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510(k) Data Aggregation
(90 days)
Masimo Root Monitoring System and Accesories
The Masimo Root Monitoring System is indicated for use by healthcare professionals for the monitoring of multiple physiological parameters in healthcare environments.
The Masimo Root Monitoring System can transmit data for supplemental remote viewing and alarming (e.g., at a central station).
The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments. In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate to multi-parameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 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 Root Monitoring System (Root) is a multifunctional device that monitors vital signs of patients from neonates to adults. Parameters monitored by Root include non-invasive functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), respiratory rate (RRa), inspired/expired gases during anesthesia, recovery and respiratory care, state of the brain by real-time data acquisition and processing of EEG signals, and Patient State Index (PSI) which is an EEG variable that is related to the effect of anesthetic agents.
Root displays patient monitoring information from the connected modules. Visual alarms are shown on the Root display and audible alarms are generated through the Root internal speaker. When the module is disconnected from Root, the monitoring information from the module is no longer displayed on Root.
Data from connected modules, including patient monitoring data, can be communicated to network systems. Root also functions as a pass-through means for communicating information between connected devices and network systems.
The provided document describes the Masimo Root Monitoring System and its accessories. The submission is for a device modification and new indications for use, specifically the addition of the Masimo Radius-7 Pulse Oximeter module. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K140188).
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a typical quantitative format (e.g., target specificity, sensitivity, or quantifiable error rates for a diagnostic device). Instead, the performance is evaluated through various verification and validation tests against established standards and the functionality of the predicate device. The acceptance criterion for each test appears to be "Pass," indicating successful completion and meeting predefined internal requirements.
| Monitored Parameter | Test Description | Test Objective | Study Endpoints | Results Summary | Conclusion |
|---|---|---|---|---|---|
| SpO2, PR, and RRa | Display verification of Root and Radius-7 module | To verify Root user interface when connected to Radius-7 | Test personnel began and ended test cases for the Root with Radius-7 user interface, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from Radius-7. |
| SpO2, PR, PI, PVI and RRa | Display validation of Radius-7 module | To validate human factors/usability | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Radius-7's ease of use was validated by the clinicians. |
| SpO2, PR, and RRa | Display validation of Radius-7 module (for Root and Radius-7) | To validate human factors/usability for Root and Radius-7 | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Radius-7's ease of use was validated by the clinicians. |
| N/A (General battery) | Battery life and operation verification for Radius-7 module | To verify battery life and operation for Radius-7 | Test personnel began and ended battery life/operation test cases, and recorded the test results per test procedures. | Pass | Radius-7's battery life and operation was verified to work properly. |
| N/A (Display/speaker) | Visual/audio alarm verification for Radius-7 module | To verify visual/audio alarm compliance to IEC 60601-1-8 | Test personnel began and ended visual/audio alarm test cases per the IEC standards, and recorded test results. | Pass | Radius-7 visual/audio alarms are compliant to IEC60601-1-8. |
| SpO2, PR, and RRa | Visual/audio alarm verification for Root and Radius-7 | To verify audio and visual alarms on Root | Test personnel began and ended audio/visual alarm verification test cases, and recorded test results per test procedures. | Pass | Root correctly generated visual/audio alarms from Radius-7. |
| N/A (General wireless) | Wireless (Bluetooth) connection verification for Root and Radius-7 | To verify Bluetooth connection between Root and Radius-7 | Test personnel began and ended Bluetooth verification test cases, and recorded test results per test procedures. | Pass | Root properly connected to Radius-7 via Bluetooth connection. |
| N/A (General wireless) | Wireless connection verification for Root and Radius-7 | To verify wireless co-existence per FDA Wireless Guidance | Test personnel began and ended wireless co-existence testing per FDA Guidance, and recorded the test results. | Pass | Root with Radius-7 met FDA Wireless Guidance requirements for wireless co-existence testing. |
| N/A (General wireless) | Wireless connection verification for Root and Radius-7 | To verify wireless quality of service per FDA Wireless Guidance | Test personnel began and ended wireless quality of service testing verification per FDA Guidance, and recorded test results. | Pass | Root with Radius-7 met FDA Wireless Guidance requirements for wireless quality of service testing. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa | Display verification of Root and Radical-7 module | To verify Eagle (Root) user interface | Test personnel began and ended test cases for the Root user interface, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the connected modules. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Display validation of Root and Radical-7, ISA, and Sedline modules | To validate human factors/usability | Clinicians (users) started and completed the usability test cases and recorded the test results per test procedures. | Pass | Root's ease of use was validated by the clinicians. |
| EEG and PSI | Display verification of Root and Sedline module | To verify Sedline indicator and display | Test personnel began and ended test cases for indicator/display verification, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the Sedline module. |
| Breathing Gases and RR | Display verification of Root and ISA module | To verify ISA module indicator and display | Test personnel began and ended test cases for indicator/display verification, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the ISA module. |
| N/A (General wireless) | Wireless interface verification of information from any connected module | To verify the wireless communication between a module fixture and Root | Test personnel began and ended test cases for the wireless interface verification, and recorded the test results per test procedures. | Pass | A module fixture wirelessly connected to Root in the similar communication as a wired connection. |
| N/A (General docking) | Docking station function verification for Root and Radical-7 | To verify battery management | Test personnel began and ended battery management test cases, and recorded the test results per test procedures. | Pass | Root docking station interfaced correctly with the Radical-7 module. |
| EEG and PSI | MOC-9 interface verification for Root and Sedline module | To verify MOC-9 Port EEPROM | Test personnel began and ended MOC-9 EEPROM verification test cases, and recorded the test results per test procedures. | Pass | The MOC-9 interface functioned correctly in EEPROM identification. |
| Breathing gases, RR, EEG and PS | MOC-9 interface verification for Root and ISA and Sedline modules | To verify EEPROM Identification for Iris and MOC-9 | Test personnel began and ended EEPROM Identification test cases for Iris and MOC-9, and recorded test results per test procedures. | Pass | The MOC-9 and Iris interfaces functioned correctly in EEPROM identification for connected modules. |
| Breathing Gases and RR | Root and ISA module verification | To verify Root/PhaseIn (ISA) capnography module integration | Test personnel began and ended ISA integration test cases, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the ISA module. |
| EEG and PSI | Root and Sedline module verification | To verify Root/Sedline integration | Test personnel began and ended Sedline integration test cases, and recorded the test results per test procedures. | Pass | Root correctly displayed monitoring information from the Sedline module. |
| EEG and PSI | Root and Sedline module verification | To verify Sedline board communication | Test personnel began and ended Sedline board communication test cases, and recorded test results per test procedures. | Pass | Root correctly communicated with the Sedline module. |
| N/A (Display/speaker) | Visual/audio alarm verification for Root | To verify visual/audio alarm compliance to IEC 60601-1-8 | Test personnel began and ended visual/audio alarm test cases per the IEC standards, and recorded test results. | Pass | Root visual/audio alarms are compliant to IEC60601-1-8. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Visual/audio alarm verification for Root and Radical-7, ISA, and Sedline modules | To verify visual/audio alarm acknowledgment | Test personnel began and ended visual/audio alarm acknowledgment test cases, and recorded the test results per test procedures. | Pass | Root correctly generated visual/audio alarms from the connected modules. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Visual/audio alarm verification for Root and Radical-7, ISA, and Sedline modules | To verify audio and visual alarms | Test personnel began and ended audio/visual alarm verification test cases, and recorded test results per test procedures. | Pass | Root correctly generated visual/audio alarms from the connected modules. |
| SpO2, PR, SpCO, SpMet, SpHb, RRa, Breathing Gases, RR, EEG and PSI | Alarm limit controls verification for Root and Radical-7, ISA, and Sedline modules | To verify alarm limit controls | Test personnel began and ended alarm limit controls verification test cases, and recorded test results per test procedures. | Pass | Root correctly generated alarm limits from the connected modules. |
| N/A (General wired) | Wired connection verification for Root | To verify Ethernet connection | Test personnel began and ended Ethernet verification test cases, and recorded test results per test procedures. | Pass | Root functioned correctly in its connectivity via the Ethernet. |
| N/A (General wired) | Wired connection verification for Root | To verify Iris connectivity to network system | Test personnel began and ended Iris/Patient SafetyNet connectivity test cases, and recorded test results per test procedures. | Pass | Root's Iris interface functioned correctly in its connectivity to system networks such as the Patient SafetyNet. |
| N/A (General wireless) | Wireless connection verification for Root | To verify internal radio module | Test personnel began and ended radio module verification test cases, and recorded test results per test procedures. | Pass | Root's internal radio module performed correctly. |
| N/A (General wireless) | Wireless connection verification for Root | To verify wireless co-existence per FDA Wireless Guidance | Test personnel began and ended wireless co-existence testing per FDA Guidance, and recorded the test results. | Pass | Root met FDA Wireless Guidance requirements for wireless co-existence testing. |
| N/A (General wireless) | Wireless connection verification for Root | To verify wireless quality of service per FDA Wireless Guidance | Test personnel began and ended wireless quality of service testing verification per FDA Guidance, and recorded test results. | Pass | Root met FDA Wireless Guidance requirements for wireless quality of service testing. |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a quantitative "sample size" in terms of patients or cases for most of the tests. The tests are described as functional verification and usability studies.
- For "Display validation of Radius-7 module" and "Display validation of Root and Radical-7, ISA, and Sedline modules": The document mentions "Clinicians (users)" participated in usability tests. The exact number of clinicians is not provided.
- For all other verification tests: "Test personnel" conducted the tests. No specific number is provided.
- Data Provenance: The studies appear to be internal, non-clinical (laboratory/in-house) verification and validation tests, not involving real-world patient data collection from a specific country or in a retrospective/prospective manner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the traditional sense for this type of device submission. The "ground truth" for these functional and usability tests is established by adherence to engineering specifications, regulatory standards (like IEC 60601-1-8), and successful operation as designed.
- Usability testing: Involved "Clinicians (users)," implying healthcare professionals as experts for evaluating usability. Specific qualifications (e.g., years of experience, specialty) are not detailed.
- For other verification tests, "Test personnel" are likely engineers or technicians qualified to conduct technical evaluations.
4. Adjudication Method for the Test Set
No formal adjudication method like "2+1" or "3+1" is described. The acceptance criterion for all tests is simply "Pass," meaning the device either successfully performed the function or met the standard, or it did not. This implies a binary outcome based on whether the test objectives and endpoints were met, likely determined by the test personnel or clinicians involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is typically performed for diagnostic devices where human readers interpret patient data (e.g., images) with and without AI assistance to measure improvement in diagnostic accuracy. The Masimo Root Monitoring System is a monitoring system and user interface, not a diagnostic imaging AI algorithm.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop) Performance
The device itself is a "monitoring system and accessories" that functions as a user interface and communication hub for previously cleared modules. Its primary function is to display data, generate alarms, and connect to networks. Therefore, "standalone" performance in the context of an algorithm's diagnostic accuracy without human involvement is not a relevant metric for this device. The performance evaluated here is the functionality and safety of the monitoring system itself, especially its new integration with the Radius-7 module.
7. Type of Ground Truth Used
The "ground truth" is based on:
- Engineering specifications and design requirements: For successful display, connectivity, and communication functions.
- Regulatory standards: Such as IEC 60601-1-8 for alarm compliance, IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC, ISO-10993 for biocompatibility, and FDA guidances for Usability, Wireless, and Software.
- Functionality of previously cleared predicate devices/modules: The Root system primarily integrates and acts as a user interface for these existing, cleared technologies.
8. Sample Size for the Training Set
The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense. The device's functionality is based on established hardware and software integration, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for machine learning, this question is not applicable.
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