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 Intelli Vue 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.

The monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for home use.

The MX400/MX450/MX500/MX550 monitors are additionally intended for use in transport situations within hospital environments.

Device Description

The IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and 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 at the patient bedside vicinity and can also be used during patient transport inside hospitals. The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display. The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

AI/ML Overview

This document is a 510(k) Summary for the Philips IntelliVue Patient Monitor MX400, MX450, MX500, and MX550. It does not describe a study involving an AI/algorithm that requires detailed acceptance criteria, ground truth establishment, or specific human reader studies as typically seen for AI-enabled medical devices. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to software and hardware modifications allowing integration with external measurement devices like the Masimo SedLine Sedation Monitor.

Therefore, many of the requested points, particularly those related to AI/algorithm performance studies (e.g., sample size for test set/training set, expert adjudication, MRMC studies, standalone performance, specific effect sizes), are not applicable to this type of 510(k) submission.

However, I can extract information related to the overall device performance and testing as described in the document.

Here's an analysis of the provided text in relation to your request, with an emphasis on what is and is not present:

Device: IntelliVue Patient Monitor MX400, MX450, MX500, MX550

Study Type: This is a 510(k) premarket notification primarily demonstrating substantial equivalence (predicate pathway) for modifications to an existing patient monitor, specifically related to software updates and integration of an external monitoring module (Masimo SedLine Sedation Monitor). It is not a de novo submission for a new AI/algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific quantitative acceptance criteria for an AI/algorithm's performance (e.g., accuracy, sensitivity, specificity metrics) nor does it provide a "reported device performance" table in that context.

Instead, the "acceptance criteria" can be inferred from the non-clinical tests performed to demonstrate compliance with recognized standards for medical electrical equipment. The "reported device performance" is that the device "passed all safety tests" and "perform as intended."

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with IEC 62304 Ed 1.1 (Software life cycle processes)	Passed all safety tests for demonstrated compliance with the standard
Compliance with ANSI AAMI ES60601-1 (Basic safety & essential performance)	Passed all safety tests for demonstrated compliance with the standard
Compliance with IEC 60601-1-2 Ed 4.0 (Electromagnetic disturbances)	Passed all safety tests for demonstrated compliance with the standard
Compliance with IEC 60601-1-8 Ed 2.2 (Alarm systems)	Passed all safety tests for demonstrated compliance with the standard
Compliance with IEC 60601-1-6 Ed 3.1 (Usability)	Passed all safety tests for demonstrated compliance with the standard
No new issues of substantial equivalence introduced	Substantially equivalent to predicate devices; performs as intended

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable/not specified for an AI/algorithm test set. The testing described is primarily for system-level safety, performance, and software validation.
Data Provenance: Not applicable in the context of an AI/algorithm dataset. The document discusses compliance with various electrical, safety, software, and usability standards for the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth establishment by experts is typically for diagnostic AI/imaging algorithms. This submission is for a patient monitor system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for expert review of images or clinical data for AI algorithm validation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a patient monitor, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm in the sense of a diagnostic or predictive model being evaluated in standalone mode. It's a medical device system. While it has "software," the performance evaluation is centered on its functionality as a patient monitor and its compliance with relevant standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's performance validation is its ability to correctly acquire, display, and alert on physiological parameters according to established benchmarks and safety standards (e.g., AAMI EC11 for ECG, IEC standards for electrical safety). It's not a diagnostic AI's ground truth based on clinical diagnoses or pathological findings.

8. The sample size for the training set

Not applicable. This is not an AI/ML model generated from a training set in the typical sense of deep learning or machine learning algorithms.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary of what the document does discuss regarding validation and performance:

The document emphasizes non-clinical bench tests and compliance with harmonized standards (e.g., IEC 62304 for software, ANSI AAMI ES60601-1 for basic safety, IEC 60601-1-8 for alarms, IEC 60601-1-6 for usability). The "performance data" section primarily lists these standards and states that the devices "passed all safety tests."

Key statements from the document regarding performance:

"The subject devices have passed all safety tests for demonstrated compliance with the recognized standards below." (See table in section 1.8 Performance Data)
"No new issues of substantial equivalence are introduced because of using this device." (Section "Non-clinical Bench Tests")
"The subject devices, like the primary predicate devices, did not require clinical trials. Any clinical studies performed for the Masimo SedLine parameter are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor." (Section "Clinical Studies")
"Compliance to the FDA Quality System Regulations, 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." (Section "Clinical Studies")
"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, usability and interoperability testing, 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." (Section 1.9 CONCLUSIONS)

In conclusion, this 510(k) submission for the Philips IntelliVue Patient Monitor MX series primarily relies on demonstrating compliance with recognized electrical safety, performance, and software development standards, along with a comparison to predicate devices, rather than an AI/algorithm performance study with specific metrics, expert adjudication, or MRMC studies.

Summary

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August 22, 2023

Philips Medizin Systeme Boeblingen GmbH Siegfried Breitling Regulatory Affairs Specialist Hewlett-Packard-Strasse 2 Boeblingen, BW 71034 Germany

Re: K223574

Trade/Device Name: IntelliVue Patient Monitor MX400 (866060), Intelli Vue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) 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, MLD, DSJ, DSK, DXN, DRT, DPS, DQA, DSF, MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWQ, GWS, FLL Dated: November 29, 2022 Received: November 30, 2022

Dear Siegfried Breitling:

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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

Jennifer W. Shih -S

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) K223574

Device Name

IntelliVue Patient Monitor MX400 (866060); IntelliVue Patient Monitor MX450 (866062); IntelliVue Patient Monitor MX500 (866064); IntelliVue Patient Monitor MX550 (866066)

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 only for use on one patient at a time.

The monitors are 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.

The monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for home use.

The MX400/MX450/MX500/MX550 monitors are additionally intended for use in transport situations within hospital environments.

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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510(k) Summary

510(k) Summary
1.1 Submitter
Date Prepared	November 29, 2022
Submitter/Owner	Philips Medizin Systeme Böblingen GmbHFDA Establishment Number 9610816Hewlett-Packard-Str. 271034 BöblingenGermany
Key Contact	Siegfried BreitlingRegulatory Affairs Specialistsiegfried.breitling@philips.comPhone: +49 151 200 443 77
510(k) Submission Type	This is a traditional 510(k).
1.2 Device
Trade Name	IntelliVue Patient Monitor MX400IntelliVue Patient Monitor MX450IntelliVue Patient Monitor MX500IntelliVue Patient Monitor MX550
Common Name	Multiparameter Patient Monitor
Classification Name	Panel & Name: Cardiovascular DevicesSubpart & Division: 21 CFR §870.1025Regulatory Class: IIClassification Product Code: MHXSubsequent Product Codes: MLD, DSJ, DSK, DXN, DRT, DPS, DQA, DSF,MSX, CCK, CBQ, NHO, NHP, NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI,GWQ, GWS, FLL
1.3 Predicate Device

	510(k) No.	Company	Device Name	Product Code
Predicate Device	K182979	Philips	IntelliVue Patient Monitor MX400IntelliVue Patient Monitor MX450IntelliVue Patient Monitor MX500IntelliVue Patient Monitor MX550	MHXDRT, DSI, DSJ, DSK, DXN, MLD, MSX

Image /page/4/Picture/6 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and four stars, also in white. The overall design is simple and recognizable, representing the brand's identity.

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	K172890	OLW
		GXY, OLT, OMC, ORT
The subject devices are substantially equivalent to the legally marketed predicate devices.
1.4	Device Description
IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 - description of the device per 21CFR 807.92(a) (4)
The IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 acquire multiple physiologicalpatient signals, display measurement values, waves and trends, generate physiological andtechnical alarms, provide data recording and support patient data management.
The monitors support multiple non-invasive and 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, andgas analysis.
The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatalcare environments. They are located at the patient bedside vicinity and can also be used duringpatient transport inside hospitals. The monitors have a color display with touchscreen as a primaryinput device. They also support a specialized remote control, keyboard and pointing devices such asa mouse. External displays can be connected to a built-in video port to provide an adaptiveduplicate image of the primary display. The monitors can interact with several compatible externalmeasuring and auxiliary devices locally at the bedside or in transport situations and with the CentralStation via LAN or wireless link.

Intended Use and Indication for Use 1.5

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

Intended Use:

The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:

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 only for use on one patient at a time.

Image /page/5/Picture/11 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble water or sound waves. Above and below the waves are four-pointed star shapes. Above the shield, the word "PHILIPS" is written in a sans-serif font, also in blue.

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The monitors are 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 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 Protocol Watch 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 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 conditions, and for patients who are well or poorly perfused.

Image /page/6/Picture/13 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble water or sound waves. Above and below the wavy lines, there are four-pointed stars. The word "PHILIPS" is written in white letters at the top of the shield.

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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.

The monitors are intended for use by trained healthcare professionals in a hospital environment. They are not intended for home use. The MX400/MX450/MX550 monitors are additionally intended for use in transport situations within hospital environments.

Comparison of Intended Uses for Subject Device and Predicate 1.6

The modified IntelliVue MX400, MX450, MX500 and MX550 have the same intended use and indications as the predicate devices. Additionally, the MX500 and MX550 devices inherited the Masimo SedLine Sedation Monitor indication:

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.

1.7 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 architecture monitor hardware entirely unchanged device design of added external measurements 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 module SedLine (867186), are the same as those of other legally marketed plug-in modules biocompatibility aspects do not apply because the devices do not have patient contact. materials used in the added external measurement Masimo SedLine, are identical to their predicate devices. biocompatibility aspects of accessories are not affected, because all accessories of the predicate devices remain unchanged
Energy Source	powered by AC mains or from built-in battery, same as predicate devices devices do not deliver energy to the patients for their function, same as predicate devices the added external measurement Masimo SedLine, does not have its own power supply; It is supplied by its host patient monitor. This is the same as for its predicate device
Software/HardwareFeatures	proposed modification does not introduce any new technological hardware features predicate devices already support plug-in modules, with these modules offering built-in measurements as well as interfaces to external measurements hardware and software of the added external measurement Masimo SedLine is unchanged from its predicate device measurements of physiological parameters are exactly the same as in the predicate devices
PhysiologicalParameters	existing physiological parameters of the predicate devices remain unchanged the added external measurement Masimo SedLine is the same as those of its respective predicate device
Performancespecifications	specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications remain unchanged performance specifications of the added external measurement Masimo SedLine remains unchanged
Operating Principleand Mechanism ofAction	unchanged from the predicate devices
Human Interface	human interface of the IntelliVue MX400, MX450, MX500 and MX550 remain exactly the same the newly added external measurement Masimo SedLine does not have a human interface of its own
MeasurementAccessories	all accessories of the predicate devices IntelliVue Patient Monitor MX400 IntelliVue Patient Monitor MX450 IntelliVue Patient Monitor MX500 IntelliVue Patient Monitor MX550 as well as those of the added external measurement Masimo SedLine are re-used without any change
Differences
Hardware	one new plug-in module SedLine (product number 867186)is created, which acts as a digital communication interface between the IntelliVue Patient Monitors MX400/MX450/MX500/MX550 and the external Masimo measurement devices the new plug-in module does not alter or modify the contents of the transferred data the new plug-in module also provides electrical isolation for both power and communication between patient monitor and the external SedLine measurement device; 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 device Masimo SedLine also connects to a host monitor / backboard device using an isolated digital interface, where the isolation must be provided by that host monitor / backboard device; the new plug-in module 867186 provides exactly this isolated digital interface as optional plug-in module, specialized for the IntelliVue Patient Monitors MX400, MX450, MX500 and MX550

Image /page/7/Picture/10 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble sound waves or water waves. Above and below the waves are four-pointed star shapes. The word "PHILIPS" is written in white at the top of the shield.

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Image /page/8/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The font is sans-serif and the overall impression is clean and modern.

Image /page/8/Picture/4 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and four stars. The word "PHILIPS" is written in white at the top of the shield.

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Image /page/9/Picture/4 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" in white at the top. Inside the shield, there are two wavy lines and two stars. The wavy lines are white and positioned horizontally across the center of the shield. The stars are four-pointed and located on either side of the wavy lines.

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Software	The software of the subject devices IntelliVue MX400, MX450, MX500 and MX550 has been extended so that the new plug-in module will be accepted as compatible and the physiological data provided by the Masimo SedLine measurement device will be displayed on the patient monitor screen. Additionally, a new software version designated as IntelliVue Software P.01 introduced the following new features: New alarm sounds designated as "Philips 2021" sounds. New Visual Patient feature, which displays patients's vital signs in an animated patient avatar alongside the conventional vital sign waveforms and numerics. Configurable alarm management, limiting changes in alarm settings to pre-defined authorized personnel. Additionally, the new Software revision will further enhance the following existing features: Early Warning Score Validation followed by user identification via Single Sign On Additional SPO2 fallback configuration Additional Lead Diagram presentation for ECG Enhancement of presentation of the global "alarm off" state
PhysiologicalParameters	For marketing reasons, the proposed modification does not provide the parameters and graphical presentations DSA (SedLine) which the predicate device is providing.

Software

The software of the subject devices IntelliVue MX400, MX450, MX500 and MX550 has been extended so that the new plug-in module will be accepted as compatible and the physiological data provided by the Masimo SedLine measurement device will be displayed on the patient monitor screen. Additionally, a new software version designated as IntelliVue Software P.01 introduced the following new features: New alarm sounds designated as "Philips 2021" sounds. New Visual Patient feature, which displays patients's vital signs in an animated patient avatar alongside the conventional vital sign waveforms and numerics. Configurable alarm management, limiting changes in alarm settings to pre-defined authorized personnel. Additionally, the new Software revision will further enhance the following existing features: Early Warning Score Validation followed by user identification via Single Sign On Additional SPO2 fallback configuration Additional Lead Diagram presentation for ECG Enhancement of presentation of the global "alarm off" state

PhysiologicalParameters

For marketing reasons, the proposed modification does not provide the parameters and graphical presentations DSA (SedLine) which the predicate device is providing.

Image /page/10/Picture/4 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and four stars. The word "PHILIPS" is written in blue at the top of the shield.

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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)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)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
60601-1-8 Edition 2.22020-07CONSOLIDATEDVERSION	5-131	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
60601-1-6 Edition 3.12013-10	5-89	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability

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Non-clinical Bench Tests

No new issues of substantial equivalence are introduced because 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 SedLine parameter are still valid as the measurements are not modified; they are only being connected to an additional host patient monitor.

Compliance to the FDA Quality System Regulations, 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.

No new issues of substantial equivalence are 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, usability and interoperability testing, 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.