(169 days)
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 provided text is a truncated 510(k) submission summary for the Zio® ECG Utilization Service (ZEUS) System. Unfortunately, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the specific study that proves the device meets those criteria.
Specifically, the document states: "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." However, it does not present the specific acceptance criteria (e.g., target sensitivity/predictivity values) nor does it provide a table of acceptance criteria alongside reported device performance. It also explicitly states, "No clinical testing was performed in support of this premarket notification." Therefore, the detailed study information you requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance details, training set info) is not present in this document.
Based on the available text, here's what can be extracted:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implied): The device was expected to demonstrate sensitivity and positive predictivity levels that "satisfy requirements and minimize safety or efficacy concerns" for "any claimed analysis metrics."
- Reported Device Performance: The document states, "The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements..." However, no specific numerical values or a table comparing criteria to performance are provided.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided in the document. The text mentions that a "Certified Cardiographic Technician (CCT) to review and generate a report of the findings contained within the data," but this refers to the intended use of the device for clinical review, not the establishment of ground truth for a performance study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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:
- No, an MRMC comparative effectiveness study is not mentioned or implied. The document explicitly states, "No clinical testing was performed in support of this premarket notification."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document states, "Automated ECG analysis performance was quantified for any claimed analysis metrics." This suggests standalone algorithm performance was evaluated, but the results and methodology are not detailed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This information is not explicitly provided. Given the nature of ECG analysis, it would typically be expert annotation/consensus, but the document does not confirm this.
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The sample size for the training set:
- This information is not provided in the document.
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How the ground truth for the training set was established:
- This information is not provided in the document.
Summary of available information regarding performance evaluation:
- Device Name: Zio® ECG Utilization Service (ZEUS) System
- Purpose of Evaluation (Implied): To quantify automated ECG analysis performance for claimed metrics, demonstrating sensitivity and positive predictivity.
- Type of Testing: "Automated ECG analysis performance was quantified." This was part of "Overall system performance testing" and "Software verification testing" as "nonclinical testing."
- Result (General): "The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns."
- Lack of Detail: The document explicitly states "No clinical testing was performed" and does not provide specific numerical results, acceptance thresholds, sample sizes, methodology for ground truth, or details of expert involvement in performance studies.
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iRhythm Technologies, Inc. Gabrielle Logan Senior Regulatory Affairs Specialist 650 Townsend Street, Ste 500 San Francisco, California 94103
Re: K190593
Trade/Device Name: Zio® ECG Utilization Service (ZEUS) System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK Dated: July 19, 2019 Received: July 23, 2019
Dear Gabrielle Logan:
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/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 medical devices and radiation-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,
Nicole Goodsell Assistant Director (Acting) External Heart Rhythm and Rate Devices Team 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) K190593
Device Name Zio® ECG Utilization Service (ZEUS) System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Notification K190593
l. General Information
Applicant:
iRhythm Technologies, Inc. 650 Townsend Street, Suite 500 San Francisco, CA 94103, USA Phone: 415-632-5700 Fax: 415-632-5701
Contact Person:
Gabrielle Logan Sr. Regulatory Affairs Specialist Phone: 415-214-7092 Email: glogan@irhythmtech.com
Date Prepared: August 22, 2019
ll. Device Information
Trade Name: Zio® ECG Utilization Service (ZEUS) System
Generic/Common Name:
Programmable diagnostic computer
Classification Names:
Programmable diagnostic computer [21CFR§870.1425]
Regulatory Class: Class II
Product Codes: DQK
III. Predicate Devices
The following predicate device has been selected:
- iRhythm Technologies, Inc. Zio® AT ECG Monitoring System [K181502] |
No reference devices were used in this submission.
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Section 1b 510(k) Summary
IV. Indications for Use
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. After patient 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.
V. Device Description
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.
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.
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Section 1b 510(k) Summary
VI. Substantial Equivalence
The proposed indications for use statement for the Zio Utilization Service (ZEUS) System is substantially equivalent to the intended use in the cleared Indications for Use statement for the predicate device. The performance testing results demonstrate that the differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Therefore, the ZEUS System is determined to be substantially equivalent to the predicate device.
VII. Nonclinical Testing in Support of Substantial Equivalence Determination
There are no required FDA performance standards for the ZEUS System. Overall system performance testing was conducted as part of the verification activities on incremental changes to the ZEUS System to ensure performance as intended per specifications and to support a determination of substantial equivalence to the predicate device.
Nonclinical testing included:
- . System performance testing
- . Software verification testing
The results confirm by examination and provision of objective evidence that the design output met the design input requirements in conformance with the following list of recognized consensus standards:
| FDA# | Body | Number / Version | Title |
|---|---|---|---|
| 5-70 | AAMIANSI ISO | 14971:2007(R)2010(Corrected 4 October 2017) | Medical Devices – Applications Of RiskManagement To Medical Devices |
| 3-127 | AAMIANSI IEC | 60601-2-47:2012 | Medical Electrical Equipment -- Part 2-47: Particular Requirements For TheBasic Safety And Essential PerformanceOf Ambulatory ElectrocardiographicSystems |
| 3-118 | AAMIANSI | EC57:2012 | Testing And Reporting PerformanceResults 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 forManagement of Cybersecurity inMedical Devices |
No clinical testing was performed in support of this premarket notification.
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Section 1b 510(k) Summary
VIII. Conclusion
The ZEUS System 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).