Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a multi-parameter patient monitoring system that collects and displays physiological data. While it processes EEG signals to derive a "Patient State Index (PSI)," this is described as a "proprietary computed EEG variable" and not explicitly as an AI/ML algorithm. There is no mention of AI, ML, or related terms in the document.

Therapeutic

No.
The device is described as a "Monitoring System" that measures and displays multiple physiological parameters. While monitoring can inform therapeutic decisions, the device itself does not perform any therapeutic intervention or treatment. Its function is explicitly for "monitoring" rather than therapy.

Diagnostic

Yes
The device is a diagnostic device because it monitors multiple physiological parameters (SpO2, pulse rate, SpCO, SpMet, SpHb, RRa, inspired/expired gases, EEG signals) and provides information related to the state of the brain (PSI), which are all used to assess a patient's health status.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Root Monitoring System is a "multifunctional device" that "monitors vital signs of patients from neonates to adults." It also mentions displaying information from "connected modules" and having an "internal speaker" for audible alarms. This indicates the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, the Masimo Root Monitoring System itself is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Masimo Root Monitoring System Function: The description clearly states that the Root system monitors physiological parameters in healthcare environments. It connects to various modules and sensors that measure things like oxygen saturation, pulse rate, gas concentrations in breathing, and brain activity (EEG). These are all measurements taken directly from the patient or their breathing circuit, not from a sample taken from the patient and tested outside the body.
Optional Modules: While some of the optional modules (like the ISA gas analyzers) are involved in analyzing gases related to breathing, this is still monitoring the patient's respiratory function directly, not performing a diagnostic test on a biological sample.

Therefore, the Masimo Root Monitoring System is a patient monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

MWI, JKS, CCK, BZQ, DQA, DPZ, GXY, GWQ, OLT, OLW, OMC, ORT

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonates to adults, adult, pediatric, and neonatal patients, adult, pediatric and infant patients.

Intended User / Care Setting

healthcare professionals, hospital-type facilities, mobile, and home environments, operating suite, intensive care unit and patient room, road ambulances, operating room (OR), intensive care unit (ICU), and clinical research laboratory.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance studies included:

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

No clinical testing was done.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K121013 - Welch Allyn Connex Vital Signs Monitor Series, K110028 - Masimo Radical 7 Pulse CO-oximeter and Accessories, K103604 - ISA-Infrared Sidestream Gas Analyzer, K051874 - Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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K140188 p.1 of 10

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 of
Manufacturing Facility: | Masimo Corporation
40 Parker
Irvine, CA 92618
Phone: (949) 297-76
FAX: (949) 297-7592 | | | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| Date: | May 16, 2014 | | | |
| Contact: | Marguerite Thomlinson
Senior 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/MWI
21 CFR 862.3220, Class II/JKS
21 CFR 868.1400, Class II/CCK
21 CFR 868.2375, Class II/BZQ
21 CFR 870.2700, Class II/DQA
21 CFR 870.2710, Class II/DPZ
21 CFR 882.1320, Class II/GXY
21 CFR 882.1400, Class II/GWQ
21 CFR 882.1400, Class II/OLT
21 CFR 882.1400, Class II/OLW
21 CFR 882.1400, Class II/OMC
21 CFR 882.1400, Class II/ORT | | | |
| Establishment Registration
Number: | 2031172 | | | |
| Reason for Premarket
Notification: | Device modification and new indications for use | | | |
| Predicate Devices: | K121013 - Welch Allyn Connex Vital Signs Monitor 6000
Series
K110028 - Masimo Radical 7 Pulse CO-oximeter and
Accessories
K103604 - ISA-Infrared Sidestream Gas Analyzer
K051874 - Sedline Sedation Monitor with Frontal PSI and
SEDTrace EEG Electrode Set | | | |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. | | | |

1

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

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.

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

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.

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;

2

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/Module
Connection	Wired/docking interface
Wireless interface
MOC-9 interface
Iris interface
Nurse call interface
USB interface
SD card interface
Ethernet
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)

3

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).

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

4

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.

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.

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

5

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; .

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.

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

6

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
Monitored
Parameter	Test
Description	Test Objective	Study Endpoints	Results
Summary	Conclusion	Substantial
Equivalence
(SE)
Yes/No?
SpO2, PR,
SpCO,
SpMet, SpHb
and RRa	Display
verification	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.	Yes SE to
K110028
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.	Yes SE to
K110028,
K103604
K051874
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.	Yes SE to
K110028,
K103604
K051874
Monitored
Parameter	Test
Description	Test Objective	Study Endpoints	Results
Summary	Conclusion	Substantial
Equivalence
(SE)
Yes/No?
EEG and PSI	Display
verification of
Sedline module	To verify Sedline
indicator and
display	Test personnel began and
ended test cases for
indictor/display
verification, and
recorded the test results
per test procedures	Pass	Root correctly
displayed
monitoring
information from
the Sedline module.	Yes SE to
K051874
Breathing
Gases and
RR	Display
verification of
ISA module	To verify ISA
module indicator
and display	Test personnel began and
ended test cases for
indictor/display
verification, and
recorded the test results
per test procedures	Pass	Root correctly
displayed
monitoring
information from
the ISA module.	Yes SE to
K103604
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.	Yes SE to
K110028
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.	Yes SE to
K110028
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.	Yes SE to
K051874
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.	Yes SE to
K103604
K051874
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.	Yes SE to
K103604
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.	Yes SE to
K051874
TABLE 18
Monitored
Parameter	Test
Description	Test Objective	Study Endpoints	Results
Summary	Conclusion	Substantial
Equivalence
(SE)
Yes/No?
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.	Yes SE to
K051874
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.	Yes SE to
K110028
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.	Yes SE to
K110028,
K103604
K051874
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.	Yes SE to
K110028,
K103604
K051874
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	Yes SE to
K110028,
K103604
K051874
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.	Yes SE to
K110028
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.	Yes SE to
K110028
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.	Yes SE to
K110028
Monitored
Parameter	Test
Description	Test Objective	Study Endpoints	Results
Summary	Conclusion	Substantial
Equivalence
(SE):
Yes/No?
N/A. General
wireless
connection	Wireless
connection
verification	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.	Yes SE to
K110028
N/A. General
wireless
connection	Wireless
connection
verification	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.	Yes SE to
K110028

7

K140188 p.8 of 10

,

.

·

:

8

K140188 p.9 of 10

9

K140188 p.10 of 10

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.

10

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

r

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.

11

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

12

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.

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:

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)

Image /page/12/Picture/14 description: The image shows a logo with the letters FDA in the center. Above the logo, the date 2014.06.25 is printed. Below the logo, the time 09:02:04 is printed. Further below, the number 04:00 is printed.

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

13

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

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.

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)

Image /page/13/Picture/11 description: The image shows a logo with some text. The text "2014 06 25 09:02:25 04:00" is visible on the right side of the logo. The logo appears to be a seal or stamp, with the text arranged in a circular or triangular pattern.