MARS HOLTER ANALYSIS WORKSTATION

K051026 · Ge Medical Systems Information Technologies · DQK · Jul 19, 2005 · Cardiovascular

Device Facts

• Record ID: K051026
• Device Name: MARS HOLTER ANALYSIS WORKSTATION
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

MARS Holter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG 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 adult and pediatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and holter analysis capabilities.

Device Story

MARS Holter Analysis Workstation is a PC-based software system for processing ambulatory ECG data. It acquires data from ambulatory ECG recorders; performs automated analysis to detect and label cardiac beats; and presents data via various screens for user review and editing. The system generates and stores final reports, which can be transmitted to the MUSE Cardiology Information Management System for long-term archiving. Used in hospital or clinic environments by trained operators under the supervision of a licensed healthcare practitioner. The output assists physicians in diagnosing cardiac abnormalities; however, it does not replace physician overread. The device provides arrhythmia studies and Holter analysis capabilities to support clinical decision-making regarding patient cardiac health.

Clinical Evidence

No clinical data provided. The submission relies on bench testing, including requirements specification review, risk analysis, software and hardware testing, performance testing, safety testing, and environmental testing.

Technological Characteristics

PC-based software system. Functions as a programmable diagnostic computer (21 CFR 870.1425). Supports acquisition from ambulatory ECG recorders. Connectivity includes integration with MUSE Cardiology Information Management System. Software-based analysis for beat detection and labeling.

Indications for Use

Indicated for adult and pediatric (>10kg) patients for: evaluation of symptoms of cardiac arrhythmia, conduction disturbances, or myocardial ischemia; detection of ECG events altering prognosis in heart disease; detection/analysis of pacemaker function/failure; determination of cardiac response to lifestyle; evaluation of therapeutic interventions; and investigations in epidemiology and clinical trials.

Regulatory Classification

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.

Predicate Devices

• GEMS-IT MARS Unity Workstation (K991786)
• Agilent Technologies 2010 Plus Holter for Windows (K010949)

Submission Summary (Full Text)

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## JUL 1 9 2005

KDS1026 8/ / 2

## Section 2 Summary and Certification

| 510(k) Summary of Safety and Effectiveness | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | April 20, 2005 |
| Submitter: | GE Medical Systems Information Technologies<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 USA |
| Contact Person: | Lisa M. Baumhardt<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Device: Trade Name: | MARS Holter Analysis Workstation |
| Common/Usual Name: | Holter Analysis Workstation |
| Classification Names: | 21 CFR 870.1425 Programmable Diagnostic Computer |
| Predicate Devices: | K991786 GEMS-IT MARS Unity Workstation<br>K010949 Agilent Technologies 2010 Plus Holter for Windows |
| Device Description: | The MARS Holter Analysis Workstation system is a software-system<br>that runs on PC based hardware. The MARS Holter Analysis<br>Workstation supports a number of software applications including<br>analysis, user editing and final report processing.<br><br>The MARS Holter Analysis Workstation analyzes ambulatory ECG<br>data, to detect and label beats, and then presents it in a variety of<br>screens to the user for review and data editing purposes. The MARS<br>Holter Analysis Workstation system stores and prints final reports and<br>allows reports to be sent to the MUSE Cardiology Information<br>Management System for long- term archive. The MARS Holter<br>Analysis Workstation supports acquisition from ambulatory ECG<br>Recorders. A variety of different final report formats can be stored and<br>printed. The final report is used by trained medical personal to<br>diagnosis a patient's cardiac abnormalities. |
| | |
| Intended Use: | MARS Holter Analysis Workstation is designed for acquisition, analysis,<br>edit, review, report and storage of ambulatory ECG data. Results of the<br>automated analysis are intended to assist the physician in the<br>interpretation of the recorded data. This information is not intended to<br>serve as a substitute for the physician overread of the recorded ECG<br>data. The MARS Holter Analysis Workstation is intended to be used by<br>trained operators under the direct supervision of a licensed healthcare<br>practitioner in a hospital or clinic environment. Patient population<br>includes both adult and pediatric (greater than 10Kg) human patients.<br>The MARS Holter Analysis Workstation provides the user arrhythmia<br>studies and holter analysis capabilities. |

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K051026

p. 2/2

Data acquired may be use 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 employs the same Technology: functional scientific technology as the predicate devices MARS Unity (K991786) and 2010 Plus Holter for Windows (K010949)
- The MARS complies with the voluntary standards as defailed in Section Test Summary: 9 of this submission. The following quality assurance measures were applied to the development of the device:
- Requirements specification review .
- Risk analysis .
- Software and hardware testing .
- Performance testing .
- Safety testing .
- Environmental testing ◆
- . Clinical use evaluation
- Final validation .

## Conclusion:

The results of these measurements demonstrated that the MARS Holter Analysis Workstation is as safe, as effective, and performs as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Medical Systems Information Technologies c/o Lisa Baumhardt Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K051026

K051020
Trade Name: MARS Holter Analysis Workstation
Trade Name: MARS Holter 270-1405 Trade : Number: 21 CFR 870.1425 Regulation Number. 21 Crici - Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: April 20, 2005 Received: April 22, 2005

Dear Ms. Baumhardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 5 I ((L) premarket in mailvent (for the indications
referenced above and have device is substantialy equivalent (for the indications referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed previces marketed in interstate for use stated in the enclosure) to legally marketed previce manice America Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Fede devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that and require approval of a preval application (PMA). and Cosmetic Act (Act) that do not require approval or approvations of the Act. The
You may, therefore, market the device, subject to the general ontrols provisions of the You may, therefore, market the device, subject to the general connual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the Act include requirements to them and one of the management in adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
ed its can be and the call of the case of a Fricting major regulatio If your device is classified (see above) into either class in (special Conadions affecting your device can
may be subject to such additional controls: Existing major regulat may be subject to such additional controls. Exismig major regantals be found in the Code of Federal Regulations, Print 27, 2011
publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Lisa Baumhardt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please or advised that I DA 3 tosaanse vice complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must of ally I coleral statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Act 8 requirements, 01); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provins (seting your device as described in your Section 510(k) I his icter will anow you've oogin maing of substantial equivalence of your device to a legally premarket notification: "The PDF miamig of castion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your act [phone]. Also, please note the regulation entitled, Connact the Office of Comp to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B. Zimmerman 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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## Indications for Use

510(k) Number (if known): __ Ko 51026 Device Name: MARS® Holter Analysis Workstation

Indications for Use:

\$

MARS Hotter Analysis Workstation is designed for acquisition, analysis, edit, review, report and storage of ambulatory ECG 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 adult nodiatric (greater than 10Kg) human patients. The MARS Holter Analysis Workstation provides the user arrhythmia studies and holter analysis capabilities.

Data acquired may be use 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 × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alummo

Sivision Sign-Off) Division of Cardlovascular Devices 251026 510(k) Number_

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