MAC 5500 HD, MAC 3500

K110266 · Ge Medical Systems Information Technologies, Inc. · DPS · Apr 29, 2011 · Cardiovascular

Device Facts

• Record ID: K110266
• Device Name: MAC 5500 HD, MAC 3500
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

MAC 5500 HD: The MAC 5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops; and can be upgraded to provide software analysis options such as high resolutions signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility. MAC 3500: The MAC 3500 ECG Analysis System is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Basic systems deliver 3.6. 12, or 15 lead ECG's, including interpretive andlysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Device Story

MAC 5500 HD and MAC 3500 are mobile electrocardiograph systems; acquire, analyze, display, and record ECG signals from surface electrodes. MAC 5500 HD uses external CAM HD acquisition module for improved signal fidelity; MAC 3500 has integrated acquisition module. Systems provide 3, 6, 12, or 15 lead ECGs; interpretive analysis; vector loops (MAC 5500 HD); and high-resolution signal averaging (optional). Devices feature alphanumeric keyboard, VGA display, thermal writer, and removable storage. Operated by trained personnel in clinical settings; optional connectivity to central cardiovascular information systems. Output assists clinicians in cardiac assessment and diagnosis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrocardiograph; mains or rechargeable battery powered. Components: processing unit, patient acquisition module (CAM HD for 5500 HD, integrated for 3500). Connectivity: optional transmission/reception to central information systems. Form factor: mobile (trolley) or desktop. Software analysis: interpretive analysis, vector loops, high-resolution signal averaging.

Indications for Use

Indicated for adult and pediatric patients requiring acquisition, analysis, display, and recording of electrocardiographic information. Used in hospital or medical professional facilities under supervision of a licensed healthcare practitioner.

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 ECG Analysis System (K073625)

Submission Summary (Full Text)

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K110266 P1/3

APR 2 9 2011

510(k) Premarket Notification Submission

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## 510(k) Summary

| In accordance with 21 CFR 807.92 the following summary of information is provided: | | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Date: | 24-January-2011 | |
| Submitter: | GE Medical Systems Information Technologies, Inc.<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 | |
| Primary Contact Person: | Patricia Taige<br>Regulatory Affairs Leader<br>GE Medical Systems Information Technologies, Inc.<br>Phone:[phone]<br>Fax: [phone] | |
| Secondary Contact Person: | Joe Lucas<br>Regulatory Affairs Leader<br>GE Medical Systems Information Technologies, Inc.<br>Phone:[phone]<br>Fax: [phone] | |
| Device: | Trade Name: MAC 5500 HD ECG Analysis-System.<br>MAC 3500 ECG Analysis System | |
| Common/Usual Name: | Electrocardiograph | |
| Classification Names: | 21 CFR 870.2340 Electrocardiograph | DPS |
| Product Code: | 21 CFR 870.1425 Programmable Diagnostic Computer<br>21 CFR 870.2920 Telephone Electrocardiograph<br>Transmitter and Receiver | DQK<br>DXH |
| Predicate Device(s): | K073625 MAC 5500 ECG Analysis System | |
| Device Description: | The MAC 5500 HD and MAC 3500 ECG Analysis Systems are<br>designed to acquire, analyze, display, and record ECG signals from<br>surface ECG electrodes. The devices consist of two basic<br>components: the processing unit and the patient acquisition module.<br>The MAC 5500 HD and MAC 3500 can deliver 3, 6, 12, or 15 lead<br>ECG's, including interpretive analysis and 12 or 15 lead ECG's on full-<br>size reports. In addition MAC 5500 HD can deliver vector loops and<br>can be upgraded to provide software analysis options such as high<br>resolution signal averaging of QRS and P wave portions of the<br>electrocardiogram.<br>The MAC 5500 HD acquires ECG data using the external CAM HD<br>patient data acquisition module. By placing the data acquisition<br>device closer to the patient, signal fidelity is improved and noise is<br>reduced: MAC 3500 has the patient data acquisition module<br>integrated into the main device.<br>The MAC 5500 HD and MAC 3500 incorporate an alphanumeric<br>keyboard for patient demographics and other data entry, a full VGA<br>graphics and waveform display, an integrated thermal writer and | |

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and appear to be handwritten. The logo is black and white.

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KI10266 PZ

GE Healthcare

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### 510(k) Premarket Notification Submission

removable data storage.

Models provide mains or, for customer convenience, rechargeable battery operation as well as optional transmission and reception of ECG data to and from a central ECG cardiovascular information system via communication links.

MAC 5500 HD and MAC 3500 are intended as mobile devices by offering an optional trolley for transporting the equipment but the main units can be separated from the trolley and used as desktop units.

Intended Use:

MAC 5500 HD: The MAC 5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops; and can be upgraded to provide software analysis options such as high resolutions signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained. operators in a hospital or medical professional's facility.

MAC 3500: The MAC 3500 ECG Analysis System is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Basic systems deliver 3.6. 12, or 15 lead ECG's, including interpretive andlysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The MAC 5500 HD and MAC 3500 employ.the same fundamental. Technology: scientific technology as their predicate device MAC 5500 ECG Analysis System (K073625).

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The MAC 5500 HD and MAC 3500 and their 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 systems:

- Requirement Definition
- Risk Analysis .
- . Software Safety Classification
- Technical Review ●
- Formal Design Review ●
- Code Inspection

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K110266 P3/3

# GE Healthcare

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#### 510(k) Premarket Notification Submission

- Integration Testing (Module and System verification) .
- Final Acceptance Testing .
- Performance Testing .
- Safety testing .

#### Summary of Clinical Tests:

The subject of this premarket submission, MAC 5500 HD and MAC 3500, did not require clinical studies to support substantial equivalence.

GE Medical Systems Information Technologies, Inc. considers the Conclusion: MAC 5500 HD / MAC 3500 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

Image /page/2/Picture/10 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, creating a recognizable and iconic symbol.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

APR 2 9 2011

GE Medical Systems Information Technologies, Inc. c/o Ms. Patricia Taige Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, WI 53226

Re: K110266

Trade/Device Name: MAC 5500 HD and MAC 3500 ECG Analysis Systems Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Codes: DPS, DQK, DXH Dated: January 24, 2011 Received: February 1, 2011

Dear Ms. Taige:

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 rou may, ateresters, mains 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 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 - Ms. Patricia Taige

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 of any : each 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 form in the quality of events (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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

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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## GE Healthcare 510(k). Premarket. Notification. Submission.

510(k) Number (if known): K110266

Device Name: MAC 5500 HD

Indications for Use:

The MAC 5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediations. Basic systems deliver 3,6, 12, or 15 lead ECG's, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolutions signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The MAC 5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.

Risten Sign-Off sion of Cardiovascular Devices

510(k) Number_k110266

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Image /page/6/Picture/0 description: The image shows the logo for GE Healthcare. The text is in a simple, sans-serif font. The words "GE Healthcare" are on the first line. The image is a document that is likely a premarket notification submission.

510(k) Premarket Notification Submission

510(k) Number (if known): K I (0766

Device Name: MAC 3500

Indications for Use:

The MAC 3500 ECG Analysis System is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, including interpretive analysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The MAC 3500 is intended to be used under the direct supervision of a licensed healthcare proctitioner, by trained operators in a hospital or medical professional's facility.

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).

K110266
(Division Sign-Off)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K1102616