MAC 600 RESTING ECG ANALYSIS SYSTEM

K103765 · Ge Medical Systems Information Technologies, Inc. · DPS · May 17, 2011 · Cardiovascular

Device Facts

• Record ID: K103765
• Device Name: MAC 600 RESTING ECG ANALYSIS SYSTEM
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: May 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MAC 600 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. Basic systems deliver 3 or 12 lead ECGs, and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram. Transmission of ECG data to a central ECG cardiovascular information system is optional. The MAC 600 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices, outreach centers or wherever ECG testing is performed to record ECG signals from surface electrodes.

Device Story

MAC 600 is a portable resting ECG analysis system; acquires, analyzes, displays, and records ECG signals via surface electrodes. Features integrated 4.3" color display, thermal writer for real-time waveforms/reports, and numeric keypad. Operates on rechargeable lithium-ion battery. Used by trained operators in hospitals, clinics, and physician offices. Provides "hookup advisor" for lead quality assessment; optional software upgrade enables 12-lead interpretive analysis and measurement using Marquette 12SL program. Data stored on removable SD memory; exportable as XML or PDF. Optional transmission to central cardiovascular information systems. Benefits include portable diagnostic capability for cardiac assessment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including risk analysis, module verification, system integration, performance verification, safety testing, and simulated use validation.

Technological Characteristics

Portable ECG system; rechargeable lithium-ion battery; 4.3" color display; integrated thermal writer; SD card storage. Connectivity includes optional transmission to central information systems. Software includes optional Marquette 12SL interpretive analysis. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for adult and pediatric patients requiring ECG acquisition, analysis, and recording. Contraindicated for use as a vital signs monitor, during patient transport, for intra-cardiac application, or with high-frequency surgical units.

Regulatory Classification

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.

Predicate Devices

• MAC 5500 RESTING ECG ANALYSIS SYSTEM (K073625)

Reference Devices

• Marquette 12SL ECG Analysis program (K060833)

Submission Summary (Full Text)

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MAY 1 7 2011

GE Healthcare

2011 - - - - GE Healthcare - GE Healthcare
510(k) Premarket Notification Submission

## 510(k) Summary

| | | In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------|
| <b>Date:</b><br><b>Submitter:</b> | December 10, 2010<br>GE Healthcare (GE Medical Systems Information Technologies, Inc.)<br>9900 Innovation Drive<br>Wauwatosa, WI 53226<br>Joe Lucas | | |
| <b>Primary Contact Person:</b><br><b>Secondary Contact<br/>Person:</b> | Regulatory Affairs - Diagnostic Cardiology<br>9900 Innovation Drive<br>Wauwatosa, WI 53226<br>T: [phone]<br>F: [phone]<br>Kristin Pabst<br>Regulatory Affairs - Diagnostic Cardiology<br>9900 Innovation Drive<br>Wauwatosa, WI 53226<br>T: [phone]<br>F: [phone] | | |
| <b>Device:</b> | <b>Trade Name:</b> MAC 600 Resting ECG Analysis System | | |
| <b>Common/Usual<br/>Name:</b> | MAC 600 | | |
| <b>Classification Names:</b> | <b>21 CFR</b> | <b>Classification Name</b> | <b>Code</b> |
| <b>Product Code:</b> | 870.2340 | Electrocardiograph | DPS |
| | 870.1425 | Programmable Diagnostic Computer | DQK |
| | 870.2920 | Transmitters and Receivers,<br>Electrocardiographs, Telephone | DXH |
| <b>Predicate Device(s):</b> | K073625 MAC 5500 RESTING ECG ANALYSIS SYSTEM | | |
| <b>Device Description:</b> | The MAC 600 Resting ECG Analysis System is intended to perform<br>ECG acquisition, analysis and recording. It can display 3, 6 or 12<br>leads of ECG data and can print the ECG data 3 leads at a time. The<br>MAC 600 will provide, in resting ECG mode, ECG quality<br>information using the hookup advisor that advises users of poor lead<br>quality based on noise measurement. The MAC 600 can be upgraded<br>to provide software analysis options such as 12-lead interpretive<br>analysis and 12-lead resting ECG measurement and interpretation<br>utilizing the Marquette 12SL ECG Analysis program (K060833).<br>Transmission of ECG data to a central ECG cardiovascular<br>information system is also optional. | | |
| | The MAC 600 delivers multiple leads of ECG on reports and includes<br>a numeric keypad, and function keys for entering patient ID and other<br>data entry. There is an integrated 4.3" color display, and an integrated<br>thermal writer. The thermal writer will print real time continuous<br>waveform, alphanumeric data and non-real time reports. The device | | |

Image /page/0/Picture/6 description: The image shows a logo of General Electric (GE). The logo is a circular shape with the letters "GE" intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The logo is black and white.

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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 within a circle. The letters and the circle are in black, while the background is white.

GE Healthcare 510(k) Premarket Notification Submission

has removable memory storage to store resting ECG records. The device also can export the resting ECG record to an XML or PDF file on an SD card. The MAC 600 can be run off of a rechargeable lithium-ion battery to allow it to be used as a portable unit.

The MAC 600 Resting ECG Analysis System is intended to acquire, Intended Use: analyze, display, and record electrocardiographic information for adult and pediatric populations. Basic systems deliver 3 or 12 lead ECGs, and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram. Transmission of ECG data to a central ECG cardiovascular information system is optional.

> The MAC 600 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices, outreach centers or wherever ECG testing is performed to record ECG signals from surface electrodes.

Contra-indications

- 1. MAC 600 is not intended for use as a vital signs physiological monitor.
- 2. MAC 600 is not intended for use during patient transport.
- 3. MAC 600 is not intended for intra cardiac application.
- 4. MAC 600 is not intended for use with high frequency surgical units.

The MAC 600 Resting ECG Analysis System employs the same Technology: functional scientific technology as its predicate devices.

## Determination of Summary of Non-Clinical Tests:

Substantial Equivalence:

The MAC 600 Resting ECG Analysis System and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- Risk Analysis
- . Requirements Reviews
- . Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- Performance testing (Verification) .
- Safety testing (Verification) .
- Simulated use testing (Validation) .

Summary of Clinical Tests:

The subject of this premarket submission, MAC 600 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence.

- GE Healthcare considers the MAC 600 Resting ECG Analysis System Conclusion: to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

GE Medical Systems Information Technologies, Inc c/o Mr. Joe Regulatory Affairs 9900 Innovation Drive Wauwatosa, WI 53226

MAY 1 7 2011

Re: K103765

Trade/Device Name: MAC 600 Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: December 20, 2011 Received: February 18, 2011

## 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 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.

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Page 2 - Mr. Joseph Lucas

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Singerely gours,

Sincerely yours,

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/4/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 letters and the circle are black, creating a strong contrast against the white background. The logo is a well-known symbol representing the multinational conglomerate.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): K103765

MAC 600 Device Name:

## Indications for Use:

The MAC 600 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediations. Basic systems deliver 3 or 12 lead ECGs, and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram.

Transmission of ECG data to a central ECG cardiovascular information system is optional. The MAC 600 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics, physician offices, outreach centers or wherever ECG testing is performed to record ECG signals from surface electrodes.

Contra-indications

- 1. MAC 600 is not intended for use as a vital signs physiological monitor.
- 2. MAC 600 is not intended for use during patient transport.
- 3. MAC 600 is not intended for intra cardiac application.
- 4. MAC 600 is not intended for use with high frequency surgical units.

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sidn-C