(127 days)
Not Found
No
The summary describes a standard multi-parameter patient monitoring system that processes and displays vital signs. There is no mention of AI, ML, or any advanced analytical techniques beyond basic signal processing and calculation of derived parameters.
No
The device is primarily for monitoring vital signs and does not provide any treatment or therapy. It is used to monitor patients during MRI procedures.
No
This device is described as a "patient monitoring system" that measures vital signs like ECG, SpO2, NIBP, etc. Its purpose is to monitor these parameters and provide signals for MRI scanner synchronization, not to diagnose a disease or condition. While it provides data that can be used by healthcare professionals for diagnostic purposes, the device itself is for monitoring, not diagnosis.
No
The device description explicitly lists multiple hardware components including a cart with touchscreen display, wireless modules, batteries, charger, and power cord, in addition to various accessories.
Based on the provided information, the Expression MR400 MRI Patient Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring vital signs for patients undergoing MRI procedures." This involves measuring physiological parameters directly from the patient's body (ECG, SpO2, NIBP, etc.).
- Device Description: The description details the components and parameters measured, all of which are related to monitoring the patient's physiological state in real-time.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly monitor the body itself. The Expression MR400 falls under the category of a patient monitoring system, which is a different type of medical device.
N/A
Intended Use / Indications 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 (02), and/or temperature.
Product codes
MWI
Device Description
The Expression MR400 is a multi-parameter patient monitoring system used to monitor the vital signs of patients in an MRI magnet room and throughout an MRI suite. The MR400's software simultaneously processes and displays multiple parameters, waveforms, measurement numeric values and alarms. All patient information is provided on a wheeled cart which consists of a patient monitor with a touch screen display. The device is powered by either AC line power or its internal battery. The standard and optional parameters which can be monitored by the MR400 include:
- Electrocardiogram (ECG)
- Heart rate (HR, ECG and SPO2 derived) ●
- Blood oxygen saturation/pulse oximetry (SPO2)
- End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) ●
- Invasive blood pressure (IBP) (P1 and P2) ●
- Anesthetic agents (AGENT) ●
- o Desflurane (DES)
- o Enflurane (ENF)
- o Halothane (HAL)
- o Isoflurane (ISO)
- o Sevoflurane (SEV)
- Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O ● and FiN2O)
- Temperature (TEMP) ●
- Non-invasive blood pressure (NIBP)
- . Respiration rate (CO2-derived and/or bellows-derived)
The MR400 consists of the following key components:
- Cart with touchscreen display ●
- Wireless ECG module .
- Wireless SpO2 module ●
- Batteries for both the Cart and Wireless Modules ●
- Battery charger ●
- Power cord ●
Accessories to the MR400 are offered to accommodate various patient sizes-neonatal, infant, pediatric, adult, and large adult. Key accessories include:
- . ECG lead cables and electrodes
- SPO2 probes and clips ●
- NIBP cuffs and hoses ●
- IBP transducer
- Temperature probe and sheath ●
- Cannulas ●
- Water traps ●
- Chest pneumograph ●
- Expression IP5 (optional secondary display for control room w/printer) ●
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
Not Found
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 modified device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and the specifications of the modified device. Results of the non-clinical testing demonstrate that the modified device operates as intended within the performance specifications and is substantially equivalent to the cleared device. The results do not raise issues regarding the safety and effectiveness of the device. Clinical data was not required to substantiate claims of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2015
Invivo Corporation c/o Christine Trefethen Regulatory Manager Philips Medical Systems 3000 Minuteman Rd. Andover, MA 01801
Re: K152330
Trade/Device Name: Expression MR400 MRI Patient Monitoring System (Model MR400) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: November 24, 2015 Received: November 25, 2015
Dear Christine Trefethen:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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), 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 yours,
Mitchell Stein
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) K152330
Page 1 of 1
Device Name
Expression MR400 MRI Patient Monitoring System (Model MR400)
Indications for Use (Describe)
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 (02), and/or temperature.
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 Invivo logo. The logo consists of a purple circle with the letter "i" inside, followed by the word "Invivo" in purple. Below the word "Invivo" is the text "A Philips Company" in gray.
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SPECIAL 510(K) SUMMARY
SUBMITTER INFORMATION
| Establishment Name:
Establishment Address: | Invivo Corporation
12151 Research Parkway
Orlando, FL 32826 USA |
|-----------------------------------------------|------------------------------------------------------------------------------------------------|
| Company Phone: | (407) 252-0414 |
| Company Fax: | (407) 249-2022 |
| Person to contact
regarding questions: | Rusty Kelly
Sr. Manager Quality and Regulatory
(407)-252-0414
Rusty.Kelly@philips.com |
| Establishment
Registration Number: | 1051786 |
DEVICE IDENTIFICATION
Date Summary Prepared:
| Trade name: | Expression MR400 MRI Patient Monitoring
System (Model MR400) |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Common name: | MRI patient monitoring system |
| Classification name: | Cardiac monitor (including cardiotachometer and
rate alarm)
(21 CFR 870.2300, Product Code MWI) |
August 11, 2015
4
IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE
The Expression MR400 MRI Patient Monitoring System also referred to as the Expression MR400 or MR400, is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Clearance Date |
|---|---|---|---|
| MRI Patient Monitoring System | |||
| (Model 865214) | Invivo Corporation | K124061 | Feb 22, 2013 |
DEVICE DESCRIPTION
The Expression MR400 is a multi-parameter patient monitoring system used to monitor the vital signs of patients in an MRI magnet room and throughout an MRI suite. The MR400's software simultaneously processes and displays multiple parameters, waveforms, measurement numeric values and alarms. All patient information is provided on a wheeled cart which consists of a patient monitor with a touch screen display. The device is powered by either AC line power or its internal battery. The standard and optional parameters which can be monitored by the MR400 include:
- Electrocardiogram (ECG)
- Heart rate (HR, ECG and SPO2 derived) ●
- Blood oxygen saturation/pulse oximetry (SPO2)
- End-tidal and fractional inspired CO2 (EtCO2 and FiCO2) ●
- Invasive blood pressure (IBP) (P1 and P2) ●
- Anesthetic agents (AGENT) ●
- o Desflurane (DES)
- o Enflurane (ENF)
- o Halothane (HAL)
- o Isoflurane (ISO)
- o Sevoflurane (SEV)
- Fractional inspired O2 (FiO2), and end-tidal and fractional inspired N2O (EtN2O ● and FiN2O)
- Temperature (TEMP) ●
- Non-invasive blood pressure (NIBP)
- . Respiration rate (CO2-derived and/or bellows-derived)
5
The MR400 consists of the following key components:
- Cart with touchscreen display ●
- Wireless ECG module .
- Wireless SpO2 module ●
- Batteries for both the Cart and Wireless Modules ●
- Battery charger ●
- Power cord ●
Accessories to the MR400 are offered to accommodate various patient sizes-neonatal, infant, pediatric, adult, and large adult. Key accessories include:
- . ECG lead cables and electrodes
- SPO2 probes and clips ●
- NIBP cuffs and hoses ●
- IBP transducer
- Temperature probe and sheath ●
- Cannulas ●
- Water traps ●
- Chest pneumograph ●
- Expression IP5 (optional secondary display for control room w/printer) ●
INDICATIONS 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 (02), and/or temperature.
TECHNOLOGICAL CHARACTERISTICS
The modified device has the same fundamental scientific technology as the predicate device.
6
| Technological
Characteristic | Predicate: MRI Patient
Monitoring System
(K124061) | Modified Device: Expression
MR400 MRI Patient
Monitoring System | Comparison |
|--------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Cart | | | |
| Display | Detachable, located on
top front of display | Permanently installed, located on
the rear of the display | Substantially
Equivalent |
| Expression IP5 | Software is compatible
with the predicate device | Software was updated to be
compatible with the predicate
device and the Expression
MR400 | Substantially
Equivalent |
| Printer | Integrated on side of
display | No printer permanently installed
on display. | Substantially
Equivalent |
| Alarms Set Up,
Printer Set Up and
Monitor Set Up | Separate key on the
keypad which is visible to
the operator at all times | Collapsed within one Setup key
on the virtual keypad that is
visible to the operator at all times | Substantially
Equivalent |
| Power Supply | External | Integrated | Substantially
Equivalent |
| Internal Batteries | Four User-replaceable | Two Permanently installed and
two User-replaceable | Substantially
Equivalent |
| Alarms | Vital Sign Alarms | Added user adjustable alarms for
extreme bradycardia, extreme
tachycardia, apnea and
desaturation | Substantially
Equivalent |
| Non-Invasive Blood Pressure | | | |
| NIBP Connector | Connector ports are for
unique predicate
accessories | Accommodate locking
connectors unique to the
modified device accessories | Substantially
Equivalent |
| NIBP Hose | 3 meters in length | 5 meters in length | Substantially
Equivalent |
| NIBP Data
Collection &
Measurement | Performed in the
processing unit within the
cart. | Performed in the processing unit
within the cart using the
picoNIBP OEM Module | Substantially
Equivalent |
| CO2 | | | |
| CO2 Connector | Connector ports are for
unique predicate
accessories | Accommodate locking
connectors unique to the
modified device accessories | Substantially
Equivalent |
| CO2 Collection &
Measurement
CO2 cannula | Completed using
Excelitas CO2 Sensor
22 ft. in length | Completed using LoFloC5 Co2
Sensor
17ft. in length | Substantially
Equivalent |
| ECG | | | |
| ECG Cable Cover | Wire bundle enclosed in a
silicone foam trunk | Flat wire assembly enclosed in
Azote foam | Substantially
Equivalent |
| Wireless ECG
Module- communication | 5 user-selectable
networks | 10 user-selectable networks.
(only 5 per module, either 1-5 or
6-10) | Substantially
Equivalent |
| Wireless ECG
Module- battery | Operates on one (1) 3.7
VDC user-replaceable
lithium battery | Operates on two (2) 3.7 VDC
user-replaceable lithium batteries | Substantially
Equivalent |
| Wireless ECG
Module- housing | Plastic covering, single
battery slot, Ingress
Protection IPX1 | Plastic housing made of same
materials as predicate, supports
two batteries, has eject buttons
for batteries, improved Ingress
Protection rating of IP21 | Substantially
Equivalent |
| SPO2
Wireless SPO2
Module- communication | 5 user-selectable
networks | 10 user-selectable networks.
(only 5 per module, either 1-5 or
6-10) | Substantially
Equivalent |
| Wireless SPO2
Module- housing | Plastic covering, single
battery slot, Ingress
Protection IPX1 | Plastic housing made of same
materials as predicate, has eject
button for battery, improved
Ingress Protection rating of IP21 | Substantially
Equivalent |
7
SUMMARY OF NON-CLINICAL PERFORMANCE DATA
Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified device with respect to the predicate. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and the specifications of the modified device. Results of the non-clinical testing demonstrate that the modified device operates as intended within the performance specifications and is substantially equivalent to the cleared device. The results do not raise issues regarding the safety and effectiveness of the device. Clinical data was not required to substantiate claims of safety and effectiveness. The modified device, the Expression MR400 MRI Patient Monitoring System, described in this submission is substantially equivalent to the cleared device, the MRI Patient Monitoring System (Model 865214).