(59 days)
Not Found
No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities.
No
The device is a patient monitoring system designed to measure vital signs during MRI procedures, not to treat a condition or disease.
No
Explanation: The device is a patient monitoring system that measures and displays vital signs during MRI procedures. It provides data on the patient's physiological status but does not diagnose a medical condition itself.
No
The device description explicitly states it is a "multi-parameter vital signs monitor" and mentions being powered by AC or internal battery, having a handle, and being mountable, all indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The IRadimed 3880 MRI Patient Monitoring System monitors vital signs directly from the patient's body (ECG, NIBP, IBP, Temperature, SpO2, Respiration, Capnography, Anesthetic Agents, Oxygen). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states monitoring vital signs of patients undergoing MRI procedures. This is a direct patient monitoring function, not an in vitro diagnostic test.
Therefore, the device falls under the category of a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / 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):
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).
Product codes (comma separated list FDA assigned to the subject device)
MWI
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)
The 3880 MRI Patient Monitoring System can be ordered with the following configurations:
Standard Configuration:
3880 MRI Patient Monitor
Configuration: ECG (X), SpO2 (X), NIBP (X), CO2 (X), Temp (X)
Optional Configurations:
Anesthetic Agents (Requires 3880 Monitor and 3886 Multi-Gas Unit):
3886 Multi-Gas Unit
Optional Configuration: AGENTS (X), CO2 (X), O2 (X)
Invasive Blood Pressure (IBP) (Requires 3880 Monitor and 3883 ipPOD):
3883 ipPOD
Optional Configuration: IBP (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
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult: greater than 22 years
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
Neonate: from birth through the first 28 days of life
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-34, ISO 80601-2-30, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10, ASTM F2052-15, ASTM F2213-11, IEC 62133, IEC 62366.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K182900
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 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).
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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3
05 | 510(k) Summary
SUBMITTER INFORMATION:
| Establishment Name: | IRadimed Corporation |
|---|---|
| Establishment Address: | 1025 Willa Springs Drive |
| Winter Springs, FL 32708 | |
| Contact Name: | Mr. Francis Casey |
| Contact E-mail: | fcasey@iradimed.com |
| Contact Phone: | 407-677-8022 x106 |
| Contact Fax: | 407-677-5037 |
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 |
4
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) 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 |
5
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 |
6
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.
| Technological
Characteristic | Primary Predicate Device:
IRadimed Corporation's
3880 MRI Patient Monitoring System
(K172200) | Proposed Device:
IRadimed Corporation's
3880 MRI Patient Monitoring System
(Pending 510(k)) | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| MONITOR | | | |
| Intended Use/
Indication 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 Types/Ages:
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 | 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 Types/Ages:
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 | Same
Same
Substantially
Equivalent
Same
Same
Same |
| Table 5-1, Technological Characteristics Comparison Table of Primary Predicate: | |||
|---|---|---|---|
7
| Technological
Characteristic | Primary Predicate Device:
IRadimed Corporation's
3880 MRI Patient Monitoring System
(K172200) | Proposed Device:
IRadimed Corporation's
3880 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 mounting
accessory for attachment to wheeled
stand or patient bed), Touchscreen | No cart required, (optional mounting
accessory for attachment to wheeled stand
or patient bed), Touchscreen | Same |
| Remote Monitoring
capabilities
(optional for both) | Remote Monitoring Tablet (3885T),
operates on battery power, can be docked
for charging and desktop use in the Base
Station (3885B) which is plugged into
AC mains power | Remote Monitoring Tablet (3885T),
operates on battery power, can be docked
for charging and desktop use in the Base
Station (3885B) which is plugged into
AC mains power | Same |
| MRI Conditions of
Use | Monitor: $NIBP | | | |
| NIBP Materials | NIBP Hose- Medical Grade, Class IV
PVC (non-latex)
NIBP Cuffs for Adults and pediatric
patients- medical grade urethane
NIBP Cuffs for neonatal patients-
medical grade soft fabric | NIBP Hose- Medical Grade, Class IV
PVC (non-latex)
NIBP Cuffs for Adults and pediatric
patients- medical grade urethane
NIBP Cuffs for neonatal patients- medical
grade soft fabric | Same |
| Operating Principle | Oscillometric technology (with an
inflatable cuff) determines systolic and
diastolic pressures | Oscillometric technology (with an
inflatable cuff) determines systolic and
diastolic pressures | Same |
| NIBP Information
Displayed | Numeric | Numeric | Same |
| CO2 | | | |
| Materials | Various sized nasal and oral cannulas for
different patient types- Medical Grade
Co-extruded PVC | Various sized nasal and oral cannulas for
different patient types- Medical Grade
Co-extruded PVC | Same |
| Operating Principle | Side stream, NDIR (non-dispersive
infrared absorption) technique | Side stream, NDIR (non-dispersive
infrared absorption) technique | Same |
| CO2 Information
Displayed | Waveform and Numeric | Waveform and Numeric | Same |
| ANESTHETIC AGENTS, O2 | | | |
| Materials | Scavenge Hose- Medical Grade PVC
O2 Oxygen Cell- Paramagnetic
Co-Extruded Sample Line | Scavenge Hose- Medical Grade PVC
O2 Oxygen Cell- Paramagnetic
Co-Extruded Sample Line | Same |
| Operating Principle | Side Stream, non-dispersive infrared
(NDIR) absorption technique | Side Stream, non-dispersive infrared
(NDIR) absorption technique | Same |
| Anesthetic Agents
Monitored | 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 Agents
Information
Displayed | Waveform and Numeric | Waveform and Numeric | Same |
| TEMP | | | |
| Materials | Fiber-optic Temperature Sensor, Medical
Grade PVC | Fiber-optic Temperature Sensor, Medical
Grade PVC | Same |
| Technological
Characteristic | Primary Predicate Device:
IRadimed Corporation's
3880 MRI Patient Monitoring System
(K172200) | Proposed Device:
IRadimed Corporation's
3880 MRI Patient Monitoring System
(Pending 510(k)) | Comparison |
| Operating Principle | Fiber-optic Technology | Fiber-optic Technology | Same |
| TEMP Information
Displayed | Numeric, Celsius (°C) or Fahrenheit (°F) | Numeric, Celsius (°C) or Fahrenheit (°F) | Same |
8
9
Table 5-2, Technological Characteristics Comparison Table of Invasive Blood Pressure Predicate Device:
| Technological
| Characteristic | IBP Predicate Device: | Proposed Device: | Comparison |
|---|---|---|---|
| Invivo Corporation (Philips) | |||
| Expression MR400 MRI Patient Monitoring | |||
| System (K152330) | IRadimed Corporation | ||
| 3880 MRI Patient Monitoring System | |||
| (Pending 510(k)) | |||
| Intended Use/ | |||
| Indication for Use | The Expression MR400 MRI Patient Monitoring | ||
| System (Model MR400) is intended to monitor | |||
| vital signs for patients undergoing MRI procedures | |||
| and to provide signals for synchronization for the | |||
| MRI scanner. |
The Expression MR400 MRI Patient Monitoring
System (Model MR400) is intended for use by
healthcare professionals.
The Expression MR400 MRI Patient Monitoring
System (Model MR400) provides monitoring for
the following vital sign parameters: ECG, pulse
oximetry (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 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 | Substantially
equivalent |
| Operating Principle | Conversion of intra-arterial blood
pressure measurements into electrical
signals (via transducer) | Conversion of intra-arterial blood
pressure measurements into electrical
signals (via transducer) | Same |
| Materials | IBP signal processing board housed in
MR400 Cart with connection ports for
P1 or P2 channels. | IBP signal processing board housed in
3883 ipPOD with connection ports for
P1 and P2 channels. | Substantially
equivalent |
| IBP Information
Displayed | 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:
| FDA
Recognition
| Standard # | Standard Development Organization /
Title of Standard | Revision/Year | Results |
|-------------------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------|
| 19-4 | 60601-1* | IEC/ Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential Performance | Edition 3.1 2005/(R)2012
And A1:2012 | Pass |
| 19-5 | 60601-1-2* | IEC/ Medical Electrical Equipment - Part 1-2: General
Requirements 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: 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 | Edition 2.1 2012 | Pass |
| 3-126 | 60601-2-27 | IEC/ Medical Electrical Equipment - Part 2-27: Particular
Requirements For The Basic Safety And Essential
Performance 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: Particular
Requirements For The Basic Safety, Including Essential
Performance, Of Invasive Blood Pressure Monitoring
Equipment | Edition 3.0 2011 | Pass |
Table 5-2, FDA Recognized Consensus Standards Summary Table:
11
| FDA
Recognition
| Standard # | Standard Development Organization /
Title of Standard | Revision/Year | Results |
|-------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|---------|
| 3-123 | 80601-2-30 | ISO/ Medical Electrical Equipment - Part 2-30: Particular
Requirements For The Basic Safety And Essential
Performance Of Automated Non-Invasive
Sphygmomanometers | Edition 1.1 2013 | Pass |
| 1-96 | 80601-2-55 | ISO/ Medical Electrical Equipment - Part 2-55: Particular
Requirements For The Basic Safety And Essential
Performance Of Respiratory Gas Monitors | Edition 1.0 2011 | Pass |
| 6-232 | 80601-2-56 | ISO/ Medical Electrical Equipment - Part 2-56: Particular
Requirements For Basic Safety And Essential Performance
Of Clinical Thermometers For Body Temperature
Measurement | Edition 1.0 2009 | Pass |
| 1-85 | 80601-2-61 | ISO/ Medical Electrical Equipment - Part 2-61: Particular
Requirements For Basic Safety And Essential Performance
Of Pulse Oximeter Equipment | Edition 1.0 2011 | Pass |
| 5-40 | 14971* | ISO/ Medical Devices - Application Of Risk Management
To 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 of
Magnetically Induced Displacement Force on Medical
Device in MR Environment | 2015 | Pass |
| 8-128 | F2213-11* | ASTM/ Standard Test Method For Measurement Of
Magnetically Induced Torque On Medical Devices In The
Magnetic Resonance Environment | 2011 | Pass |
| 19-13 | 62133 | IEC/ 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 [Including:
Corrigendum 1 (2013)] | Edition 2.0 2012 | Pass |
| 5-114 | 62366 | IEC/ Medical Devices - Part 1: Application Of Usability
Engineering To Medical Devices [Including
CORRIGENDUM 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
12
(K172200) and the IBP parameter-specific predicate device, Invivo's Expression MR400 MRI Patient Monitoring System (K152330).