(128 days)
The IQvitals Zone is intended to be used by clinicians and medically qualified personnel for measuring and monitoring:
· Noninvasive blood pressure for adult and pediatric patients (3 years and above)
- · Pulse rate for adult and pediatric patients
- · Noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) for adult and pediatric patients
- · Body temperature measured at Temporal Artery for adult and pediatric patients
The most likely location for IQvitals Zone device to be used is for monitoring patient in general medical locations, hospitals and alternative care environments.
The IQvitals Zone is designed to be used for measuring and monitoring systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. All functions of the device are performed via the touch screen display, except the power on/off function, which is a separate button on the back of the device.
The IQvitals Zone can be wirelessly connected with low energy Bluetooth to mobile computers or be connected with a USB cable to computers and has the ability to send the measurement results to the computers.
The device has a rechargeable lithium ion battery and two mounting options: a mobile cart and a wall mount. All vitals parameters can be simultaneously measured and easily viewed on the touch screen display or the connected computer. Temperature is measured at Temporal Artery and the Temperature Probe is connected serially to the IQvitals Zone.
The IQvitals Zone is a multi-parameter vital signs monitor intended for use by clinicians and medically qualified personnel for measuring and monitoring noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature at the temporal artery for adult and pediatric patients (3 years and above).
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The provided document presents the performance characteristics of the IQvitals Zone and compares them to predicate devices. This comparison implicitly serves as the acceptance criteria for the device, demonstrating that its performance is substantially equivalent to legally marketed devices. Since the device is a vital signs monitor designed to directly measure physiological parameters, the "algorithm only" or "standalone" performance is inherent in these functional specifications.
| Characteristic | Acceptance Criteria (Predicate Device K072516, K101445, K060576, K110028) | Reported Device Performance (IQvitals Zone) |
|---|---|---|
| NIBP Monitor Module | ||
| Measurement Accuracy | ± 5 mmHg (standard deviation |
§ 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).