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The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing. The Zio AT device is designed to be used with the interoperable Zio ECG Utilization Service (ZEUS) SaMD which provides an arrhythmia detection algorithm for analysis and reporting.

The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing.

The device is intended to capture, and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. After wear, ECG data from compatible monitoring devices is processed and analyzed by the ZEUS System. A final report is generated on the beat-to-beat information from the entire ECG recording. For the Zio AT service, the ZEUS System supports the capture and analysis of automatically-detected arrhythmia events, as well as the analysis of uploaded patient-triggered events. The ZEUS System is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

The Zio® Service consists of single-patient-use monitoring devices and the Zio ECG Utilization Software (ZEUS) System, the subject device of this submission, for analysis and reporting of cardiac information derived from ECG data. The ZEUS System is a software system consisting of a collection of software modules designed to store and analyze data from compatible cardiac monitoring devices to curate a report of preliminary findings intended for use by clinicians as an aid in arrhythmia diagnosis and management. The subject ZEUS System utilizes an artificial intelligence (AI) Al-based AutoTrigger Engine (ATE) software application for processing requests originating from the Gateway Service as part of the Zio AT system enabling asymptomatic ECG triggers, and Al-based ECG Analysis Software (ECGDL) to generate the initial ECG-based cardiac information. The output of ECG Analysis Software of the ZEUS System is used by Certified Cardiographic Technicians (CCTs) prior to publishing the cardiac information in the patient report and is not utilized directly by the prescribing clinician or patient. The reported cardiac information includes beats, ectopic runs, ECG segments, rhythms, and heart rate measurements. Recorded ECG is processed by an automated ECG analysis platform; results are quality reviewed by CCTs, findings and associated ECG are captured in a report provided to clinicians via a secure website. For the Zio® AT Patch/Gateway, the ZEUS System provides capabilities to automatically detect clinically actionable arrhythmia during the monitoring period, as well as receive baseline, scheduled, symptomatic, and asymptomatic transmissions. The subject of this 510(k) are proposed software modifications to the ZEUS System to allow AF/AFL burden estimate reporting in the daily reports. In addition, software modifications were made to the ECGDL software of the ZEUS System to target modest performance improvements.

The ZEUS System (Zio Watch), as part of the Zio Watch Service, is intended to process and analyze electrocardiogram (ECG) and photoplethysmogram (PPG) based data to detect and report on the presence of Atrial Fibrillation (AF) over the monitoring period. The report provides ECG information for the intended user to diagnose AF and contextual information for AF, both to be interpreted based on clinical judgment and experience. It is indicated for use on adult patients 22 years or older who are susceptible to developing or who have been diagnosed with AF. It is not intended for use on critical care patients.

The ZEUS System (Zio Watch), the subject device of this 510(k) submission, is a software as a medical device (SaMD) system consisting of a collection of modules designed to process and analyze data from the Zio Watch into a curated report of preliminary findings intended for use by clinicians to aid in AF diagnosis. The subject ZEUS System utilizes an artificial intelligence (Al) based ECG Analysis Software (ECGDL) to generate the initial ECG-based cardiac information provided to the clinician in Transmission Reports. In addition, continuously recorded PPG-based data is processed by a separate artificial intelligence (AI) based analysis software, the AF Context Engine (ACE), that detects the presence of AF. Specifically, the subject ZEUS System (Zio Watch) utilizes machine learning techniques for both the ECGDL and AF Context Engine algorithms. These results are also presented along with the ECG data in the Zio Watch Transmission Reports. The reported cardiac information includes AF detection (including PPG-based AF summary) and heart rate measurements. The ECG-based preliminary findings in the Zio Watch Transmission Reports are quality reviewed by Certified Cardiographic Technicians (CCTs) prior to publishing. After CCT review, the report containing the preliminary findings and associated ECG are provided to clinicians via a secure website.

The Zio Monitor is a prescription-only, single-patient-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue or anxiety.

The Zio monitor is a non-sterile, single-patient-use, long-term ambulatory ECG monitor that is adhered to a patient's left pectoral region in a modified Lead II orientation. The goal of the Zio monitor is to help physicians initiate long-term, patient-compliant ECG monitoring utilizing proprietary technology. The Zio monitor is applied and activated by the patient at home or at a clinic. Once activated, the device provides continuous, uninterrupted ECG recording into memory with minimal patient interaction. There is a button on the surface of the Zio monitor, which serves to activate the device and may be pressed by the patient during wear to indicate when he or she is experiencing a symptom. Additionally, there is a surface LED light that blinks green to confirm proper activation or that the device is working, and orange to indicate loss of connection with the skin or the presence of error conditions.

The device is intended to capture, and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. After wear, ECG data from compatible monitoring devices is processed and analyzed by the ZEUS System. A final report is generated on the beat-to-beat information from the entire ECG recording. For the Zio AT service, the ZEUS System supports the capture and analysis of automatically-detected arrhythmia event, as well as the analysis of uploaded patient-triggered events. The ZEUS System is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

The Zio® Service consists of single-patient-use monitoring devices and the Zio ECG Utilization Software (ZEUS) System, the subject device of this submission, for analysis and reporting of cardiac information derived from ECG data. The ZEUS System is a software system consisting of a collection of software modules designed to store and analyze data from compatible cardiac monitoring devices to curate a report of preliminary findings intended for use by clinicians as an aid in arrhythmia diagnosis and management. The ECG Analysis Software of the ZEUS System is used by Certified Cardiographic Technicians (CCTs) prior to publishing the reported cardiac information in the Final Report and is not utilized directly by the prescribing clinician or patient. The reported cardiac information includes beats, ectopic runs, ECG segments, rhythms, and heart rate measurements. Recorded ECG is processed by an automated ECG analysis platform; results are quality reviewed by CCTs, findings and associated ECG are captured in a report provided to clinicians via a secure website. For the Zio® AT Patch/Gateway, the ZEUS System provides capabilities to automatically detect clinically actionable arrhythmia during the monitoring period, as well as receive baseline, scheduled, symptomatic and asymptomatic transmissions.

The Zio ECG Utilization Service (ZEUS) System is intended to analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring by Zio XT or Zio AT Patch, a final report is generated based on the beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

The ZEUS System is an electrocardiogram (ECG) processing and analysis system, designed to handle continuously recorded, single-lead ECG data. It downloads, stores, analyzes and aggregates the ECG data for a Certified Cardiographic Technician (CCT) to review and generate a report of the findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.

The device is intended to capture, and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically-detected arthythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on the beat information from the entire ECC recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

The ZEUS System is an electrocardiogram (ECG) analysis and reporting software system, designed to process continuously recorded, signal-lead ECG data. The ZEUS System downloads, stores, analyzes and sorts the ECG data to allow iRhythm's Certified Cardiographic Technicians (CCTs) to generate and distribute a report of the findings contained within the data, thereby enabling the provision of a complete ECG processing and analysis service.

The Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on beat-to-beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

The Zio® QX ECG Monitoring System consists of three key device components: (1) Zio QX Patch Recorder with Bluetooth technology, (2) Zio QX Wireless Gateway with both Bluetooth and cellular technology, and (3) the Zio ECG Utilization Service (ZEUS) System for data analysis and reporting. The Zio® QX Patch is a non-sterile, single-patient-use ECG monitor that provides a continuous, single-channel recording in addition to asymptomatic and symptomatic data transmission for up to 14 days. The Zio® QX Patch is applied and activated by the patient. Once activated, the Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. The Zio® QX Patch, in conjunction with the Wireless Gateway and the ZEUS System, has arrhythmia auto-detection capabilities. Additionally, patients have the option of pressing a convenient trigger button which marks the continuous record and initiates the wireless transfer of a 90-second ECG strip. The wireless transfer of data is enabled by the Zio® QX Gateway, which requires Bluetooth proximity to the Patch and cellular network reception but no patient interaction to transmit to the monitoring center. The patient is encouraged to document symptomatic events in either the provided booklet, mobile medical app (iOS 9+, Android 4.4+) or via a patient website, which will support symptom-rhythm correlation in the Zio QX Report. At the conclusion of the wear period (up to 14 days), the patient removes the Zio® QX Patch and returns it by mail to an iRhythm data processing center. Upon receipt of both symptomatic/asymptomatic transmissions (during wear) and downloaded continuous ECG data (post wear) at iRhythm's Clinical Center (iCC), the data is processed through the ZEUS detection algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm's Certified Cardiographic Technicians (CCTs) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are made aware of performance limitations and anomalies with both the detection algorithms and software workflow tools. All anomalies are visible to and, where appropriate, are manually corrected by iRhythm Technologies CCTs during the QA review and/or Patch Report edits. The CCT generates a final report (Zio QX Report) of the ECG findings contained within the data, thereby providing a complete ECG processing and analysis service. Upon explicit request from a clinician responsible for the patient's healthcare, longer segments of ECG data from the continuous recording on the Patch can also be wirelessly retrieved during the wear period. Alternatively, such periods are also available for inclusion in the final report, where the entire ECG recording is available for review and selective inclusion based on clinical relevance.

The ZIO® SR ECG Monitoring Service is intended to capture, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

The ZIO® SR ECG Monitoring Service consists of three components: (1) ZIO SR Patch Recorder with Bluetooth technology, (2) ZIO SR Wireless Gateway, and (3) ZIO ECG Utilization Service System. The ZIO® SR Patch is a single-patient-use ECG monitor that provides a continuous, singlechannel recording in addition to symptomatic data transmission for up to 14 days. The ZIO® SR Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. Patients have the option of pressing a convenient trigger button which marks the continuous record and initiates a wireless transfer of an ECG strip of 90-second duration. The wireless transfer of data is enabled by the ZIO® SR Gateway, which requires proximity and reception but no patient interaction. The patient is encouraged to fill out a log to document symptomatic events, which will support symptom-rhythm correlation in the ZIO SR Report. Alternatively, the patient can enter symptom logs and view received transmissions via an online patient portal. At the conclusion of the wear period (up to 14 days), the patient removes the ZIO® SR Patch and returns it by mail to an iRhythm data processing center. Upon receipt of symptomatic or continuous ECG data at iRhythm's Clinical Center (iCC) the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are of algorithm performance anomalies. Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits. The CCT generates a final report of the ECG findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service. Upon explicit request from a clinician responsible for the patient's healthcare, longer segments of ECG data from the continuous recording on the Patch can also be wirelessly retrieved during the wear period. Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns.