(214 days)
No
The document describes a multi-parameter vital signs monitor and its various modules. While it processes physiological signals (EEG, SpO2, etc.) and calculates parameters like the Patient State Index (PSI), there is no mention of AI or ML being used in the processing or calculation methods. The PSI is described as a "proprietary computed EEG variable," which doesn't inherently imply AI/ML.
No.
The device is a monitoring system that measures and displays physiological parameters; it does not provide therapy.
Yes
Explanation: The device monitors multiple physiological parameters (e.g., oxygen saturation, pulse rate, blood pressure, temperature, CO2, EEG signals) to assess the patient's condition, which is a classic function of a diagnostic device.
No
The device description explicitly states that the Masimo Root Monitoring System is a "multifunctional device that monitors vital signs for neonatal to adult patients" and that "Parameters monitored by Root are from cleared measurement modules and their corresponding accessories". It lists several hardware components and modules (Pulse CO-Oximeter, Gas Analyzer, Sedation Monitor, Temperature module, NIBP module) that are integral to the system's function of acquiring physiological data. While software is involved in processing and displaying this data, the system relies on these hardware components for data acquisition, making it a hardware-based medical device with accompanying software.
Based on the provided text, the Masimo Root Monitoring System and Accessories, including the optional ISA module, are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Definition of IVD: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Intended Use and Device Description: The text describes the Masimo Root system as a device for monitoring physiological parameters directly from the patient (e.g., oxygen saturation, pulse rate, blood pressure, temperature, brain activity, breathing gases). While some modules analyze gases, this is done in the context of monitoring the patient's breathing circuit, not analyzing a sample taken from the body.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens (blood, urine, etc.) in a laboratory setting.
Therefore, the Masimo Root Monitoring System and Accessories fall under the category of patient monitoring devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances.
The Masimo Root Monitoring System and Accessories 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 motions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+) and accessories including Nomoline. 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 intent population is adult, pediatric, infant and neonatal 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, CBR, DXN, DQA, FLL, BZO, CCK, CBS, NHO, CBO, NHP, CCL, DPZ, GXY, GWQ, OLT, OLW, OMC, ORT, CAT
Device Description
The Masimo Root Monitoring System and Accessories (Root) is a multifunctional device that monitors vital signs for neonatal to adult patients. Parameters monitored by Root are from cleared measurement modules and their corresponding accessories, consisting of:
- Masimo Radical-7 and Radius-7 Pulse CO-Oximeter measurement modules and accessories (i.e. RD SET disposable sensors, RD Rainbow sensors, RAS-45 or RRa sensors) with technologies for the monitoring of non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and respiratory rate (RRa);
- Masimo Sweden ISA-Infrared Sidestream Gas Analyzer measurement modules (ISA) and accessories (Nomoline product family) with technologies for breathing gases and respiratory rate monitoring, including inspired/expired gases during anesthesia, recovery and respiratory care;
- Masimo Sedline Sedation Monitor measurement module and accessories (i.e. RD Sedline EEG sensor) with technologies for 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;
- Temperature measurement module and accessories (i.e. temperature probe) with technologies for oral/axillary body temperature measurements; and
- Non-invasive blood pressure measurement module and accessories (i.e. reuse and disposable pressure cuffs) with technologies for systolic, diastolic and mean arterial pressure (MAP) measurements.
Root is intended to be used as a user interface to facilitate access control and monitoring device functions. 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. The user accesses the wired or wirelessly connected modules' monitoring functions, using the Root display. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root. Data from connected modules, including patient monitoring data, can be communicated to network systems such as the Patient SafetyNet (K071047) and hospital EMR. Root also functions as a pass-through means for communicating information between connected devices and network systems.
The Root under K151644 consists of various measurement modules, including the ISA product family (ISA) and corresponding accessories, Nomoline product family (Nomoline).
The Nomoline Product Family (Nomoline) in this submission includes single use configurations and resposable configurations, (combination of single use sampling line and reuse Nomo Section). The subject device is intended to be used on adult, pediatric, infant and neonatal patients. Same as the predicate, Nomoline, the new Nomoline models are intended to be used with gas analyzers such as ISA, for the measurement of respiratory rate and/or respiratory and anesthetic gases.
Configurations for Nomoline include the following main components:
- sampling line,
- patient interface or airway adapter for connection to patient interface,
- Nomo Section
The patient interface, which directly or indirectly contacts the patient, is attached to one end of the sampling line and the Nomo section is attached to the opposite end of the sampling line. The end with the Nomo section includes a compatible mating connector for connection to a capnography monitoring system such as the ISA gas measurement instrument.
The sampling line in this submission has the same medical grade tubing material, same nominal tubing length, same inner diameter dimension and same standard luer connection as the sampling line for the predicate, Nomoline (K103604).
The subject device, Nomoline, includes configurations with patient interfaces that can either indirectly or directly contact the patient. For all configurations, the patient interface is integral with the sampling line and it is intended for single use.
Airway Adapter Set (Connection to Breathing Circuit for Intubated Patient) – The airway adapter set consists of a T-adapter, which integrates with one end of the sampling line. The airway adapter set does not have direct contact with the patient because the T-adapter allows a connection with the breathing circuit tubing on an intubated patient. The other end of the sampling line attaches to the Nomo section.
Airway adapter sets are available in two sizes. One size with a dead space of
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
November 17, 2017
Masimo Corporation Marguerite Thomlinson Senior Director, Regulatory Affairs 52 Discovery Irvine, California 92618
Re: K171121
Trade/Device Name: Masimo Root Monitoring System and Accessories Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, CBR, DXN, DQA, FLL, BZO, CCK, CBS, NHO, CBO, NHO, NHP, CCL, DPZ, GXY, GWQ, OLT, OLW, OMC, ORT, CAT Dated: October 18, 2017 Received: October 18, 2017
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.
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171121
Device Name
Masimo Root Monitoring System and Accessories
Indications for Use (Describe)
The Masimo Root Monitoring System and Accessories are indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments. The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances.1
The Masimo Root Monitoring System and Accessories 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 motions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable Pulse CO-Oximeter and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Indications for Use Masimo Root Monitoring System (continued from page 1)
The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2, ISA AX+ and ISA OR+) and accessories including Nomoline. 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 intent population is adult, pediatric, infant and neonatal 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 |
l The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. The optional ISA module can be used in road ambulances with other monitoring systems in accordance with the intended environment of use for those systems.
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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618".
| Submitter and Address of | Masimo Corporation |
|---|---|
| Manufacturing Facility: | 52 Discovery |
| Irvine, CA 92618 | |
| Phone: (949) 297-7683 | |
| Date: | November 17, 2017 |
| Official Correspondent | Marguerite Thomlinson |
| Senior Director, Regulatory Affairs | |
| Masimo Corporation | |
| Phone: (949) 297-7683 | |
| Mthomlinson@Masimo.com | |
| Trade Name: | Masimo Root Monitoring System and Accessories |
| Common Name: | Patient Monitor |
| Primary Classification Regulation/ | |
| Product Code: | 21 CFR 878.2300, Class II/MWI |
| Secondary Product Code(s): | BZQ, CAT, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, |
| DXN, FLL, GWQ, GXY, NHO, NHP, NHQ, OLT, OLW, | |
| OMC, ORT | |
| Establishment Registration Number: | 2031172 |
| Reason for Premarket Notification: | Device modification and new indications for use |
| Predicate Device: | Primary predicate: |
| K151644, Masimo Root Vital Signs Monitoring System | |
| Reference predicate: | |
| K103604, PhaseIn AB, ISA CO2, ISA AX+, ISA OR+ | |
| K980327, Oridion Microstream Filterline ICU | |
| Performance Standards | No performance standards for the above device have been |
| promulgated pursuant to Section 514. |
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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
Device Description
The Masimo Root Monitoring System and Accessories (Root) is a multifunctional device that monitors vital signs for neonatal to adult patients. Parameters monitored by Root are from cleared measurement modules and their corresponding accessories, consisting of:
- . Masimo Radical-7 and Radius-7 Pulse CO-Oximeter measurement modules and accessories (i.e. RD SET disposable sensors, RD Rainbow sensors, RAS-45 or RRa sensors) with technologies for the monitoring of non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and respiratory rate (RRa);
- Masimo Sweden ISA-Infrared Sidestream Gas Analyzer measurement modules (ISA) and accessories (Nomoline product family) with technologies for breathing gases and respiratory rate monitoring, including inspired/expired gases during anesthesia, recovery and respiratory care;
- Masimo Sedline Sedation Monitor measurement module and accessories (i.e. RD . Sedline EEG sensor) with technologies for 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;
- Temperature measurement module and accessories (i.e. temperature probe) with technologies for oral/axillary body temperature measurements; and
- . Non-invasive blood pressure measurement module and accessories (i.e. reuse and disposable pressure cuffs) with technologies for systolic, diastolic and mean arterial pressure (MAP) measurements.
Root is intended to be used as a user interface to facilitate access control and monitoring device functions. 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. The user accesses the wired or wirelessly connected modules' monitoring functions, using the Root display. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root. Data from connected modules, including patient monitoring data, can be communicated to network systems such as the Patient SafetyNet (K071047) and hospital EMR. Root also functions as a pass-through means for communicating information between connected devices and network systems.
The Root under K151644 consists of various measurement modules, including the ISA product family (ISA) and corresponding accessories, Nomoline product family (Nomoline).
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Image /page/6/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a stylized red circle containing a white checkmark to the left of the word. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
The predicate. Nomoline with the integrated Nomo Section HH, can be used in both high humidity (HH) and low (LH) environments. It is intended for single-patient use and intended to be used with third-party or generic patient interfaces (i.e. nasal cannulas. Tadapter). In addition, the predicate, Nomoline, can be used on an infant/neonate patient if it is used with a generic airway adapter (T-adapter) with less than 0.7 ml of dead space.
The Nomoline Product Family (Nomoline) in this submission includes single use configurations and resposable configurations, (combination of single use sampling line and reuse Nomo Section). The subject device is intended to be used on adult, pediatric, infant and neonatal patients. Same as the predicate, Nomoline, the new Nomoline models are intended to be used with gas analyzers such as ISA, for the measurement of respiratory rate and/or respiratory and anesthetic gases.
Configurations for Nomoline include the following main components:
- sampling line,
- patient interface or airway adapter for connection to patient interface,
- Nomo Section ●
The patient interface, which directly or indirectly contacts the patient, is attached to one end of the sampling line and the Nomo section is attached to the opposite end of the sampling line. The end with the Nomo section includes a compatible mating connector for connection to a capnography monitoring system such as the ISA gas measurement instrument.
The sampling line in this submission has the same medical grade tubing material, same nominal tubing length, same inner diameter dimension and same standard luer connection as the sampling line for the predicate, Nomoline (K103604).
The subject device, Nomoline, includes configurations with patient interfaces that can either indirectly or directly contact the patient. For all configurations, the patient interface is integral with the sampling line and it is intended for single use.
Airway Adapter Set (Connection to Breathing Circuit for Intubated Patient) – The airway adapter set consists of a T-adapter, which integrates with one end of the sampling line. The airway adapter set does not have direct contact with the patient because the T-adapter allows a connection with the breathing circuit tubing on an intubated patient. The other end of the sampling line attaches to the Nomo section.
Airway adapter sets are available in two sizes. One size with a dead space of 1 The Root Monitoring System, when used with the optional ISA module, is not intended to be used in road ambulances. The optional ISA module can be used in road ambulances with other monitoring systems in accordance with the intended environment of use for those systems.
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Image /page/11/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in bold, black letters, with a red symbol to the left of the word. To the right of the logo, the text "MASIMO CORPORATION" is displayed in a smaller, gray font. Below that, the address "52 Discovery, Irvine, CA 92618" is also displayed in a smaller, gray font.
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 |
Technological Characteristics
Principle of Operation
The principle of operation for Root is as follows:
Root functions as a user interface that allows access, control and monitoring from the connected modules (external and internal).
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 principle of operation for ISA and Nomoline is as follows:
The principle of the ISA's gas measurement technology per K151644 (originally cleared in K103604) is based on the absorption of different gases at different wavelengths, using infrared spectrometry.
The subject device, Nomoline, is a conduit for the transport of respiratory gas from the patient to a gas analyzer such as ISA, with an optional oxygen (O2) delivery line. The principle of water/moisture collection from the sampling line is based on the
510(k) Summary: K171121, Root Monitoring System and Accessories Page 8 of 12
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Image /page/12/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in a smaller, sans-serif font, followed by the address "52 Discovery, Irvine, CA 92618".
wicking concept. Nomoline can absorb low amount of moisture and store the moisture in its filter cap component. Additionally, Nomoline HH products can remove the collected water/moisture through the principle of evaporating the moisture into the surrounding air. This principle is based on using a hydrophilic, thermoplastic, elastomer material for its high moisture absorption rate and high water permeability.
Mechanism of Action for Achieving the Intended Effect
The mechanism of action for achieving the intended effect for the subject device, Root with ISA and Nomoline, is as follows:
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 external 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.
For the use with ISA and Nomoline, the Nomoline end with the Nomo section is connected to the gas measurement instrument such as ISA. The other end of Nomoline, the end with the sampling line with integrated patient interface, is connected to the patient breathing circuit or directly to the patient. If the Nomoline model includes the oxygen delivery line. then that line is connected to an oxygen source. Use begins when Nomoline is connected and the gas analyzer is turned on. Once use is completed, disconnect Nomoline from the patient breathing circuit or the patient and turn power off on the system.
Summary of Technological Characteristics of Subject Device Compared to Predicate
Similarities and Differences between Subject Device and Primary Predicate, Masimo Monitoring System (Root) with ISA and Nomoline per K151644
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Image /page/13/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.
The subject device. Root with ISA and Nomoline, and the primary predicate device, Root with ISA and Nomoline (K151644), have the following key similarities:
- Both devices are intended for patient monitoring of multiple physiological ● parameters, including respiratory gases measurements;
- Both devices have the same principle of operation, same mechanism for achieving ● the intended effect and same performance specifications;
- Both devices are intended to be used on the same patient population of adult, ● pediatric and infant patients;
- Both devices, specifically Nomoline, include the technology for moisture/water ● collection using the wicking concept and moisture/water removal using hydrophilic material; and
- . Both devices are supplied non-sterile.
The subject device, Root with ISA and Nomoline, and the primary predicate device, Root with ISA and Nomoline (K151644), have the following key differences:
- The subject device includes the neonatal patient population in the indications for use for ISA and Nomoline; whereas neonatal patient population is not included in the predicate device; and
- The subject device includes additional Nomoline models that were not available with ● the predicate device:
Similarities and Differences between Subject Device, Root with ISA and Nomoline, and Reference Predicate, ISA – Infrared Sidestream Gas Analyzer (ISA and Nomoline) per K103604
The subject device. Root with ISA and Nomoline, and the reference predicate device, ISA and Nomoline (K103604), have the following key similarities:
- Both devices are intended to be used for respiratory gas measurements; ●
- . Both devices have the same principle of operation, same mechanism for achieving the intended effect and same performance specifications for respiratory gas measurements;
- Both devices are intended to be used on the same patient population of adult, pediatric and infant patients;
- Both devices, specifically Nomoline, include the technology for moisture/water ● collection using the wicking concept and moisture/water removal using hydrophilic material; and
- Both devices are supplied non-sterile. ●
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The subject device. Root with ISA and Nomoline, and the reference predicate device, ISA and Nomoline (K103604), have the following key differences:
- . The subject device includes the neonatal patient population in the indications for use for ISA and Nomoline; whereas neonatal patient population is not included in the predicate device: and
- The subject device includes additional Nomoline models that were not available with ● the predicate device;
Similarities and Differences between Subject Device, Nomoline, and Reference Predicate, Microstream Filterline ICU ISA (Microstream) per K980327
The subject device, Nomoline, and the reference predicate device, Microstream (K980327), have the following key similarities:
- Both devices are intended to be used as accessories for respiratory gas ● measurements;
- Both devices have the same principle of operation, same mechanism for achieving ● the intended effect;
- Both devices are intended to be used on the same patient population of adult, ● pediatric, infant and neonate patients;
- Both devices are supplied non-sterile.
The subject device, Nomoline, and the reference predicate device, Microstream (K980327), have the following key differences:
- The subject device and the predicate have different moisture removal technologies, ● with the subject device has the Nomo Section, using the wicking concept and models having moisture/water removal using hydrophilic material and the predicate having the nafion material; and
- the subject device consists of more variety of product configurations including ● airway adapters, cannulas and sampling lines with optional oxygen delivery; whereas, the predicate consists of airway adapters and general sampling lines.
Non-clinical Testing
Root with ISA and Nomoline has been subjected to bench testing. The following nonclinical testing was performed in accordance with Masimo design control requirements and quality system to demonstrate substantial equivalence of the subject device with its predicates:
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Image /page/15/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red symbol on the left, followed by the word "Masimo" in black. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray. The logo is clean and professional, and the colors are simple and effective.
- Electrical safety testing per IEC-60601-1
- EMC testing per IEC-60601-1-2 ●
- Respiratory gas monitoring testing per ISO 80601-2-55 ●
- Software verification, including integration testing with host monitors, per FDA Software Guidance
- Mechanical testing (same as K151644) per ISTA-2A and MIL-STD 810E ●
- Environmental testing per IEC-60601-1
- Particulate matter testing per ISO-18562-2
- Shelf life testing ●
- . Cross-contamination and cleaning testing of reuse components
- Biocompatibility testing per the following standards: ●
| ISO-10993-1 | Biological evaluation of medical devices – part 1: Evaluation
and testing within a risk management process |
|--------------|-------------------------------------------------------------------------------------------------------------------|
| ISO-10993-5 | Biological evaluation of medical devices – part 5: cytotoxicity |
| ISO-10993-10 | Biological evaluation of medical devices – part 10: Tests for
irritation and skin sensitization |
| ISO-10993-12 | Biological evaluation of medical devices – part 12: Sample
preparation and reference materials |
| ISO-10993-17 | Biological evaluation of medical devices – part 17:
Establishment of allowable limits for leachable substances |
| ISO-10993-18 | Biological evaluation of medical devices – part 18: Chemical
characterization of materials |
Clinical Testing
Clinical testing was not performed with the subject device, Root with ISA and Nomoline, to support substantial equivalence.
Conclusion
The non-clinical testing provided in this 510(k) submission demonstrates that the subject device, Root with ISA and Nomoline, is substantially equivalent to its predicate.