The MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

The monitors are only for use on one patient at a time. 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 EC 11).

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

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

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 Masimo rainbow SET measurement is indicated for the noninvasive monitoring 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 transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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 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.

Device Description

The IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 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 noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, spirometry, 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. Several monitor models can also be used mobile, during patient transport inside or outside of hospitals.

The monitors have a color display with touch-screen and/or keys and a navigation point as a primary input device. They also support further local input devices such as specialized remote control, keyboard, and 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.

With the current software Rev. N.0 the following modifications have been introduced:

Implementation of the existing feature Alarm Advisor into the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3. Alarm Advisor provides feedback on recurring and continuous alarm limit violations based on configured criteria. The information provided by the Alarm Advisor supports device operator in adapting alarm limits more specifically. This is the same functionality as that in other IntelliVue Patient Monitors: MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, and MX800 (cleared with K161531).
Modification of a few specific elements of the Graphical User Interface (GUI) of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, and the Intelli Vue Multi-Measurement Module X3:
- The key 'Silence' has been renamed to 'Acknowledge',
- A new default configuration for the Pause/Switch off of alarms via 'Acknowledge' key combined with a specific pop-up window has been added to all monitor models,
- New default configurations of visual alarm indicators with other colors and flashing behavior of the alarm numerics and limits have been added.

AI/ML Overview

The provided document is a 510(k) premarket notification from Philips Medizin Systeme Boeblingen GmbH to the FDA for their IntelliVue Patient Monitors. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and addressing minor software modifications, specifically the implementation of an "Alarm Advisor" feature and GUI changes related to alarm management.

The document does not contain the specific details required to answer all parts of your request, particularly regarding clinical performance studies with specific acceptance criteria, sample sizes for test and training sets, expert consensus, or MRMC studies for an AI device. This is because the submission is for a patient monitor and its software updates, not an AI-powered diagnostic device in the sense that would require such extensive clinical validation to demonstrate improved human reader performance or standalone algorithm performance.

However, I can extract information related to the acceptance criteria and study proving the device meets its acceptance criteria, based on the scope of this type of submission.

Here's an analysis based on the provided text, while acknowledging the limitations for a full AI device performance study:

Acceptance Criteria and Device Performance (as evident from this 510(k) submission):

For this type of device (patient monitors with software updates), the "acceptance criteria" and "device performance" are primarily demonstrated through compliance with recognized standards, hazard analysis, and functional/regression testing rather than a clinical trial with a defined performance metric like sensitivity/specificity for a diagnostic AI.

Acceptance Criterion (Implicit/Explicit)	Reported Device Performance (Summary)
Safety: Device operates without introducing new hazards or increasing existing risks.	"All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures." "All specified test requirements have been met and no new hazards have been identified."
Usability: User interface is intuitive and effective, especially for new features or changes.	"Evaluated and improved iteratively during the design phase conducting several formative usability evaluations. They included established usability engineering methods like focus groups, expert reviews and usability tests using user interface prototypes. User feedback was translated into iterative user interface improvements."
Functionality: New features (Alarm Advisor, GUI changes) operate as designed and specified.	"Functional tests... with feature Alarm Advisor at System Level. All tests have been passed." "Functional tests... with the feature blinking behavior of numerics at System Level. All tests have been passed." "Functional tests... with the feature Alarm Acknowledge at System Level. All tests have been passed." "Functional tests... with the feature Pause/Switch off Alarms at System Level. All tests have been passed. The performed functional tests demonstrate that the new features... are correctly presented on the display, can be correctly operated, controlled, configured, and function as specified and according to the labeling claims."
Reliability/Maintain Existing Functionality: Unchanged functions continue to work correctly after software modifications.	"Regression tests... All tests have been passed. The performed regression tests demonstrate that the unchanged and not affected functions also work correctly and in accordance with all specifications and labeling claims in the modified software."
Compliance with Standards: Adherence to relevant medical device and software standards.	"Testing according to the recognized consensus standard: IEC 60601-1-8: 2012 (Ed. 2.1) (Alarms) - All applicable requirements have been met." "Compliance with the recognized consensus process standards: AAMI ANSI IEC 62304:2006 (Ed. 1) (Software life cycle processes); IEC 60601-1-6: 2013 (Ed. 3.1) (Usability). The modified devices are compliant with all applicable requirements of the above stated process standards."
Substantial Equivalence: Device performs similarly to predicate devices.	"Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence." "The results demonstrate that the Philips IntelliVue Patient Monitors... meet all defined reliability requirements and performance claims."

Study Details (based on the provided document):

Given that this is a 510(k) for patient monitors with minor software updates, the "study" is primarily a series of verification and validation (V&V) activities focused on engineering and software aspects, rather than a clinical trial for an AI diagnostic.

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a "test set" in the context of a dataset for an AI model. Instead, it refers to V&V activities that include:
  - Hazard Analysis Testing: "All specified pass/fail criteria have been met." (No specific sample size of incidents/scenarios mentioned, typically an engineering analysis).
  - Functional System Level Tests: Performed on a variety of monitor models (MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, Multi-Measurement Module X3) for the new features (Alarm Advisor, blinking numerics, Alarm Acknowledge, Pause/Switch off Alarms). No specific number of test cases or "patients" is provided.
  - Regression Tests: Performed on the same range of monitor models to ensure unchanged functions still work.
- Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The tests are performed on the device itself and its software.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not described as "ground truth" establishment in this context. For usability testing, it mentions "expert reviews" as part of formative evaluations, but the specific number and qualifications of these experts are not detailed. These would typically be human factors engineers, clinical specialists, or design experts.
Adjudication Method for the Test Set:
- Not applicable as there is no "test set" of clinical cases requiring adjudication. The V&V activities are based on engineering specifications and standard compliance.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This submission is for patient monitors and their alarm management and GUI features, which do not involve diagnostic interpretation in that manner. The "Alarm Advisor" provides feedback on alarm limit violations, which is a clinical decision support tool related to device settings, not an image interpretation aid.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
- Yes, to an extent, in the sense that the new software features were functionally tested independently of human interaction (e.g., "Functional tests... All tests have been passed"). The "Alarm Advisor" functionality and GUI changes needed to perform as specified by the algorithm/software design. However, this is not a "standalone performance study" in the context of an AI diagnostic that might output a diagnosis or risk score. It's more about verifying software logic and output.
The Type of Ground Truth Used:
- Engineering Specifications and Standards Compliance. For the new features and existing functionalities, the "ground truth" is whether the software performs according to its design specifications, established industry standards (e.g., IEC 60601-1-8 for alarms), and internal quality requirements. For usability, "user feedback" (from focus groups, usability tests) serves as the basis for improvement.
The Sample Size for the Training Set:
- Not applicable. This device is not an AI model that undergoes a "training phase" from a clinical dataset in the traditional machine learning sense. The software development process involves design, coding, and V&V activities.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 19, 2019

Philips Medizin Systeme Boeblingen GmbH Markus Stacha Sr. Regulatory Affairs Engineer Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany

Re: K182979

Trade/Device Name: IntelliVue Patient Monitors MX100, MX430, MX450, MX500, MX550, MX700, MX800, MP5, MP5SC, Multi-Measurement Module X3 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, DSI, MLD, DSJ, DSK, DXN, DXG, KRB, DRO, DRT, DPS, MLC, DRW, KRC, DRJ. DOA. DSB. DSH. DSF. DRS. DSA. MSX. DRG. CCK. CBO. NHO. NHP. NHQ, CBS, CBR, CCL, BZC, BZQ, LKD, KLK, KOI, GWR, GWS, FLL Dated: September 10, 2019 Received: September 16, 2019

Dear Markus Stacha:

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 (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.

Jessica E. Paulsen 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

510(k) Number (if known) K182979

Device Name: IntelliVue Patient Monitors MP5 and MP5SC

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. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

Continued on next page

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

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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Indications for Use for IntelliVue Patient Monitors MP5 and MP5SC (continued)

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

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

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

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.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

Indications for Use

510(k) Number (if known) K182979

Device Name: IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3

Indications for Use (Describe)

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

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

The monitor is also intended for use during patient transport inside the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only.

Continued on next page

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)
----------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 ER

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Indications for Use for IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 (continued)

The ECG measurement is intended to be used for diagnostic recording of thythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

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

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 which are mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult 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.

{6}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

510(k) Number (if known) K182979

Device Name: IntelliVue Patient Monitors MX400, MX450, MX500, MX550, MX700, MX800

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

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

Continued on next page

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 ER

{7}------------------------------------------------

Indications for Use for IntelliVue Patient Monitors MX400, MX430, MX500, MX550, MX700, MX800 (continued)

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 transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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.

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Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.

510(k) Summary

This summary of 510(k) information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. Submitter of this premarket notification
  Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: +49 7031 463-2840 Fax: +49 7031 463-2442 e-mail: markus.stacha@philips.com

This summary was prepared on November 19, 2019.

1. The name and classification of the devices:
  Trade name: IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3.

Common name: Multiparameter Patient Monitor.

Classification:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	§870.1025, II	MHX	Monitor, Physiological, Patient (witharrhythmia detection or alarms)
	§870.1025, II	DSI	Detector and alarm, arrhythmia
	§870.1025, II	MLD	Monitor, ST Segment with Alarm
	§870.1100, II	DSJ	Alarm, Blood Pressure
	§870.1110, II	DSK	Computer, Blood Pressure
	§870.1130, II	DXN	System, Measurement, Blood-Pressure,Non-Invasive
	§870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed,Single-Function
	§870.1915, II	KRB	Probe, Thermodilution
	§870.2060, II	DRQ	Amplifier and Signal Conditioner,Transducer Signal
	§870.2300, II	DRT	Monitor, Cardiac (incl. Cardiotachometer& Rate Alarm)
	§870.2340, II	DPS	Electrocardiograph
	§870.2340, II	MLC	Monitor, ST Segment
	§870.2350, II	DRW	Electrocardiograph, Lead SwitchingAdapter
	§870.2370, II	KRC	Tester, Electrode, Surface,Electrocardiograph
	§870.2600, I	DRJ	System, Signal Isolation
Device Panel	Classification	ProCode	Description
	8870.2700, II	DQA	Oximeter
	8870.2770, II	DSB	Plethysmograph, Impedance
	8870.2800, II	DSH	Recorder, Magnetic tape, Medical
	8870.2810, I	DSF	Recorder, Paper Chart
	8870.2850, II	DRS	Extravascular Blood Pressure Transducer
	8870.2900, I	DSA	Cable, Transducer and Electrode, incl.Patient Connector
		MSX	System, Network and Communication,Physiological Monitors
	8870.2910, II	DRG	Transmitters and Receivers, PhysiologicalSignal, Radiofrequency
AnesthesiologyDevices	8868.1400, II	CCK	Analyzer, Gas, Carbon Dioxide, Gaseous-Phase
	$868.1500. II	CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase(Anesthetic Concentration)
	$868.1500, II	NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
	8868.1500, II	NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
	$868.1500, II	NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase(Anesthetic Concentration)
	8868.1620, II	CBS	Analyzer, Gas, Halothane, Gaseous-Phase(Anesthetic Concentration)
	$868.1700, II	CBR	Analyzer, Gas, Nitrous Oxide, Gaseous-Phase (Anesthetic Concentration)
	$868.1720, II	CCL	Analyzer, Gas, Oxygen, Gaseous-Phase
	$868.1880, II	BZC	Data calculator Pulmonary-function
	8868.2375, II	BZQ	Monitor, Breathing Frequency
	8868.2480, II	LKD	Monitor, Carbon Dioxide, Cutaneous
	$868.2500, II	KLK	Monitor, Oxygen, Cutaneous, for Infantnot under Gas Anesthesia
	$868.2775 II	KOI	Electrical peripheral nerve stimulator
Neurological Devices	$882.1400, II	GWR	Electroencephalograph
	8882.1420, I	GWS	Analyzer, Spectrum,Electroencephalograph Signal
General Hospital andPersonal Use Devices	§880.2910, II	FLL	Thermometer, Electronic, Clinical

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1. The modified Philips IntelliVue Patient Monitors MP5, MX400, MX430, MX450, MX500, MX550, MX700, MX800 with software Rev. N.0, are substantially equivalent to the previously cleared IntelliVue Patient Monitors MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, MX800, marketed pursuant to K161531. The modified Philips IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3 with software Rev. N.0 are substantially equivalent to the previously cleared IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3, marketed pursuant to K171801 and K181314.

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Description of the device 4.
The IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 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 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.

With the current software Rev. N.0 the following modifications have been introduced:

I Implementation of the existing feature Alarm Advisor into the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3. Alarm Advisor provides feedback on recurring and continuous alarm limit violations based on configured criteria. The information provided by the Alarm Advisor supports device operator in adapting alarm limits more specifically. This is the same functionality as that in other IntelliVue Patient Monitors: MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, and MX800 (cleared with K161531).
" Modification of a few specific elements of the Graphical User Interface (GUI) of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, and the Intelli Vue Multi-Measurement Module X3:
- The key 'Silence' has been renamed to 'Acknowledge',
- । A new default configuration for the Pause/Switch off of alarms via 'Acknowledge' key combined with a specific pop-up window has been added to all monitor models,
- New default configurations of visual alarm indicators with other colors and । flashing behavior of the alarm numerics and limits have been added.

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5. Intended Use

The modified IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 have the same intended use and indications for use as the legally marketed predicate devices.

IntelliVue Patient Monitors MP5 and MP5SC:

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 MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment: only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the

TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

The monitors are only for use on one patient at a time. 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 EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

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.

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is also intended for use during patient transport inside the hospital environment.

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The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use 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 Masimo rainbow SET measurement is indicated for the noninvasive monitoring 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.

IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX700, and MX800:

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

The monitors are only for use on one patient at a time. 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.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

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

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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.

1. Technological Characteristics
  The modifications to the Intelli Vue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 are limited to some minor software changes that do not affect technological characteristics of the devices. The common software of the devices has slightly been modified to add the feature Alarm Advisor to the models MX100 and X3 and to optimize the Graphical User Interface in the area of alarm controls and visualization. Design, materials, energy source, portability, radio technology, measurement principle, and all physical, environmental, and performance specifications of the devices remain all unchanged.

7. Summary of V&V activities

The modified IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450. MX500. MX550. MX700. MX800 and IntelliVue Multi-Measurement Module X3 with the current software Revision N.0 have been subject to the following V&V activities:

-Testing as required by the Hazard Analysis. All specified pass/fail criteria have been met. The test results confirmed the effectiveness of the implemented design risk mitigation measures.
Testing according to the recognized consensus standard: -
- IEC 60601-1-8: 2012 (Ed. 2.1) (Alarms) I All applicable requirements have been met.
Compliance with the recognized consensus process standards: -
- AAMI ANSI IEC 62304:2006 (Ed. 1) (Software life cycle processes) I
- . IEC 60601-1-6: 2013 (Ed. 3.1) (Usability).

The modified devices are compliant with all applicable requirements of the above stated process standards.

-Usability and User Preference Testing
The features of the current software Revision N.0 were evaluated and improved iteratively during the design phase conducting several formative usability evaluations. They included established usability engineering methods like focus groups, expert reviews and usability tests using user interface prototypes. User feedback was translated into iterative user interface improvements.

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All specified test requirements have been met and no new hazards have been identified.

Integration tests, functional system level tests, and regression system level tests:
- . Integration Level tests of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi Measurement Module X3. All tests have been passed. These tests demonstrate that all individual software modules for the current software Revision N.0 have been successfully combined and bundled into one software package.
- 트 Functional tests of the IntelliVue Patient Monitor MX100 and IntelliVue Multi Measurement Module X3 with feature Alarm Advisor at System Level. All tests have been passed.
- 트 Functional tests of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi Measurement Module X3 with the feature blinking behavior of numerics at System Level. All tests have been passed.
- 트 Functional tests of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi Measurement Module X3 with the feature Alarm Acknowledge at System Level. All tests have been passed.
- Functional tests of the IntelliVue Patient Monitors MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, MX800 with the feature Pause/Switch off Alarms at System Level. All tests have been passed. The performed functional tests demonstrate that the new features in the IntelliVue Patient Monitors are correctly presented on the display, can be correctly operated, controlled, configured, and function as specified and according to the labeling claims.
- 트 Regression tests of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi Measurement Module X3 at System Level.

The performed regression tests demonstrate that the unchanged and not affected functions also work correctly and in accordance with all specifications and labeling claims in the modified software.

8. Conclusion

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the specific predicates. V & V testing comprised well-established functionality and regression tests at integration and system level, safety and essential performance tests, and usability tests.

Test methods and acceptance criteria were the same as those for the predicate devices and test results showed substantial equivalence.

The results demonstrate that the Philips Intelli Vue Patient Monitors MP5. MP5SC. MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 meet all defined reliability requirements and performance claims.

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.