(63 days)
Not Found
No
The description mentions an "algorithm" for processing and analysis, but explicitly states that the results are reviewed and/or adjusted by certified technicians, and any software anomalies are manually corrected. There is no mention of AI, ML, or any related terms, and the process relies on human oversight and correction, which is not typical of an AI/ML-driven system.
No.
The device is intended for assessment and analysis of ECG data, providing reports for clinician review to aid in diagnosis, not to provide therapy.
No
The device description explicitly states, "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." This indicates the device provides data for diagnosis but does not perform the diagnosis itself.
No
The device description explicitly states it is an "ECG processing and analysis system" that handles "continuously recorded, single-lead ECG data." While the summary focuses on the software analysis, it implies the existence of a hardware component (the source of the ECG data) that is integral to the system's function, even if not included in the 510(k) submission itself. The predicate device also suggests a system that includes hardware for data acquisition.
Based on the provided information, the ZEUS System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- ZEUS System Function: The ZEUS System analyzes electrocardiogram (ECG) data, which is a measurement of electrical activity of the heart. This data is obtained from the patient's body, but it is not a biological specimen in the way that IVDs typically analyze.
- Intended Use: The intended use clearly states it's for the "assessment of ambulatory electrocardiogram (ECG) data". It does not mention analyzing biological samples.
- Device Description: The description focuses on processing and analyzing ECG data, not biological specimens.
Therefore, the ZEUS System falls under the category of a medical device that analyzes physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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 codes
DQK
Device 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.
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
adult patients 18 years or older
Intended User / Care Setting
qualified medical professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, positive predictivity
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).
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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
1
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.