The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical 7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive 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 (RRa). The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.

The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2. ISA AX+ and ISA OR+), intended to be connected to other medical backboard devices for monitoring of breath rate and the following breathing gases:

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

The optional SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It 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.

Device Description

The Root Monitoring System (Root) is a multifunctional device that monitors vital signs of patients from neonates to adults. Parameters monitored by Root include non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), respiratory rate (RRa), inspired/expired gases during anesthesia, recovery and respiratory care, state of the brain by real-time data acquisition and processing of EEG signals, and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents.

Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root.

Data from connected modules, including patient monitoring data, can be communicated to network systems. Root also functions as a pass-through means for communicating information between connected devices and network systems.

AI/ML Overview

Here's an analysis of the provided text regarding the Masimo Root Monitoring System's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Monitored Parameter	Test Description	Test Objective	Study Endpoints (Acceptance Criteria)	Results Summary (Reported Performance)	Conclusion
SpO2, PR, SpCO, SpMet, SpHb and RRa	Display verification	To verify Root user interface	Test personnel began and ended test cases for the Root user interface, and recorded the test results per test procedures.	Pass	Root correctly displayed monitoring information from the connected modules.
SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI	Display validation of Radical 7, ISA and Sedline modules	To validate human factors/ usability	Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures.	Pass	Root's ease of use was validated by the clinicians.
SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI	Display validation	To validate human factors/ usability	Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures.	Pass	Root's ease of use was validated by the clinicians.
EEG and PSI	Display verification of Sedline module	To verify Sedline indicator and display	Test personnel began and ended test cases for indicator/display verification, and recorded the test results per test procedures.	Pass	Root correctly displayed monitoring information from the Sedline module.
Breathing Gases and RR	Display verification of ISA module	To verify ISA module indicator and display	Test personnel began and ended test cases for indicator/display verification, and recorded the test results per test procedures.	Pass	Root correctly displayed monitoring information from the ISA module.
N/A. General wireless functions	Wireless interface verification of information from any connected module	To verify the wireless communication between a module fixture and Root	Test personnel began and ended test cases for the wireless interface verification, and recorded the test results per test procedures.	Pass	A module fixture wirelessly connected to Root in the similar communication as a wired connection.
N/A. General docking functions	Docking station function verification	To verify battery management	Test personnel began and ended battery management test cases, and recorded the test results per test procedures.	Pass	Root docking station interfaced correctly with the Radical 7.
EEG and PSI	MOC-9 interface verification	To verify MOC-9 Port EEPROM	Test personnel began and ended MOC-9 EEPROM verification test cases, and recorded the test results per test procedures.	Pass	The MOC-9 interface functioned correctly in EEPROM identification.
N/A. Breathing gases, RR, EEG and PSI	MOC-9 interface verification	To verify EEPROM Identification for Iris and MOC-9	Test personnel began and ended EEPROM Identification test cases for Iris and MOC-9, and recorded test results per test procedures.	Pass	The MOC-9 and Iris interfaces functioned correctly in EEPROM identification for connected modules.
Breathing Gases and RR	Root and ISA module verification	To verify Root/PhaseIn (ISA) capnography module integration	Test personnel began and ended ISA integration test cases, and recorded the test results per test procedures.	Pass	Root correctly displayed monitoring information from the ISA module.
EEG and PSI	Root and Sedline module verification	To verify Root/Sedline integration	Test personnel began and ended Sedline integration test cases, and recorded the test results per test procedures.	Pass	Root correctly displayed monitoring information from the Sedline module.
EEG and PSI	Root and Sedline module verification	To verify Sedline board communication	Test personnel began and ended Sedline board communication test cases, and recorded test results per test procedures.	Pass	Root correctly communicated with the Sedline module.
N/A. General display and speaker functions	Visual/audio alarm verification	To verify visual/audio alarm compliance to IEC 60601-1-8	Test personnel began and ended visual/audio alarm test cases per the IEC standards, and recorded test results.	Pass	Root visual/audio alarms are compliant to IEC60601-1-8.
SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI	Visual/audio alarm verification	To verify visual/audio alarm acknowledgment	Test personnel began and ended visual/audio alarm acknowledgment test cases, and recorded the test results per test procedures.	Pass	Root correctly generated visual/audio alarms from the connected modules.
SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI	Visual/audio alarm verification	To verify audio and visual alarms	Test personnel began and ended audio/visual alarm verification test cases, and recorded test results per test procedures.	Pass	Root correctly generated visual/audio alarms from the connected modules.
SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI	Alarm limit controls verification	To verify alarm limit controls	Test personnel began and ended alarm limit controls verification test cases, and recorded test results per test procedures.	Pass	Root correctly generated alarm limits from the connected modules.
N/A. General wired connection	Wired connection verification	To verify Ethernet connection	Test personnel began and ended Ethernet verification test cases, and recorded test results per test procedures.	Pass	Root functioned correctly in its connectivity via the Ethernet.
N/A. General wired connection	Wired connection verification	To verify Iris connectivity to network system	Test personnel began and ended Iris/Patient SafetyNet connectivity test cases, and recorded test results per test procedures.	Pass	Root's Iris interface functioned correctly in its connectivity to system networks such as the Patient SafetyNet.
N/A. General wireless connection	Wireless connection verification	To verify internal radio module	Test personnel began and ended radio module verification test cases, and recorded test results per test procedures.	Pass	Root's internal radio module performed correctly.
N/A. General wireless connection	Wireless co-existence per FDA Wireless Guidance	To verify wireless co-existence per FDA Wireless Guidance	Test personnel began and ended wireless co-existence testing per FDA Guidance, and recorded the test results.	Pass	Root met FDA Wireless Guidance requirements for wireless co-existence testing.
N/A. General wireless connection	Wireless quality of service per FDA Wireless Guidance	To verify wireless quality of service per FDA Wireless Guidance	Test personnel began and ended wireless quality of service testing verification per FDA Guidance, and recorded test results.	Pass	Root met FDA Wireless Guidance requirements for wireless quality of service testing.

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

The provided document refers to "test cases" for various verifications. However, the exact sample sizes (number of test cases or specific data points) for the test sets are not explicitly mentioned for most tests. The provenance of the data is not specified in terms of country of origin, nor is it explicitly stated whether the data was retrospective or prospective. The tests appear to be laboratory/engineering verification tests rather than clinical studies with patient data.

For "Display validation of Radical 7, ISA and Sedline modules" and "Display validation" related to human factors/usability, it states "Clinicians (users) started and completed the usability test cases...". This suggests prospective testing with users.

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

For the majority of the tests (display verification, interface verification, alarm verification, etc.), the ground truth was established based on the expected functional behavior of the device according to its design specifications and relevant standards (e.g., IEC standards). The document indicates "Test personnel began and ended test cases... and recorded the test results per test procedures." These "test personnel" would be the experts verifying against the predetermined criteria. Their specific qualifications (e.g., experience level, specific certifications) are not detailed.

For the "Display validation (human factors/usability)" tests, the ground truth was established by "Clinicians (users)." Their specific number or qualifications (e.g., "radiologist with 10 years of experience") are not detailed, beyond being identified as "clinicians."

4. Adjudication Method for the Test Set

The document states that "Test personnel began and ended test cases... and recorded the test results per test procedures." This implies that the results were observed and recorded, likely against a predefined set of expected outcomes for each test case. There is no mention of an adjudication method like "2+1" or "3+1" that would typically involve multiple independent reviewers resolving discrepancies through consensus or a tie-breaker. This suggests a direct pass/fail determination by the test personnel.

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 MRMC comparative effectiveness study was done. The device (Masimo Root Monitoring System) is a patient monitor, essentially an alternative user interface and aggregation system for existing cleared modules. It is not an AI-assisted diagnostic tool that would typically undergo an MRMC study comparing human reader performance with and without AI. The studies focused on verifying the functionality, usability, and compliance of the Root system itself.

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

This refers to the performance of the device itself, functioning independently. The tests for "Display verification," "Wireless interface verification," "Docking station function verification," "MOC-9 interface verification," "Root and ISA module verification," "Root and Sedline module verification," "Visual/audio alarm verification," "Alarm limit controls verification," and "Wired connection verification" all assess the standalone performance of the Root system and its integration with modules.

The overall conclusion is that "the subject device, Masimo Root Monitoring System, is substantially equivalent to its predicates with respect to safety and effectiveness, based on the nonclinical tests discussed above." This implies that its standalone performance was deemed acceptable and comparable to existing devices.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these tests was primarily:

Design Specifications and Expected Functional Behavior: For tests like display verification, interface verification, communication, and alarm functionalities, the device's output and behavior were compared against predefined engineering and operational specifications.
Compliance with Standards: For alarms and wireless functionalities, the ground truth was adherence to international standards like IEC60601-1-8 and FDA Wireless Guidance.
User Feedback/Usability: For the human factors/usability tests, the ground truth was established by the "clinicians (users)" validating the "ease of use." This could be considered a form of expert feedback.

No pathology or outcomes data was used as ground truth, as this device itself does not diagnose or determine clinical outcomes independently, but rather displays data from other monitoring modules.

8. The Sample Size for the Training Set

The document explicitly states "No clinical testing was done." This implies that there was no "training set" in the context of a machine learning or AI algorithm that typically requires large datasets for training. The device's functionality is based on established engineering principles and interaction with pre-cleared modules, rather than models trained on clinical data.

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

Since "No clinical testing was done" and there's no mention of a training set, this question is not applicable in the context of this submission. The device's functionality relies on established principles and integration with pre-existing, cleared technologies, rather than being a novel algorithm requiring a training phase with a specific ground truth.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Masimo Corporation. The logo features the word "MASIMO" in bold, black letters. To the right of the name is the text "MASIMO CORPORATION, Forty Parker, Irvine, CA 92618". The text is smaller than the name and is in a less bold font.

Submitter and Address ofManufacturing Facility:	Masimo Corporation40 ParkerIrvine, CA 92618Phone: (949) 297-76FAX: (949) 297-7592
Date:	May 16, 2014
Contact:	Marguerite ThomlinsonSenior Director, Regulatory Affairs
Trade Name:	Masimo Root Monitoring System and Accessories
Common Name:	Patient Monitor
Classification Regulation/Product Code:	21 CFR 878.2300, Class II/MWI21 CFR 862.3220, Class II/JKS21 CFR 868.1400, Class II/CCK21 CFR 868.2375, Class II/BZQ21 CFR 870.2700, Class II/DQA21 CFR 870.2710, Class II/DPZ21 CFR 882.1320, Class II/GXY21 CFR 882.1400, Class II/GWQ21 CFR 882.1400, Class II/OLT21 CFR 882.1400, Class II/OLW21 CFR 882.1400, Class II/OMC21 CFR 882.1400, Class II/ORT
Establishment RegistrationNumber:	2031172
Reason for PremarketNotification:	Device modification and new indications for use
Predicate Devices:	K121013 - Welch Allyn Connex Vital Signs Monitor 6000SeriesK110028 - Masimo Radical 7 Pulse CO-oximeter andAccessoriesK103604 - ISA-Infrared Sidestream Gas AnalyzerK051874 - Sedline Sedation Monitor with Frontal PSI andSEDTrace EEG Electrode Set
Performance Standards	No performance standards for the above device have beenpromulgated pursuant to Section 514.

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Device Description - Disease/Conditions that Device Diagnose, Treat, Prevent, Cure or Mitigate, Including Patient Population

Explanation of Why Differences in Indication Statement Are Not Critical to Intended Use, and Why Difference Do Not Affect Safety and Effectiveness of Device When Used as Labeled

Root is intended to be used with the previously FDA cleared measurement technologies for the modules of:

Masimo Radical 7 Pulse CO-Oximeter (Radical 7 module), K110028; .
ISA-Infrared Sidestream Gas Analyzer (ISA module), K103604 and .
Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set (Sedline module), . K051874.

Root is intended to be used as an alternative user interface to facilitate access control and monitoring device functions and to connect system networks such as the Patient SafetyNet (K071047).

Device Description - General Description from Labeling, Including Explanation of How Device Functions, Scientific Concepts that Form Basis For the Device

Subject device and the predicate, Welch Allyn Connex Vital Signs Monitor, K121013 (VSM), are similar in the following manners:

designed to provide a scalable, modular system that can be configured to address monitoring . needs;

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display monitoring information from optional module, including the Masimo Rainbow SET Pulse . CO-Oximetry technology (K110028);
. display monitoring information for capnography from optional module.
. communicate with network systems via wired or wireless connection;
transfer patient monitoring information for supplemental remote viewing and alarming. .

The subject device is mainly different from the predicate device in that the subject is connected to the optional ISA module and Sedline module. The predicate is connected to the optional Oridion module, although both the ISA module and Oridion module have capnography monitoring technology. As the result, the indications for use statements for the subject and the predicate device slightly differ, although both the subject and the predicate device are generally intended to provide displays for their respective connected modules.

Device Description - Significant Physical and Performance Characteristics of the Device

The significant physical characteristics for Root include an LCD touchscreen for patient monitoring. The instrument can be powered by AC or by its internal rechargeable battery. The approximate size and weight of the instrument are 11' x 10.5" x 5.5'' (27.9 cm x 26.7 cm x 14 cm) and approximately 8 pounds.

The device specifications are shown below for the general functions of the subject device.

FEATURE	SPECIFICATION
Display	Color LCD touchscreen
Connected Module	Parameter
Radical 7	Parameters per K110028
ISA Module	Parameters per K103604
Sedline Module	Parameters per K051874
General
Visual/audible alarm	IEC60601-1-8 compliant
Storage/recording	Trend/data storage
Electrical
AC Power	100-240 volt, 47-63 Hz
Battery	Rechargeable battery
Interface
Root and Device/ModuleConnection	Wired/docking interfaceWireless interfaceMOC-9 interfaceIris interfaceNurse call interfaceUSB interfaceSD card interfaceEthernet
Network Connectivity	Wi-Fi, 802.11 a/b/g; Bluetooth 2.0
Mechanical
Dimensions	11 x 10.5 x 5.5 inch (27.9 x 26.7 x 14 cm)
Weight	Approximately 8 lbs (3.63 kg)
Environmental
Operating Temperature	32 to 122°F (0-50°C)

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FEATURE	SPECIFICATION
Storage Temperature	-40 to 158°F (-40 to 70°C),
Humidity	10-95% non-condensing humidity
Mode of Operation
Mode of Operation	Continuous

Intended Use

Root serves as a convenient alternative user interface to integrate modules to provide health care professionals the ability to access, control and monitor measurement technologies (within the respective modules) that have been previously cleared by the FDA. Root does not affect the intended use, or alter the indications for use, for the cleared modules with which it is intended to function. Additionally Root is intended to communicate with network systems.

Indications For Use

The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing

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circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also intended to be used in road ambulances. The intended patient population is adult, pediatric and infant patients.

Technological Characteristics

Principle of Operation

Root functions as an alternative user interface that allows access, control and monitoring from the connected modules.

Mechanism of Action for Achieving the Intended Effect

The system begins functioning when the power is turned on for Root.

Root communicates with connected modules and displays the modules' patient monitoring information on the Root display. The healthcare provider controls the functions of each module using the Root touchscreen display. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker.

By connecting modules or devices to Root, data can be communicated between Root and network systems via wired or wireless connection. Information from network systems can be shown on the Root display for viewing and notification purposes.

Once use is complete, the user then turns the power "off" for Root.

Summary of Technological Characteristics of Subject Device Compared to Predicate Devices

Similarities and Differences between Predicate Device, VSM (K121013) and Subject Device, Root

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Subject device and the predicate, Welch Allyn Connex Vital Signs Monitor, K121013 (VSM), are similar in the following manners:

. designed to provide a scalable, modular system that can be configured to address monitoring needs;
. display monitoring information from optional modules, including the Masimo Rainbow SET Pulse CO-Oximetry technology (K110028);
. display monitoring information for capnography from optional module.
communicate to network systems via wired or wireless connection; .
transfer patient monitoring information for supplemental remote viewing and alarming; .

Similarities and Differences between Predicate Device, Radical 7 Docked to RDS-1/1B (K110028) and Subject Device, Radical 7 Docked to Root

The main features which are the same for predicate and subject devices are listed below.

. Both have the same fit, form and function for docking the Radical 7.
Both can recharge the internal battery of the Radical 7 while the Radical 7 is docked. .
Both can operate on AC power or internal battery while the Radical 7 is docked. .
Both can communicate with a network system such as the Patient SafetyNet (K071047) . through wired or wireless connection.

The main differences between the predicate and the subject devices are the following.

The predicate does not have an alternate LCD display. The subject device includes an . alternate LCD display to the Radical 7 LCD display.
. For the predicate, the user accesses patient monitoring features by using the Radical 7 LCD display. For the subject device, Root, the user accesses patient monitoring features by using the Root display while the Radical 7 is connected to Root.
For the predicate, alarms are generated by using the Radical 7 internal speaker and LCD . display. For the subject device, visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker.

Similarities and Differences between Predicate Device, ISA Module Connected to Host Backboard Device (K103604) and Subject Device, ISA Module Connected to Root

The predicate (Host Backboard Device) and the subject (Root) devices are essentially the same in that they function as displays for the ISA module. Both devices display monitoring information from the ISA module. The user performs patient monitoring functions on both predicate (Host Backboard

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Device) and subject (Root) devices.

The main difference between the predicate and subject devices is the different interface connections with the ISA module. The predicate device connects to the ISA module through an RS-232 interface. However the subject device connects to the ISA module through the MOC-9 interface.

Similarities and Differences between Predicate Device, Sedline Module Connected to Sedline Monitor (K051874) and Subject Device, Sedline Module Connected to Root

The predicate (Sedline Monitor) and the subject (Root) devices are essentially the same in that they function as displays for the Sedline measurements. Both the predicate and subject devices display monitoring information from the Sedline module. The user performs patient monitoring functions on both predicate and subject devices.

Root differs from the Sedline Monitor in the type of connection between Root and the Sedline module. In this submission, the Sedline module connects to Root through the MOC-9 interface. However in the K051874 filing, the Sedline module connects to the Patient Module Port.

Below is a summary of the monitored parameters and their substantial equivatlence.

TABLE 18
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
SpO2, PR,SpCO,SpMet, SpHband RRa	Displayverification	To verify Eagle(Root) userinterface	Test personnel began andended test cases for theRoot user interface, andrecorded the test resultsper test procedures.	Pass	Root correctlydisplayedmonitoringinformation fromthe connectedmodules.	Yes SE toK110028
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Displayvalidation ofRadical 7, ISAand Sedlinemodules	To validatehuman factors/usability	Clinicians (users) startedand completed theusability test cases andrecorded the test resultsper test procedures.	Pass	Root's ease of usewas validated bythe clinicians.	Yes SE toK110028,K103604 K051874
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Displayvalidation	To validatehuman factors/usability	Clinicians (users) startedand completed theusability test cases andrecorded the test resultsper test procedures.	Pass	Root's ease of usewas validated bythe clinicians.	Yes SE toK110028,K103604 K051874
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
EEG and PSI	Displayverification ofSedline module	To verify Sedlineindicator anddisplay	Test personnel began andended test cases forindictor/displayverification, andrecorded the test resultsper test procedures	Pass	Root correctlydisplayedmonitoringinformation fromthe Sedline module.	Yes SE toK051874
BreathingGases andRR	Displayverification ofISA module	To verify ISAmodule indicatorand display	Test personnel began andended test cases forindictor/displayverification, andrecorded the test resultsper test procedures	Pass	Root correctlydisplayedmonitoringinformation fromthe ISA module.	Yes SE toK103604
N/A. Generalwirelessfunctions	Wirelessinterfaceverification ofinformationfrom anyconnectedmodule	To verify thewirelesscommunicationbetween amodule fixtureand Root	Test personnel began andended test cases for thewireless interfaceverification, andrecorded the test resultsper test procedures	Pass	A module fixturewirelesslyconnected to Rootin the similarcommunication as awired connection.	Yes SE toK110028
N/A. Generaldockingfunctions	Docking stationfunctionverification	To verify batterymanagement	Test personnel began andended batterymanagement test cases,and recorded the testresults per testprocedures.	Pass	Root dockingstation interfacedcorrectly with theRadical 7.	Yes SE toK110028
EEG and PSI	MOC-9interfaceverification	To verify MOC-9Port EEPROM	Test personnel began andended MOC-9 EEPROMverification test cases,and recorded the testresults per testprocedures	Pass	The MOC-9interface functionedcorrectly inEEPROMidentification.	Yes SE toK051874
N/A.Breathinggases, RR,EEG and PSI	MOC-9interfaceverification	To verifyEEPROMIdentification forIris and MOC-9	Test personnel began andended EEPROMIdentification test casesfor Iris and MOC-9, andrecorded test results pertest procedures.	Pass	The MOC-9 andIris interfacesfunctionedcorrectly inEEPROMidentification forconnected modules.	Yes SE toK103604 K051874
BreathingGases andRR	Root and ISAmoduleverification	To verifyRoot/PhaseIn(ISA)capnographymoduleintegration	Test personnel began andended ISA integrationtest cases, and recordedthe test results per testprocedures.	Pass	Root correctlydisplayedmonitoringinformation fromthe ISA module.	Yes SE toK103604
EEG and PSI	Root andSedline moduleverification	To verifyRoot/Sedlineintegration	Test personnel began andended Sedline integrationtest cases, and recordedthe test results per testprocedures	Pass	Root correctlydisplayedmonitoringinformation fromthe Sedline module.	Yes SE toK051874
TABLE 18
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
EEG and PSI	Root andSedline moduleverification	To verify Sedlineboardcommunication	Test personnel began andended Sedline boardcommunication testcases, and recorded testresults per testprocedures	Pass	Root correctlycommunicated withthe Sedline module.	Yes SE toK051874
N/A. Generaldisplay andspeakerfunctions	Visual/audioalarmverification	To verifyvisual/audioalarm complianceto IEC 60601-1-8	Test personnel began andended visual/audio alarmtest cases per the IECstandards, and recordedtest results.	Pass	Root visual/audioalarms arecompliant toIEC60601-1-8.	Yes SE toK110028
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Visual/audioalarmverification	To verifyvisual/audioalarmacknowledgment	Test personnel began andended visual/audio alarmacknowledgment testcases, and recorded thetest results per testprocedures.	Pass	Root correctlygeneratedvisual/audio alarmsfrom the connectedmodules.	Yes SE toK110028,K103604 K051874
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Visual/audioalarmverification	To verify audioand visual alarms	Test personnel began andended audio/visual alarmverification test cases,and recorded test resultsper test procedures	Pass	Root correctlygeneratedvisual/audio alarmsfrom the connectedmodules.	Yes SE toK110028,K103604 K051874
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Alarm limitcontrolsverification	To verify alarmlimit controls	Test personnel began andended alarm limitcontrols verification testcases, and recorded testresults per testprocedures	Pass	Root correctlygenerated alarmlimits from theconnected modules	Yes SE toK110028,K103604 K051874
N/A. Generalwiredconnection	Wiredconnectionverification	To verifyEthernetconnection	Test personnel began andended Ethernetverification test cases,and recorded test resultsper test procedures	Pass	Root functionedcorrectly in itsconnectivity via theEthernet.	Yes SE toK110028
N/A. Generalwiredconnection	Wiredconnectionverification	To verify Irisconnectivity tonetwork system	Test personnel began andended Iris/PatientSafetyNet connectivitytest cases, and recordedtest results per testprocedures	Pass	Root's Iris interfacefunctionedcorrectly in itsconnectivity tosystem networkssuch as the PatientSafetyNet.	Yes SE toK110028
N/A. Generalwirelessconnection	Wirelessconnectionverification	To verify internalradio module	Test personnel began andended radio moduleverification test cases,and recorded test resultsper test procedures.	Pass	Root's internalradio moduleperformedcorrectly.	Yes SE toK110028
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE):Yes/No?
N/A. Generalwirelessconnection	Wirelessconnectionverification	To verifywireless co-existence perFDA WirelessGuidance	Test personnel began andended wireless co-existence testing perFDA Guidance, andrecorded the test results.	Pass	Root met FDAWireless Guidancerequirements forwireless co-existence testing.	Yes SE toK110028
N/A. Generalwirelessconnection	Wirelessconnectionverification	To verifywireless qualityof service perFDA WirelessGuidance	Test personnel began andended wireless quality ofservice testingverification per FDAGuidance, and recordedtest results.	Pass	Root met FDAWireless Guidancerequirements forwireless quality ofservice testing.	Yes SE toK110028

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Non-clinical Testing

See below for the non-clinical testing that was completed.

. Electrical safety testing per IEC60601-1
EMC testing per IEC60601-1-2 .
Alarm testing per IEC60601-1-8 .
Usability testing per FDA Human Factors and Usability Draft Guidance .
. Wireless testing per FDA Wireless Guidance
Software verification per FDA Software Guidance .
Mechanical and environmental testing .
Cleaning validation .

The results demonstrate that all requirements and performance specifications were satisfied, and that the subject device is substantially equivalent to the predicate device.

Clinical Testing

No clinical testing was done.

Conclusion

It is concluded that the subject device, Masimo Root Monitoring System, is substantially equivalent to its predicates with respect to safety and effectiveness, based on the nonclinical tests discussed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G609 Silver Spring, MD 20993-0002

Masimo Corporation Marguerite Thomlinson Sr. Director, Regulatory Affairs 40 Parker

Irvine, California, 92618

Re: K140188

Trade/Device Name: Masimo Root Monitoring System Regulation Number: 21 CFR 878.2300 Regulation Name: Patient Monitor Regulatory Class: Class II Product Code: MWI Dated: May 16, 2014 Received: May 19, 2014

Dear Marguerite Thomlinson,

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. 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.

June 25, 2014

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

Image /page/10/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the caduceus. The caduceus is depicted in black, and the text is also in black against a white background.

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Page 2 - Marguerite Thomlinson

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-638-2041 or (301) 796-7100 or at its Internet address free number (800) http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the 'Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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 Statement Section 4.

Indications for Use

510(k) Number:

Device Name: Masimo Root Monitoring System

Indications for Use:

The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.

The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station).

The optional Masimo Radical 7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive 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 (RRa). The Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical 7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical 7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over The Counter Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Masimo Root 510(k), K140188, Page 18 of 131

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Section 4. Indications for Use Statement

ISA CO2: CO2

ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over The Counter Use (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).