Masimo Root Monitoring System
Device Facts
| Record ID | K253417 |
|---|---|
| Device Name | Masimo Root Monitoring System |
| Applicant | Masimo Corporation |
| Product Code | MWI · Cardiovascular |
| Decision Date | Aug 12, 2026 |
| 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 Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital- type facilities, home environments, and transport within healthcare facilities. The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare 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. The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table: Newborn (neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older The optional Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in hospitals, hospital-type facilities, and healthcare facilities. The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments. The LiDCO Module is intended for adult patients requiring cardiovascular monitoring who have peripheral arterial pressure monitoring in hospital and hospital-type settings. The LiDCO Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. It digitizes, analyses & transfers the hemodynamic parameters derived from the analog signal obtained from vital signs monitor to a host device (e.g. Root) for display. In addition to arterial blood pressure parameters (Sys, MAP, Dia) and cardiac output, the LiDCO Module calculates a number of derived parameters: Oxygen Delivery and Oxygen Delivery Index, Oxygen Consumption and Oxygen Consumption Index, Cardiac Index, Stroke Volume and Stroke Volume Index, Heart Rate, Systemic Vascular Resistance and Systemic Vascular Resistance Index, Stroke Volume Variation %, Pulse Pressure Variation % and Body Surface Area.
Device Story
Masimo Root Monitoring System is a modular patient monitor; provides user interface for display, alarms, and data management of connected medical technology modules. Subject device adds LiDCO Module for hemodynamic monitoring. LiDCO Module receives analog blood pressure signals from third-party transducers/monitors; processes data via PulseCO algorithm to derive hemodynamic parameters (e.g., cardiac output, stroke volume, SVR, oxygen delivery/consumption). Root displays these parameters; supports wired/wireless communication to EHR or Patient SafetyNet. Used by clinicians in hospitals/ICU/OR/clinical settings. Benefits include integrated hemodynamic monitoring to assist in clinical decision-making for cardiovascular management in adult patients.
Clinical Evidence
No clinical testing was conducted. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation, and human factors/usability testing. The LiDCO PulseCO algorithm remains unchanged from its original clearance (K163334).
Technological Characteristics
Modular patient monitor with touchscreen display; supports wired/wireless (Wi-Fi, Bluetooth) connectivity. LiDCO Module uses proprietary PulseCO algorithm to derive hemodynamic parameters from invasive arterial blood pressure signals. Power: AC/rechargeable battery. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-34 (performance). Software: Enhanced level of concern, verified/validated per FDA guidance.
Indications for Use
Indicated for adult, pediatric, and neonatal patients in hospital, hospital-type, mobile, and home environments for monitoring physiological parameters including SpO2, PR, SpCO, SpMet, SpHb, RRa, RRp, EEG (SedLine), temperature, NIBP, patient orientation/activity (Centroid), and hemodynamic parameters (LiDCO Module) in adult patients requiring cardiovascular monitoring.
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
Reference Devices
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
August 12, 2026
Masimo Corporation
Sindura Penubarthi
Associate Director, Regulatory Affairs
52 Discovery
Irvine, California 92618
Re: K253417
Trade/Device Name: Masimo Root Monitoring System
Regulation Number: 21 CFR 870.2300
Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)
Regulatory Class: Class II
Product Code: MWI, DXG, KMI, BZQ, CCK, GXY, DQA, DPZ, GWQ, OLT, OLW, OMC, ORT, DXN, FLL
Dated: July 9, 2026
Received: July 10, 2026
Dear Sindura Penubarthi:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K253417 - Sindura Penubarthi
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
{2}
K253417 - Sindura Penubarthi
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
JAMES J. LEE -S
for Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253417 | ? |
| Please provide the device trade name(s). | | ? |
| Masimo Root Monitoring System | | |
| Please provide your Indications for Use below. | | ? |
| The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances.The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities.The Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital- type facilities, home environments, and transport within healthcare facilities.The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. | | |
{4}
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare 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.
The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
{5}
Patient Population Approximate Age Range
Newborn (neonate) Birth to 1 month of age
Infant 1 month to 2 years of age
Child 2 to 12 years of age
Adolescent 12-21 years of age
Adult 21 years of age and older
The optional Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in hospitals, hospital-type facilities, and healthcare facilities.
The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments.
The LiDCO Module is intended for adult patients requiring cardiovascular monitoring who have peripheral arterial pressure monitoring in hospital and hospital-type settings.
The LiDCO Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
It digitizes, analyses & transfers the hemodynamic parameters derived from the analog signal obtained from vital signs monitor to a host device (e.g. Root) for display.
In addition to arterial blood pressure parameters (Sys, MAP, Dia) and cardiac output, the LiDCO Module calculates a number of derived parameters:
Oxygen Delivery and Oxygen Delivery Index, Oxygen Consumption and Oxygen Consumption Index, Cardiac Index, Stroke Volume and Stroke Volume Index, Heart Rate, Systemic Vascular Resistance and Systemic Vascular Resistance Index, Stroke Volume Variation %, Pulse Pressure Variation % and Body Surface Area
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
?
{6}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Submitter and Address of Manufacturing Facility: | Masimo Corporation 52 Discovery Irvine, CA 92618 Phone: (949) 297-7000 FAX: (949) 297-7592 |
| --- | --- |
| Date: | August 12, 2026 |
| Contact: | Sindura Penubarthi Associate Director, Regulatory Affairs Masimo Corporation Phone: (949) 396-4041 |
| Trade Name: | Masimo Root Monitoring System |
| Common Name: | Patient Monitor |
| Classification Regulation/ Product Code: | 21 CFR 870.2300, Class II/MWI |
| Additional Product Codes: | 21 CFR 870.1435, Class II/DXG 21 CFR 880.2400, Class I/KMI 21 CFR 868.2375, Class II/BZQ 21 CFR 862.3220, Class II/JKS 21 CFR 868.1400, Class II/CCK 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 21 CFR 870.1130, Class II/DXN 21 CFR 880.2910, Class II/FLL |
| Establishment Registration Number: | 2031172 |
| Reason for Premarket Notification: | Device modification to add expanded indication for use |
| Predicate Device: | K191882 - Masimo Root Monitoring System and Accessories |
| Secondary Predicate: | K163334 - LiDCOUnity Monitor |
| Reference Device: | K242451- HemoSphere Alta Advanced Monitoring Platform |
| Performance Standards | No performance standards for the above device have been promulgated pursuant to Section 514. |
# 1 Device Description
The Masimo Root (Root) is an FDA cleared monitor (K191882) that supports expanded monitoring capabilities of patients through the connection of various medical technologies. For these medical technologies, the Root provides a user interface for display of parameter data, visual and audible alarms, and ability to capture user inputs (e.g., entering of data, configuring of settings). The Root can be
{7}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
configured to support clinician workflows by the connection and disconnection of different medical technologies. Root also supports both wired and wireless communication, including the ability to send data to an EHR or to Masimo Patient SafetyNet.
The LiDCO Module is an optional medical technology module that provides the PulseCO algorithm cleared as part of FDA cleared LiDCOUnity Monitor (K163334) in a modular form factor so that it can be used in connection with a backboard device (e.g., Root). The LiDCO Module includes an integrated technology board with the PulseCO algorithm that receives power from a connected host device (e.g., Root). The blood pressure data used by the PulseCO algorithm is obtained through the connection of the LiDCO Module to a third-party blood pressure source. The blood pressure source is either a third-party monitor connected to a third-party pressure transducer or a direct connection of the module to a third-party blood pressure transducer.
The LiDCO PulseCO algorithm processes the captured blood pressure data to derive blood pressure waveforms and calculate blood pressure measurements (e.g., systolic, diastolic, MAP) as well as other hemodynamic parameters (e.g., stroke volume, cardiac output).
The LiDCO sensor is used to support the oxygen delivery (cDO2) feature. The LiDCO sensors support FDA cleared SpO2, PR, SpHb, and SpMet parameters.
The Root specifications are provided in Table 1-1 below:
| Table 1-1 | |
| --- | --- |
| Masimo Root | |
| Feature | Specification |
| Monitoring Function | |
| Display | Touchscreen |
| Measurement Modules | Radical-7; Radius-7; ISA; SedLine; Temperature; NiBP, and Centroid, LiDCO |
| Visual/Audible Alarm | IEC 60601-1-8 compliant |
| Storage/Recording | Trend/Data Storage |
| Communication Interface | |
| Interface | Wired/ Wireless; MOC-9; Iris; Nurse call; USB; SD card; temperature probe port; NIBP port |
| Network connectivity | Ethernet; Wi-Fi, 802.11 a/b/g; Bluetooth 2.0 |
| Power | |
| AC Power | 100-240 Vac, 47-63 Hz |
| Battery type | Rechargeable Lithium |
| Mechanical | |
| Dimensions/Weight | 11 x 10.5 x 5.5 inch (27.9 x 26.7 x 14 cm) |
| Weight | 3.37 kg (7.43 lbs.) |
| Environmental | |
| Operating Temperature | 0 to 50°C |
| Storage Temperature | -40 to 70°C |
| Operating/ Storage Humidity | 10% to 95%, non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1,060 mbar (540 hPa to 1060 hPa) |
| Classification per IEC 60601-1 | |
| Mode of Operation | Continuous |
{8}
MASIMO
MASIMO CORPORATION
62 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
See Table 1-2 below for the LiDCO Module specifications.
| Table 1-2 | |
| --- | --- |
| Masimo LiDCO Module | |
| Feature | Specification |
| **Supported Parameters** | |
| Blood Pressure Derived Parameters | Systolic, Diastolic, Mean Arterial Pressure, Heart Rate, Stroke Volume |
| Calculated Parameters | Body Surface Area (BSA), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Pulse Pressure Variation (PPV), Cardiac Output (CO), Cardiac Index (CI), Oxygen Delivery (DO2) (cDO2), Oxygen Delivery Index (DO2I) (cDO2I), Oxygen consumption (VO2), Oxygen consumption Index (VO2I), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI) |
| **Display Range** | |
| Heart/Pulse Rate (HR) | 35-240 bpm |
| Pulse Pressure Variation (PPV) | 0-100 % |
| Stroke Volume (SV) | 1-500 ml |
| Stroke Volume Index (SVI) | 1-500 ml/m² |
| Stroke Volume Variation (SVV) | 0-100 % |
| Cardiac Output (CO) | 0.1-30 l/min |
| Cardiac Index (CI) | 0.1-30 l/min/m² |
| Oxygen consumption (VO2) | 10-3000 ml/min |
| Oxygen consumption Index (VO2I) | 10-3000 ml/min/m² |
| Systemic Vascular Resistance (SVR) | 100-12000 dyn s/cm⁵ |
| Systemic Vascular Resistance Index (SVRI) | 100-12000 dyn s m²/cm⁵ |
| Oxygen Delivery (DO2) (cDO2) | 10-3000 ml/min |
| Oxygen Delivery Index (DO2I) (cDO2I) | 10-3000 ml/min/m² |
| Systolic Pressure | 40-300 mmHg |
| Diastolic Pressure | 30-250 mmHg |
| Mean Arterial Pressure | 35-260 mmHg |
## 2 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 Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances.
The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station).
{9}
MASIMO
MASIMO CORPORATION
62 Discovery
Irvine, CA 92618
## 510(k) Summary
(K253417)
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities.
The Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital- type facilities, home environments, and transport within healthcare facilities.
The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities.
{10}
MASIMO
MASIMO CORPORATION
62 Discovery
Irvine, CA 92618
## 510(k) Summary
(K253417)
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.
The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare 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.
The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table:
| Patient Population | Approximate Age Range |
| --- | --- |
| Newborn (neonate) | Birth to 1 month of age |
| Infant | 1 month to 2 years of age |
| Child | 2 to 12 years of age |
| Adolescent | 12-21 years of age |
| Adult | 21 years of age and older |
{11}
MASIMO
MASIMO CORPORATION
62 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
The optional Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in hospitals, hospital-type facilities, and healthcare facilities.
The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments.
The LiDCO Module is intended for adult patients requiring cardiovascular monitoring who have peripheral arterial pressure monitoring in hospital and hospital-type settings.
The LiDCO Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.
It digitizes, analyses & transfers the hemodynamic parameters derived from the analog signal obtained from vital signs monitor to a host device (e.g. Root) for display.
In addition to arterial blood pressure parameters (Sys, MAP, Dia) and cardiac output, the LiDCO Module calculates a number of derived parameters:
Oxygen Delivery and Oxygen Delivery Index, Oxygen Consumption and Oxygen Consumption Index, Cardiac Index, Stroke Volume and Stroke Volume Index, Heart Rate, Systemic Vascular Resistance and Systemic Vascular Resistance Index, Stroke Volume Variation %, Pulse Pressure Variation % and Body Surface Area.
# 3 Technological Characteristics
# Principle of Operation
There have been no changes to the principles of operation from what was previously cleared for the Root (K191882). The Root uses the same principles of operation in providing connectivity and a user interface (UI) for supported technologies.
The LiDCO Module relies on the same principles of operation as the FDA cleared LiDCOUnity Monitor (K163334) to provide the same calculations based upon blood pressure data using the proprietary LiDCO PulseCO algorithm.
# Mechanism of Action for Achieving the Intended Effect
Similar to how the other modules are supported, the LiDCO Module is connected to the Root to begin the communication between the LiDCO Module and the Root. To initiate the monitoring of the LiDCO parameters on the Root, a connection between a continuous blood pressure source and the LiDCO Module needs to be established. Similar to the predicate device, LiDCOUnity Monitor (K163334), the blood pressure source can be a direct connection to a third-party arterial blood pressure transducer or indirectly through a third-party patient monitor that is connected to a third-party arterial blood pressure transducer.
{12}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
When the LiDCO sensors are applied to the patient, the FDA cleared SpO2 and SpHb parameter data can be incorporated to automate the established calculation for oxygen delivery (DO2) and oxygen consumption (VO2).
Similar to the FDA cleared Root (K191882), Root can communicate data, including the LiDCO data, to Patient SafetyNet (K071047) or the hospital electronic health record (EHR) system.
## 4 Discussion of Similarities and Differences Between Primary Predicate and Subject Device
Similarities and Differences between Predicate and Subject Device Masimo Root
The subject device, Masimo Root, and the predicate device, Masimo Root (K191882), have the following key similarities:
- Both devices have the same intended use;
- Both devices support communication to multiple modules;
- Both devices support wireless communication;
- Both devices support audible and visual alarm.
The subject device, Masimo Root, and the predicate device, Masimo Root (K191882), have the following key differences:
- Expansion of the indications to include hemodynamic monitoring through the compatibility to the LiDCO Module.
As part of this submission, the Masimo Root's (K191882) indications for use is being expanded to include hemodynamic monitoring by the integration of the FDA cleared LiDCOUnity Monitor (K163334) PulseCO algorithm through compatibility with the LiDCO Module and the clearance for LiDCO sensor.
To support there are no technological characteristic differences that raise different questions of safety and effectiveness, testing is provided as part of this submission. The test results support the substantial equivalence of the subject device.
{13}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| Classification | Class II, Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) | Class II, Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) | Class II, Computer, Diagnostic, Pre- Programmed, Single- Function | Same. |
| Regulation/ Product Code | 21 CFR 870.2300/MWI | 21 CFR 870.2300/MWI | 21 CFR 870.1435/ DXG | Same. |
| Additional Product Code(s) | DXG, BZQ, CAT, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, DXN, FLL, GWQ, GXY, NHO, NHP, NHQ, OLT, OLW, OMC, ORT | BZQ, CAT, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, DXN, FLL, GWQ, GXY, NHO, NHP, NHQ, OLT, OLW, OMC, ORT | GWQ, DXN | The subject device includes additional product code DXG, the same as the secondary predicate. |
| 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 Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. | The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. | The LiDCOrapid Hemodynamic Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. The LiDCOrapid monitor should be used in conjunction with a patient monitor at all times. | Same. |
| 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 Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. | The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. | The LiDCOrapid Hemodynamic Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for | Different. The subject device has expanded indications for hemodynamic monitoring, the same as the secondary predicate. |
{14}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| | The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of | The Masimo Root Monitoring System can communicate with network systems for supplemental remote viewing and alarming (e.g., at a central station). The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of 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. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during | the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. The LiDCOrapid monitor should be used in conjunction with a patient monitor at all times. When connected to the BIS Module: intended for monitoring the state of the brain by data acquisition of EEG signals and may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation. When connected to the CNAP Module: intended for the noninvasive continuous monitoring of blood pressure in adults and pediatric (>4yrs) patients by medical professionals. The LiDCO CNAP Module is intended for use with the LiDCOrapid monitor. | |
{15}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| | adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused | no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radical-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from photoplethysmogram (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radius-7 Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in | In addition to arterial blood pressure parameters and cardiac output, the LiDCOrapid Monitor calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation %, Stroke Volume Variation %, Cardiac Index, Stroke Volume, Stroke Volume Index, Systemic Vascular Resistance, Systemic Vascular Resistance Index Oxygen Delivery/Index. Suitable Patients and Locations of use LiDCOrapid: Adult patients requiring cardiovascular monitoring who have peripheral arterial pressure monitoring – Medical & Surgical ICU’s – Operating Suites – Step Down / High Dependency Units – Trauma / A&E (ER) Departments – Coronary Intensive Care Units | |
{16}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| | in hospitals, hospital-type facilities, mobile, and home environments. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion | hospitals, hospital-type facilities, mobile, and home environments. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions in hospitals and hospital-type facilities. The Masimo Radius and Accessories are not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, and neonatal patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions in hospitals and hospital-type facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of respiratory rate (RRa) for adult, pediatric, and neonatal patients during no motion | – Cardiac Catheter Laboratories BIS: Adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. CNAP: Adult and pediatric patients from the age of 4 years, and is to be operated by medical professional staff in hospitals, clinical institutions, medical practices and outpatient settings. The LiDCOunity Hemodynamic Monitor System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of cardiac output via Lithium Indicator Dilution in adult patients (>40Kg/88lbs) with pre-inserted arterial and venous catheters, and for monitoring continuous blood pressure and cardiac output in patients with pre-existing | |
{17}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| | conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The optional ISA product family consists of three types of sidestream gas analyzers (ISACO2, 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 | conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities. The Radius-7 and Accessories are indicated for the continuous non-invasive monitoring of Respiratory Rate from Pleth (RRp) for adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, home environments, and transport within healthcare 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 | peripheral arterial line access. The LiDCOunity monitor should be used in conjunction with a patient monitor at all times. Derived Parameters – In addition to arterial blood pressure parameters and cardiac output the LiDCOunity Hemodynamic Monitor System calculates a number of derived parameters: Body Surface Area, Pulse Pressure Variation %, Cardiac Index, Stroke Volume, Stroke Volume Variation %, Stroke Volume Index, Systemic Vascular Resistance/Index, Oxygen Delivery/Index. Suitable Patients – Patients who have had arterial and venous catheters inserted and require monitoring. Locations of use – Suitable patients may be found in the following areas: | |
{18}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| | 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. The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table: | 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. The optional temperature module is indicated to measure temperature (oral, adult axillary, pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider. The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive measurement of arterial blood pressure in healthcare environments. The NIBP module is designed to measure blood pressure for patient population described in the following table: | • Medical & Surgical Intensive Care Units • Operating Rooms / Theatres • Step Down / High Dependency Units • Trauma / Accident & Emergency / Emergency Rooms • Coronary Intensive Care Units • Cardiac Catheter Laboratories | |
| Patient Population | Approximate Age Range | Patient Population Newborn (neonate) | Approximate Age Range Birth to 1 month of age | |
{19}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | | Masimo Root, Primary Predicate (K191882) | | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- | --- | --- |
| | Newborn (neonate) | Birth to 1 month of age | Infant | 1 month to 2 years of age | | |
| | Infant | 1 month to 2 years of age | Child | 2 to 12 years of age | | |
| | Child | 2 to 12 years of age | Adolescent | 12-21 years of age | | |
| | Adolescent | 12-21 years of age | Adult | 21 years of age and older | | |
| | Adult | 21 years of age and older | The optional Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in hospitals, hospital-type facilities, and healthcare facilities. The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments. The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments. The LiDCO Module is indicated for the following: | | | |
| | | | | | | |
| | | | The optional Centroid System is intended for monitoring the orientation and activity of patients. The Centroid System is intended to provide alerts when patient orientation or activity deviates from parameters set by healthcare providers. The Centroid System is indicated for monitoring the orientation and activity of patients including those susceptible to pressure ulcers. The Centroid System is intended for use in hospitals, hospital-type facilities, and healthcare facilities. The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments. The Centroid System is also indicated for the measurement of respiration rate of adults in healthcare environments. | | | |
{20}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| | The LiDCO Module is intended for adult patients requiring cardiovascular monitoring who have peripheral arterial pressure monitoring in hospital and hospital-type settings. The LiDCO Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients. It digitizes, analyses & transfers the hemodynamic parameters derived from the analog signal obtained from vital signs monitor to a host device (e.g. Root) for display. In addition to arterial blood pressure parameters (Sys, MAP, Dia) and cardiac output, the LiDCO Module calculates a number of derived parameters: Oxygen Delivery and Oxygen Delivery Index, Oxygen Consumption and Oxygen Consumption Index, Cardiac Index, Stroke Volume and Stroke Volume Index, Heart Rate, Systemic Vascular Resistance and Systemic Vascular Resistance Index, Stroke Volume Variation %, Pulse Pressure Variation % and Body Surface Area. | | | |
{21}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| Principles of Operation | Root functions as a 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. | Root functions as a 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. | The LiDCO algorithm derives a digitalized arterial pressure waveform from continuous arterial blood pressures measured using a 3rd party invasive arterial catheter. From the digitalized arterial waveform, the proprietary LiDCO algorithm can calculate other clinically relevant hemodynamic parameters (i.e., derived, calculated) | Same |
| Measurement Modules | Radical-7, Radius-7, ISA, SedLine, Temperature, NiBP, Centroid, LiDCO Module. | Radical-7, Radius-7, ISA, SedLine, Temperature, NiBP, and Centroid. | N/A | The subject device includes compatibility to LiDCO Module. |
| Alarms | Visual and Audible | Visual and Audible | Alerts only, Visual and Audible | Same |
| **Electrical** | | | | |
| Electrical Power | AC Power and Rechargeable Battery | AC Power and Rechargeable Battery | AC Power and Rechargeable Battery | Same |
| **Display** | | | | |
| Display Type | Touch Screen | Touch Screen | Touch Screen | Same |
| **Communication** | | | | |
| Interface, including network connectivity | Ethernet, nurse call, MOC-9, USB interface, RS-232/ RJ-45 (Iris), docking, wireless (Wi-Fi and Bluetooth) | Ethernet, nurse call, MOC-9, USB interface, RS-232/ RJ-45 (Iris), docking, wireless (Wi-Fi and Bluetooth) | TCP/IP, (RS232) or HL7 | Same. |
| **Environmental** | | | | |
| Operating Temperature/ Humidity | 0 to 50°C / 10-95% non-condensing | 0 to 50°C / 10-95% non-condensing | 10 to 40 °C / 30-75%, non-condensing | Same |
| Storage Temperature/ Humidity | -40 to 70°C/ 10-95% non-condensing | -40 to 70°C/ 10-95% non-condensing | -20 to 50 °C/ 10-90, % non-condensing | Same |
{22}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| **LiDCO Module** | | | | |
| **Supported Hemodynamic Parameters** | | | | |
| Principle of Operation | LiDCO Module algorithm relies on the relationship between cardiac activity and arterial blood pressure. The LiDCO Module also relies on the Fick principle that describes the relationship between cardiac output and oxygenation. | N/A | LiDCO Monitor algorithm relies on the relationship between cardiac activity and arterial blood pressure. The LiDCO Monitor also relies on the Fick principle that describes the relationship between cardiac output and oxygenation. | The LiDCO Module adds capabilities to the Root, the same as the secondary predicate. |
| Derived/ Calculated Hemodynamic parameters | Systolic, Diastolic, Mean Arterial Pressure, Heart Rate, Stroke Volume, Body Surface Area (BSA), Stroke Volume Index (SVI), Storke Volume Variation (SVV), Pulse Pressure Variation (PPV), Cardiac Output (CO), Cardiac Index (CI), Oxygen Delivery (DO2) (cDO2), Oxygen Delivery Index (DO2I) (cDO2I) Oxygen consumption (VO2), Oxygen consumption Index (VO2I), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI) | N/A | Systolic, Diastolic, Mean Arterial Pressure, Heart Rate, Stroke Volume, Volume Index (SVI), Storke Volume Variation (SVV), Pulse Pressure Variation (PPV), Cardiac Output (CO), Cardiac Index (CI), Oxygen Delivery (DO2), Oxygen Delivery Index (DO2I), Oxygen consumption (VO2), Oxygen consumption Index (VO2I), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI) | The LiDCO Module adds capabilities to the Root, the same as the secondary predicate. From the secondary predicate, cDO2 and VO2 are added calculated parameters. cDO2 provides the ability to automatically calculate DO2 using the SpO2 and SpHb outputs of the Radical-7 connected to Root. VO2 feature is an added calculation. Testing is provided to support substantial equivalence |
{23}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| Indicated Population | Adult | Adult | Adult | Same |
| **Accessories** | | | | |
| BP Cables Types | Analog and Transducer | N/A | Analog and Transducer | Same as secondary predicate. |
| **Display Range** | | | | |
| Heart/Pulse Rate (HR) | 35-240 bpm | N/A | 0-220 bpm | Different. Testing is provided to support substantial equivalence. |
| Pulse Pressure Variation (PPV) | 0-100 % | N/A | 0-100 % | Same as secondary predicate. |
| Stroke Volume Variation (SVV) | 0-100 % | N/A | 0-100 % | Same as secondary predicate. |
| Cardiac Output (CO) | 0.1-30 l/min | N/A | 0-30 l/min | Different. Testing is provided to support substantial equivalence. |
| Cardiac Index (CI) | 0.1-30 l/min/m² | N/A | 0-30 l/min/m² | Different. Testing is provided to support substantial equivalence. |
| Stroke Volume (SV) | 1-500 ml | N/A | 1-500 ml | Same as secondary predicate. |
| Stroke Volume Index (SVI) | 1-500 ml/m² | N/A | 1-500 ml/m² | Same as secondary predicate. |
| Systemic Vascular Resistance (SVR) | 100-12000 dyn s /cm⁵ | N/A | 50-60,000 dyn s /cm⁵ | Different. Testing is provided to support substantial equivalence. |
| Systemic Vascular Resistance Index (SVRI) | 100-12000 dyn s m²/cm⁵ | N/A | 50-60,000 dyn s m²/cm⁵ | Different. |
{24}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| | | | | Testing is provided to support substantial equivalence. |
| Oxygen Delivery (DO2) (cDO2) | 10-3000 ml/min | N/A | 0-12000 ml/min m² | Different. Testing is provided to support substantial equivalence. |
| Oxygen Delivery Index (DO2I) (cDO2I) | 10-3000 ml/min/m² | N/A | 0-12000 ml/min/m² | Different. Testing is provided to support substantial equivalence |
| Oxygen Consumption (VO2) | 10-3000 ml/min | N/A | N/A | Different. Testing is provided to support the proper implementation of the calculation. |
| Oxygen Consumption Index (VO2I) | 10-3000 ml/min/m² | N/A | N/A | Different.. Testing is provided to support the proper implementation of the calculation. |
| Systolic Pressure | 40-300 mmHg | N/A | 0-240 mmHg | Different. Testing is provided to support substantial equivalence. |
| Diastolic Pressure | 30-250 mmHg | N/A | 0-240 mmHg | Different. Testing is provided to support substantial equivalence. |
{25}
Masimo
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
## 510(k) Summary
(K253417)
| Feature 510(k) Number | Masimo Root with LiDCO Module, Subject Device | Masimo Root, Primary Predicate (K191882) | LiDCO Monitor, Secondary Predicate (K163334) | Comparison |
| --- | --- | --- | --- | --- |
| Mean Arterial Pressure | 35-260 mmHg | N/A | 0-240 mmHg | Different. Testing is provided to support substantial equivalence. |
{26}
MASIMO
MASIMO CORPORATION
62 Discovery
Irvine, CA 92618
# 510(k) Summary
(K253417)
## 5 Performance Data
As part of this submission, non-clinical bench testing is included to support this submission. Performance testing was provided that supported the integration of the LiDCO Module.
### Biocompatibility Testing
As part of this submission, no biocompatibility testing was conducted because of prior clearance of the contacting components.
### Electromagnetic Compatibility, Electrical Safety, Environmental, Mechanical and Cleaning
EMC testing was conducted in accordance with IEC 60601-1-2: 4th Edition and electrical safety in accordance with IEC 60601-1 standard. Environmental, mechanical, cleaning, and chemical resistance testing was conducted.
### Software Verification and Validation Testing
Software verification and validation testing were conducted and provided as part of this submission as recommended by the FDA Guidance, “Content of Premarket Submissions for Software Device Software Functions”, June 2023. Enhanced level of software documentation was provided.
### Wireless Testing
Wireless testing for the subject device was performed in accordance with FDA Guidance, “Radio Frequency Wireless Technology in Medical Devices”, August 2013. The testing supports the acceptability of the wireless capabilities of the subject device. Wireless function risk was assessed per Tier 1.
### Cybersecurity Testing
The cybersecurity information in accordance with FDA Guidance for Industry, Food, and Drug Administration Staff- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, June 27, 2025, was provided to support this submission,
### Human Factors and Usability Testing
To support the usability of the subject device, human factors and usability evaluation was conducted in accordance with the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016.
### Non-Clinical Testing
The following non-clinical tests were performed:
- Electrical safety testing per IEC 60601-1
- EMC testing per IEC 60601-1-2
- Usability testing per FDA Human Factors and Usability Guidance
{27}
MASIMO
MASIMO CORPORATION
52 Discovery
Irvine, CA 92618
## 510(k) Summary
(K253417)
- Software verification and validation testing per FDA Software Guidance
- Mechanical testing per IEC 60601-1
- Performance testing per IEC 60601-2-34
### Clinical Testing
No clinical testing was needed to support this submission, due to no changes in the LiDCO PulseCO algorithm from its clearance (K163334).
### 6 Conclusion
The data supported the substantial equivalence of the subject device.
