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The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) are intended for use by healthcare professionals.

The Expression MR200 MRI Patient Monitoring System (Model MR200) and the Expression IP5 Information Portal (Model IP5) provide monitoring for the following vital sign parameters: ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, carbon dioxide (CO2).

The modified device, the Expression MR200 MRI Patient Monitoring System, is predicated from the MRI Patient Monitoring System (Model 865214) that received clearance to market under 510(k) K090785 on December 15, 2009. The modified device, the Expression IP5 Information Portal is predicated from the Expression Information Portal that received clearance to market under 510(k) K121424 on June 13, 2012. The Expression IP5 is a supplement to the Expression MR200 display; together they comprise a medical system. The Expression MR200 incorporates the same indications for use and fundamental scientific technology used in the cleared device, the MRI Patient Monitoring System (Model 865214). As such, the modified Expression MR200 MRI Patient Monitoring System is substantially equivalent to the cleared device. The Expression IP5 incorporates the same indications for use and fundamental scientific technology used in the cleared device, the Expression Information Portal. As such, the Expression IP5 is substantially equivalent to the cleared device.

The cleared MRI Patient Monitoring System (Model 865214) consists of a processing unit within a Cart, a detachable wireless display, wireless ECG module, and wireless SpO2 module. The cleared device communicates wirelessly with the Expression IP5. The Expression IP5 is a supplement or alternate for the MRI Patient Monitoring System (Model 865214) display. The Expression IP5 does not perform any data collection or processing as a stand-alone patient monitoring system. The Expression IP5 relies upon the MRI Patient Monitoring System (Model 865214) processing unit, wireless modules, and patient applied parts to complete data collection and processing. Identical to the cleared device, the Expression MR200 is capable of operating from AC mains or battery power and the wireless modules operate on battery power only. The modified device, the Expression MR200 MRI Patient Monitoring System, is structurally identical to the cleared device with the exception of the following:

• The Expression MR200 power supply is built into the Cart (rather than a separate external power converter connected to the Cart via power cord).
• The Expression MR200 display is not detachable from the Cart. Subsequently, the carrying handle has been removed from the permanent display and the transmission of information between the Cart and the MR200 display is not wireless.
• The speaker is located on the top rear of the Cart display (rather than the front of the display).
• The Alarms Setup, Printer Setup, and Monitor Setup functions are collapsed within one Setup key on the keypad which is visible to the operator at all times (rather than separate keys for each Setup function). This feature is identical to the cleared Expression IP5.
• The alarm light located on the top of the display is removed. (Other visual alarm indicators consistent with IEC 60601-1-8, error messages, and audible alarms are still provided on the modified display, identical to the cleared device. Note that the alarm light is an optional visual indication per IEC 60601-1-8.)
• A printer option is not offered in the Expression MR200 display. (The printer is provided as separate USB-connected peripheral equipment to the Expression IP5, identical to the cleared Expression IP5.)
• The NiBP and CO2 connector ports on the Expression MR200 Cart are revised slightly to accommodate the new unique connectors.
• The mechanical aesthetic design of the Cart was made consistent with other patient monitoring devices distributed by Philips Medical Systems.

The modified Expression IP5 is a supplement to the Expression MR200 display. Identical to the cleared device, the Expression IP5 operates on AC mains power only. Identical to the cleared devices, communication between the Expression MR200 and the Expression IP5 is wireless and the Expression IP5 relies upon the Expression MR200 processing unit, wireless modules, and patient applied parts to complete data collection and processing.

The cleared device provides patient monitoring data for ECG, pulse oximetry (SpO2), respiration, non-invasive blood pressure (NiBP), invasive blood pressure (IBP), temperature, oxygen (O2), end-tidal carbon dioxide (CO2), and anesthetic agents. The cleared device is capable of providing the patient's pulse rate data derived from ECG, SpO2, or NiBP. The modified device, the Expression MR200, employs the same parameters as those cleared to market in 510(k) K090785 with the exception of invasive blood pressure, temperature, oxygen, and anesthetic agents. The modified device is capable of providing the patient's pulse rate data derived from ECG or SpO2 only; NiBP-derived pulse rate is not provided in the modified device. The cleared and modified devices are intended for the neonatal. pediatric, and adult patient populations. The cleared and modified devices provide user-adjustable alarms which are generated by the patient monitoring system display and the Expression IP5 display.

The wireless ECG module collects all ECG data, performs most of the ECG gradient filtering, and transmits the data to the processing unit within the Expression MR200 Cart. Additional ECG filtering, data processing, and heart rate derivation is performed in the Expression MR200 Cart. The modified device incorporates the same wireless ECG module, ECG processor in the Cart, and electrodes that are currently used with the cleared device. All ECG patient cables are identical to those cleared to market with the MRI Patient Monitoring System (Model 865214), with the exception of the Advanced Filter ECG Cable. The ECG leads on the Advanced Filter ECG Cable have been lengthened from 5 inches to 11 inches for improved performance during Vectorcardiography (VCG) applications when providing signals for synchronization for the MRI scanner. The cable trunk design that includes the resistance and insulation, the connector. and the electrode clips are identical to the cleared device. The modified device has the same intended use, indications for use, performance specifications, and labeling as the cleared device regarding ECG.

The cleared device's SpO2 patient data is obtained from the wireless SpO2 module. The wireless SpO2 module collects and processes all SpO2 and bellowsderived respiration data and transmits the data to the processing unit within the cleared device's Cart. Identical to the cleared device, the modified device's SpO2 patient data is obtained from the cleared wireless SpO2 module. The wireless SpO2 module collects and processes all SpO2 and bellows-derived respiration data and transmits the data to the processing unit within the modified device's Cart. The modified device incorporates the same wireless SpO2 module, fiber optic sensor, clips, and grips that are currently used with the cleared device. Therefore, the modified device has the same intended use, indications for use, performance specifications, and labeling as the cleared device regarding SpO2.

The cleared device's NiBP patient data is collected and measured in the processing unit within the Cart. Identical to the cleared device, NiBP data collection and measurement is performed in the modified device's processing unit within the Cart. However, in the modified device, the NiBP data collection and measurement is completed using the picoNBP OEM module that was cleared to market in 510(k) K051366 on September 14, 2005. The picoNBP OEM module is a complete non-invasive arterial blood pressure measurement unit that incorporates all hardware control and signal processing and the algorithms to derive systolic, diastolic, and mean blood pressure. The derived data is provided to the Expression MR200 MRI Patient Monitoring System.

The cleared device's CO2 patient data is collected and measured in the processing unit within the Cart. Identical to the cleared device, inspired and end-tidal CO2 data collection and measurement is performed in the modified device's processing unit within the Cart. However, in the modified device, the CO2 data collection and measurement is completed using the LoFlo C5 CO2 sensor that was cleared to market in 510(k) K053174 on January 12, 2006.

The cleared device's respiration patient data is bellows-derived from the SpO2 measurement. The modified device's respiration patient data can be bellowsderived from the SpO2 measurement, identical to the cleared device, or derived from the CO2 measurement.

The cleared device's processing unit transmits the patient data and power/communication status to the detachable display and the Expression IP5 using telemetry. Identical to the cleared device, the modified device's processing unit transmits the patient data and power/communication status to the Expression IP5 using telemetry. However, the modified device's processing unit transmits the patient data and power/communication status to the Expression MR200 immovable display using a wired connection. In the cleared and modified devices, all data and status transmission occurs simultaneously using a transceiver and antenna that support bi-directional 2.4 GHz wireless communication and operate within the frequency band reserved for industrial, scientific, and medical (ISM) equipment.

The cleared device's detachable display and the modified device's permanent display incorporate an LCD display for viewing, and keypad and rotary knob for navigation. When located within the MR control, induction, or recovery rooms, the cleared device's detachable display may provide data output to the Hospital Information System (HIS) in ASCII character format via connection to a thirdparty serial-to-Ethernet adapter wired to the RS232 port on the rear of the display. In addition, the cleared device may provide data output to the HIS in HL7 format via a standard Ethernet connection on the cleared Expression IP5. The modified device, the Expression MR200, does not provide HIS-interface data output directly from the Expression MR200. However, the Expression MR200 may provide HIS-interface data output via the modified Expression IP5 in a manner identical to the cleared device. The cleared and modified Expression IP5s provide data output to the HIS in HL7 format, compliant to HL7 Messaging Standard Version 2.6. No data is input from the HIS to the cleared or modified devices. The cleared and modified Expression IP5 Information Portals employ a touchscreen LCD display.

This document describes the 510(k) summary for the Expression MR200 MRI Patient Monitoring System and Expression IP5 Information Portal. This is a submission for modifications to a previously cleared device, not a new device. Therefore, the "acceptance criteria" discussed are primarily compliance with various standards and verification/validation activities to demonstrate that the modifications do not negatively impact safety and effectiveness and that the modified device remains substantially equivalent to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification submission for a patient monitoring system, the acceptance criteria are not typically expressed as specific performance metrics in a table like one would see for a diagnostic device. Instead, they are framed as compliance with recognized standards and successful verification/validation of design changes. The document repeatedly states that the device "complies with the applicable requirements of these standards" and "operates as intended within the performance specifications."

Here's a summary of the types of "acceptance criteria" and the reported "performance" based on the provided text, focusing on the changes and how their performance was validated:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a "test set" in terms of patient data or clinical samples for a performance study. This submission is for modifications to an existing device, focusing on engineering verification and validation against standards and specifications. The "sample" would entail the physical product (e.g., modified ECG cables, new NiBP hoses, specific CO2 sensors) and the modified system itself undergoing various engineering and laboratory tests.
• Data Provenance: The document does not mention the country of origin of data or whether it was retrospective or prospective, as it relies on engineering testing and compliance with standards rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable. The device relies on compliance with established national and international standards and verification of engineering requirements, not on expert consensus on clinical ground truth. For components like the CO2 sensor and NiBP module, vendor verification data was reviewed.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical study involving human judgment or adjudication. The "adjudication" was effectively through compliance with pre-defined engineering specifications and national/international standards via laboratory testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This device is a patient monitoring system, not a diagnostic imaging or interpretation aid, and the submission focuses on engineering modifications and regulatory compliance. Therefore, comparative effectiveness with or without AI assistance for human readers is not relevant to this submission.

6. Standalone Performance Study (Algorithm Only)

This information is not explicitly detailed as a distinct "standalone" study in the context of an "algorithm only" performance. The product is a physical patient monitoring system. However, the document does state that the new NiBP module (picoNBP OEM module) incorporates "all hardware control and signal processing and the algorithms to derive systolic, diastolic, and mean blood pressure," and the CO2 sensor (LoFlo C5 CO2 sensor) was also evaluated. The "performance specifications" for the entire system were verified and validated, meaning the internal algorithms' output (e.g., derived heart rate, SpO2, blood pressure values) met the required accuracy and reliability against reference standards during testing. There's no specific "algorithm-only" study separated from the device's integrated function.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation studies described would be:

• Reference Standards: Measurements from calibrated reference equipment conforming to national and international standards (e.g., for ECG, SpO2, NiBP, CO2 accuracy).
• Regulatory Standards: Compliance with specific clauses and requirements of standards like IEC 60601 series, ISO 80601 series, ASTM standards, FCC regulations, etc.
• Design Specifications: The internal performance specifications defined by Invivo Corporation based on market needs, risk management, and intended use.

8. Sample Size for the Training Set

This information is not applicable. This submission describes modifications to a patient monitoring system, which does not involve a "training set" in the context of machine learning or AI models. The device's underlying technology relies on established physiological measurement principles and signal processing, not data-driven (AI) training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for this device.

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