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

The Masimo Root Monitoring System and Accessories 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 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 Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no 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 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, SpCO, SpMet, SpHb 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).

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 predicate device, Masimo Root Monitoring System (Root) was cleared in K142394, is the same as the subject device, Masimo Root Monitoring System (Root). Both the predicate and subject devices include the option to connect the Masimo Radius-7 Pulse Oximeter (Radius-7) module. The main difference is that the Radius-7 in the subject device now provides the same measurement functionality as the Radical-7 module.

AI/ML Overview

The Masimo Root Monitoring System and Accessories is a multifunctional device designed for monitoring multiple physiological parameters in healthcare environments.

Here's an analysis of its acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of compliance with various standards and successful completion of verification and validation activities. It doesn't list specific quantitative acceptance criteria for each physiological parameter (e.g., accuracy ranges for SpO2, pulse rate, etc.) for the Root system itself, as these are attributed to the individual modules (Radical-7, Radius-7, ISA, Sedline). The Root system primarily acts as an interface and data aggregator.

Feature/Standard	Acceptance Criteria	Reported Device Performance
Electrical Safety	Compliance with IEC60601-1	Testing per IEC60601-1 performed; compliant.
Electromagnetic Compatibility (EMC)	Compliance with IEC-60601-1-2	Testing per IEC-60601-1-2 performed; compliant.
Alarm System	Compliance with IEC-60601-1-8	Testing per IEC-60601-1-8 performed; compliant.
Biocompatibility	Compliance with ISO-10993	Testing per ISO-10993 performed; compliant.
Usability	Compliance with FDA Human Factors and Usability Draft Guidance	Usability testing performed; compliant.
Wireless Functionality	Compliance with FDA Wireless Guidance	Wireless testing performed; compliant.
Software Verification	Compliance with FDA Software Guidance	Software verification performed; compliant.
Mechanical and Environmental Characteristics	Compliance with Mil-Std-810	Mechanical and environmental testing performed; compliant.
Functionality (Root as an interface)	Alternative user interface to integrate modules, provide access/control/monitoring of measurement technologies (of connected modules), transmit data for remote viewing/alarming, communicate with network systems.	Functions as intended, displays data from modules, handles alarms, communicates with networks.
Modified Radius-7 Module Performance	To provide all measurements in the Radical-7 module (SpO2, pulse rate, SpCO, SpMet, SpHb, RRa).	Thoroughly tested through verification and validation; all requirements and performance specifications satisfied.

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

The document is for a 510(k) premarket notification, which often relies on non-clinical testing and substantial equivalence to a predicate device rather than extensive clinical trials for the primary monitor system itself.

The document indicates that for the Root Monitoring System and the modified Radius-7 Module, "thoroughly tested through verification and validation" was performed. This suggests a series of engineering and performance tests on the device hardware and software.

Sample Size: Not explicitly stated in numerical terms within the provided text. The testing appears to be primarily laboratory-based and engineering verification rather than a patient-based test set.
Data Provenance: The nature of the tests (electrical, mechanical, software, etc.) implies that the data was generated internally by Masimo Corporation during product development and validation phases. No information about country of origin of data or whether it was retrospective or prospective is given, as it is non-clinical.

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

This information is typically relevant for clinical studies or studies involving human judgment (e.g., image interpretation). Since the testing described is non-clinical (electrical safety, software verification, mechanical, etc.), the concept of "experts establishing ground truth for a test set" in the context of clinical outcomes or diagnostic accuracy doesn't directly apply.

Instead, the "ground truth" for these engineering and performance tests would be established by:

Engineering specifications and design documents.
Applicable voluntary standards (e.g., IEC, ISO, Mil-Std).
FDA guidances (e.g., Human Factors, Wireless, Software).

The "experts" would be the engineering and quality assurance teams responsible for designing, conducting, and evaluating these tests against established requirements and standards. Their qualifications would involve expertise in relevant engineering disciplines, regulatory compliance, and quality assurance.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation or endpoint determination is subjective and requires consensus. As the described testing is non-clinical, an adjudication method for a test set in this sense is not directly applicable.

The verification and validation processes would involve:

Test protocols defining clear pass/fail criteria.
Independent review of test results.
Conformity assessment against standards.

Any discrepancies or failures would likely be resolved through engineering review, root cause analysis, and retesting, rather than an adjudication panel.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was done." The Masimo Root system functions as an interface and aggregator for other FDA-cleared modules; its primary mode of submission is through substantial equivalence based on non-clinical tests and its role not altering the intended use of the connected modules.

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

The concept of "standalone" performance, often used for AI algorithms, isn't directly applicable here in the same way. The Masimo Root Monitoring System is a hardware device with software that integrates and displays data from other cleared modules. Its "performance" is in correctly displaying data, processing alarms, and interacting with devices and networks.

The non-clinical performance testing described (electrical, EMC, software, etc.) essentially assesses the system's "standalone" functional performance relative to its design specifications and applicable standards, without human intervention in the data generation process, but with a human-in-the-loop for monitoring.
However, if "standalone" refers to an algorithm making a diagnostic decision without human input, then no such study was done because this device is a monitoring system and not a diagnostic AI algorithm.

7. Type of Ground Truth Used:

For the non-clinical tests specified:

Engineering specifications and design requirements: For software verification, functional testing, mechanical characteristics, and interface performance.
Compliance with harmonized standards: For electrical safety (IEC60601-1), EMC (IEC-60601-1-2), alarm systems (IEC-60601-1-8), biocompatibility (ISO-10993).
Compliance with FDA Guidances: For Usability (Human Factors) and Wireless performance.
Predicate Device Equivalence: The foundation of the 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device (K142394 Masimo Root Monitoring System). The performance of the predicate device serves as an implicit "ground truth" for overall device function and safety. The modifications to the Radius-7 module were then tested to ensure they achieved the same performance as the Radical-7 module's existing cleared functionalities.

8. Sample Size for the Training Set:

This question is related to machine learning models. The Masimo Root Monitoring System is described as a medical device for monitoring and data integration, not as a device utilizing a machine learning algorithm that requires a "training set." Therefore, this information is not applicable and not provided in the document.

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

As there is no indication of a machine learning algorithm or a "training set" in the context of this device, this question is not applicable. The device's foundational components (Radical-7, Radius-7, ISA, Sedline modules) are previously cleared technologies with their own established ground truths for their respective physiological measurements, which the Root system then displays and manages.

Summary

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

June 21, 2016

Masimo Corporation Marguerite Thomlinson Senior Director, Regulatory Affairs 52 Discovery Irvine, CA 92618

Re: K153225

Trade/Device Name: Masimo Root Monitoring System and Accessories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, GXY, GWQ, OLT, OLW, OMC, ORT, BZQ, DQA, DPZ, CCK, JKS Dated: May 18, 2016 Received: May 19, 2016

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 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.

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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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153225

Device Name

Masimo Root Monitoring System and Accessories

Indications for Use (Describe)

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

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

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

ISA CO2: CO2

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

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

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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark-like shape inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".

Submitter and Address ofManufacturing Facility:	Masimo Corporation52 DiscoveryIrvine, CA 92618Phone: (949) 297-7683FAX: (949) 297-7592
Date:	June 20, 2016
Contact:	Marguerite ThomlinsonSenior Director, Regulatory Affairs
Trade Name:	Masimo Root Monitoring System and Accessories
Common Name:	Patient Monitor
Regulation Number/ Name/Product Class	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:	K142394 - Masimo Root Monitoring System andAccessories
Performance Standards	No performance standards for the above device have beenpromulgated pursuant to Section 514.

Device Description

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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 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, SpCO, SpMet, SpHb 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).

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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".

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, Root.

FEATURE	SPECIFICATION
Display	Color LCD touchscreen
Connected Module	Parameter
Radical-7	Parameters per K110028
Radius-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 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)
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

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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in a smaller, gray font, followed by the address "52 Discovery, Irvine, CA 92618" also in a smaller, gray font.

(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 measurement technologies with which it is intended to function. Additionally, Root is intended to communicate with network systems.

Indications For Use

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

The Masimo Root Monitoring System and Accessories 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 Masimo Radius-7 Wearable 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 Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no 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

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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" are the words "Masimo Corporation" and the address "52 Discovery, Irvine, CA 92618".

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.

Technological Characteristics

Principle of Operation

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

Mechanism of Action for Achieving the Intended Effect

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

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

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

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

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Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

Summary of Technological Characteristics of Subject Device Compared to Predicate Device

Similarities and Differences between Predicate Device, Root (K142394) and Subject Device, Root

The predicate, Masimo Root Monitoring System (Root), per K142394, included the key components of the Root monitor with the Radical-7 module. Radius-7 module, ISA module and Sedline module. The subject device, Masimo Root Monitoring System and Accessories (Root), is the same as the predicate with modifications to the Radius-7 module.

In the predicate, the Radius-7 module provided SpO2, pulse rate, RRa measurements, which are a sub-set of the measurements included in the Radical-7 module. In this submission, the Radius-7 module provides all measurements in the Radical-7 module which includes SpO2, pulse rate, SpCO, SpMet, SpHb and RRa measurements.

Summary of Non-Clinical Performance Testing

The Root Monitoring System and the modified Radius-7 Module have been thoroughly tested through verification and validation, including software validation. Verification of compliance with applicable voluntary standards has also been made to support the use of the device in its intended environment.

Risk Analysis
Testing on unit level (module and or component verification) ●
Integration testing (system verification)
Performance testing (verification)

The Root Monitoring System and the modified Radius-7 Module were designed and tested for compliance to the following standards and guidance:

Electrical safety testing per IEC60601-1 ●
EMC testing per IEC-60601-1-2 ●
Alarm testing per IEC-60601-1-8 ●
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

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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line running through it, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "MASIMO CORPORATION" in a smaller font, followed by the address "52 Discovery, Irvine, CA 92618".

Mechanical and environmental testing per Mil-Std-810 ●

Clinical Testing

No clinical testing was done.

Substantial Equivalent Conclusion

The results of the testing demonstrate that all requirements and performance specifications were satisfied, and that the subject device is substantially equivalent to the predicate device. Thus, it is concluded that the subject device, Masimo Root Monitoring System and Accessories, are substantially equivalent to the predicate based on the non-clinical 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).