(96 days)
Not Found
No
The summary describes a standard vital signs monitor and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No
The device is a patient monitoring system designed to measure vital signs, not to treat a condition or disease.
No
The device is a patient monitoring system designed to display vital signs during MRI procedures. It measures various physiological parameters like ECG, SpO2, NIBP, and temperature, which is characteristic of monitoring, not diagnosing.
No
The device description clearly lists multiple hardware components, including a patient monitor with buttons and touch screen display, wireless PODs, battery, power supply, and various accessories like cables, sensors, and cuffs. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
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 Diagnostic devices are 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 while they are undergoing an MRI procedure. It measures things like ECG, blood pressure, temperature, SpO2, and respiratory gases. These measurements are taken in vivo (within the living body), not in vitro (outside the body in a lab setting).
- Intended Use: The intended use clearly states it's for monitoring a patient's vital signs during MRI procedures. This is a direct patient monitoring function, not a laboratory analysis of specimens.
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), 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).
Product codes
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 (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
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
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 |
Intended User / Care Setting
The 3880 MRI Patient Monitoring System is intended for use by healthcare professionals.
...for patients undergoing Magnetic Resonance Imaging (MRI) procedures.
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/0 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 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 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 |
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)
4
- 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
5
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:
| Technological
| Characteristic | Predicate Device: | Proposed Device: | Comparison |
|---|---|---|---|
| MIPM's | IRadimed Corporation's | (see Section 12 for | |
| detailed discussion of | |||
| Substantial Equivalence) | |||
| Tesla M3 MRI Patient Monitoring System | 3880 MRI Patient Monitoring System | ||
| (K142032) | (Pending 510(k)) | ||
| MONITOR | |||
| Intended Use | The MRI Patient Monitoring System | ||
| Tesla M3 is intended for monitoring of | |||
| vital signs during MRI examinations | |||
| (MRI procedures) of patients. |
The Tesla M3 is intended for use in the | 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. | Substantially
equivalent |
| | Predicate Device: | Proposed Device: | Comparison |
| Technological
Characteristic | MIPM's
Tesla M3 MRI Patient Monitoring System
(K142032) | IRadimed Corporation's
3880 MRI Patient Monitoring System
(Pending 510(k)) | (see Section 12 for
detailed discussion of
Substantial Equivalence) |
| | Adult, Pediatric and Neonatal
populations for the continuous
monitoring 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 MRI
Patient Monitoring System is intended to
monitor a single patient's vital signs for
patients undergoing Magnetic
Resonance Imaging (MRI) procedures. | |
| | The Tesla M3 is intended for use in the
Adult and Pediatric populations for the
continuous monitoring of Pulse
Oximetry (SpO2). | The 3880 MRI Patient Monitoring
System is intended for use by healthcare
professionals. | |
| | The Tesla M3 is intended for use by
health care 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 | |
| Monitor Materials | Housing mainly coated aluminum,
antimagnetic stainless steel, plastics | Housing mainly coated aluminum,
antimagnetic stainless steel, plastics | Substantially
equivalent |
| Display | Permanently installed on wheeled cart,
Touchscreen | No cart required, (optional mounting
accessory for attachment to wheeled
stand or patient bed), Touchscreen | Substantially
equivalent |
| | 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 into
AC mains power | Remote Monitoring Tablet (3885-T),
operates on battery power, can be
docked for charging and desktop use in
the Base Station (3885-B) which is
plugged into AC mains power | Substantially
equivalent |
| Monitoring
capabilities
(optional for both) | | | |
| MRI Conditions
of Use | Monitor: