The MAC1600 is a portable ECG acquisition, analysis and recording system. The MAC1600 is intended to acquire, analyze, display and record information from adult and pediatic populations. Pediation is defined as patients between the ages of 0 and 15 years. The MAC1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The basic system shall provide 2 modes of operation: (1) Resting ECG mgnae nd (1) Arrhythmia mode. The basic systems shall print 6 or 12-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. The basic system shall be upgradeable with a third mode of operation: (3) Exercise mode for exercise stressing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional. The arrhythmia detection portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation.

The MAC1600 is used under the direct supervision of a licensed healthcare practitioner.

Device Description

The MAC 1600 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. MAC1600 is also capable of acquiring 2 additional ECG leads beyond what is needed for classical 12 lead ECG acquisition. The MAC 1600 will provide, in resting ECG mode, ECG quality information using the hookup advisor. The hookup advisor advises users of poor lead quality based on noise measurement. It can be upgraded to provide options such as ECG measurement and interpretation with 12SL as well as a stress testing option for exercise stress testing. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. Multiple QT correction formulas including Bazett, Framingham and Fridericia will be available as a user selectable option. Clinical Trials Data Guard and audit trail options are also available to support electronic record requirements.
The MAC 1600 delivers multiple leads of ECG on full-size reports and includes an alphanumeric keyboard for patient demographics and other data entry, an integrated 7" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non real time reports. The device will have optional internal memory and removable storage to store resting ECG records. An optional barcode reader to enter patient information is available. The MAC 1600 can be used as a portable unit.

AI/ML Overview

The provided text describes the MAC 1600 ECG Analysis System, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices, outlining the device's technical characteristics, intended use, and regulatory classification. It does not detail specific performance studies with quantitative results against predefined acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.

Here's why each point cannot be addressed:

Table of acceptance criteria and reported device performance: This information is not included. The document states that the "technological characteristics of the MAC 1600 have been updated to reflect use of current technology and to incorporate user requested features. Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness." This is a general statement rather than a detailed performance report against specific criteria.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The document primarily focuses on the device's own capabilities and its equivalence to predicate devices.
Standalone (i.e. algorithm only without human-in-the loop performance) study: The document describes the device's "12-lead ECG measurement and interpretive analysis" as an optional software feature and mentions "arrhythmia detection portion" for automatic documentation, implying standalone algorithmic functions. However, no specific study demonstrating its standalone performance is detailed.
Type of ground truth used: Not mentioned.
Sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

The document's conclusion, "This premarket notification submission demonstrates that the MAC 1600 ECG Analysis System is substantially equivalent to the previously cleared devices and differences in technological characteristics do not raise new questions of safety or effectiveness," indicates that the submission relies on the established safety and effectiveness of the predicate devices (CardioSmart ST V1.3 and CASE/Cardiosoft) rather than new, detailed performance studies for the MAC 1600.

Summary

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GE Medical Systems

Information Technologies

510(k) Summary 5.0

JUL 1 5 2008

Applicant and Contact Information 5.1

5.1.1 Submitter/ManufacturingInformation	GE Medical Systems Information Technologies9900 Innovation DriveWauwatosa, WI 53226
5.1.2 Establishment Registration[per 21 CFR 807.87(b)]	Active; Awaiting Assignment of Registration Number
5.1.3 Contact Person	Primary:	Margaret MuchaRegulatory Affairs LeaderGE Medical Systems Information TechnologiesRP-21229900 Innovation DriveWauwatosa, WI 53226Telephone: 414-721-4535Fax: 414-721-3863E-mail: margaret.mucha@ge.com
	Secondary:	Matthias BuergerDirector QA/RA Diagnostic CardiologyGE Medical Systems Information TechnologiesRP-21229900 Innovation DriveWauwatosa, WI 53226Telephone: 414-721-2317Fax: 414-721-3899E-mail: Matthias.Buerger@ge.comTracey FoxRegulatory Programs ManagerGE Healthcare3000 N. Grandview Blvd W-418Waukesha, WI 53188Telephone: (262) 513-4061E-mail: Tracey.Fox@ge.com

5.2 Basic Device Identification

5.2.1	Device Name	MAC 1600 ECG Analysis System
5.2.2	Device Proprietary Name[per 21 CFR 807.87(a)]	MAC 1600 ECG Analysis System
5.2.3	Common/Usual Name[per 21 CFR 807.87(a)]	Electrocardiograph
5.2.4 ClassificationNames/Numbers andCode[per 21 CFR807.87(a)]		21 CFR	Classification Name	Code
		870.2340	Electrocardiograph	DPS
		870.1425	Programmable Diagnostic Computer	DQK
		870.2920	Transmitters and Receivers,Electrocardiograph, Telephone	DXH
5.2.5	Regulatory Class[per 21 CFR 807.87(c)]	II

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GE Medical Systems

Information Technologies

5.2.6	Prescription Status	Prescription Device
5.2.7	Device/Classification Panel[per 21 CFR 807.87(c)]	Cardiovascular
5.2.8	Predicate Device	CardioSmart ST V1.3 (K973403) and CASE/Cardiosoft (K031561)
5.2.9	Sterilization Site	Not Applicable, device is sold in a non-sterile condition.
5.2.10	Sec 514 PerformanceStandards[per 21 CFR 807.87(d)]	No applicable performance standards have been established underSection 514 of the Federal Food, Drug and Cosmetic Act for thedevice subject of this submission. The MAC 1600 ECG AnalysisSystem complies with the voluntary standards as detailed in Section9 of this submission.
5.2.11	Technology	The technological characteristics of the MAC 1600 have beenupdated to reflect use of current technology and to incorporate userrequested features. Data in this submission demonstrate that thesetechnological characteristics do not raise new questions of safety oreffectiveness
5.2.12	Device Description	The MAC 1600 ECG acquisition, analysis and recording system canprint and display multiple leads of ECG data. MAC1600 is alsocapable of acquiring 2 additional ECG leads beyond what is neededfor classical 12 lead ECG acquisition. The MAC 1600 will provide, inresting ECG mode, ECG quality information using the hookupadvisor. The hookup advisor advises users of poor lead qualitybased on noise measurement. It can be upgraded to provideoptions such as ECG measurement and interpretation with 12SL aswell as a stress testing option for exercise stress testing.Transmission and reception of ECG data to and from a central ECGcardiovascular information system is also optional. Multiple QTcorrection formulas including Bazett, Framingham and Fridericia willbe available as a user selectable option. Clinical Trials Data Guardand audit trail options are also available to support electronic recordrequirements.The MAC 1600 delivers multiple leads of ECG on full-size reportsand includes an alphanumeric keyboard for patient demographicsand other data entry, an integrated 7" color display, and anintegrated thermal writer. The thermal writer will print real timecontinuous waveform, alphanumeric data and non real time reports.The device will have optional internal memory and removablestorage to store resting ECG records. An optional barcode reader toenter patient information is available. The MAC 1600 can be used asa portable unit.
5.2.13	Intended Use	The MAC1600 is a portable ECG acquisition, analysis and recordingsystem. The MAC1600 is intended to acquire, analyze, display andrecord information from adult and pediatric populations. Pediatricpopulation is defined as patients between the ages of 0 and 15years. The MAC1600 is intended to be used by trained operators ina hospital or medical professional's facility environment to recordECG signals from surface electrodes. The basic system shallprovide 2 modes of operation: (1) Resting ECG mode and (2)Arrhythmia mode. The basic systems shall print 6 or 12-leads ofECG. The device shall be upgradeable to provide software optionssuch as 12-lead ECG measurement and interpretive analysis. Thebasic system shall be upgradeable with a third mode of operation:(3) Exercise mode for exercise stress testing. Transmission andreception of ECG data to and from a central ECG cardiovascular
	portion of the MAC 1600 is provided to the customer for the convenience of automatic documentation.
	The MAC1600 is used under the direct supervision of a licensed healthcare practitioner.
	The MAC 1600 is not designed to provide alarms for arrhythmia detection.
	The device is not suitable for intra cardiac application.
	It is not intended for use:
	As a vital signs physiological monitor; or For use during patient transport.
5.2.14 Conclusion	The MAC 1600 ECG Analysis System is similar to existing CardioSmart ST and CASE/Cardiosoft devices incorporating features that have been previously cleared under different 510(k)'s. This premarket notification submission demonstrates that the MAC 1600 ECG Analysis System is substantially equivalent to the previously cleared devices and differences in technological characteristics do not raise new questions of safety or effectiveness.

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. . . .

GE Medical Systems

Information Technologies

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 2008

GE Medical Systems Information Technologies c/o Ms. Margaret Mucha Regulatory Affairs Leader 9900 Innovation Drive, RP-2122 Wauwatosa, WI 53226

Rc: K081437

Trade Name: MAC 1600 ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK, and DXH Dated: May 21, 2008 Received: May 22, 2008

Dear Ms. Mucha:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Margaret Mucha

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 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 postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Mcdical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

elmoe

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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510(k) Number (if known):

Device Name:

MAC 1600 ECG Analysis System

Indications for Use:

The MAC1600 is used under the direct supervision of a licensed healthcare practitioner.

Contraindications:

The MAC 1600 is not designed to provide alarms for arrhythmia detection. The device is not suitable for intra cardiac application. It is not intended for use:

As a vital signs physiological monitor; or .
. For use during patient transport.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence o of Device Evaluation (ODE)

elopmdQ

iovascular Devices

510(k) Number K081937

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).