The monitors are intended to be used for monitoring of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are only for use on one patient at a time. They are not intended for use in transport situations. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments.

The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentani, Desflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

Device Description

The IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors.

The monitors support multiple non-invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse.

The monitor models MX750 and MX850 differ mainly in size. While MX750 has a 19" flat panel display, MX850 has a 22″ display.

AI/ML Overview

This K221348 510(k) summary document describes the Philips IntelliVue Patient Monitor MX750 and MX850. It primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of compatibility with external Masimo measurement devices.

Based on the provided document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria (e.g., accuracy, precision thresholds) for each physiological parameter measured by the IntelliVue Patient Monitors MX750 and MX850, nor does it provide detailed reported performance values for these criteria in the context of this specific 510(k) submission.

Instead, the document states:

"Performance specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications remain unchanged" from the predicate devices.
"performance specifications of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine remain unchanged."

This implies that the acceptance criteria and reported device performance for the core functionalities of the IntelliVue Patient Monitor MX750 and MX850 (excluding the newly added external measurements) are inherently covered by the predicate devices they are compared against. For the newly integrated Masimo modules, their performance criteria and data are derived from their own prior clearances (K162603, K123043, K171121, K172890).

Therefore, a table cannot be directly constructed from this document as it doesn't provide new, specific performance data for the current submission's acceptance criteria beyond referencing existing performance.

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

The document states:

"Non-clinical Bench Tests: There were no new questions of safety or effectiveness introduced as a result of using this device."
"Clinical Studies: The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo O3, IRMA CO2, ISA CO2 and SedLine parameters are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor."

This indicates that no new test set (clinical or otherwise) with a specific sample size was used for this 510(k) submission to evaluate the primary IntelliVue devices' performance beyond what was established for their predicates. The assessment relies on the existing validation of the predicate IntelliVue device and the individual Masimo modules.

Therefore, sample sizes for a new test set are not applicable here. The provenance of existing data would refer to the previous submissions for the predicate IntelliVue devices and the Masimo modules, which are not detailed in this document.

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

As no new clinical studies or test sets were conducted for this 510(k) submission to establish new performance data, there is no information provided regarding a number of experts used to establish ground truth or their qualifications. The submission asserts that the performance characteristics (and thus, the ground truth establishment) of the individual components (IntelliVue monitor and Masimo modules) remain unchanged from their prior clearances.

4. Adjudication Method for the Test Set

Since no new test set was generated for this 510(k) submission (as per point 2), no adjudication method specific to this submission's test set is detailed.

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

The document states that "The subject devices, like the primary predicate devices, did not require clinical trials." This implies that no MRMC comparative effectiveness study was performed for this submission. The device is a patient monitor, not typically evaluated with MRMC studies in the way imaging AI algorithms are.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

The document focuses on the integration of external modules into an existing patient monitor. While the individual Masimo modules (O3, IRMA CO2, ISA CO2, SedLine) likely had standalone performance studies as part of their original clearances, this 510(k) document does not report new standalone performance studies for the integrated system or its individual components in this context. The core assertion is that the measurements are not modified, only the host monitor connection.

7. Type of Ground Truth Used

Given that no new studies were conducted, the document implicitly relies on the ground truth established during the previous clearances of the predicate IntelliVue monitors and the Masimo modules. The specific types of ground truth for these physiological parameters would typically involve:

Reference standard measurements: Comparison against highly accurate and precise clinical instruments for parameters like ECG, SpO2, blood pressure, CO2.
Clinical observation and expert interpretation: For conditions like arrhythmia detection (ECG) or state of brain monitoring (EEG/BIS/SedLine), ground truth might involve expert review of physiological waveforms and patient state.
Pathology/Outcomes data: Not explicitly mentioned or typically applicable for patient monitoring as a primary ground truth.

However, this document does not detail the specific ground truth methodologies used in those prior studies.

8. Sample Size for the Training Set

The document describes a 510(k) submission for a patient monitor and the integration of external modules. This type of device relies on established algorithms for physiological parameter measurement, rather than a machine learning model that requires a distinct "training set" in the common sense of AI/ML software. Therefore, the concept of a "training set sample size" as typically used for AI/ML does not directly apply or is not detailed here. The algorithms used in the Masimo modules and the Philips monitor were developed and validated, but this process doesn't align with a "training set" in the AI/ML context.

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

As explained in point 8, the concept of a "training set" in the AI/ML sense is not applicable or detailed in this document for these types of patient monitoring algorithms. Therefore, information on how ground truth for a training set was established is not present. The algorithms' foundational accuracy would have been established through a combination of engineering, physiological principles, and validation against clinical reference standards, as mentioned above for "Type of Ground Truth."

Summary

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February 3, 2023

Philips Medizin Systeme Böblingen GmbH Stefan Breuer Senior Regulatory Affairs Engineer Hewlett-Packard Str. 2 Böblingen, BW 71034 Germany

Re: K221348

Trade/Device Name: IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: May 12, 2022 Received: January 4, 2023

Dear Stefan Breuer:

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shruti N. Mistry -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221348

Device Name

IntelliVue Patient Monitor MX750 (866471); IntelliVue Patient Monitor MX850 (866470)

Indications for Use (Describe)

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neontors are intended for use by trained healthcare professionals in a hospital environment.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

Remifentanil, and Sevoflurane. The Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

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.

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510(k) Summary

510(k) Summary
1.1 Submitter
Date Prepared	April 27, 2022
Submitter/Owner	Philips Medizin Systeme Böblingen GmbHFDA Establishment Number 9610816Hewlett-Packard-Str. 271034 BöblingenGermanyPhone: +49 151 1961 5514Fax: +49 7031 463 2442
Key Contact	Stefan BreuerSenior Regulatory Affairs EngineerStefan.Breuer@philips.com
510(k) Submission Type	This is a traditional 510(k).
1.2 Device
Trade Name	IntelliVue Patient Monitor MX750IntelliVue Patient Monitor MX850
Common Name	Multiparameter Patient Monitor
Classification Name	Panel & Name: Cardiovascular DevicesSubpart & Division: 21 CFR §870.1025Regulatory Class: IIProduct Code: MHX
1.3 Predicate Device
	510(k) No.	Company	Device Name	Product Code
Primary Predicate Device	K210906	Philips	IntelliVue Patient Monitor MX750IntelliVue Patient Monitor MX850	MHX
Reference Devices	K162603	Masimo	O3 Regional Oximeter System	MUD
	K123043	Masimo	Infrared Mainstream (IRMA) CO2 Gas Analyzer	CCK
	K171121	Masimo	Infrared Sidestream (ISA) CO2 Gas Analyzer	CCK
	K172890	Masimo	SedLine Sedation Monitor	OLW

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The subject devices are substantially equivalent to the legally marketed predicate devices.

1.4 Device Description

IntelliVue Patient Monitors MX750 and MX850 – description of the device per 21 CFR 807.92(a) (4)

The monitor models MX750 and MX850 differ mainly in size. While MX750 has a 19" flat panel display, MX850 has a 22″ display.

1.5 Indication for Use

Intended Use as required per 21 CFR 807.92(a)(5)

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

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BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

1.6 Comparison of Intended Uses for Subject Device and Predicate

The modified IntelliVue MX750 and MX850 have the same intended use and indications as the predicate devices, with the addition of the following paragraphs, which have been adopted without change from the predicate devices Masimo O3 Regional Oximeter System and Masimo SedLine Sedation Monitor:

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· The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and <40 kg, in healthcare environments.
The SedLine Sedation Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentany), Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The SedLine Sedation Monitor is intended for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.

Adding compatibility to Masimo IRMA CO2 and ISA CO2 does not affect the intended use or indications for use of the IntelliVue MX750 and MX850. The predicate devices IntelliVue MX750 and MX850 have already been able to measure Mainstream CO2 and Sidestream CO2 using measurement modules of the same technologies as the subject devices. Therefore, adding compatibility to Masimo IRMA CO2 and ISA CO2 merely gives the customer a broader choice of CO2 measurements, but does not add indications for use or intended uses to the IntelliVue MX750 and MX850.

1.7 Comparison of Technological Characteristics with Predicate Device
Similarities
Item ofComparison	Description/Rationale
Device Design	device design of subject devices is the same as for the predicate devices unchanged hardware and software architecture monitor hardware entirely unchanged device design of added external measurements Masimo O3 Regional Oximeter System Masimo IRMA CO2 and ISA CO2 Masimo SedLine is identical to their predicate devices
Materials	• same materials used as those of the predicate devices
	• materials used in the new plug-in modules– O3 (867184)– CO2 (867185)– SedLine (867186)are the same as those of other legally marketed plug-in modules
	• biocompatibility aspects do not apply because the devices do not havepatient contact.
	• materials used in the added external measurements– Masimo O3 Regional Oximeter System– Masimo IRMA CO2 and ISA CO2– Masimo SedLineare identical to their predicate devices.
	• biocompatibility aspects of accessories are not affected, because allaccessories of the predicate devices remain unchanged
	Energy Source
		Software/HardwareFeatures

• hardware and software of the added external measurements– Masimo O3 Regional Oximeter System– Masimo IRMA CO2 and ISA CO2– Masimo SedLineis unchanged from their predicate devices
• measurements of physiological parameters are exactly the same as in thepredicate devices
PhysiologicalParameters	existing physiological parameters of the predicate devices remain unchanged the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine are the same as those of their respective predicate devices
Performancespecifications	specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications remain unchanged performance specifications of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine remain unchanged
Operating Principleand Mechanism ofAction	unchanged from the predicate devices
Human Interface	human interface of the IntelliVue MX750 and MX850 remains exactly the same the newly added external measurements Masimo O3 Masimo SedLine do not have a human interface of their own; the Masimo IRMA CO2 Masimo ISA CO2 only have a status LED. Data presentation and user control are done through the connected host monitor, same as for their predicate devices
MeasurementAccessories	all accessories of the predicate devices IntelliVue Patient Monitor MX750 IntelliVue Patient Monitor MX850 as well as those of the added external measurements Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine are re-used without any change
Differences
Hardware	three new plug-in modules O3 (product number 867184) CO2 (product number 867185) SedLine (product number 867186) are created, which act as a digital communication interface between the IntelliVue Patient Monitors MX750/MX850, and the external Masimo measurement devices the CO2 plug-in module interfaces both CO2 gas analyzers: IRMA CO2 and ISA CO2 the new plug-in modules do not alter or modify the contents of the transferred data the new plug-in modules also provide electrical isolation for both power and communication between patient monitor and the external O3, IRMA CO2, ISA CO2 and SedLine measurement devices; the patient isolation circuit is the same as for other legally marketed plug-in modules for the IntelliVue patient monitor family the predicate external measurement devices Masimo O3 Masimo IRMA CO2 and ISA CO2 Masimo SedLine also connect to a host monitor / backboard device using an isolated digital interface, where the isolation has to be provided by that host monitor / backboard device; the new plug-in modules 867184, 867185 and 867186 provide exactly this isolated digital interface as optional plug-in modules, specialized for the IntelliVue Patient Monitors MX750 and MX850
Software	The software of the subject devices IntelliVue MX750 and MX850 has been extended so that the new plug-in modules will be accepted as compatible and the physiological data provided by the Masimo O3, IRMA CO2, ISA CO2 and SedLine measurement devices will be displayed on the patient monitor screen.
PhysiologicalParameters	For marketing reasons, the proposed modification does not provide the parameters and graphical presentations Delta SpO2 / ΔSpO2 (O3) DSA (SedLine) which the predicate devices are providing.

f Technological Characteristics with Predicate Device

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Substantial Equivalence Summary

Operational and technological characteristics form the basis for the determination of substantial equivalence of the subject devices with the legally marketed predicate devices. The subject devices are substantially equivalent to the predicate devices.

1.8 Performance Data

Non-Clinical Tests – Harmonized Standards

The subject devices have passed all safety tests for demonstrated compliance with the recognized standards below.

Standard	FDARecognition #	Title #
IEC 62304 Edition 1.12015-06 consolidatedversion	13-79	Medical device software - Software life cycle processes
ANSI AAMI ES60601-1:2005/(R)2021 andA1:2012	19-4	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance
IEC 60601-1-2 Edition4.0 2014-02	19-8	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Electromagneticdisturbances - Requirements and tests
IEC60601-1-8 Edition2.1 2012-11	5-76	Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements tests and guidance for alarm systems inmedical electrical equipment and medical electricalsystems
ISO 80601-2-55 Secondedition 2018-02	1-140	Medical electrical equipment - Part 2-55: Particularrequirements for the basic safety and essentialperformance of respiratory gas monitors

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Non-clinical Bench Tests

There were no new questions of safety or effectiveness introduced as a result of using this device.

Clinical Studies

The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo O3, IRMA CO2, ISA CO2 and SedLine parameters are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor.

FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the subject devices.

Based upon the design, intended use, indications for use, classification, usability and safety testing, the subject devices are substantially equivalent to the listed predicate devices.

There were no new questions of safety or effectiveness introduced as a result of using this device.

1.9 CONCLUSIONS

The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, human factors and usability demonstrate that the modified devices do not raise different questions of safety and effectiveness when compared to the predicate, perform as intended, and have performance characteristics that are substantially equivalent to the predicate devices.

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Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.