(64 days)
No
The summary describes a standard vital signs monitor that interprets and displays physiological data. There is no mention of AI, ML, or any related technologies like image processing, deep neural networks, or training/test sets for algorithms. The focus is on real-time data display, alarms, and data storage, which are typical functions of conventional vital signs monitors.
No
The device is a vital signs monitor, intended for monitoring physiological parameters, not for treating any condition.
Yes
The device monitors basic physiological parameters and provides physiological data and patient data analysis, which are used by a licensed healthcare practitioner to interpret and understand the patient's medical condition. Monitoring these parameters and analyzing the data is a key aspect of diagnosis.
No
The device description explicitly states it is a "monitor" that "interprets and displays physiological data" and can be "custom configured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), or pulse oximetry (SpO2)". These functions inherently require hardware components (sensors, processing units, display) to acquire and process the physiological data. The predicate device is also a "Patient Monitor", further indicating a hardware-based device.
Based on the provided information, the Goldway UT4000A Vital Signs Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Goldway UT4000A Function: The Goldway UT4000A monitors physiological parameters directly from the patient's body (in vivo). It measures things like electrical activity of the heart (ECG), blood pressure (NIBP), and oxygen saturation in the blood (SpO2) through external sensors attached to the patient.
The device description and intended use clearly indicate that it's a patient monitor that collects data directly from the patient, not by analyzing samples in a lab.
N/A
Intended Use / Indications for Use
Goldway UT4000A Vital Signs Monitor is intended to monitor basic physiological parameters of patients from adults to neonates within any professional medical environment. The user, responsible to interpret the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data analysis will be made available to the user from the monitor.
Physiological data includes: electrocardiograph, non-invasive blood pressure, and pulse oximetry.
Goldway UT4000A is not intended for use as an apnea monitor. Goldway UT4000A is not intended for use during MRI or CT scans.
The UT4000A is not designed for home use. The device is restricted to be used on one patient at a time.
Product codes
MWI
Device Description
The Goldway UT4000A monitor interprets and displays physiological data of the patient including waveforms and numerical data in real time. Goldway UT4000A can be custom configured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), or pulse oximetry (SpO2). For each patient vital parameter, Goldway UT4000A will be capable of providing limit alarms and alerts, storing data trends for retrospective review and sending serial port signal to printer for report printing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults to neonates
Intended User / Care Setting
licensed healthcare practitioner / any professional medical environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0