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 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

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 Holter 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.

AI/ML Overview

The provided documentation indicates that the MARS Holter Analysis Workstation did not require clinical studies to support substantial equivalence. Therefore, there is no detailed information on acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert qualifications, or other clinical study specifics as requested.

The submission states:
"The subject of this premarket submission, MARS Holter Analysis Workstation, did not require clinical studies to support substantial equivalence."

Instead of clinical studies, the submission relies on non-clinical tests and compliance with voluntary standards and quality assurance measures during development. These measures include:

Requirement Definition
Risk Analysis
Technical Review
Formal Design Review
Code Inspection
Integration testing (Module and System verification)
Final acceptance testing (Validation)
Performance testing
Safety testing

Since no clinical study was conducted as part of this submission, the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment from a clinical trial perspective cannot be provided. The device was deemed substantially equivalent to predicate devices based on its fundamental scientific technology and non-clinical testing.

Summary

{0}------------------------------------------------

K093141 P1/3

DEC 2 9 2009

GE Healthcare 510(K) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: September 30. 2009 GE Healthcare (GE Medical Systems Information Technologies) Submitter: 9900 Innovation Drive Wauwatosa, WI 53226 Joe Lucas Primary Contact Person: Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226 T: (414) 721-2593 F: (414) 721-3863 Kristin Pabst Secondary Contact Person: Regulatory Affairs - Diagnostic Cardiology 9900 Innovation Drive Wauwatosa, WI 53226 T: (414) 721-3104 F: (414) 721-3863 Device: Trade Name: MARS Holter Analysis Workstation Common/Usual Name: Holter Analysis Workstation Classification Names: 21 CFR 870.1425 Programmable Diagnostic Computer Product Code: DOK K051026 MARS Holter Analysis Workstation Predicate Device(s): K991786 GEMS-IT MARS Unity Workstation The MARS Holter Analysis Workstation system is a software-Device Description: 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 Holter 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.

Image /page/0/Picture/5 description: The image shows a logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are bold and have a vintage look, and the entire logo is enclosed within a textured circle.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo is a circular emblem with the letters 'GE' intertwined in a stylized, cursive font. The letters are surrounded by a textured or patterned border within the circle, giving the logo a vintage or classic appearance.

GE Healthcare 510(K) Premarket Notification Submission

Intended Use:

Substantial Equivalence:

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 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 t

The MARS Holter Analysis Workstation employs the same Technology: fundamental scientific technology as its predicate devices.

Determination of Summary of Non-Clinical Tests:

The MARS Holter Analysis Workstation and its applications comply with voluntary standards as detailed in Section 9 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Requirement Definition .
Risk Analysis .
Technical Review .
Formal Design Review ●
. Code Inspection
◆ Integration testing (Module and System verification)
Final acceptance testing (Validation) ◆
Performance testing .
Safety testing

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined in a circular design. The logo is simple and recognizable, representing the well-known multinational corporation.

GE Healthcare 510(K) Premarket Notification Submission

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(s).

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 9 2009

Mr. Joseph Lucas Regulatory Affairs Leader GE Medical Systems Information Technologies 9900 Innovation Drive Wauwatosa, WI 53226

Re: K093141

Trade/Device Name: MARS® Holter Analysis Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 19, 2009 Received: November 20, 2009

Dear Mr. Lucas:

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 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 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.

{4}------------------------------------------------

Page 2 - Mr. Joseph Lucas

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 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 in black and white and has a vintage look.

GE Healthcare 510(K) Premarket Notification Submission

510(k) Number (if known): K093 4 /

Device Name: MARS® Holter Analysis Workstation

Indications for Use:

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 (Part 21 CFR 801 Subpart D) AND/OR

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)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 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).