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.

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.

AI/ML Overview

This FDA 510(k) summary for the Zio ECG Utilization Software (ZEUS) System (K202527) does not provide the detailed acceptance criteria and the comprehensive study results typically found in performance studies for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K190593) primarily through non-clinical testing and comparison of technological characteristics.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not explicitly stated within this document. The document explicitly states: "No clinical testing was performed in support of this premarket notification."

However, I can extract the available information and highlight what is missing based on your request.

Summary of Available Information and Missing Details:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a table format within the document. The document states that "nonclinical verification and performance test results established that the device meets its design requirements and intended use." It also mentions "design specifications" which would contain acceptance criteria, but these are not enumerated. The "reported device performance" is not quantified in terms of metrics like sensitivity, specificity, or F1-score for arrhythmia detection.
Sample Size Used for the Test Set and Data Provenance: Not specified. The document only mentions "nonclinical testing" and "verification and system-level regression testing." It does not detail specific test sets for performance evaluation in terms of ECG data or patient population, nor does it mention data provenance (country, retrospective/prospective). Given that no clinical testing was performed, any "test set" would likely refer to internal validation data, which is not described.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not specified. Since no clinical testing was performed and no specific test set based on expert-labeled data is described, this information is not present. The document mentions that "results are quality reviewed by CCTs" (Certified Cardiographic Technicians) as part of the overall Zio Service operation, but this refers to the workflow, not the establishment of ground truth for a predefined test set used for regulatory submission.
Adjudication Method: Not specified. No clinical study or expert-based ground truth establishment is detailed.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size: No. The document explicitly states, "No clinical testing was performed in support of this premarket notification." Therefore, no MRMC study was conducted or reported here.
If a Standalone (algorithm only without human-in-the-loop performance) was done: The document describes the ZEUS System as a "software system consisting of a collection of software modules designed to store and analyze data... to curate a report of preliminary findings intended for use by clinicians... 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." This indicates a human-in-the-loop system where the algorithm's output is reviewed by CCTs. The document does not provide standalone performance metrics for the algorithm prior to CCT review.
The Type of Ground Truth Used: Not specified. Given the lack of clinical testing and detailed performance evaluation, the method for establishing ground truth for any internal validation is not described.
The Sample Size for the Training Set: Not specified. The document does not describe the development or training of any AI/ML components in detail, nor does it specify the size of any training data used. It only mentions "ECGDL" (ECG Deep Learning?) as the rhythm detection algorithm, replacing "ECGML + ECGDL" from the predicate.
How the Ground Truth for the Training Set was Established: Not specified.

Available Information from the Document:

While the direct answers to your questions are largely "not specified" due to the nature of this 510(k) submission focusing on substantial equivalence based on non-clinical testing, here's what the document does provide:

Device: Zio ECG Utilization Software (ZEUS) System (K202527)
Intended Use: "capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring." Reports are "provided for review by the intended user to render a diagnosis based on clinical judgment and experience."
Predicate Device: iRhythm Technologies, Inc. Zio® ECG Utilization Software (ZEUS) System (K190593).
Technological Change: The subject device introduces "ECG segment detection" (specifically QT interval detection) and uses "ECGDL" for rhythm detection, whereas the predicate used "ECGML + ECGDL." It also expands interoperability to include the Zio® Monitor.
Performance Evaluation Method: "Safety and performance... has been evaluated and verified in accordance with design specifications and to support a determination of substantial equivalence... Nonclinical testing summarized in Table 2 demonstrates that the ZEUS System is in conformance with FDA-recognized consensus standards and FDA guidance documents."
Standards/Guidance Documents Used for Nonclinical Testing:
- AAMI ANSI ISO 14971:2012(R)2010 (Risk Management)
- IEC 62304 Edition 1.1 2015-06 (Medical device software - Software life cycle processes)
- AAMI ANSI IEC 60601-2-47:2012 (Ambulatory Electrocardiographic Systems)
- AAMI ANSI EC57:2012 (Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms)
- U.S. FDA October 2, 2014 Guidance (Cybersecurity in Medical Devices)
- U.S. FDA May 5, 2005 Guidance (Software Contained in Medical Devices)
Conclusion of Performance: "The nonclinical verification and performance test results established that the device meets its design requirements and intended use... The verification and system-level regression testing demonstrate that the device meets all its specifications."

In essence, this 510(k) clears the device based on demonstrating that its changes from the predicate device do not raise new questions of safety or effectiveness, supported by non-clinical engineering and software validation testing, rather than a clinical performance study with detailed acceptance criteria for diagnostic accuracy metrics.

Summary

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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

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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)

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

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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)21CFR870.142521CFR870.102521CFR870.2029
Product Code	Same	DQKDSIDXH
Patient Environment	Same	Ambulatory
Patient Population	Same	Non-pediatric, non-criticalcare patients
Technological Characteristics
Data Input	Same	Digital long-termcontinuous ECG
Data Download	Same	Yes
Data Storage	Same	Yes
Rhythm DetectionAlgorithm + ECG Analysis	ECGDL	ECGML + ECGDL
ECG Segments	QT	N/A
Interoperability	Zio® XT PatchZio® AT PatchZio® Monitor	Zio XT PatchZio 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 4October 2017)	Medical Devices – Application of riskmanagement to medical devices
13-79	IEC	62304 Edition 1.12015-06CONSOLIDATEDVERSION	Medical device software - Softwarelife cycle processes
3-127	AAMI ANSI IEC	60601-2-47:2012	Medical Electrical Equipment -- Part2-47: Particular Requirements ForThe Basic Safety And EssentialPerformance Of AmbulatoryElectrocardiographic Systems
3-118	AAMI ANSI	EC57:2012	Testing and reporting performanceresults of cardiac rhythm and STsegment measurement algorithms
N/A	U.S. FDA	October 2, 2014	Guidance for Industry and FDA Staff –Content of Premarket Submissionsfor Management of Cybersecurity inMedical Devices
N/A	U.S. FDA	May 5, 2005	Guidance for the Content ofPremarket Submissions for SoftwareContained 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.

Regulation Number and Section

§ 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).