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.

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 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 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 is validated for use with adult patients only.

The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature, invasive blood pressure and cardiac output) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.

The measurement extension can only function when it is connected to a dedicated host device.

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.

Device Description

The IntelliVue Patient Monitor MX100 and 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 devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals.

The measurement sensors are applied at diverse body locations, depending on the actual physiological parameters monitored.

The MX100 and X3 provide multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The modification that is subject of this Premarket Notification adds the derived measurement PPV (pulse pressure variation), which is calculated from beat-to-beat arterial pressure values.

The Microstream Extension 867041 adds to the dedicated host device (IntelliVue Patient Monitor or Multi-Measurement Module) physiological measurements: Microstream CO2, and optionally dual invasive pressure and temperature.

The measurement extension is not a stand-alone device; it can only function when it is connected to a dedicated host device.

The modified Microstream Extension now provides the additional optional measurement cardiac output to the host devices.

AI/ML Overview

The provided text contains information about the Philips IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, and IntelliVue Microstream Extension 867041. However, it does not contain specific acceptance criteria values or the results of a study designed to prove the device meets those specific criteria in the format requested, especially for performance metrics like sensitivity, specificity, or reader improvement.

The document focuses on explaining changes made to the devices (addition of PPV measurement and cardiac output measurement), demonstrating substantial equivalence to predicate devices, and listing various verification and validation (V&V) activities performed. These V&V activities generally ensure the device functions as intended and meets safety standards, rather than providing specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy.

Therefore, I cannot populate the table and answer all questions in the requested format based on the provided text.

Here's what can be extracted and what information is missing:

Missing Information (Crucial for the Request):

Specific Acceptance Criteria Values: The document mentions that "All applicable requirements have been met" and "All specified pass/fail criteria have been met," but it does not specify what those numerical criteria are for the derived measurements (PPV, Cardiac Output accuracy, etc.). For instance, it doesn't say "PPV accuracy must be within X%" or "Cardiac Output repeatability must be less than Y%."
Reported Device Performance: Due to the absence of specific acceptance criteria, corresponding reported device performance values are also not explicitly stated in a quantifiable manner for diagnostic type performance. It states "The modified devices perform according to the specified criteria," but the numerical results are not provided.
Sample Size for Test Set: Not mentioned for any performance-related tests involving patient data.
Data Provenance (Country, Retrospective/Prospective): Not mentioned.
Number of Experts for Ground Truth: Not mentioned.
Qualifications of Experts: Not mentioned.
Adjudication Method: Not mentioned.
Multi-Reader Multi-Case (MRMC) Study: No mention of an MRMC study or AI assistance. The devices are patient monitors, not AI diagnostic tools that typically involve human readers interpreting images with or without AI assistance.
Standalone Performance: The performance testing mentioned ("Verification of PPV calculation by comparison to predicate device", "Verification of accuracy and repeatability for right heart measurement" etc.) relates to the device's accuracy in measuring physiological parameters, which is inherently standalone measurement performance. However, specific quantifiable results are not provided.
Type of Ground Truth: For the "Performance testing of derived measurement PPV" and "Performance testing of Cardiac Output (C.O.)", the ground truth seems to be established against the predicate device's performance or standard measurement techniques. For example, "Verification of PPV calculation by comparison to predicate device."
Sample Size for Training Set: Not applicable as this is a patient monitor, not an AI or machine learning model that would typically have a separate "training set" in the diagnostic sense.
How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (General)	Reported Device Performance (General)
For IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3:
Meet requirements of AAMI ANSI IEC 62304:2006 (Software life cycle processes)	All applicable requirements have been met.
Meet requirements of IEC 60601-2-34: 2011 (Ed. 3) (Invasive blood pressure monitoring equipment)	All applicable requirements have been met.
Meet Hazard Analysis pass/fail criteria	All specified pass/fail criteria have been met. The test results confirmed the effectiveness of implemented design risk mitigation measures.
Functional unit level tests for Derived Measurement PPV	The modified devices perform according to the specified criteria.
Functional system level tests for Derived Measurement PPV	The modified devices perform according to the specified criteria.
Regression Tests for unchanged host monitors	All specified test requirements have been met. Test results demonstrate that modified and previously available device functions work correctly according to specifications and labeling claims.
Verification of PPV calculation by comparison to predicate device	All applicable requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.
Verification of PPV artifact detection mechanism	All applicable requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.
Verification of calculation of the average PPV	All applicable requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.
For IntelliVue Microstream Extension 867041:
Meet requirements of AAMI ANSI IEC 62304:2006 (Software life cycle processes)	All applicable requirements have been met.
Meet requirements of AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) (Basic safety and essential performance)	All applicable requirements have been met.
Meet requirements of IEC 60601-1-2: 2007 (Ed. 3) (Electromagnetic Compatibility)	All applicable requirements have been met.
Meet Hazard Analysis pass/fail criteria	All specified pass/fail criteria have been met. Test results confirmed the effectiveness of implemented design risk mitigation measures.
Meet Additional environmental testing (temperature, humidity) and mechanical testing (mechanical classes 7M1, 7M2, 7M3, and disinfectant resistance)	All specified test requirements have been met. Tests confirmed modified devices work safely and according to specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, disinfection, and storage.
Functional system level tests for Cardiac Output (C.O.) measurement	The modified devices perform according to the specified criteria.
Regression Tests for unchanged host monitors and other measurements in Microstream Extension 867041	All specified test requirements have been met. Test results demonstrate that modified and previously available device functions work correctly according to specifications and labeling claims.
Verification of accuracy and repeatability for right heart measurement	All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.
Verification of accuracy and repeatability for transpulmonary measurement	All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.
Verification of the visibility of Thermodilution Curve in Cardiac Output Application Window	All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.
Verification of temperature drift limits and small signal warnings	All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.
Overall substantial equivalence to predicate devices	Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates, demonstrating substantial equivalence. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence. The results demonstrate that the modified devices meet all defined reliability requirements and performance claims.

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

Sample Size: Not specified in the provided text for any performance-related tests.
Data Provenance: Not specified.

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

Not specified. The ground truth for performance was primarily established by comparison to predicate devices or specified criteria derived from standard measurement techniques, rather than expert consensus on patient data.

4. Adjudication method for the test set:

Not applicable/Not specified. The testing described largely involves verification against technical specifications and predicate device performance, not independent adjudication of clinical interpretations.

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:

No. The devices are patient monitors that acquire and display physiological parameters, and calculate derived measurements (PPV, Cardiac Output). They are not described as AI-assisted diagnostic tools requiring MRMC studies for human reader improvement.

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

Yes, implicitly. The performance verification of PPV calculation and Cardiac Output accuracy (e.g., "Verification of accuracy and repeatability") are tests of the device's standalone measurement capabilities. However, specific numerical results of these tests (e.g., actual accuracy percentages or repeatability values) are not provided.

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

Primarily comparison to predicate device performance and compliance with recognized consensus standards and internal specifications. For example, "Verification of PPV calculation by comparison to predicate device" and "All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices."

8. The sample size for the training set:

Not applicable. These are patient monitoring devices with specified measurement algorithms, not machine learning models that undergo training on a "training set" in the typical sense.

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

Not applicable, as there is no mention of a "training set" for AI/ML algorithms.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 4, 2018

Philips Medizin Systeme Boeblingen GmbH Stefan Breuer Senior Regulatory Affairs Engineer Hewlett-Packard-Str. 2 Boeblingen, 71034 De

Re: K181314

Trade/Device Name: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension 867041 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, DRT, DRQ, DPS, MLC, DRJ, DQA, DSB, DSA, MSX, DRG, CCK, BZO, FLL Dated: August 1, 2018 Received: August 6, 2018

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 mav, 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 avare 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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Arielle Drummond -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181314

Device Name

IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, Microstream Extension 867041

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020 See PRA Statement below.

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 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 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 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 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 is validated for use with adult patients only.

Type of Use (Select one or both, as applicable)	☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)
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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:

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FORM FDA 3881 (7/17)	Page 1 of 2	BSC Publishing Services (301) 443-6740	EE
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FORM FDA 3881 (7/17)	Page 1 of 2	PSC Publishing Services (301) 443-6740	EF
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Indications for Use (continued)

Indications for Use Statement for the Microstream Extension 867041

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.

FORM FDA 3881 (7/17)	Page 2 of 2	PSC Publishing Services (301) 443-6740	EF
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510(k) Summary

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

5.1 Submitter

The submitter of this Premarket Notification is: Stefan Breuer Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 71034 Boeblingen Germany Telephone: +49 7031 463-2321 Fax: +49 7031 463-2442 Email: stefan.breuer@philips.com This summary was prepared on May 15, 2018.

5.2 Name and Classification of the Devices

Trade names: IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, Microstream Extension 867041

Common name: Multiparameter Patient Monitor

Trade name: IntelliVue Microstream Extension 867041

Common name: Multifunction Patient Monitor Module.

Classification:

Device Panel	Classification	ProCode	Description
CardiovascularDevices	§870.1025, II	MHX	Monitor, Physiological, Patient (witharrhythmia detection or alarms)
CardiovascularDevices	§870.1025, II	DSI	Detector and alarm, arrhythmia
CardiovascularDevices	§870.1025, II	MLD	Monitor, ST Segment with Alarm
CardiovascularDevices	§870.1100, II	DSJ	Alarm, Blood Pressure
CardiovascularDevices	§870.1110, II	DSK	Computer, Blood Pressure
CardiovascularDevices	§870.1130, II	DXN	System, Measurement, Blood-Pressure, Non-Invasive
CardiovascularDevices	§870.1435, II	DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
CardiovascularDevices	§870.1915, II	KRB	Probe, Thermodilution
CardiovascularDevices	§870.2300, II	DRT	Monitor, Cardiac (incl.Cardiotachometer & Rate Alarm)
CardiovascularDevices	§870.2060, II	DRQ	Amplifier and Signal Conditioner,Transducer Signal
CardiovascularDevices	§870.2340, II	DPS	Electrocardiograph
CardiovascularDevices	§870.2340, II	MLC	Monitor, ST Segment
CardiovascularDevices	§870.2600, I	DRJ	System, Signal Isolation
CardiovascularDevices	§870.2700, II	DQA	Oximeter
CardiovascularDevices	§870.2770, II	DSB	Plethysmograph, Impedance
CardiovascularDevices	§870.2900, I	DSA	Cable, Transducer and Electrode,incl. Patient Connector

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Device Panel	Classification	ProCode	Description
	-	MSX	System, Network andCommunication, PhysiologicalMonitors
	§870.2910, II	DRG	Transmitters and Receivers,Physiological Signal, Radiofrequency
AnesthesiologyDevices	§868.1400, II	CCK	Analyzer, Gas, Carbon Dioxide,Gaseous-Phase
	§868.2375, II	BZQ	Monitor, Breathing Frequency
General Hospital andPersonal UseDevices	§880.2910, II	FLL	Thermometer, Electronic, Clinical

5.3 Substantial Equivalence

The modified IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 with Software Rev. M.03 with the derived measurement PPV are substantially equivalent to the legally marketed Intelli Vue Patient Monitor MX100 and Multi-Measurement Module X3, marketed pursuant to K171801, and to IntelliVue Patient Monitor MP5, marketed pursuant to K161531.

The modified IntelliVue Microstream Extension 867041 with Cardiac Output is substantially equivalent to the legally marketed IntelliVue Microstream Extension 867041 and the legally marketed IntelliVue Capnography Extension 867040, both marketed pursuant to K172904.

5.4 Description of the Device

IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3

The measurement sensors are applied at diverse body locations, depending on the actual physiological parameters monitored.

The MX100 and X3 provide multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The modification that is subject of this Premarket Notification adds the derived measurement PPV (pulse pressure variation), which is calculated from beat-to-beat arterial pressure values. This is the same measurement as in the predicate device IntelliVue Patient Monitor MP5.

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IntelliVue Microstream Extension 867041

The measurement extension is not a stand-alone device; it can only function when it is connected to a dedicated host device.

The modified Microstream Extension now provides the additional optional measurement cardiac output to the host devices. The cardiac output measurement is the same as in the predicate device IntelliVue Capnography Extension 867040.

5.5 Intended Use

IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3

This is the same Intended Use as that for the legally marketed predicate devices IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3.

The Indications for Use Statement has been modified to add the PPV Indication from the legally marketed predicate device IntelliVue Patient Monitor MP5.

Indications for Use statement for the 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.

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 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 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

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

SET measurement is indicated for use during both no motion and motion conditions. and for patients who are well or poorly perfused.

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 is validated for use with adult patients only.

IntelliVue Microstream Extension 867041

This is the same Intended Use as that for the legally marketed predicate device IntelliVue Microstream Extension 867041.

The Indications for Use Statement has been modified to add the cardiac output measurement from the legally marketed predicate device IntelliVue Capnography Extension 867040.

Indications for Use statement for the Microstream Extension 867041:

The measurement extension can only function when it is connected to a dedicated host device.

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.

5.6 Technological Characteristics

IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3

The modifications to the IntelliVue Patient Monitor MX100 and the Multi-Measurement Module X3 are limited to minor software changes that do not affect technological characteristics of the devices. The common software of the devices has slightly been modified in order to provide the derived measurement Pulse Pressure Variation (PPV).

The hardware of the subject devices remains unchanged; all accessories are re-used unchanged from the predicate devices.

IntelliVue Microstream Extension 867041

The modifications to the IntelliVue Microstream Extension 867041 are limited to the addition of the Cardiac Output measurement board. This board is re-used, without any hardware or software change, from the legally marketed predicate device IntelliVue Capnography Extension 867040. All accessories are re-used from the predicate device, without any change.

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All Subject Devices

Design, materials, energy source, portability, user interface, radio technology, measurement principle, and all physical, environmental, and performance specifications of the devices remain all unchanged. The modified IntelliVue Patient Monitor MX100, Multi-Measurement Module X3 and Microstream Extension 867041 have the same relevant technological characteristics as their predicate devices with regard to operating principles, mechanism of action, energy sources, portability, user interface, robustness, dimensions, weight and environmental specifications.

5.7 Summarv of V&V Activities

IntelliVue Patient Monitor MX100 and IntelliVue Multi-Measurement Module X3

The modified devices have been subject to a series of V&V activities:

Testing according to the recognized consensus standards: ●
- o AAMI ANSI IEC 62304:2006 (Ed. 1) (Software life cycle processes)
- o IEC 60601-2-34: 2011 (Ed. 3) (Invasive blood pressure monitoring equipment)

All applicable requirements have been met.

. Testing as required by the Hazard Analysis. All specified pass/fail criteria have been met. The test results have confirmed the effectiveness of the implemented design risk mitigation measures.
. Unit level tests, functional system level tests, and regression system level tests. The modified devices perform according to the specified criteria:
- o Functional unit level tests for Derived Measurement PPV
- o Functional system level tests for Derived Measurement PPV
- Regression Tests for unchanged host monitors o

All specified test requirements have been met. The test results demonstrate that modified and previously available device functions work correctly according to the specifications and labeling claims.

Performance testing of derived measurement PPV ●
- o Verification of PPV calculation by comparison to predicate device
- o Verification of PPV artifact detection mechanism
- o Verification of calculation of the average PPV

All applicable requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices.

IntelliVue Microstream Extension 867041

The modified devices have been subject to a series of V&V activities:

Testing according to the recognized consensus standards:
- o AAMI ANSI IEC 62304:2006 (Ed. 1) (Software life cycle processes)
- o AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012 (Ed. 3.1) (Basic safety and essential performance)

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o IEC 60601-1-2: 2007 (Ed. 3) (Electromagnetic Compatibility)

All applicable requirements have been met.

Testing as required by the Hazard Analysis. ● All specified pass/fail criteria have been met. The test results have confirmed the effectiveness of the implemented design risk mitigation measures.
. Additional environmental testing (temperature, humidity) and mechanical testing (mechanical classes 7M1, 7M2, 7M3, and disinfectant resistance) All specified test requirements have been met. The tests have confirmed that the modified devices work safely and according to their specifications and indicated claims during tests simulating general hospital conditions, handling and transport in hospital environments, disinfection, and storage.
Functional system level tests, and regression system level tests. ● The modified devices perform according to the specified criteria:
- o Functional system level tests for Cardiac Output (C.O.) measurement
- Regression Tests for unchanged host monitors and unchanged other O measurements in Microstream Extension 867041

All specified test requirements have been met. The test results demonstrate that modified and previously available device functions work correctly according to the specifications and labeling claims.

Performance testing of Cardiac Output (C.O.)
- Verification of accuracy and repeatability for right heart measurement o
- Verification of accuracy and repeatability for transpulmonary measurement o
- Verification of the visibility of Thermodilution Curve in Cardiac Output O Application Window

o Verification of temperature drift limits and small signal warnings. All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices:

5.8 Conclusion

Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the modified devices with respect to the predicates.

Testing comprised electrical and mechanical safety tests, EMC tests, environmental tests, performance tests, functional and regression tests.

Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence.

The results demonstrate that the modified devices 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.