(357 days)
No
The summary describes a standard multi-parameter vital signs monitor and does not mention any AI or ML capabilities.
No
The device is a patient monitoring system, which measures vital signs but does not provide any treatment or therapy.
No
The device is a patient monitoring system that measures and displays vital signs during MRI procedures. It does not diagnose. Its purpose is to monitor, not to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is a "multi-parameter vital signs monitor" and mentions hardware components like AC line power, internal battery, handle, and mounting options, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, the IRadimed Corporation's 3880 MRI Patient Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The 3880 MRI Patient Monitoring System directly monitors physiological parameters of a patient in vivo (within the living body) during an MRI procedure. It measures things like ECG, SpO2, NIBP, temperature, and respiratory gases.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of specimens taken from the patient.
Therefore, the 3880 MRI Patient Monitoring System falls under the category of a patient monitoring device, 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), Pulse Oximetry (SpO2), Non-Invasive Blood Pressure (NIBP), Temperature, Anesthetic Agents, Respiration, Capnography (CO2), and Oxygen (O2).
Product codes
MWI
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)
- 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
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and Pediatric, including Neonatal populations
Intended User / Care Setting
healthcare professionals.
MRI procedures/MRI suite.
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)
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.
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.
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.
Summary of results of testing: All standards listed (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30, IEC 80601-2-55, IEC 80601-2-56, IEC 80601-2-61, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10, ASTM F2052-15, ASTM F2503-13, ASTM F2213-11, IEC 62133) passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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
2
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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3
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 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 |
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 |
4
| 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 |
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
- 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:
6
| Table 5-1, Technological Characteristic | Comparison Table of Primary Predicate: | ||
|---|---|---|---|
| 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
days of life | 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). | Same
Same
Substantially
Equivalent |
| 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 |
| | Primary Predicate Device: | Proposed Device: | |
| | IRadimed Corporation's | IRadimed Corporation's | |
| Technological
Characteristic | 3880 MRI Patient Monitoring System
(K172200) | 3880 MRI Patient Monitoring System
(Pending 510(k)) | Comparison |
| MRI Conditions of
Use | Monitor: