(83 days)
Not Found
Yes
The summary explicitly states that the rhythm classification algorithm was updated to a deep-learning basis and mentions "ECGML and ECGDL" algorithms, indicating the use of machine learning and deep learning.
No
The device is described as an ECG analysis and reporting software system that helps in diagnosing cardiac events, not treating them. Its purpose is to capture and report cardiac information for diagnosis, not to provide therapy.
Yes
The device aids in diagnosis by capturing and reporting cardiac events and ECG information, which is then used by the intended user to "render a diagnosis based on clinical judgment and experience."
No
The device description explicitly states it is an "electrocardiogram (ECG) analysis and reporting software system, designed to process continuously recorded, signal-lead ECG data." While the system is software, it processes data from an external source (presumably an ECG recorder, as indicated by "continuously recorded, signal-lead ECG data"), and the performance studies mention testing according to standards for "ambulatory electrocardiographic systems," implying interaction with hardware that captures the ECG data. The 510(k) summary is for the system, which includes the software component, but the overall device functionality relies on hardware data acquisition.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes electrocardiogram (ECG) data, which is a measurement of electrical activity of the heart, not a sample taken from the body.
- The intended use is to capture and report cardiac events and continuous ECG information. This is a physiological measurement and monitoring function, not an analysis of a biological sample.
- The device description focuses on processing and analyzing ECG data. This reinforces that the input is electrical signals, not biological specimens.
Therefore, while this device is a medical device that uses sophisticated algorithms (including deep learning) to analyze physiological data, it does not fit the definition of an In Vitro Diagnostic.
No
The provided input explicitly states "Not Found" for "Control Plan Authorized (PCCP) and relevant text," meaning there is no information indicating FDA review or clearance of a PCCP for this device.
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DSH, DOK, DSI, DXH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Yes, the ZEUS System is considered modified as a result of updating its rhythm classification algorithm from a rule and machine-learning implementation to a deep-learning basis.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients 18 years or older
Intended User / Care Setting
The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. The patient environment is Ambulatory. It is not intended for use on critical care patients.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance of the modified ZEUS System has been evaluated and verified in accordance with design specifications and applicable performance standards. The modified device's arrhythmia algorithm detection was tested in accordance to AAMI ANSI EC57: 2012, Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms; it was also evaluated according to 60601-2-47:2012, Medical Electrical Equipment- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. Additionally, the information presented in this submission has been developed in consideration of the recommendations contained in FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".
The nonclinical verification and performance test results established that the device meets its design requirements and intended use, that the modifications to the originally cleared device do not raise new questions of safety and efficacy. During the development, potential hazards were evaluated and controlled by the risk management activities, including risk analysis, risk mitigation, verification and risk-benefit analysis. The verification and full system-level regression testing demonstrate that the device meets all its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
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August 29, 2018
iRhythm Technologies, Inc. Rich Laguna Director of Quality and Regulatory Affairs 650 Townsend Street, Suite 500 San Francisco, California 94103
Re: K181502
Trade/Device Name: Zio AT ECG Monitoring System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, DOK, DSI, DXH Dated: June 5, 2018 Received: June 7, 2018
Dear Rich Laguna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Arielle Drummond -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name
Zio AT ECG Monitoring System
Indications for Use (Describe)
510(k) Number (if known)
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 patienttriggered 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 5. 510(k) Summary
1. GENERAL INFORMATION
510(k) Sponsor
iRhythm Technologies, Inc.
650 Townsend Street, Suite 500
San Francisco, CA. 94103
Correspondence Person
Rich Laguna
Director of Quality and Regulatory Affairs
Contact Information
Email: rlaguna@irhythmtech.com
Phone: (415) 632-5749
Date Prepared
08/29/2018
2. PROPOSED DEVICE
Proprietary Name
Zio® AT ECG Monitoring System
Common Name
Zio® AT ECG Monitoring System
Classification Name
Medical magnetic tape recorder [21 CFR§870.2800]
Programmable diagnostic computer [21CFR8870.1425]
Telephone electrocardiograph transmitter and receiver [21CFR§870.2920]
Arrhythmia detector and alarm (including ST-segment measurement and alarm) [21
CFR§870.1025]
Regulatory Class
Class II
Product Codes
DSH, Recorder, Magnetic Tape, Medical
DQK, Computer, Diagnostic, Programmable
DXH, Transmitters And Receivers, Electrocardiograph, Telephone
DSI, Detector And Alarm, Arrhythmia
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3. PREDICATE DEVICE (ORIGINALLY CLEARED DEVICE)
iRhythm Technologies, Inc. Zio AT ECG Monitoring System (K163512)
4. DEVICE DESCRIPTION
The ZEUS System was most recently 510(k) cleared under K163512 as part of the Zio AT ECG Monitoring System ("Zio" AT"). The original cleared ECG monitoring system components consisted of the 1) Zio AT Patch Recorder Device 2) Zio AT Wireless Gateway Device with Bluetooth and Cellular Technology, and 3) ZEUS System for analysis and reporting. This submission discusses the changes made to the ZEUS System only. 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 ZEUS System is considered modified as a result of updating its rhythm classification algorithm from a rule and machine-learning implementation to a deep-learning basis. The comparison to the originally cleared device and performance test results demonstrate that the modified ZEUS System is substantially equivalent to the original ZEUS System cleared under K163512, and that the intended use of the device can be consistently fulfilled as originally cleared.
5. INDICATIONS FOR USE
The device is intended to capture, analyze 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 arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on the 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, lightheadedness, pre-syncope, 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.
5
6. SUBSTANTIAL EQUIVALENCE SUMMARY
The indications for use statement for the modified ZEUS System is an identical reflection of the indications for use as represented in the originally cleared device. The performance testing results demonstrate that the differences in the technological characteristics between the devices do not raise new issues of safety or effectiveness. Therefore, the modified ZEUS System is determined to be substantially equivalent to the original ZEUS System device. A comparison table outlining the differences and similarities between the modified and original ZEUS System is provided in Table 5.1.
| Feature/
Function | Original Device:
Zio AT ECG Monitoring
System (K163512) | Modified Device:
ZEUS System | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| General Characteristics | | | |
| Classification | Class II | Class II | |
| Classification Regulation(s) | 21 CFR 870.2800
21 CFR 870.1425
21 CFR 870.2920
21 CFR 870.1025 | 21 CFR 870.2800
21 CFR 870.1425
21 CFR 870.2920
21 CFR 870.1025 | |
| Product Code | DSH, DQK, DXH, DSI | DSH, DQK, DXH, DSI | |
| Patient Environment | Ambulatory | Ambulatory | |
| Patient Population | Non-pediatric, non-critical
care patients | Non-pediatric, non-critical care
patients | |
| Technological Characteristics | | | |
| Data Input | Digital long-term continuous
and transmission ECG | Digital long-term continuous
and transmission ECG | |
| Data Download | Yes | Yes | |
| Data Storage | Yes | Yes | |
| ECG Analysis | Beat
Runs
Rhythm Types
Heart Rates | Beat
Runs
Rhythm Types
Heart Rates | |
| Rhythm Detection Algorithm | ECGML | ECGML and ECGDL | |
| Feature/
Function | Original Device:
Zio AT ECG Monitoring
System (K163512) | Modified Device:
ZEUS System | |
| Rhythm Types | - Atrial fibrillation
- Complete heart block
- Second degree AV
block-type II - Pause >3 seconds
- Sinus rhythm
- Supraventricular
tachycardia - Ventricular bigeminy
- Ventricular fibrillation
- Ventricular tachycardia
- Ventricular trigeminy | - Atrial fibrillation
- Complete heart block
- Second degree AV block-
type II - Pause >3 seconds
- Sinus rhythm
- Supraventricular tachycardia
- Ventricular bigeminy
- Ventricular fibrillation
- Ventricular
tachycardia - Ventricular trigeminy
- Second degree AV block-
type I - Ectopic atrial rhythm
- Junctional rhythm
| |
| Result Integrator | Algorithm Controller | Algorithm Controller, updated to
initiate ECG Analysis through
ECGDL, and integrate the
ECGML and ECGDL labels | |
| Architecture | Integrated Analysis Tool | Integrated Analysis Tool | |
| Platform | PC / Server Mix to
Clinician & Patient
Websites | PC / Server Mix to Clinician &
Patient Websites | |
| QA Tool | Yes | Yes, updated to support the
expanded rhythms | |
| Report Output | Yes | Yes | |
| ZEUS Web Services | Store and retrieve the
integrated ECGML Labels
to ZEUS Database | Store and retrieve the integrated
ECGML and ECGDL Labels to
ZEUS Database | |
Table 5.1: Substantial Equivalence Summary Table
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Image /page/6/Picture/1 description: The image shows the logo for iRhythm. The logo is in a sans-serif font, with the "i" in black and the rest of the word in blue. There is a trademark symbol to the right of the word.
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7. PERFORMANCE DATA
Safety and performance of the modified ZEUS System has been evaluated and verified in accordance with design specifications and applicable performance standards. The modified device's arrhythmia algorithm detection was tested in accordance to AAMI ANSI EC57: 2012, Testing and Reporting Performance Results of Cardiac Rhythm and ST-Segment Measurement Algorithms; it was also evaluated according to 60601-2-47:2012, Medical Electrical Equipment- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. Additionally, the information presented in this submission has been developed in consideration of the recommendations contained in FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".
The nonclinical verification and performance test results established that the device meets its design requirements and intended use, that the modifications to the originally cleared device do not raise new questions of safety and efficacy. During the development, potential hazards were evaluated and controlled by the risk management activities, including risk analysis, risk mitigation, verification and risk-benefit analysis. The verification and full system-level regression testing demonstrate that the device meets all its specifications.
8. CONCLUSION
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing comparison to the originally cleared device, the modified ZEUS System raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device.