(262 days)
Yes
The document explicitly mentions "Rhythm Detection Algorithm + ECG Analysis: ECGDL", which strongly suggests the use of a deep learning (DL) model, a subset of machine learning, for ECG analysis and rhythm detection.
No.
The device is intended for diagnosis and management of cardiac conditions by providing analyzed ECG data in reports, not for direct treatment or therapy.
Yes
The device processes and analyzes ECG data from cardiac events and continuous electrocardiogram information to generate reports for clinicians, aiding in arrhythmia diagnosis and management. It specifically states that the reports are provided for the intended user "to render a diagnosis based on clinical judgment and experience," and the software is an "aid in arrhythmia diagnosis."
No
The device description explicitly states that the Zio® Service consists of "single-patient-use monitoring devices and the Zio ECG Utilization Software (ZEUS) System". While the submission focuses on the software (ZEUS System), the overall service includes hardware components (monitoring devices) that capture the ECG data. Therefore, the device as described in the context of the service is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ZEUS System processes and analyzes electrocardiogram (ECG) data captured from a wearable monitoring device. ECG data is a measurement of electrical activity of the heart, not a sample taken from the body.
- Intended Use: The intended use is to capture, report, and analyze cardiac events and continuous ECG information for long-term monitoring to aid clinicians in arrhythmia diagnosis and management. This is focused on analyzing physiological signals, not analyzing biological samples.
- Input Data: The input is ECG data, not biological samples.
Therefore, the ZEUS System falls under the category of a medical device that analyzes physiological signals, rather than an in vitro diagnostic device.
No
The input states "PCCP and relevant text: Not Found", which does not include explicit language indicating that the FDA reviewed and approved or cleared a PCCP for this specific 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. 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.
Product codes
DQK, DSI, DXH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
clinicians, Certified Cardiographic Technicians (CCTs) / Ambulatory
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
No clinical testing was performed in support of this premarket notification. Nonclinical testing summarized in Table 2 demonstrates that the ZEUS System is in conformance with FDA-recognized consensus standards and FDA guidance documents. The nonclinical verification and performance test results established that the device meets its design requirements and intended use, that the modifications to the cleared device are as safe and effective as the predicate. During the development, potential hazards were evaluated and controlled by the risk management activities, including risk analysis, risk mitigation, verification and benefit-risk analysis. The verification and system-level regression testing demonstrate that the device meets all its specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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May 21, 2021
iRhythm Technologies, Inc. Rev Jacinto Sr. Manager, Regulatory Affairs 699 8th Street San Francisco, California 94103
Re: K202527
Trade/Device Name: Zio ECG Utilization Software (ZEUS) System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DSI, DSI, DXH Dated: August 31, 2020 Received: September 1, 2020
Dear Rey Jacinto:
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
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202527
Device Name Zio® ECG Utilization Service (ZEUS) System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Notification K202527
l. General Information
Applicant:
iRhythm Technologies, Inc.
699 8th Street, Suite 600
San Francisco, CA 94103 USA
Phone: 415-632-5700
Fax: 415-632-5701
Contact Person:
Rey Jacinto Sr. Manager, Regulatory Affairs Phone: 415-214-7440 Email: rey.jacinto@irhythmtech.com Date Prepared: August 31, 2020
II. Device Information
Trade Name:
ZEUS System
Generic/Common Name:
Programmable diagnostic computer
Classification Names:
Programmable diagnostic computer [21CFR§870.1425]
Arrhythmia detector and alarm (including ST-segment measurement and alarm)[21CFR§870.1025]
Telephone electrographic transmitter and receiver [21CFR§870.2029]
Regulatory Class:
Class II (Special controls)
Product Codes:
DQK, Computer, Diagnostic, Programmable
DSI, Detector and Alarm, Arrhythmia
DXH, Transmitters and Receivers, Electrocardiographic, Telephone
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III. Predicate Devices
The following predicate device has been selected:
- iRhythm Technologies, Inc. Zio® ECG Utilization Software (ZEUS) System [K190593]
IV. Indications for Use
The Indications for Use statement for the ZEUS System is as follows:
The device is intended to capture, analyze 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, 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.
V. Device Description
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.
5
VI. Comparison of Technological Characteristics with Predicate Devices (Substantial Equivalence)
The proposed indications for use statement for the ZEUS System are identical to the indications for use in the predicate device. The differences in the technological characteristics, namely the introduction of ECG segment detection, between the devices are substantially equivalent as the fundamental scientific technology and intended use is unchanged. Thus, the ZEUS System is considered substantially equivalent to the predicate device.
A comparison table outlining the differences and similarities between the subject device and the predicate device is provided in Table 1.
| Feature | Subject Device:
ZEUS System
(K202527) | Predicate Device:
ZEUS System
(K190593) |
|----------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------|
| General Characteristics | | |
| Classification | Same | Class II (Special controls)
21CFR870.1425
21CFR870.1025
21CFR870.2029 |
| Product Code | Same | DQK
DSI
DXH |
| Patient Environment | Same | Ambulatory |
| Patient Population | Same | Non-pediatric, non-critical
care patients |
| Technological Characteristics | | |
| Data Input | Same | Digital long-term
continuous ECG |
| Data Download | Same | Yes |
| Data Storage | Same | Yes |
| Rhythm Detection
Algorithm + ECG Analysis | ECGDL | ECGML + ECGDL |
| ECG Segments | QT | N/A |
| Interoperability | Zio® XT Patch
Zio® AT Patch
Zio® Monitor | Zio XT Patch
Zio AT Patch |
Table 1. Substantial Equivalence Summary Table
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VII. Performance Data
Safety and performance of the ZEUS System has been evaluated and verified in accordance with design specifications and to support a determination of substantial equivalence to the predicate device.
Nonclinical testing summarized in Table 2 demonstrates that the ZEUS System is in conformance with FDA-recognized consensus standards and FDA guidance documents.
| FDA # | Body | Number/Version | Title |
|---|---|---|---|
| 5-40 | AAMI ANSI ISO | 14971:2012(R)2010 | |
| (Corrected 4 | |||
| October 2017) | Medical Devices – Application of risk | ||
| management to medical devices | |||
| 13-79 | IEC | 62304 Edition 1.1 | |
| 2015-06 | |||
| CONSOLIDATED | |||
| VERSION | Medical device software - Software | ||
| life cycle processes | |||
| 3-127 | AAMI ANSI IEC | 60601-2-47:2012 | Medical Electrical Equipment -- Part |
| 2-47: Particular Requirements For | |||
| The Basic Safety And Essential | |||
| Performance Of Ambulatory | |||
| Electrocardiographic Systems | |||
| 3-118 | AAMI ANSI | EC57:2012 | Testing and reporting performance |
| results of cardiac rhythm and ST | |||
| segment measurement algorithms | |||
| N/A | U.S. FDA | October 2, 2014 | Guidance for Industry and FDA Staff – |
| Content of Premarket Submissions | |||
| for Management of Cybersecurity in | |||
| Medical Devices | |||
| N/A | U.S. FDA | May 5, 2005 | Guidance for the Content of |
| Premarket Submissions for Software | |||
| Contained in Medical Devices |
Table 2. FDA-Recognized Consensus Standards & Guidance Document Summary
The nonclinical verification and performance test results established that the device meets its design requirements and intended use, that the modifications to the cleared device are as safe and effective as the predicate. During the development, potential hazards were evaluated and controlled by the risk management activities, including risk analysis, risk mitigation, verification and benefit-risk analysis. The verification and system-level regression testing demonstrate that the device meets all its specifications.
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VIII. Clinical Testing in Support of Substantial Equivalence Determination
No clinical testing was performed in support of this premarket notification.
IX. Conclusion
The results confirm by examination and provision of objective evidence that the design output met the design input requirements. The results of the nonclinical testing performed demonstrate that the ZEUS System meets the requirements of established conformance standards and performance specifications necessary for its intended use and does not raise new questions of safety or effectiveness as compared to the predicate device. The ZEUS System is substantially equivalent to the predicate device.