(121 days)
K#093141
K#093141
No
The document describes automated analysis of ECG data but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with such technologies.
No.
The device is a Holter analysis workstation used for the acquisition, analysis, and storage of ambulatory ECG and multi-parameter data, intended to assist physicians in interpreting recorded data for diagnostic purposes, not for providing therapy.
Yes.
The device's "Intended Use / Indications for Use" states that the "Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data." and that the "Data acquired may be used for the following indications: - Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances..." The "Device Description" also states, "The final report is used by trained medical personal to diagnose a patient's cardiac abnormalities." These statements clearly indicate its use in diagnosing medical conditions.
Yes
The device description explicitly states "The MARS Holter Analysis Workstation system is a software-system that runs on PC based hardware." and focuses solely on the software's functions for analysis, editing, and reporting of ECG data. While it interacts with hardware (PC, recorders), the device being cleared is the software itself.
Based on the provided information, the MARS Holter Analysis Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- MARS Holter Analysis Workstation Function: The description clearly states that the device is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory ECG and multi-parameter data. This data is acquired directly from the patient's body (electrical signals from the heart), not from specimens taken from the body.
- Intended Use: The intended use focuses on assisting physicians in interpreting recorded ECG data for evaluating cardiac conditions and responses to interventions. This is based on physiological measurements, not laboratory analysis of biological samples.
Therefore, the MARS Holter Analysis Workstation falls under the category of a medical device that processes physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG and multi-parameter data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and Holter analysis capabilities. Data acquired may be used for the following indications:
- Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction ● disturbances
- Evaluation of symptoms that may be due to myocardial ischemia .
- Detection of ECG events that alter prognosis in certain forms of heart disease .
- Detection and analysis of pacemaker function and failure .
- Determination of cardiac response to lifestyle .
- Evaluation of therapeutic interventions .
- Investigations in epidemiology and clinical trials .
Product codes
DOK
Device Description
The MARS Holter Analysis Workstation system is a software-system that runs on PC based hardware. The MARS Holter Analysis Workstation supports a number of software applications including analysis, user editing and final report processing.
The MARS Hotter Analysis Workstation analyzes ECG data, to detect and label beats, and then presents it in a variety of screens to the user for review and data editing purposes. The MARS Holter Analysis Workstation system stores and prints final reports and allows reports to be sent to the MUSE Cardiology Information Management System for long- term archive.
The MARS Holter Analysis Workstation supports acquisition from ambulatory ECG Recorders and multi-parameter data from the CIC Pro Clinical Information Center. A variety of different final report formats can be stored and printed. The final report is used by trained medical personal to diagnose a patient's cardiac abnormalities.
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
Patient population includes both adult and pediatric (greater than 10Kg) human patients.
Intended User / Care Setting
The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment.
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
The subject of this premarket submission, MARS Holter Analysis Workstation, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
MARS Holter Analysis Workstation K#093141
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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DEC 0 4 2013
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white and has a vintage look.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
August 1. 2013 Date:
GE Medical Systems Information Technologies Submitter: 9900 Innovation Drive Wauwatosa, WI 53226
Primary Contact Person:
.
Kristin Pabst Regulatory Affairs Manager GE Medical Systems Information Technologies Phone: (414) 721-3104 Fax: (414) 721-3863
Secondary Contact Person:
Device:
Doug Kentz Regulatory Affairs GE Medical Systems Information Technologies Phone (414) 362-2038 FAX: (414) 362-2585
Trade Name: MARS Holter Analysis Workstation
Common/Usual Name: ECG Analysis Computer
Classification Names: Programmable Diagnostic Computer (21 CFR 870.1425)
Product Code: DOK
Predicate Device(s): MARS Holter Analysis Workstation K#093141
Device Description:
The MARS Holter Analysis Workstation system is a software-system that runs on PC based hardware. The MARS Holter Analysis Workstation supports a number of software applications including analysis, user editing and final report processing.
The MARS Hotter Analysis Workstation analyzes ECG data, to detect and label beats, and then presents it in a variety of screens to the user for review and data editing purposes. The MARS Holter Analysis Workstation system stores and prints final reports and allows reports to be sent to the MUSE Cardiology Information Management System for long- term archive.
The MARS Holter Analysis Workstation supports acquisition from ambulatory ECG Recorders and multi-parameter data from the CIC Pro Clinical Information Center. A variety of different final report formats can be stored and printed. The final report is used by trained medical personal to diagnose a patient's cardiac abnormalities.
MARS Holter Analysis Workstation is designed for acquisition, analysis. Intended Use: edit, review, report and storage of ambulatory ECG and multiparameter data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic
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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The logo is black and white and has a vintage look.
Determination of Substantial
Equivalence:
GE Healthcare
510(k) Premarket Notification Submission
environment. Patient population includes both adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and holter analysis capabilities.
Data acquired may be used for the following indications:
- . Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction disturbances
- . Evaluation of symptoms that may be due to myocardial ischemia
- Detection of ECG events that alter prognosis in certain forms of . heart disease
- . Detection and analysis of pacemaker function and failure
- Determination of cardiac response to lifestyle .
- Evaluation of therapeutic interventions .
- Investigations in epidemiology and clinical trials
The proposed MARS Holter Analysis Workstation is a software device Technology: that runs on IT hardware employing the same functional scientific technology as the predicate device MARS Holter Analysis Workstation (K093141).
Summary of Non-Clinical Tests:
The MARS Holter Analysis Workstation complies with voluntary standards:
- IEC 60601-1-1:2000 2nd edition Medical Electrical . Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2:2007 Medical Electrical Equipment -◆ Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility Requirements and Tests, Edition 3
- . IEC 60601-1-4:1996, +A1:1999 (AKA IEC 60601-1-4:2000) Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems
- AAMI EC-57: 1998 (R2008) Testing and reporting . performance results of cardiac rhythm and ST seament measurement algorithms
The following quality assurance measures are applied to the development of the system:
- Requirements Definition .
- Risk Analysis .
- . Requirements Reviews
- Design Reviews .
- Code Inspection .
- Testing on unit level (Module verification) .
- Integration testing (Module and System verification) .
.
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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be in a cursive font.
GE Healthcare
510(k) Premarket Notification Submission
- Performance testing (Verification) .
- Final Acceptance testing (Validation) .
- Safety testing (Verification) .
Summary of Clinical Tests:
The subject of this premarket submission, MARS Holter Analysis Workstation, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the MARS Holter Analysis Workstation to be as safe, as effective, and performance is substantially equivalent to the predicate device.
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Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol featuring a human figure embracing a three-barred cross, which is the symbol of the Public Health Service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MI) 20993-0002
December 4, 2013
GE Medical Systems Information Technologies, Inc. Kristin Pabst 9900 West Innovation Drive Wauwatosa. WI 53226 US
Re: K132437
Trade/Device Name: MARS HOLTER analysis workstation Regulation Number: 21 CFR 870.14257 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 5, 2013 Received: November 5, 2013
Dear Kristin Pabst:
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
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Page 2 - Kristin Pabst
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
OwenFDEaris -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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Image /page/5/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters "GE" intertwined within a circle. The letters are stylized with curved lines, giving them a classic, almost handwritten appearance.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Number: K132437
Device Name: MARS Holter Analysis Workstation
Indications for Use:
MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG and multi-parameter data. Results of the automated analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The MARS Holter Analysis Workstation is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. Patient population includes both and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and Holter analysis capabilities. Data acquired may be used for the following indications:
- Evaluation of symptoms that may be caused by cardiac arrhythmia and/or conduction ● disturbances
- Evaluation of symptoms that may be due to myocardial ischemia .
- Detection of ECG events that alter prognosis in certain forms of heart disease .
- Detection and analysis of pacemaker function and failure .
- Determination of cardiac response to lifestyle .
- Evaluation of therapeutic interventions .
- Investigations in epidemiology and clinical trials .
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/18 description: The image shows a signature and a digitally signed stamp. The stamp indicates that the document was digitally signed by Owen Faris -S. The date of the signature is 2013.12.04, and the time is 10:22:30-05'00'.