Who is the manufacturer of MASIMO ROOT MONITORING SYSTEM?

Masimo Corporation filed the 510(k) submission for MASIMO ROOT MONITORING SYSTEM (K140188).

What is the FDA product code for MASIMO ROOT MONITORING SYSTEM?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MASIMO ROOT MONITORING SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MASIMO ROOT MONITORING SYSTEM?

Welch Allyn Connex Vital Signs Monitor 6000 Series (K121013); Masimo Radical 7 Pulse CO-oximeter and Accessories (K110028); ISA-Infrared Sidestream Gas Analyzer (K103604); Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set (K051874).

Who can help prepare an FDA 510(k) submission like MASIMO ROOT MONITORING SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MASIMO ROOT MONITORING SYSTEM

K140188 · Masimo Corporation · MWI · Jun 25, 2014 · Cardiovascular

Device Facts

Record ID	K140188
Device Name	MASIMO ROOT MONITORING SYSTEM
Applicant	Masimo Corporation
Product Code	MWI · Cardiovascular
Decision Date	Jun 25, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

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: 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 Story

Root is a modular, multifunctional patient monitoring system; serves as an alternative user interface for connected modules (Radical 7, ISA gas analyzer, Sedline EEG monitor). Inputs: physiological signals from modules (SpO2, pulse, gases, EEG). Operation: Root processes and displays data on an LCD touchscreen; generates visual/audible alarms; acts as a pass-through for network communication (e.g., Patient SafetyNet). Used in OR, ICU, clinical labs, and home environments by healthcare professionals. Output: real-time monitoring data and alarms. Benefits: centralized control and display of multiple physiological parameters; facilitates remote viewing and alarming; improves clinical workflow by integrating disparate monitoring technologies into a single interface.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including display verification, usability/human factors testing, alarm compliance (IEC 60601-1-8), wireless co-existence/quality of service (FDA Wireless Guidance), and software verification.

Technological Characteristics

Modular patient monitor with LCD touchscreen; powered by AC or internal rechargeable battery. Connectivity: wired/docking, MOC-9, Iris, USB, Ethernet, Wi-Fi (802.11 a/b/g), Bluetooth 2.0. Dimensions: 11" x 10.5" x 5.5"; weight ~8 lbs. Compliant with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-1-8 (alarms).

Indications for Use

Indicated for healthcare professionals to monitor physiological parameters in neonates, infants, pediatric, and adult patients in hospitals, OR, ICU, clinical labs, mobile, and home environments. Monitors SpO2, pulse rate, SpCO, SpMet, SpHb, RRa, breathing gases (CO2, O2, N2O, anesthetic agents), and EEG/PSI.

Regulatory Classification

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.

Predicate Devices

Welch Allyn Connex Vital Signs Monitor 6000 Series (K121013)
Masimo Radical 7 Pulse CO-oximeter and Accessories (K110028)
ISA-Infrared Sidestream Gas Analyzer (K103604)
Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set (K051874)

Reference Devices

Patient SafetyNet (K071047)

Submission Summary (Full Text)

{0}------------------------------------------------ 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.

MASIMO ROOT MONITORING SYSTEM

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MASIMO ROOT MONITORING SYSTEM

Device Facts

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Identification

Predicate Devices

Reference Devices

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