Who is the manufacturer of Masimo Root Monitoring System and Accesories?

Masimo Corporation filed the 510(k) submission for Masimo Root Monitoring System and Accesories (K142394).

What is the FDA product code for Masimo Root Monitoring System and Accesories?

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 and Accesories?

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

What are the predicate devices for Masimo Root Monitoring System and Accesories?

Masimo Root Monitoring System (K140188).

Who can help prepare an FDA 510(k) submission like Masimo Root Monitoring System and Accesories?

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 and Accesories

K142394 · Masimo Corporation · MWI · Nov 25, 2014 · Cardiovascular

Device Facts

Record ID	K142394
Device Name	Masimo Root Monitoring System and Accesories
Applicant	Masimo Corporation
Product Code	MWI · Cardiovascular
Decision Date	Nov 25, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices. The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities environments. 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 Monitoring System acts as central user interface/display for modular physiological monitoring; connects to Radical-7, Radius-7, ISA gas analyzers, and SedLine EEG modules. Inputs: physiological signals from modules (SpO2, pulse, gases, EEG). Processing: Root aggregates data, manages alarms (IEC 60601-1-8), and provides touchscreen control. Outputs: visual/audible patient data, alarm notifications, and network communication via wired/wireless (Bluetooth/Wi-Fi) interfaces to systems like Patient SafetyNet. Used by healthcare professionals in clinical environments (OR, ICU, patient rooms). Benefits: centralized monitoring, improved access to patient data, and integrated alarm management.

Clinical Evidence

No clinical testing was done. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm verification (IEC 60601-1-8), biocompatibility (ISO-10993), usability, wireless coexistence, and software verification.

Technological Characteristics

LCD touchscreen interface; AC/battery powered; dimensions 11x10.5x5.5 inches; weight ~8 lbs. Connectivity: Ethernet, Wi-Fi (802.11 a/b/g), Bluetooth 2.0, USB, SD card, nurse call. Interfaces: MOC-9, Iris. Continuous operation mode. Software-based data aggregation and alarm management.

Indications for Use

Indicated for adult, pediatric, neonatal, and infant patients in hospitals, hospital-type facilities, mobile, home, OR, ICU, and clinical research labs. Used for monitoring SpO2, pulse rate, SpCO, SpMet, SpHb, RRa, breathing gases (CO2, O2, N2O, anesthetic agents), and EEG/PSI state of brain.

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

Masimo Root Monitoring System (K140188)

Reference Devices

Masimo Radical-7 Pulse CO-Oximeter (K110028)
Masimo Radius-7 Pulse Oximeter (K110028)
ISA-Infrared Sidestream Gas Analyzer (K103604)
Sedline Sedation Monitor (K051874)
Patient SafetyNet (K071047)

Related Devices

K140188 — MASIMO ROOT MONITORING SYSTEM · Masimo Corporation · Jun 25, 2014
K151644 — Masimo Root Vital Signs Monitoring System and Accessories · Masimo Corporation · Feb 12, 2016
K153225 — Masimo Root Monitoring System and Accessories · Masimo Corporation · Jun 21, 2016
K171121 — Masimo Root Monitoring System and Accessories · Masimo Corporation · Nov 17, 2017
K110622 — INTELLIVUE PATIENT MONITOR · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Mar 31, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping heads. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 25, 2014 Masimo Corporation Marguerite Thomlinson Senior Director, Regulatory Affairs 40 Parker Irvine, California 92618 Re: K142394 Trade/Device Name: Masimo Root Monitoring System And Accesories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, JKS, CCK, BZQ, DQA, DPZ, GXY, GWQ, OLT, OLW, OMC, ORT Dated: August 25, 2014 Received: August 27, 2014 Dear Marguerite Thomlinson, We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply {1}------------------------------------------------ with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Melissa A. Torres -S For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Section 4. Indications for Use Statement #### Indications for Use 510(k) Number: Device Name: Masimo Root Monitoring System #### Indications for Use: The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate to multi-parameter devices for the display of those devices. The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 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) {3}------------------------------------------------ #### Section 4. Indications for Use Statement Wearable Pulse Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities. 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. 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) {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white waveform inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the company name is the text "MASIMO CORPORATI," followed by the address "Forty Parker, Irvine, CA 92618". | Submitter and Address of Manufacturing Facility: Date: | Masimo Corporation 40 Parker Irvine, CA 92618 Phone: (949) 297-76 FAX: (949) 297-7592 August 25, 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: | K140188 – Masimo Root Monitoring System | | Performance Standards | No performance standards for the above device have been promulgated pursuant to Section 514. | {5}------------------------------------------------ ### 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), with cleared technologies of SpO2, pulse rate, SpCO, SpMet, SpHb and RRa monitoring per K110028. - Masimo Radius-7 Pulse Oximeter (Radius-7 module), with cleared technologies of SpO2, pulse rate and RRa monitoring per K110028. - ISA-Infrared Sidestream Gas Analyzer (ISA module), with cleared technologies of breathing gases and respiratory rate monitoring per K103604. - Sedline Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set ● (Sedline module), with cleared technologies of EEG and PSI monitoring per K051874. Root is intended to be used as an alternative user interface to facilitate access control and monitoring device functions and to connect system networks such as the Patient SafetyNet (K071047). ### Device Description - General Description from Labeling, Including Explanation of How Device Functions, Scientific Concepts that Form Basis For the Device 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. {6}------------------------------------------------ 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 K140188, is the same as the subject device, Masimo Root Monitoring System (Root). The main difference is that the subject device includes the addition of the optionally connected Masimo Radius-7 Pulse Oximeter (Radius-7) module. #### Device Description - Significant Physical and Performance Characteristics of the Device The significant physical characteristics for Root include an LCD touchscreen for patient monitoring. The instrument can be powered by AC or by its internal rechargeable battery. The approximate size and weight of the instrument are 11' x 10.5' x 5.5'' (27.9 cm x 26.7 cm x 14 cm) and approximately 8 pounds. | FEATURE | SPECIFICATION | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Display | Color LCD touchscreen | | Connected Module | Parameter | | Radical-7 | Parameters per K110028 | | Radius-7 | Parameters per K110028 for SpO2, pulse rate and RRa | | ISA Module | Parameters per K103604 | | Sedline Module | Parameters per K051874 | | General | | | Visual/audible alarm | IEC60601-1-8 compliant | | Storage/recording | Trend/data storage | | Electrical | | | AC Power | 100-240 volt, 47-63 Hz | | Battery | Rechargeable battery | | Interface | | | Root and Device/Module Connection | Wired/docking interface Wireless interface MOC-9 interface Iris interface Nurse call interface USB interface SD card interface | | Network Connectivity | Ethernet 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) | The device specifications are shown below for the general functions of the subject device, Root. {7}------------------------------------------------ | FEATURE | SPECIFICATION | |-----------------------|--------------------------------| | Environmental | | | Operating Temperature | 32 to 122°F (0-50°C) | | Storage Temperature | -40 to 158°F (-40 to 70°C), | | Humidity | 10-95% non-condensing humidity | | Mode of Operation | | | Mode of Operation | Continuous | #### Intended Use Root serves as a convenient alternative user interface to integrate modules to provide health care professionals the ability to access, control and monitor measurement technologies (within the respective modules) that have been previously cleared by the FDA. Root does not affect the intended use, or alter the indications for use, for the cleared modules with which it is intended to function. Additionally Root is intended to communicate with network systems. #### Indications For Use The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices. The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities environments. {8}------------------------------------------------ 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. ### 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. {9}------------------------------------------------ Once use is complete, the user then turns the power "off" for Root. ### Summary of Technological Characteristics of Subject Device Compared to Predicate Device ### Similarities and Differences between Predicate Device, Root (K140188) and Subject Device, Root The main features which are the same for predicate and subject devices are listed below. - Both have the same fit, form and function. - Both can function with the Radical-7, ISA and/or Sedline modules. - Both have the same principle of operation and the mechanism of action for ● achieving the intended effect. - Both can communicate with a network system such as the Patient SafetyNet . (K071047) through wired or wireless connection. The main difference between the predicate and the subject devices is that the Radius-7 is an added measurement module that can function with the subject device. Below is a summary of the monitored parameters and their substantial equivalence. | TABLE 18 | | | | | | | |--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Monitored Parameter | Test Description | Test Objective | Study Endpoints | Results Summary | Conclusion | Substantial Equivalence (SE) Yes/No? | | SpO2, PR, and RRa | Display verification of Root and Radius-7 module | To verify Root user interface when connected to Radius-7 | Test personnel began and ended test cases for the Root with Radius-7 user interface, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from Radius-7. | Yes SE to K140188 | | SpO2, PR, PI, PVI and RRa | Display validation of Radius-7 module | To validate human factors/ usability | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Radius-7's ease of use was validated by the clinicians. | Yes SE to K140188 | | SpO2, PR, and RRa | Display validation of Radius-7 module | To validate human factors/ usability for Root and Radius-7 | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Radius-7's ease of use was validated by the clinicians. | Yes SE to K140188 | | | | | TABLE 18 | | | | | Monitored Parameter | Test Description | Test Objective | Study Endpoints | Results Summary | Conclusion | Substantial Equivalence (SE) Yes/No? | | N/A. General battery functions. | Battery life and operation verification for Radius-7 module | To verify battery life and operation for Radius-7 | Test personnel began and ended battery life/operation test cases, and recorded the test results per test procedures. | Pass | Radius-7's battery life and operation was verified to work properly. | Yes SE to K140188 | | N/A. General display and speaker functions. | Visual/audio alarm verification for Radius-7 module | To verify visual/audio alarm compliance to IEC 60601-1-8 | Test personnel began and ended visual/audio alarm test cases per the IEC standards, and recorded test results. | Pass | Radius-7 visual/audio alarms are compliant to IEC60601-1-8. | Yes SE to K140188 | | SpO2, PR, and RRa | Visual/audio alarm verification for Root and Radius-7 | To verify audio and visual alarms on Root | Test personnel began and ended audio/visual alarm verification test cases, and recorded test results per test procedures | Pass | Root correctly generated visual/audio alarms from Radius-7. | Yes SE to K140188 | | N/A. General wireless connection | Wireless (Bluetooth) connection verification for Root and Radius-7 | To verify Bluetooth connection between Root and Radius-7 | Test personnel began and ended Bluetooth verification test cases. and recorded test results per test procedures. | Pass | Root properly connected to Radius- 7 via Bluetooth connection. | Yes SE to K140188 | | N/A. General wireless connection | Wireless connection verification for Root and Radius-7 | To verify wireless co- existence per FDA Wireless Guidance | Test personnel began and ended wireless co- existence testing per FDA Guidance, and recorded the test results. | Pass | Root with Radius-7 met FDA Wireless Guidance requirements for wireless co-existence testing. | Yes SE to K140188 | | N/A. General wireless connection | Wireless connection verification for Root and Radius-7 | To verify wireless quality of service per FDA Wireless Guidance | Test personnel began and ended wireless quality of service testing verification per FDA Guidance, and recorded test results. | Pass | Root with Radius-7 met FDA Wireless Guidance requirements for wireless quality of service testing. | Yes SE to K140188 | | SpO2, PR, SpCO, SpMet, SpHb and RRa | Display verification of Root and Radical-7 module | To verify Eagle (Root) user interface | Test personnel began and ended test cases for the Root user interface, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the connected modules. | Yes SE. See predicates in K140188. | | SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Display validation of Root and Radical-7, ISA and Sedline modules | To validate human factors/ usability | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Root's ease of use was validated by the clinicians. | Yes SE. See predicates in K140188. | | TABLE 18 | | | | | | | | Monitored Parameter | Test Description | Test Objective | Study Endpoints | Results Summary | Conclusion | Substantial Equivalence (SE) Yes/No? | | SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Display validation of Root and Radical-7, ISA and Sedline modules | To validate human factors/ usability | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Root's ease of use was validated by the clinicians. | Yes SE. See predicate in K140188. | | EEG and PSI | Display verification of Root and 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. See predicate in K140188. | | Breathing Gases and RR | Display verification of Root and ISA module | To verify ISA module indicator and display | Test personnel began and ended test cases for indictor/display verification, and recorded the test results per test procedures | Pass | Root correctly displayed monitoring information from the ISA module. | Yes SE. See predicate in K140188. | | 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. See predicate in K140188. | | N/A. General docking functions | Docking station function verification for Root and Radical-7 | To verify battery management | Test personnel began and ended battery management test cases, and recorded the test results per test procedures. | Pass | Root docking station interfaced correctly with the Radical-7 module. | Yes SE. See predicate in K140188. | | EEG and PSI | MOC-9 interface verification for Root and Sedline module | To verify MOC-9 Port EEPROM | Test personnel began and ended MOC-9 EEPROM verification test cases, and recorded the test results per test procedures | Pass | The MOC-9 interface functioned correctly in EEPROM identification. | Yes SE. See predicate in K140188. | | Breathing gases, RR, EEG and PS | MOC-9 interface verification for Root and ISA and Sedline modules | To verify EEPROM Identification for Iris and MOC-9 | Test personnel began and ended EEPROM Identification test cases for Iris and MOC-9, and recorded test results per test procedures. | Pass | The MOC-9 and Iris interfaces functioned correctly in EEPROM identification for connected modules. | Yes SE. See predicate in K140188. | | | | | TABLE 18 | | | | | Monitored Parameter | Test Description | Test Objective | Study Endpoints | Results Summary | Conclusion | Substantial Equivalence (SE) Yes/No? | | 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. See predicate in K140188. | | 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. See predicate in K140188. | | 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. See predicate in K140188. | | N/A. General display and speaker functions | Visual/audio alarm verification for Root | To verify visual/audio alarm compliance to IEC 60601-1-8 | Test personnel began and ended visual/audio alarm test cases per the IEC standards, and recorded test results. | Pass | Root visual/audio alarms are compliant to IEC60601-1-8. | Yes SE. See predicate in K140188. | | SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Visual/audio alarm verification for Root and Radical-7, ISA and Sedline modules | To verify visual/audio alarm acknowledgment | Test personnel began and ended visual/audio alarm acknowledgment test cases, and recorded the test results per test procedures. | Pass | Root correctly generated visual/audio alarms from the connected modules. | Yes SE. See predicate in K140188. | | SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Visual/audio alarm verification for Root and Radical-7, ISA and Sedline modules | To verify audio and visual alarms | Test personnel began and ended audio/visual alarm verification test cases, and recorded test results per test procedures | Pass | Root correctly generated visual/audio alarms from the connected modules. | Yes SE. See predicate in K140188. | | SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Alarm limit controls verification for Root and Radical-7, ISA and Sedline modules | To verify alarm limit controls | Test personnel began and ended alarm limit controls verification test cases, and recorded test results per test procedures | Pass | Root correctly generated alarm limits from the connected modules. | Yes SE. See predicate in K140188. | | | | | TABLE 18 | | | | | Monitored Parameter | Test Description | Test Objective | Study Endpoints | Results Summary | Conclusion | Substantial Equivalence (SE) Yes/No? | | N/A. General wired connection | Wired connection verification for Root | To verify Ethernet connection | Test personnel began and ended Ethernet verification test cases, and recorded test results per test procedures | Pass | Root functioned correctly in its connectivity via the Ethernet. | Yes SE. See predicates in K140188. | | N/A. General wired connection | Wired connection verification for Root | To verify Iris connectivity to network system | Test personnel began and ended Iris/Patient SafetyNet connectivity test cases, and recorded test results per test procedures | Pass | Root's Iris interface functioned correctly in its connectivity to system networks such as the Patient SafetyNet. | Yes SE. See predicates in K140188. | | N/A. General wireless connection | Wireless connection verification for Root | To verify internal radio module | Test personnel began and ended radio module verification test cases, and recorded test results per test procedures. | Pass | Root's internal radio module performed correctly. | Yes SE. See predicates in K140188. | | N/A. General wireless connection | Wireless connection verification for Root | To verify wireless co- existence per FDA Wireless Guidance | Test personnel began and ended wireless co- existence testing per FDA Guidance, and recorded the test results. | Pass | Root met FDA Wireless Guidance requirements for wireless co-existence testing. | Yes SE. See predicates in K140188. | | N/A. General wireless connection | Wireless connection verification for Root | To verify wireless quality of service per FDA Wireless Guidance | Test personnel began and ended wireless quality of service testing verification per FDA Guidance, and recorded test results. | Pass | Root met FDA Wireless Guidance requirements for wireless quality of service testing. | Yes SE. See predicates in K140188. | {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ ## Non-clinical Testing See below for the non-clinical testing that was completed. - Electrical safety testing per IEC60601-1 ● - EMC testing per IEC60601-1-2 - Alarm testing per IEC60601-1-8 ● - Biocompatibility testing per ISO-10993 ● - Usability testing per FDA Human Factors and Usability Draft Guidance ● - Wireless testing per FDA Wireless Guidance ● - Software verification per FDA Software Guidance ● - Mechanical and environmental testing {14}------------------------------------------------ - 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.