Masimo Root Monitoring System and Accesories by MASIMO CORPORATION

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 and 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 (SpO-) and pulse rate to multi-parameter devices for the display of those devices.

The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

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

The provided document describes the Masimo Root Monitoring System and its accessories. The submission is for a device modification and new indications for use, specifically the addition of the Masimo Radius-7 Pulse Oximeter module. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140188).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a typical quantitative format (e.g., target specificity, sensitivity, or quantifiable error rates for a diagnostic device). Instead, the performance is evaluated through various verification and validation tests against established standards and the functionality of the predicate device. The acceptance criterion for each test appears to be "Pass," indicating successful completion and meeting predefined internal requirements.

Monitored Parameter	Test Description	Test Objective	Study Endpoints	Results Summary	Conclusion
SpO2, PR, and RRa	Display verification of Root and Radius-7 module	To verify Root user interface when connected to Radius-7	Test personnel began and ended test cases for the Root with Radius-7 user interface, and recorded the test results per test procedures.	Pass	Root correctly displayed monitoring information from Radius-7.
SpO2, PR, PI, PVI and RRa	Display validation of Radius-7 module	To validate human factors/usability	Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures.	Pass	Radius-7's ease of use was validated by the clinicians.
SpO2, PR, and RRa	Display validation of Radius-7 module (for Root and Radius-7)	To validate human factors/usability for Root and Radius-7	Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures.	Pass	Radius-7's ease of use was validated by the clinicians.
N/A (General battery)	Battery life and operation verification for Radius-7 module	To verify battery life and operation for Radius-7	Test personnel began and ended battery life/operation test cases, and recorded the test results per test procedures.	Pass	Radius-7's battery life and operation was verified to work properly.
N/A (Display/speaker)	Visual/audio alarm verification for Radius-7 module	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	Radius-7 visual/audio alarms are compliant to IEC60601-1-8.
SpO2, PR, and RRa	Visual/audio alarm verification for Root and Radius-7	To verify audio and visual alarms on Root	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 Radius-7.
N/A (General wireless)	Wireless (Bluetooth) connection verification for Root and Radius-7	To verify Bluetooth connection between Root and Radius-7	Test personnel began and ended Bluetooth verification test cases, and recorded test results per test procedures.	Pass	Root properly connected to Radius-7 via Bluetooth connection.
N/A (General wireless)	Wireless connection verification for Root and Radius-7	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 with Radius-7 met FDA Wireless Guidance requirements for wireless co-existence testing.
N/A (General wireless)	Wireless connection verification for Root and Radius-7	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 with Radius-7 met FDA Wireless Guidance requirements for wireless quality of service testing.
SpO2, PR, SpCO, SpMet, SpHb, RRa	Display verification of Root and Radical-7 module	To verify Eagle (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 Root and 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.
EEG and PSI	Display verification of Root and 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 Root and 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)	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)	Docking station function verification for Root and Radical-7	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 module.
EEG and PSI	MOC-9 interface verification for Root and Sedline module	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.
Breathing gases, RR, EEG and PS	MOC-9 interface verification for Root and ISA and Sedline modules	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 (Display/speaker)	Visual/audio alarm verification for Root	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 for Root and Radical-7, ISA, and Sedline modules	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 for Root and Radical-7, ISA, and Sedline modules	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 for Root and Radical-7, ISA, and Sedline modules	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)	Wired connection verification for Root	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)	Wired connection verification for Root	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)	Wireless connection verification for Root	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)	Wireless connection verification for Root	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)	Wireless connection verification for Root	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 for the Test Set and Data Provenance

The document does not specify a quantitative "sample size" in terms of patients or cases for most of the tests. The tests are described as functional verification and usability studies.

For "Display validation of Radius-7 module" and "Display validation of Root and Radical-7, ISA, and Sedline modules": The document mentions "Clinicians (users)" participated in usability tests. The exact number of clinicians is not provided.
For all other verification tests: "Test personnel" conducted the tests. No specific number is provided.
Data Provenance: The studies appear to be internal, non-clinical (laboratory/in-house) verification and validation tests, not involving real-world patient data collection from a specific country or in a retrospective/prospective manner.

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

This section is not applicable in the traditional sense for this type of device submission. The "ground truth" for these functional and usability tests is established by adherence to engineering specifications, regulatory standards (like IEC 60601-1-8), and successful operation as designed.

Usability testing: Involved "Clinicians (users)," implying healthcare professionals as experts for evaluating usability. Specific qualifications (e.g., years of experience, specialty) are not detailed.
For other verification tests, "Test personnel" are likely engineers or technicians qualified to conduct technical evaluations.

4. Adjudication Method for the Test Set

No formal adjudication method like "2+1" or "3+1" is described. The acceptance criterion for all tests is simply "Pass," meaning the device either successfully performed the function or met the standard, or it did not. This implies a binary outcome based on whether the test objectives and endpoints were met, likely determined by the test personnel or clinicians involved.

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is typically performed for diagnostic devices where human readers interpret patient data (e.g., images) with and without AI assistance to measure improvement in diagnostic accuracy. The Masimo Root Monitoring System is a monitoring system and user interface, not a diagnostic imaging AI algorithm.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop) Performance

The device itself is a "monitoring system and accessories" that functions as a user interface and communication hub for previously cleared modules. Its primary function is to display data, generate alarms, and connect to networks. Therefore, "standalone" performance in the context of an algorithm's diagnostic accuracy without human involvement is not a relevant metric for this device. The performance evaluated here is the functionality and safety of the monitoring system itself, especially its new integration with the Radius-7 module.

7. Type of Ground Truth Used

The "ground truth" is based on:

Engineering specifications and design requirements: For successful display, connectivity, and communication functions.
Regulatory standards: Such as IEC 60601-1-8 for alarm compliance, IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC, ISO-10993 for biocompatibility, and FDA guidances for Usability, Wireless, and Software.
Functionality of previously cleared predicate devices/modules: The Root system primarily integrates and acts as a user interface for these existing, cleared technologies.

8. Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense. The device's functionality is based on established hardware and software integration, not data-driven model training.

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

As no training set is mentioned or implied for machine learning, this question is not applicable.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads.

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

November 25, 2014

Masimo Corporation Marguerite Thomlinson Senior Director, Regulatory Affairs 40 Parker Irvine, California 92618

Re: K142394

Trade/Device Name: Masimo Root Monitoring System And Accesories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, JKS, CCK, BZQ, DQA, DPZ, GXY, GWQ, OLT, OLW, OMC, ORT Dated: August 25, 2014 Received: August 27, 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.

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

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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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -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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Section 4. Indications for Use Statement

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).

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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Section 4. Indications for Use Statement

Wearable Pulse Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

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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Image /page/4/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white waveform inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the company name is the text "MASIMO CORPORATI," followed by the address "Forty Parker, Irvine, CA 92618".

Submitter and Address ofManufacturing Facility:Date:	Masimo Corporation40 ParkerIrvine, CA 92618Phone: (949) 297-76FAX: (949) 297-7592August 25, 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:	K140188 – Masimo Root Monitoring System
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), with cleared technologies of SpO2, pulse rate, SpCO, SpMet, SpHb and RRa monitoring per K110028.
Masimo Radius-7 Pulse Oximeter (Radius-7 module), with cleared technologies of SpO2, pulse rate and RRa monitoring per K110028.
ISA-Infrared Sidestream Gas Analyzer (ISA module), with cleared technologies of breathing gases and respiratory rate monitoring per K103604.
Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set ● (Sedline module), with cleared technologies of EEG and PSI monitoring per 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

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The predicate device, Masimo Root Monitoring System (Root) was cleared in K140188, is the same as the subject device, Masimo Root Monitoring System (Root). The main difference is that the subject device includes the addition of the optionally connected Masimo Radius-7 Pulse Oximeter (Radius-7) module.

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.

FEATURE	SPECIFICATION
Display	Color LCD touchscreen
Connected Module	Parameter
Radical-7	Parameters per K110028
Radius-7	Parameters per K110028 for SpO2, pulse rate and RRa
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/Module Connection	Wired/docking interfaceWireless interfaceMOC-9 interfaceIris interfaceNurse call interfaceUSB interfaceSD card interface
Network Connectivity	EthernetWi-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)

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

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FEATURE	SPECIFICATION
Environmental
Operating Temperature	32 to 122°F (0-50°C)
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).

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 and 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.

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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.

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.

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

Summary of Technological Characteristics of Subject Device Compared to Predicate Device

Similarities and Differences between Predicate Device, Root (K140188) and Subject Device, Root

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

Both have the same fit, form and function.
Both can function with the Radical-7, ISA and/or Sedline modules.
Both have the same principle of operation and the mechanism of action for ● achieving the intended effect.
Both can communicate with a network system such as the Patient SafetyNet . (K071047) through wired or wireless connection.

The main difference between the predicate and the subject devices is that the Radius-7 is an added measurement module that can function with the subject device. Below is a summary of the monitored parameters and their substantial equivalence.

TABLE 18
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
SpO2, PR,and RRa	Displayverification ofRoot andRadius-7module	To verifyRoot userinterface whenconnected toRadius-7	Test personnel began andended test cases for theRoot with Radius-7 userinterface, and recordedthe test results per testprocedures.	Pass	Root correctlydisplayed monitoringinformation fromRadius-7.	Yes SE toK140188
SpO2, PR,PI, PVIand RRa	Displayvalidation ofRadius-7module	To validatehuman factors/usability	Clinicians (users) startedand completed theusability test cases andrecorded the test resultsper test procedures.	Pass	Radius-7's ease ofuse was validated bythe clinicians.	Yes SE toK140188
SpO2, PR,and RRa	Displayvalidation ofRadius-7module	To validatehuman factors/usability for Rootand Radius-7	Clinicians (users) startedand completed theusability test cases andrecorded the test resultsper test procedures.	Pass	Radius-7's ease ofuse was validated bythe clinicians.	Yes SE toK140188
			TABLE 18
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
N/A.Generalbatteryfunctions.	Battery life andoperationverification forRadius-7module	To verify batterylife and operationfor Radius-7	Test personnel began andended batterylife/operation test cases,and recorded the testresults per testprocedures.	Pass	Radius-7's batterylife and operationwas verified to workproperly.	Yes SE toK140188
N/A.Generaldisplay andspeakerfunctions.	Visual/audioalarmverification forRadius-7module	To verifyvisual/audioalarm complianceto IEC 60601-1-8	Test personnel began andended visual/audio alarmtest cases per the IECstandards, and recordedtest results.	Pass	Radius-7visual/audio alarmsare compliant toIEC60601-1-8.	Yes SE toK140188
SpO2, PR,and RRa	Visual/audioalarmverification forRoot andRadius-7	To verify audioand visual alarmson Root	Test personnel began andended audio/visual alarmverification test cases,and recorded test resultsper test procedures	Pass	Root correctlygeneratedvisual/audio alarmsfrom Radius-7.	Yes SE toK140188
N/A.Generalwirelessconnection	Wireless(Bluetooth)connectionverification forRoot andRadius-7	To verifyBluetoothconnectionbetween Rootand Radius-7	Test personnel began andended Bluetoothverification test cases.and recorded test resultsper test procedures.	Pass	Root properlyconnected to Radius-7 via Bluetoothconnection.	Yes SE toK140188
N/A.Generalwirelessconnection	Wirelessconnectionverification forRoot andRadius-7	To verifywireless co-existence perFDA WirelessGuidance	Test personnel began andended wireless co-existence testing perFDA Guidance, andrecorded the test results.	Pass	Root with Radius-7met FDA WirelessGuidancerequirements forwireless co-existencetesting.	Yes SE toK140188
N/A.Generalwirelessconnection	Wirelessconnectionverification forRoot andRadius-7	To verifywireless qualityof service perFDA WirelessGuidance	Test personnel began andended wireless quality ofservice testingverification per FDAGuidance, and recordedtest results.	Pass	Root with Radius-7met FDA WirelessGuidancerequirements forwireless quality ofservice testing.	Yes SE toK140188
SpO2, PR,SpCO,SpMet,SpHb andRRa	Displayverification ofRoot andRadical-7module	To verify Eagle(Root) userinterface	Test personnel began andended test cases for theRoot user interface, andrecorded the test resultsper test procedures.	Pass	Root correctlydisplayed monitoringinformation from theconnected modules.	Yes SE.See predicatesin K140188.
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Displayvalidation ofRoot andRadical-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 by theclinicians.	Yes SE.See predicatesin K140188.
TABLE 18
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Displayvalidation ofRoot andRadical-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 by theclinicians.	Yes SE.See predicatein K140188.
EEG and PSI	Displayverification ofRoot andSedline module	To verify Sedlineindicator anddisplay	Test personnel began andended test cases forindictor/displayverification, and recordedthe test results per testprocedures	Pass	Root correctlydisplayed monitoringinformation from theSedline module.	Yes SE.See predicatein K140188.
BreathingGases andRR	Displayverification ofRoot and ISAmodule	To verify ISAmodule indicatorand display	Test personnel began andended test cases forindictor/displayverification, and recordedthe test results per testprocedures	Pass	Root correctlydisplayed monitoringinformation from theISA module.	Yes SE.See predicatein K140188.
N/A.Generalwirelessfunctions	Wirelessinterfaceverification ofinformationfrom anyconnectedmodule	To verify thewirelesscommunicationbetween amodule fixtureand Root	Test personnel began andended test cases for thewireless interfaceverification, and recordedthe test results per testprocedures	Pass	A module fixturewirelessly connectedto Root in the similarcommunication as awired connection.	Yes SE.See predicatein K140188.
N/A.Generaldockingfunctions	Docking stationfunctionverification forRoot andRadical-7	To verify batterymanagement	Test personnel began andended batterymanagement test cases,and recorded the testresults per testprocedures.	Pass	Root docking stationinterfaced correctlywith the Radical-7module.	Yes SE.See predicatein K140188.
EEG and PSI	MOC-9interfaceverification forRoot andSedline module	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.See predicatein K140188.
Breathinggases, RR,EEG and PS	MOC-9interfaceverification forRoot and ISAand Sedlinemodules	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 and Irisinterfaces functionedcorrectly inEEPROMidentification forconnected modules.	Yes SE.See predicatein K140188.
			TABLE 18
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
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 correctlydisplayed monitoringinformation from theISA module.	Yes SE.See predicatein K140188.
EEG and PSI	Root andSedline moduleverification	To verifyRoot/Sedlineintegration	Test personnel began andended Sedline integrationtest cases, and recordedthe test results per testprocedures	Pass	Root correctlydisplayed monitoringinformation from theSedline module.	Yes SE.See predicatein K140188.
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.See predicatein K140188.
N/A.Generaldisplay andspeakerfunctions	Visual/audioalarmverification forRoot	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 are compliantto IEC60601-1-8.	Yes SE.See predicatein K140188.
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Visual/audioalarmverification forRoot andRadical-7, ISAand Sedlinemodules	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.See predicatein K140188.
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Visual/audioalarmverification forRoot andRadical-7, ISAand Sedlinemodules	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.See predicatein K140188.
SpO2, PR,SpCO,SpMet,SpHb, RRa,BreathingGases, RR,EEG and PSI	Alarm limitcontrolsverification forRoot andRadical-7, ISAand Sedlinemodules	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.See predicatein K140188.
			TABLE 18
MonitoredParameter	TestDescription	Test Objective	Study Endpoints	ResultsSummary	Conclusion	SubstantialEquivalence(SE)Yes/No?
N/A.Generalwiredconnection	Wiredconnectionverification forRoot	To verifyEthernetconnection	Test personnel began andended Ethernetverification test cases,and recorded test resultsper test procedures	Pass	Root functionedcorrectly in itsconnectivity via theEthernet.	Yes SE.See predicatesin K140188.
N/A.Generalwiredconnection	Wiredconnectionverification forRoot	To verify Irisconnectivity tonetwork system	Test personnel began andended Iris/PatientSafetyNet connectivitytest cases, and recordedtest results per testprocedures	Pass	Root's Iris interfacefunctioned correctlyin its connectivity tosystem networkssuch as the PatientSafetyNet.	Yes SE.See predicatesin K140188.
N/A.Generalwirelessconnection	Wirelessconnectionverification forRoot	To verify internalradio module	Test personnel began andended radio moduleverification test cases,and recorded test resultsper test procedures.	Pass	Root's internal radiomodule performedcorrectly.	Yes SE.See predicatesin K140188.
N/A.Generalwirelessconnection	Wirelessconnectionverification forRoot	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-existencetesting.	Yes SE.See predicatesin K140188.
N/A.Generalwirelessconnection	Wirelessconnectionverification forRoot	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.See predicatesin K140188.

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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 ●
Biocompatibility testing per ISO-10993 ●
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

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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.

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).