Patient Monitoring Systems are medical for the tracking of physiological parameters in patients for diagnostic or therapeutic purposes. These systems provide real-time data on vital signs like heart rate, blood pressure, oxygen saturation, and temperature, enabling clinicians to assess patient status and intervene as necessary. They are regulated as Class II medical devices under the U.S. FDA when they present moderate risk and require special controls.

Intended Use of Patient Monitoring Devices

Patient Monitoring Devices are intended to monitor specific physiological signals or patient status parameters to assist healthcare professionals in evaluating patient condition. Depending on device design, these systems may be used for continuous or intermittent monitoring in clinical or remote settings. Patient monitoring devices are commonly used in:

• Hospital wards and specialty clinics
• Sleep laboratories and home sleep settings.
• Ambulatory and remote patient monitoring programs
• Neurological and cardiovascular monitoring applications

Low Patient Acuity Monitoring System

Intended Use

Low Patient Acuity Monitoring Systems are intended to monitor physiological parameters such as heart rate and related cardiac activity in patients who do not require high-acuity or intensive care monitoring. These devices support clinical observation and patient management in lower-risk care environments.

Device Description

A Low Patient Acuity Monitoring System is an electronic monitoring device that acquires and displays cardiac-related physiological signals, including heart rate and rhythm. The system typically consists of patient sensors, signal processing electronics, a display interface, and alarm functionality. These devices are designed for use in general care areas, step-down units, or outpatient settings where continuous high-acuity monitoring is not required.

Sleep Appliances with Patient Monitoring

Intended Use

Sleep Appliances with Patient Monitoring are intended to treat snoring and/or obstructive sleep apnea while simultaneously monitoring patient parameters related to sleep and respiratory function.

Device Description

These devices are intraoral appliances designed to be worn during sleep. In addition to mechanically repositioning oral or mandibular structures to maintain airway patency, the system incorporates patient monitoring capabilities to assess sleep-related parameters. Monitoring data may be recorded or transmitted for clinical review to support therapy assessment and patient compliance.

Sub-Scalp Implanted Electroencephalogram System for Remote Patient Monitoring

Intended Use

Sub-Scalp Implanted Electroencephalogram (EEG) Systems for Remote Patient Monitoring are intended to continuously record and monitor cerebral electrical activity for clinical evaluation in patients requiring long-term neurological monitoring.

Device Description

This system consists of implantable EEG electrodes placed beneath the scalp, an implanted or external signal acquisition unit, and associated software for data processing and transmission. The device enables long-term EEG monitoring and remote data access by healthcare professionals. The system does not deliver therapy and is intended solely for diagnostic and monitoring purposes.

Physiological Patient Monitor (without arrhythmia detection or alarms)

Intended Use: This device is intended to non-invasively monitor various physiological signs, such as heart rate, without specialized arrhythmia detection or alarming features. It is used for general observation rather than critical intervention based on rate alarms.

Device Description: A general monitoring apparatus designed to interface with patient sensors (e.g., ECG leads, SpO2 probes). It displays data but lacks the specialized software algorithms for complex condition detection or alarm mechanisms found in higher-risk monitors.

Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)

Intended Use

The Physiological Patient Monitor with Arrhythmia Detection or Alarms is intended to monitor cardiac electrical activity and detect arrhythmias, including ST-segment changes, and to provide alarms when abnormal cardiac conditions are identified.

Device Description

This device is an electronic physiological monitoring system that acquires ECG signals via patient-applied electrodes and processes the signals using embedded algorithms to detect arrhythmias and ST-segment deviations. The system displays waveforms and numeric data, provides audible and visual alarms, and supports data storage and review. These devices are used under professional supervision in clinical care environments.

System, Measurement, Blood-Pressure, Non-Invasive

Intended Use

Intended for the non-invasive measurement of blood pressure (systolic, diastolic, mean arterial pressure) in human subjects. Used in hospitals and home-use settings for diagnostics and monitoring chronic conditions.

Device Description

Typically, a cuff-based system that uses Oscillo metric technology to measure blood pressure automatically. The device includes an inflatable cuff, a pressure sensor, a pump, a display, and control software.

Oximeter (Pulse Oximeter)

Intended Use

An oximeter is a non-invasive device intended to measure and display arterial oxygen saturation (SpO2) and pulse rate. It is indicated for use in operating rooms, recovery rooms, intensive care units, and home care environments.

Device Description

A physiological monitor that employs a sensor typically placed on a fingertip or earlobe. It uses spectrophotometry to measure oxygen saturation by passing light through tissue and measuring absorption characteristics.

Continuous Measurement Thermometer

Intended Use

This clinical electronic thermometer is indicated for measuring the body or skin temperature of a person continuously or at specified intervals. It is used in healthcare facilities and home settings.

Device Description

A device using a thermistor probe or a patch with adhesive backing to monitor temperature. It may be connected via wire or wirelessly to a separate monitor or smart device to display the temperature reading.

Radiofrequency Physiological Signal Transmitter

Intended Use

Intended to transmit physiological signals (e.g., ECG waveforms, SpO2) wirelessly from a patient-worn device to a remote monitoring station.

Device Description

A battery-powered, wearable transmitting unit that connects to patient sensors. It uses RF communication protocols to send data to a compatible receiver or central station for display and analysis.

Electrocardiograph Software for Over-the-Counter Use

Intended Use

Electrocardiograph Software for Over the Counter (OTC) Use is intended to create, analyze, and display electrocardiographic (ECG) data for consumer use. The software is intended to provide information related to heart rhythm, including identification of potential cardiac arrhythmias. This device is not intended to provide a clinical diagnosis or to replace professional medical evaluation.

The device is intended for use by lay users in non-clinical environments and supports general cardiac rhythm monitoring for informational purposes.

Device Description

Electrocardiograph Software for Over-the-Counter Use is a software-based medical device that operates on consumer-grade electronic platforms and is designed for handheld or wearable configurations. The software acquires ECG signals from leads or electrodes that are attached to or in contact with the user’s hands, wrists, arms, or chest to detect electrical potential differences and generate an ECG waveform.

The software processes and displays ECG data and may perform signal analysis to identify patterns associated with cardiac arrhythmias. The device presents waveform and numerical information to the user through a graphical interface. The system does not provide diagnostic conclusions and does not initiate therapeutic action. The software is intended for use without direct supervision of a healthcare professional.

Performance Testing for Patient Monitoring Systems

• Accuracy of measured parameters:Verification of all vital signs against reference standards (e.g., ISO 81060-2 for NIBP, ISO 80601-2-61 for pulse oximetry).
• Reliability and endurance testing.
• Electrical safety(IEC 60601-1) and electromagnetic compatibility (EMC) (IEC 60601-1-2).
• Software Validation and Cybersecurity
• Biocompatibility Evaluation:Testing per ISO 10993 for all patient-contacting materials (e.g., cuffs, probes, electrodes).
• Compatibility Testing:Required for Verification of all accessories and connected systems (e.g., central stations, mobile apps) function safely and effectively together.
• Usability (Human Factors) Testing:Evaluation of user interactions in a simulated environment to ensure safety and effectiveness.

Clinical Testing:

No Guidance available for 510k submission