3, Technological Characteristics Comparison Table of CO₂/AGENTS Specific Predicate Device:
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SIMILARITIES AND DIFFERENCES:
No changes have been made to the technological characteristics, specifications, operating principals, materials, system hardware or software of the proposed device; all are the same when compared to the primary predicate device (K172200). Both devices are intended to monitor patients vital signs while undergoing MRI procedures. Both devices provide the same vital sign monitoring parameters which are patient population specific ranging from adult to infant, or adult to neonatal patients.
The proposed and predicate devices differ in the following ways; the product labeling in the proposed device has been revised to include the application of pulse oximetry (SpO2). Capnography (CO2), Anesthetic Agents (AGENTS), and Oxygen (O2) with neonatal patients.
SpO2:
The sensors, hardware, SpO2 sensor attachment accessories (sensor grips), and methods of attachment are substantially equivalent to those found in the SPO2 specific predicate devices (Invivo's K050399 and Masimo's K053269). The proposed device's intended use / indications for use statement differs in that it includes more detail regarding the patient population the device is intended to be used with, as well as a listing of the parameters intended to be monitored.
CO2/AGENTS:
The primary predicate (K172200) as well as the CO2/AGENTS specific predicate (K171121) and the proposed device all use Masimo's ISA OR+ Multi-Gas Analyzer and Nomoline Accessories for monitoring of the CO2/AGENTS parameters. However, Iradimed's primary predicate device was cleared to market one month prior to Masimo receiving clearance to market the ISA OR+ Gas Module and Nomoline Accessories for use with neonatal patients. This 510(k) is intended to clarify the indications for use statement to include neonatal monitoring of CO2/AGENTS with the proposed device.
The risks identified in the modified device are identical to those provided in 510(k) K172200 and no new risks have been introduced as a result of the proposed modifications. Based on this information the differences between the modified and predicate devices do not affect the safety and effectiveness of the device when used as labeled. Therefore, the modified device as described in the submission is substantially equivalent to the predicate devices.
SUMMARY OF NON-CLINICAL PERFORMANCE DATA:
The proposed modifications to the 3880 MRI Patient Monitoring Systems labeling does not require non-clinical performance testing. The non-clinical performance testing provided in K 172200 has not changed since the submission and is still applicable to the modified device (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). Based on this information, additional non-clinical performance data is not necessary to demonstrate substantial equivalence.
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| FDARecog. # | Standard # | Title of Standard | Rev/Year | Results |
|---|---|---|---|---|
| 19-4 | 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety andEssential Performance | 3.1 / 2005+A1:2012 | Pass |
| 19-5 | 60601-1-2 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety andEssential Performance - Collateral Standard: Electromagnetic Compatibility –Requirements and Tests | 3.0 / 20074.0 / 2014 | Pass |
| 5-76 | 60601-1-8 | Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety AndEssential Performance - Collateral Standard: General Requirements, Tests And GuidanceFor Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems | 2.1 / 2012 | Pass |
| 3-126 | 60601-2-27 | Medical Electrical Equipment - Part 2-27: Particular Requirements For The Basic SafetyAnd Essential Performance Of Electrocardiographic Monitoring Equipment [Including:Corrigendum 1 (2012)] | 3.0 / 2011 | Pass |
| 3-123 | 80601-2-30 | Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic SafetyAnd Essential Performance Of Automated Non-Invasive Sphygmomanometers | 1.1 / 2013 | Pass |
| 1-96 | 80601-2-55* | Medical Electrical Equipment - Part 2-55: Particular Requirements For The Basic SafetyAnd Essential Performance Of Respiratory Gas Monitors | 1.0 / 2011 | Pass |
| 6-232 | 80601-2-56 | Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety AndEssential Performance Of Clinical Thermometers For Body Temperature Measurement | 1.0 / 2009 | Pass |
| 1-85 | 80601-2-61* | Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety AndEssential Performance Of Pulse Oximeter Equipment | 1.0 / 2011 | Pass** |
| 5-40 | 14971 | Medical Devices – Application Of Risk Management To Medical Devices | 2.0 / 2007 | Pass |
| 2-220 | 10993-1 | Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within ARisk Management Process | 4.0 / 2009 | Pass |
| 2-245 | 10993-5 | Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | 3.0 / 2009 | Pass |
| 2-174 | 10993-10 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And SkinSensitization | 3.0 / 2010 | Pass |
| 8-422 | F2052-15 | Standard Test Method for Measurement of Magnetically Induced Displacement Force onMedical Device in MR Environment | 2015 | Pass |
| 3-349 | F2503-13 | Standard Practice for Marking Medical Devices and Other Items for Safety in theMagnetic Resonance Environment | 2013 | Pass |
| 8-128 | F2213-11 | Standard Test Method For Measurement Of Magnetically Induced Torque On MedicalDevices In The Magnetic Resonance Environment | 2011 | Pass |
| 19-13 | 62133 | Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes -Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made FromThem, For Use In Portable Applications [Including: Corrigendum 1 (2013)] | 2.0 / 2012 | Pass |
Table 5-4, FDA Recognized Consensus Standards Testing Summary Table:
*All FDA Recognized Consensus Standards test reports listed above were provided and reviewed with the primary predicate device, which was cleared to market under K172200. The test reports provided in this submission, identified with asterisks in the table above, have been supplied in Section 18 to support substantial equivalence with the parameter specific predicates for the SpO2 and CO2/AGENTS parameters.
** Additional bench testing comparing performance of the Masimo SET Rad 8 was conducted to demonstrate equivalence of the subject device which integrates Masimo MS Series Module and sensor technology. The testing demonstrated equivalence of both systems when configured for use in neonates.
SUMMARY OF CLINICAL PERFORMANCE DATA:
The SpO2 volunteer blood study testing results using ISO 80601-2-61:2011 were submitted with K172200. In accordance with the FDA guidance document titled "Pulse Oximeters-Premarket Notification Submissions [510(k)s]" and non-clinical performance data provided, no new clinical performance data is necessary to demonstrate substantial equivalence.
STATEMENT OF SUBSTANTIAL EQUIVALENCE:
The indications for use statement has been modified to include the application of the SpO2 and CO2/AGENTS parameters with neonatal patients. Although the neonate population was
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not specifically indicated for use with the SpO2 and CO2/AGENTS parameters in the primary predicate device, the same technology and accessory types (SPO2- fiber optic sensors, silicone grips and CO2/AGENTS-ISA OR+ Multi-Gas Analyzer with Nomoline Accessories) were cleared for use with neonatal patients in the parameter specific predicate devices (SPO2-Invivo's 510(k) K050399, Masimo's 510(k) K053269 and CO2/AGENTS -Masimo's 510(k) K171121).
Therefore, IRadimed Corporation's 3880 MRI Patient Monitoring System, as described in this submission, is substantially equivalent to the primary predicate device, the Iradimed 3880 MRI Patient Monitoring System (K172200), and the parameter specific predicate devices, Invivo's 3160 Precess MRI Patient Monitoring System (SpO2) (K050399), Masimo's Corporation's SET® Rad-8 Pulse Oximeter (K053629) and Masimo's Root Monitoring System and Accessories (CO2/AGENTS), specifically the ISA OR+ Multi-Gas Module and the Nomoline Accessories (K171121).
§ 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).