(96 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 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 |
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)
- 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)
- Desflurane (DES)
- Enflurane (ENF)
- Halothane (HAL)
- Isoflurane (ISO)
- Sevoflurane (SEV)
- 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
The provided text is a 510(k) summary for the IRadimed Corporation's 3880 MRI Patient Monitoring System. It focuses on demonstrating substantial equivalence to a predicate device, the MIPM Tesla M3 MRI Patient Monitoring System (K142032). The device performance is primarily established through non-clinical testing and conformance to recognized consensus standards, with limited clinical data for a specific function.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for overall device performance in the way one might expect for a diagnostic AI device (e.g., predefined sensitivity/specificity thresholds). Instead, the acceptance criteria are implicitly tied to conformance with various recognized consensus standards (largely related to safety, essential performance, and electromagnetic compatibility) and functional equivalence to the predicate device. For the NIBP function specifically, the acceptance criterion was meeting the requirements of ISO 81060-2.
Here's a summary derived from the "SUMMARY OF NON-CLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA" sections within the provided text:
| Performance Metric/Standard | Acceptance Criteria (Implicit from Compliance) | Reported Device Performance |
|---|---|---|
| Overall Device | Performance, functionality, usability, and reliability characteristics established through verification, validation, and testing activities, adhering to specifications cleared for the predicate device and the 3880 MRI Patient Monitoring System, and requirements from FDA Recognized Consensus Standards. | "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... 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." |
| Safety and Essential Performance | Compliance with IEC 60601-1 (General Requirements for Basic Safety and Essential Performance) | Pass |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (EMC Requirements) | Pass |
| Alarm Systems | Compliance with IEC 60601-1-8 (Alarm Systems) | Pass |
| ECG Monitoring | Compliance with IEC 60601-2-27 (Electrocardiographic Monitoring Equipment) | Pass |
| Non-Invasive Blood Pressure (NIBP) | Compliance with ISO 81060-2 (Clinical Validation Of Automated Measurement Type) and operating as intended within performance specifications. | "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." |
| Respiratory Gas Monitors | Compliance with IEC 80601-2-55 (Respiratory Gas Monitors) | Pass |
| Clinical Thermometers | Compliance with IEC 80601-2-56 (Clinical Thermometers for Body Temperature Measurement) | Pass |
| Pulse Oximeters | Compliance with IEC 80601-2-61 (Pulse Oximeter Equipment) | Pass |
| Risk Management | Compliance with ISO 14971 (Application of Risk Management to Medical Devices) | Pass |
| Biocompatibility | Compliance with ISO 10993-1, 10993-5, 10993-10 (Biological Evaluation of Medical Devices) | Pass |
| MRI Environment Testing | Compliance with ASTM F2052-15 (Magnetically Induced Displacement Force), ASTM F2503-13 (Marking Medical Devices), ASTM F2213-11 (Magnetically Induced Torque) | Pass |
| Batteries | Compliance with IEC 62133 (Secondary Cells and Batteries) | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "clinical performance data provided in Section 20" for NIBP. However, Section 20 is not included in the provided text. Therefore, details regarding the sample size, data provenance (country of origin, retrospective/prospective nature) for the NIBP clinical test set are not available in this document.
For the non-clinical performance data, the "test set" would refer to the physical devices and simulated conditions used for testing against the consensus standards. No sample sizes are specified for these tests. Their provenance is implied to be IRadimed Corporation's testing facilities.
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)
This section is not applicable in the context of this 510(k) submission. The 3880 MRI Patient Monitoring System is a vital signs monitor, not a diagnostic imaging AI device. Its performance is evaluated against physiological measurement accuracy standards and safety/performance standards, not against expert consensus on images. For the NIBP clinical data, the "ground truth" would be established by a reference NIBP measurement method, not human experts evaluating images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for this device type and evaluation. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers of diagnostic images where consensus among experts is needed to establish ground truth for ambiguous cases. This device measures physiological parameters.
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
This is not applicable. The 3880 MRI Patient Monitoring System is a vital signs monitor and does not involve AI assistance for human readers of diagnostic images. Therefore, an MRMC comparative effectiveness study is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone vital signs monitor. Its performance in measuring vital signs (ECG, NIBP, SpO2, Temperature, CO2, Anesthetic Agents, O2) is assessed as an algorithm/device-only performance in relation to established physiological measurement standards. The non-clinical testing referenced demonstrates this standalone performance. The NIBP clinical study also evaluates the device's standalone accuracy against a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing (conformance to IEC/ISO standards), the "ground truth" is effectively the defined specifications and measurement accuracy requirements within those standards. These are objective, measurable criteria.
For the NIBP clinical validation, the ground truth would be established by a reference method for blood pressure measurement, as per ISO 81060-2. This standard specifies how clinical validation should be performed and what constitutes an accurate reference measurement.
8. The sample size for the training set
This information is not applicable. The 3880 MRI Patient Monitoring System is a traditional medical device (vital signs monitor) and not an AI/Machine Learning device that undergoes a "training" phase with a dataset in the conventional sense. Its design and performance are based on engineering principles and compliance with established standards, not on learning from a large dataset.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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 |
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:
| TechnologicalCharacteristic | Predicate Device: | Proposed Device: | Comparison |
|---|---|---|---|
| MIPM's | IRadimed Corporation's | (see Section 12 fordetailed discussion ofSubstantial Equivalence) | |
| Tesla M3 MRI Patient Monitoring System | 3880 MRI Patient Monitoring System | ||
| (K142032) | (Pending 510(k)) | ||
| MONITOR | |||
| Intended Use | The MRI Patient Monitoring SystemTesla M3 is intended for monitoring ofvital signs during MRI examinations(MRI procedures) of patients.The Tesla M3 is intended for use in the | The IRadimed Corporation's 3880 MRIPatient Monitoring System is intended tomonitor a single patient's vital signs forpatients undergoing MagneticResonance Imaging (MRI) procedures. | Substantiallyequivalent |
| Predicate Device: | Proposed Device: | Comparison | |
| TechnologicalCharacteristic | MIPM'sTesla M3 MRI Patient Monitoring System(K142032) | IRadimed Corporation's3880 MRI Patient Monitoring System(Pending 510(k)) | (see Section 12 fordetailed discussion ofSubstantial Equivalence) |
| Adult, Pediatric and Neonatalpopulations for the continuousmonitoring of Electrocardiogram (ECG),Non-Invasive Blood Pressure (NIBP),Invasive Blood Pressure (IBP),Temperature, Respiration, Capnography(etCO2), Oxygen and Anesthetic Agents. | The IRadimed Corporation's 3880 MRIPatient Monitoring System is intended tomonitor a single patient's vital signs forpatients undergoing MagneticResonance Imaging (MRI) procedures. | ||
| The Tesla M3 is intended for use in theAdult and Pediatric populations for thecontinuous monitoring of PulseOximetry (SpO2). | The 3880 MRI Patient MonitoringSystem is intended for use by healthcareprofessionals. | ||
| The Tesla M3 is intended for use byhealth care professionals. | The 3880 MRI Patient MonitoringSystem is intended for use in Adult andPediatric, including Neonatalpopulations, for monitoring ofElectrocardiogram (ECG), Non-InvasiveBlood Pressure (NIBP), andTemperature. | ||
| The 3880 MRI Patient MonitoringSystem is also intended for use in Adultand Pediatric, not including Neonatalpopulations, for monitoring of PulseOximetry (SpO2), Anesthetic Agents,Respiration, Capnography (CO2), andOxygen (O2). | |||
| The 3880 MRI Patient MonitoringSystem provides monitoring for threedistinct patient types as defined below(Note: Pediatric group excludesNeonates): | |||
| Patient Types/Ages:1_Adult/ Greater than 22 years2_Pediatric/ (Includes: Infant, Child andAdolescent)- Adolescent/ aged 12 through 21 (up tobut not 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 first28 days of life | |||
| Monitor Materials | Housing mainly coated aluminum,antimagnetic stainless steel, plastics | Housing mainly coated aluminum,antimagnetic stainless steel, plastics | Substantiallyequivalent |
| Display | Permanently installed on wheeled cart,Touchscreen | No cart required, (optional mountingaccessory for attachment to wheeledstand or patient bed), Touchscreen | Substantiallyequivalent |
| 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 intoAC mains power | Remote Monitoring Tablet (3885-T),operates on battery power, can bedocked for charging and desktop use inthe Base Station (3885-B) which isplugged into AC mains power | Substantiallyequivalent |
| Monitoringcapabilities(optional for both) | |||
| MRI Conditionsof Use | Monitor: < 200 gaussWireless modules: < 30,000 gaussMulti-Gas Module: < 200 gaussSecondary Display (single piece):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 | Substantiallyequivalent |
| Printer | Integrated into secondary display | Integrated into secondary display- BaseStation (3885-B) | Substantiallyequivalent |
| Energy Source | External power supply connected to ACmains power or lithium ion internalbattery power | External power supply connected to ACmains power or lithium polymer internalbattery power | Substantiallyequivalent |
| WirelessCommunication | ECG and SpO2 patient modules link tothe Monitor via wireless 2.4 GHz link. | ECG and SpO2 patient PODS link to theMonitor via wireless 2.4 GHz link. | Substantiallyequivalent |
| 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 | Substantiallyequivalent |
| Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1, 10993-5,10993-10 | Substantiallyequivalent |
| Sterility | Not Applicable | Not Applicable | Substantiallyequivalent |
| ECG | |||
| Wireless ECGMaterials | Plastic housing with enclosed battery,ECG Lead Wires and Electrodes | Plastic housing with enclosed battery,ECG Lead Wires and Electrodes | Substantiallyequivalent |
| Module EnergySource | Lithium ion battery | Lithium polymer battery | Substantiallyequivalent |
| ECG InformationDisplayed | Waveform and Numeric | Waveform and Numeric | Substantiallyequivalent |
| ECG Accuracyduring MRI Scan | Affected by MRI gradients | Affected by MRI gradients | Substantiallyequivalent |
| SpO2 | |||
| Wireless SpO2Materials | Module is enclosed in a plastic housingwith enclosed battery, SpO2 sensorcable and grip(s) | Module is enclosed in a plastic housingwith enclosed battery, SpO2 sensor cableand grip(s) | Substantiallyequivalent |
| OperatingPrinciple | Red & Infrared Light Absorption | Red & Infrared Light Absorption | Substantiallyequivalent |
| Module EnergySource | Lithium ion battery | Lithium polymer battery | Substantiallyequivalent |
| SPO2 InformationDisplayed | Waveform and Numeric | Waveform and Numeric | Substantiallyequivalent |
| Predicate Device: | Proposed Device: | Comparison | |
| MIPM's | IRadimed Corporation's | (see Section 12 for | |
| TechnologicalCharacteristic | Tesla M3 MRI Patient Monitoring System(K142032) | 3880 MRI Patient Monitoring System(Pending 510(k)) | detailed discussion ofSubstantial Equivalence) |
| NIBP | |||
| NIBP Materials | NIBP Hose- Medical Grade, Class IVPVC (non-latex) | NIBP Hose- Medical Grade, Class IVPVC (non-latex) | Substantiallyequivalent |
| 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 | ||
| OperatingPrinciple | Oscillometric technology (with aninflatable cuff) determines systolic,diastolic and mean arterial pressures | Oscillometric technology (with aninflatable cuff) determines systolic, anddiastolic pressures | Substantiallyequivalent |
| NIBP InformationDisplayed | Numeric | Numeric | Substantiallyequivalent |
| CO2 | |||
| Materials | Various sized nasal and oral cannulas fordifferent patient types- Medical GradePVC | Various sized nasal and oral cannulas fordifferent patient types- Medical GradePVC | Substantiallyequivalent |
| OperatingPrinciple | Side stream, NDIR (non-dispersiveinfrared absorption) technique. | Side stream, NDIR (non-dispersiveinfrared absorption) technique. | Substantiallyequivalent |
| CO2 InformationDisplayed | Waveform and Numeric | Waveform and Numeric | Substantiallyequivalent |
| ANESTHETIC AGENTS, O2 | |||
| Materials | Scavenge Hose- Medical Grade PVC | Scavenge Hose- Medical Grade PVC | Substantiallyequivalent |
| O2 Oxygen Cell- Paramagnetic | O2 Oxygen Cell- Paramagnetic | ||
| Co-Extruded Sample Line | Co-Extruded Sample Line | ||
| OperatingPrinciple | Side Stream, non-dispersive infrared(NDIR) absorption technique | Side Stream, non-dispersive infrared(NDIR) absorption technique | Substantiallyequivalent |
| Anesthetic AgentsMonitored | Desflurane (DES) | Desflurane (DES) | Substantiallyequivalent |
| Enflurane (ENF) | Enflurane (ENF) | ||
| Halothane (HAL) | Halothane (HAL) | ||
| Isoflurane (ISO) | Isoflurane (ISO) | ||
| Sevoflurane (SEV) | Sevoflurane (SEV) | ||
| Nitrous Oxide (N2O) | Nitrous Oxide (N2O) | ||
| Anesthetic AgentsInformationDisplayed | Waveform and Numeric | Waveform and Numeric | Substantiallyequivalent |
| TEMP | |||
| Materials | Fiber-optic Temperature Sensor,Medical Grade PVC | Fiber-optic Temperature Sensor,Medical Grade PVC | Substantiallyequivalent |
| OperatingPrinciple | Fiber-optic Technology | Fiber-optic Technology | Substantiallyequivalent |
| TEMPInformationDisplayed | Numeric, Celsius (°C) only | Numeric, Celsius (°C) or Fahrenheit (°F) | Substantiallyequivalent |
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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.
| FDARecognition# | Standard # | Title of Standard | Revision/Year | Results |
|---|---|---|---|---|
| 19-4 | 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safetyand Essential Performance | Edition 3.12005/(R)2012And A1:2012 | Pass |
| 19-5 | 60601-1-2 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safetyand Essential Performance - Collateral Standard: Electromagnetic Compatibility- Requirements and Tests | Edition 3: 2007 | Pass |
| 5-76 | 60601-1-8 | Medical Electrical Equipment - Part 1-8: General Requirements For Basic SafetyAnd Essential Performance - Collateral Standard: General Requirements, TestsAnd Guidance For Alarm Systems In Medical Electrical Equipment And MedicalElectrical Systems | Edition 2.1 2012 | Pass |
| 3-126 | 60601-2-27 | Medical Electrical Equipment - Part 2-27: Particular Requirements For The BasicSafety And Essential Performance Of Electrocardiographic MonitoringEquipment [Including: Corrigendum 1 (2012)] | Edition 3.0 2011 | Pass |
| 3-123 | 80601-2-30 | Medical Electrical Equipment - Part 2-30: Particular Requirements For The BasicSafety And Essential Performance Of Automated Non-InvasiveSphygmomanometers | Edition 1.1 2013 | Pass |
| 1-96 | 80601-2-55 | Medical Electrical Equipment - Part 2-55: Particular Requirements For The BasicSafety 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 BasicSafety And Essential Performance Of Clinical Thermometers For BodyTemperature Measurement | Edition 1.0 2009 | Pass |
| 1-85 | 80601-2-61 | Medical Electrical Equipment - Part 2-61: Particular Requirements For BasicSafety 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 TestingWithin A Risk Management Process | Edition 4.0 2009 | Pass |
| 2-245 | 10993-5 | Biological Evaluation Of Medical Devices - Part 5: Tests For In VitroCytotoxicity | Edition 3.0 2009 | Pass |
| 2-174 | 10993-10 | Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation AndSkin Sensitization | Edition 3.0 2010 | Pass |
| 8-422 | F2052-15 | Standard Test Method for Measurement of Magnetically Induced DisplacementForce on Medical 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 OnMedical Devices In The Magnetic Resonance Environment | 2011 | Pass |
| 19-13 | 62133 | Secondary Cells And Batteries Containing Alkaline Or Other Non-AcidElectrolytes - Safety Requirements For Portable Sealed Secondary Cells, And ForBatteries Made From Them, For Use In Portable Applications [Including: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).
§ 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).