(214 days)
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 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 multiparameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable 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 Radius-7 Wearable Pulse CO-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+) 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 intended patient 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 |
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 provided text describes a 510(k) premarket notification for the Masimo Root Monitoring System and Accessories. It outlines the device's indications for use, technological characteristics, and a comparison to predicate devices, focusing on the ISA and Nomoline components.
No clinical studies are mentioned for the subject device to support acceptance criteria within this document. The document explicitly states: "Clinical testing was not performed with the subject device, Root with ISA and Nomoline, to support substantial equivalence."
Therefore, I can only provide information based on the non-clinical testing and general specifications mentioned.
Here's a breakdown of the requested information based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides "Specifications" for the Root system and the ISA module, which can be interpreted as acceptance criteria for the non-clinical tests conducted. The "reported device performance" is implicitly that the device met these specifications, as the conclusion states the non-clinical testing "demonstrates that the subject device...is substantially equivalent to its predicate."
| Feature/Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Implied) |
|---|---|---|
| Root (General) | ||
| Display | Color LCD touchscreen | Met specification |
| Measurement modules | Radical-7; Radius-7; ISA; Sedline; temperature; NIBP | Met specification |
| Visual/audible alarm | IEC-60601-1-8 compliant | Met specification |
| Storage/recording | Trend/data storage | Met specification |
| Power | AC power 100-240 volt, 47-63 Hz; Rechargeable battery | Met specification |
| Interface | Wired/wireless; MOC-9; Iris; Nurse call; USB; SD card; temperature probe port; NIBP port | Met specification |
| Network connectivity | Ethernet; Wi-Fi, 802.11 a/b/g; Bluetooth 2.0 | Met specification |
| Dimensions/Weight | 11 x 10.5 x 5.5 inch (27.9 x 26.7 x 14 cm)/ 3.37 kg | Met specification |
| Operating temperature | 50 to 104°F (10 to 40°C) | Met specification |
| Storage temperature | -4 to 122°F (-20 to 50°C) | Met specification |
| Humidity | 15 to 95% non-condensing humidity | Met specification |
| Electrical safety | IEC-60601 compliant | Met specification |
| EMC | IEC-60601 compliant | Met specification |
| Mode of operation | Continuous | Met specification |
| ISA (Gas Analyzer) | ||
| Patient population | Adult, pediatric, infant and neonate patients | Met specification |
| Sampling flow rate | 50 ± 10 ml/min | Met specification |
| Respiration rate | 0 to 150 ± 10 breaths/min | Met specification |
| Rise time (CO2) | ≤ 250 ms | Met specification |
| Rise time (N2O) | ≤ 350 ms | Met specification |
| Rise time (O2) | ≤ 450 ms | Met specification |
| Rise time (HAL, ISO, ENF, SEV, DES) | ≤ 350 ms | Met specification |
| Accuracy (CO2) | 0-15 vol%; ±0.2 vol% + 2 % of reading | Met specification |
| Accuracy (O2) | 0-100 vol %; ±1 vol% + 2 % of reading | Met specification |
| Accuracy (N2O) | 0-100 vol%; ±(2 vol% + 2 % of reading) | Met specification |
| Accuracy (HAL/ISO/ENF) | 0-8 vol%; ±0.15 vol% + 5 % of reading | Met specification |
| Accuracy (SEV) | 0-10 vol%; ±0.15 vol% + 5 % of reading | Met specification |
| Accuracy (DES) | 0-22 vol%; ±0.15 vol% + 5 % of reading | Met specification |
| Agent identification threshold | 0.15 vol% | Met specification |
| Mixture agent threshold (secondary) | 0.2 vol% + 10% of total agent concentration | Met specification |
| Interface | MOC-9 or RS-232 | Met specification |
| Dimensions/Weight (ISA CO2/AX+) | 1.3 x 3.1 x 1.9 inch (33 x 78 x 49 mm)/ 130 g | Met specification |
| Dimensions/Weight (ISA OR+) | 1.9 x 3.5 x 3.9 inch (49 x 90 x 100 mm)/ 420 g | Met specification |
| Operating temperature (ISA CO2) | 32 to 122°F (0 to 50°C) | Met specification |
| Operating temperature (ISA AX+/OR+) | 41 to 122°F (5 to 50°C) | Met specification |
| Storage temperature (ISA) | -40 to 158°F (-40 to 70°C) | Met specification |
| Operating humidity (ISA) |
§ 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).