(239 days)
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 optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate to multi-parameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse Oximeter and accessories are indicated for use with adult, and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, and hospital-type facilities.
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 |
The Root Monitoring System (Root) is a multifunctional device that monitors vital signs of patients from neonates to adults. Parameters monitored by Root include non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), respiratory rate (RRa), inspired/expired gases during anesthesia, recovery and respiratory care, state of the brain by real-time data acquisition and processing of EEG signals, temperature, non-invasive blood pressure (NIBP) and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents.
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 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. Root also functions as a pass-through means for communicating information between connected devices and network systems.
The subject device is the same as the primary predicate (K142394). The main difference is that the subject device has been modified to integrate internal modules for temperature and NIBP measurement technologies.
The provided text describes a 510(k) premarket notification for the Masimo Root Vital Signs Monitoring System and Accessories. It outlines the device's intended use, technological characteristics, and a comparison to predicate devices, focusing on the integration of new internal temperature and non-invasive blood pressure (NIBP) modules.
However, the document states:
"Clinical Testing: Not applicable. Clinical performance testing was not performed with the subject device, Root, to support substantial equivalence."
This means that the submission does not include a study proving the device meets specific acceptance criteria based on clinical performance. Instead, the substantial equivalence determination for this particular submission is based on non-clinical testing (bench testing, alarm testing, usability testing, software verification) and the fact that the new internal modules utilize previously cleared measurement technologies from predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria in the clinical sense, as such a study was explicitly stated as "Not applicable" and "not performed" in this regulatory filing.
I can, however, extract related information that was used for the substantial equivalence determination:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding performance data from clinical studies. The performance is assessed based on the fact that existing, cleared technologies are integrated.
2. Sample size used for the test set and the data provenance
No clinical test set was used for performance assessment of the new integrated modules. The acceptance for these modules is based on their prior clearance as standalone devices or integrated into other predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth establishment was conducted.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No MRMC study was performed. The submission explicitly states "Clinical performance testing was not performed."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept typically applies to AI/algorithm performance. While the device integrates various measurement technologies (which could be considered "standalone" in their function), the document does not detail specific algorithm-only performance studies for the integrated components in the context of this 510(k) submission for the Root system itself. Instead, it relies on the previous clearance of the individual measurement technologies.
7. The type of ground truth used
For the integrated temperature and NIBP modules, the "ground truth" for their performance was established during the original 510(k) clearances of the predicate devices they are derived from (K101680 for temperature, K090989 for NIBP). The current submission relies on the established equivalence of these previously cleared technologies.
8. The sample size for the training set
Not applicable, as this submission does not describe the development or training of new algorithms that would require a training set. It concerns the integration of existing, cleared technologies.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
Summary of what the document does state regarding the basis for approval:
The FDA's decision for substantial equivalence is based on:
- Non-clinical testing: Bench testing, alarm testing (IEC60601-1-8), usability testing (per FDA Human Factors and Usability Draft Guidance), and software verification (per FDA Software Guidance). These tests focused on the system's functionality and safety, not the clinical accuracy of the physiological parameters, which are handled by the integrated, previously cleared modules.
- The fact that the device integrates previously FDA-cleared measurement technologies for the modules (Radical-7, Radius-7, ISA, Sedline, and the newly integrated internal temperature and NIBP modules). The specific regulatory clearances cited for these modules are:
- Masimo Radical-7 Pulse CO-Oximeter: K110028
- Masimo Radius-7 Pulse Oximeter: K110028
- ISA Module: K103604
- SEDLine Sedation Monitor: K051874
- Internal temperature module (from Welch Allyn Spot Ultra Vital Signs/Welch Allyn Spot Vital Signs LXi): K101680
- Internal non-invasive blood pressure (NIBP) module (from Zoll R Series): K090989
- The argument that the differences between the subject device and the predicates (mainly the integration of internal temperature and NIBP modules) are not critical to intended use and do not affect the safety and effectiveness of the device when used as labeled, because these are existing, cleared technologies.
§ 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).