(83 days)
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 provided text describes the 510(k) premarket notification for the Zio AT ECG Monitoring System, specifically focusing on the modifications made to the ZEUS System's rhythm classification algorithm from a rule and machine-learning implementation to a deep-learning basis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that "Safety and performance of the modified ZEUS System has been evaluated and verified in accordance with design specifications and applicable performance standards." and "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."
However, there is no specific table of acceptance criteria with corresponding performance metrics provided in the text. The document broadly refers to compliance with standards like AAMI ANSI EC57: 2012 and IEC 60601-2-47:2012. These standards typically outline performance requirements for ECG analysis systems (e.g., sensitivity, specificity for various arrhythmias), but the specific numerical targets set as acceptance criteria by iRhythm and the reported device performance against those targets are not detailed in this public FDA letter.
2. Sample size used for the test set and the data provenance:
The document mentions that "The modified device's arrhythmia algorithm detection was tested in accordance to AAMI ANSI EC57: 2012". While AAMI ANSI EC57: 2012 provides guidelines for testing and reporting performance, it does not explicitly state the sample size (number of patients or recordings) used for the test set.
Data Provenance: The document does not specify the country of origin of the data, nor does it explicitly state whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document mentions that the ZEUS System enables "iRhythm's Certified Cardiographic Technicians (CCTs) to generate and distribute a report of the findings contained within the data". However, it does not specify the number of experts used to establish the ground truth for the test set used to validate the deep-learning algorithm, nor does it explicitly state their qualifications (e.g., number of years of experience, specific certifications beyond "Certified Cardiographic Technicians").
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method used for the test set to establish ground truth. It implies that CCTs generate reports, but not the process for an independent adjudicated ground truth for testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus of this submission is on the technological change to the algorithm itself and demonstrating its substantial equivalence to the predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the document implies that standalone performance testing of the algorithm was done. It states: "The modified device's arrhythmia algorithm detection was tested in accordance to AAMI ANSI EC57: 2012" and "The ZEUS System is an electrocardiogram (ECG) analysis and reporting software system, designed to process continuously recorded, signal-lead ECG data." This suggests that the algorithm's performance in detecting arrhythmias was evaluated independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document indicates that "iRhythm's Certified Cardiographic Technicians (CCTs) generate and distribute a report of the findings contained within the data". This implies that the ground truth for the data used in the system's operation is established by CCTs. For the testing data, it's highly probable that expert review (likely by CCTs, and potentially also by cardiologists as part of a gold standard process not explicitly detailed here) was used to establish ground truth for the arrhythmias. However, it does not explicitly state "expert consensus" or provide details on how many experts.
8. The sample size for the training set:
The document does not specify the sample size for the training set used for the deep-learning algorithm. It only states that the algorithm was updated "from a rule and machine-learning implementation to a deep-learning basis."
9. How the ground truth for the training set was established:
The document does not explicitly state how the ground truth for the training set was established. Given that 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," it is highly probable that the training data and their corresponding labels (ground truth) were derived from previous ECG recordings marked up by these Certified Cardiographic Technicians or similar qualified personnel.
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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
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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
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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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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.
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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 MonitoringSystem (K163512) | Modified Device:ZEUS System | |
|---|---|---|---|
| General Characteristics | |||
| Classification | Class II | Class II | |
| Classification Regulation(s) | 21 CFR 870.280021 CFR 870.142521 CFR 870.292021 CFR 870.1025 | 21 CFR 870.280021 CFR 870.142521 CFR 870.292021 CFR 870.1025 | |
| Product Code | DSH, DQK, DXH, DSI | DSH, DQK, DXH, DSI | |
| Patient Environment | Ambulatory | Ambulatory | |
| Patient Population | Non-pediatric, non-criticalcare patients | Non-pediatric, non-critical carepatients | |
| Technological Characteristics | |||
| Data Input | Digital long-term continuousand transmission ECG | Digital long-term continuousand transmission ECG | |
| Data Download | Yes | Yes | |
| Data Storage | Yes | Yes | |
| ECG Analysis | BeatRunsRhythm TypesHeart Rates | BeatRunsRhythm TypesHeart Rates | |
| Rhythm Detection Algorithm | ECGML | ECGML and ECGDL | |
| Feature/Function | Original Device:Zio AT ECG MonitoringSystem (K163512) | Modified Device:ZEUS System | |
| Rhythm Types | - Atrial fibrillation- Complete heart block- Second degree AVblock-type II- Pause >3 seconds- Sinus rhythm- Supraventriculartachycardia- 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- Ventriculartachycardia- Ventricular trigeminy- Second degree AV block-type I- Ectopic atrial rhythm- Junctional rhythm | |
| Result Integrator | Algorithm Controller | Algorithm Controller, updated toinitiate ECG Analysis throughECGDL, and integrate theECGML and ECGDL labels | |
| Architecture | Integrated Analysis Tool | Integrated Analysis Tool | |
| Platform | PC / Server Mix toClinician & PatientWebsites | PC / Server Mix to Clinician &Patient Websites | |
| QA Tool | Yes | Yes, updated to support theexpanded rhythms | |
| Report Output | Yes | Yes | |
| ZEUS Web Services | Store and retrieve theintegrated ECGML Labelsto ZEUS Database | Store and retrieve the integratedECGML and ECGDL Labels toZEUS Database |
Table 5.1: Substantial Equivalence Summary Table
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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.
§ 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).