(63 days)
The ZEUS System is intended for use by qualified medical professionals for the assessment ambulatory electrocardiogram (ECG) data from adult patients 18 years or older. The system is intended to be marketed as a service that downloads and analyzes up to 14 days of ECG data. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.
The ZIO ECG Utilization Service System ("ZEUS System") is an electrocardiogram (ECG) processing and analysis system, designed to handle continuously recorded, single-lead ECG data. Once the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy. iRhythm trained Patch in-take and CCT personnel follow internal procedures for processing and are of the algorithm performance anomalies. Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits. The CCT generates a final report of the ECG findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.
The provided text describes the ZEUS (ZIO ECG Utilization Services) System, a programmable diagnostic computer for ambulatory ECG data analysis. It details the device's indications for use, product description, and claims of substantial equivalence to a predicate device. However, it does not provide specific details about acceptance criteria, reported device performance metrics in a table, sample sizes for test/training sets, ground truth establishment methods in detail, or information regarding multi-reader multi-case studies.
Based on the provided document, here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance:
| Metric / Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Automated ECG Analysis Performance | Satisfy requirements to minimize safety or efficacy concerns (specific thresholds not provided). | "The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns." (No specific numbers or metrics are given). |
Missing Information: Specific numerical acceptance criteria (e.g., sensitivity > X%, specificity > Y%) and the actual reported numerical performance of the device against these metrics.
2. Sample size used for the test set and the data provenance:
Missing Information: The document states "Automated ECG analysis performance was quantified for any claimed analysis metrics," but does not provide the sample size of the test set used for this quantification. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Missing Information: The document states that the output of the algorithm is delivered to a "QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." It also mentions "iRhythm trained Patch in-take and CCT personnel follow internal procedures for processing and are of the algorithm performance anomalies." However, it does not specify the number of experts (CCTs or other medical professionals) used to establish ground truth for a test set, nor their specific qualifications (e.g., years of experience beyond "Certified Cardiographic Technicians"). It also doesn't explicitly state that these CCTs established the ground truth for a separate test set, but rather that they review and adjust algorithm output in the operational workflow.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Missing Information: The document mentions that CCTs review and adjust results, implying a human-in-the-loop process. However, it does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth on a specific test set for performance evaluation.
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:
Missing Information: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance. The system's output is intended for review by a clinician, but no study is described to quantify improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document implies a system that includes human review: "Once the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." And "Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits." While the "Automated ECG analysis performance was quantified," the provided text does not explicitly state if a standalone algorithm-only performance evaluation was conducted entirely separate from this human-in-the-loop review process for regulatory submission. It seems the described system always includes human review as part of the service.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth appears to be established by Certified Cardiographic Technicians (CCTs) who review and adjust the algorithm's output. The document states: "the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." This suggests expert review/adjudication as the basis for accuracy.
8. The sample size for the training set:
Missing Information: The document does not provide any information regarding the sample size used for training the algorithm.
9. How the ground truth for the training set was established:
Missing Information: The document does not describe how ground truth was established for the training set. It only mentions how "accuracy" for the analysis is handled, which seems to describe the operational workflow rather than a specific ground truth generation process for a dataset.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2014
Irhythm Technologies, Inc. Rich Laguna Director Qa/ra 650 Townsend Street. Suite 380 San Francisco, California 94103
Re: K142681
Trade/Device Name: Zeus (zio Ecg Utilization Service) System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: October 22, 2014 Received: October 24, 2014
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -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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IRHYTHM TECHNOLOGIES, INC.
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K142681
Device Name: ZEUS (ZIO ECG Utilization Services) System
Indications for Use:
The ZEUS System is intended for use by qualified medical professionals for the assessment ambulatory electrocardiogram (ECG) data from adult patients 18 years or older. The system is intended to be marketed as a service that downloads and analyzes up to 14 days of ECG data. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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SECTION 5 510(k) SUMMARY
This summary of the 510(k) premarket notification for the ZEUS System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
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IRHYTHM TECHNOLOGIES, INC.
SECTION 5 510(k) SUMMARY (Cont.)
510(k) Notification K142681
GENERAL INFORMATION
Applicant:
iRhythm Technologies, Inc. 650 Townsend Street, Suite 380 San Francisco, CA 94103 U.S.A Phone: 415-632-5700 Fax: 415-632-5701
Contact Person:
Rich Laguna Director Quality & Regulatory Affairs eMail: rlaguna@irhythmtech.com Phone: 415-632-5749 Fax: 415-632-5701
Date Prepared: October 22, 2014
DEVICE INFORMATION
Classification: Computer, diagnostic, programmable, 21 CFR§870.1425
Product Code: DOK
Trade Name: ZEUS (ZIO ECG Utilization Services) System
Generic/Common Name: Programmable diagnostic computer
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PREDICATE DEVICE(S)
ZEUS (ZIO ECG Utilization Services) System (K091075)
INDICATIONS FOR USE
The ZEUS System is intended for use by qualified medical professionals for the assessment ambulatory electrocardiogram (ECG) data from adult patients 18 years or older. The system is intended to be marketed as a service that downloads and analyzes up to 14 days of ECG data. Analysis metrics are provided in a report which is available for clinician review and printing. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.
PRODUCT DESCRIPTION
The ZIO ECG Utilization Service System ("ZEUS System") is an electrocardiogram (ECG) processing and analysis system, designed to handle continuously recorded, single-lead ECG data. Once the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy. iRhythm trained Patch in-take and CCT personnel follow internal procedures for processing and are of the algorithm performance anomalies. Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits. The CCT generates a final report of the ECG findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.
The ZEUS System is substantially equivalent to the previously 510(k) cleared (K091075) with the same intended use.
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 5 510(k) SUMMARY (Cont.)
SUBSTANTIAL EQUIVALENCE
The indications for use for the ZEUS System are equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the ZEUS System is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
There are no required FDA performance standards for the product code DQK of the ZEUS System. All necessary software verification and validation was conducted on the modified ZEUS System to support determination of substantial equivalence to the predicate devices. The results confirm by examination and provision of objective evidence that the software design output met the software design input requirements in conformance with the following list of recognized standards:
- AAMI / ANSI / ISO ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices / Use & Design Risk analysis
- . AAMI / ANSI / ISO 60601-2-47:2012, medical electrical equipment -- part 2-47: particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. (Cardiovascular)
SUMMARY
The ZEUS (ZIO ECG Utilization Services) 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).