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 Description

The MAC 5500 HD and MAC 3500 ECG Analysis Systems are designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The devices consist of two basic components: the processing unit and the patient acquisition module. The MAC 5500 HD and MAC 3500 can deliver 3, 6, 12, or 15 lead ECG's, including interpretive analysis and 12 or 15 lead ECG's on full-size reports. In addition MAC 5500 HD can deliver vector loops and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The MAC 5500 HD acquires ECG data using the external CAM HD patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced: MAC 3500 has the patient data acquisition module integrated into the main device. The MAC 5500 HD and MAC 3500 incorporate an alphanumeric keyboard for patient demographics and other data entry, a full VGA graphics and waveform display, an integrated thermal writer and 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.

AI/ML Overview

The GE Medical Systems Information Technologies, Inc. K110266 510(k) submission for the MAC 5500 HD and MAC 3500 ECG Analysis Systems does not contain a study that establishes acceptance criteria through performance data specific to these devices.

Instead, the submission relies on the concept of substantial equivalence to a predicate device (K073625 MAC 5500 ECG Analysis System). This means the manufacturer is asserting that the new devices are as safe and effective as a previously cleared device that employed the same fundamental technology.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be directly extracted from this document in the traditional sense of a performance study with defined metrics.

However, I can extract information related to the tests and measures taken to ensure substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit via Substantial Equivalence): The devices are considered to have met acceptance criteria if they are found to be "as safe, as effective, and performance is substantially equivalent to the predicate device." There are no specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) provided in this document as acceptance criteria.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided for the MAC 5500 HD and MAC 3500 in this document. The manufacturer states that the devices employ the "same fundamental technology" as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable. The document explicitly states: "The subject of this premarket submission, MAC 5500 HD and MAC 3500, did not require clinical studies to support substantial equivalence."
Data Provenance: Not applicable, as no clinical studies were performed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not applicable, as no clinical studies were performed, and thus no ground truth for a test set was established using experts.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical studies were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:

No. The document explicitly states that clinical studies were not required.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document describes the devices as "ECG Analysis Systems" that acquire, analyze, display, and record ECG signals, including "interpretive analysis." While this implies an algorithmic component, no standalone algorithm performance study is detailed in this submission. The focus is on the substantial equivalence of the entire integrated device.

7. The Type of Ground Truth Used:

Not applicable, as no clinical studies were performed to establish a new ground truth for these devices. The basis for safety and effectiveness is through comparison to a predicate device.

8. The Sample Size for the Training Set:

Not applicable. As no de novo algorithmic development or performance study for these specific devices is presented, no training set information is provided.

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary of Non-Clinical Tests and Quality Assurance Measures Applied:

While no clinical performance studies were conducted, the submission highlights the following measures to demonstrate safety and effectiveness through non-clinical means and quality assurance:

Compliance with Voluntary Standards: The devices and their applications comply with voluntary standards (detailed in Sections 9, 11, and 17 of the full submission, not provided here).
Quality Assurance Measures Applied to Development:
- Requirement Definition
- Risk Analysis
- Software Safety Classification
- Technical Review
- Formal Design Review
- Code Inspection
- Integration Testing (Module and System verification)
- Final Acceptance Testing
- Performance Testing
- Safety Testing

Summary

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K110266 P1/3

APR 2 9 2011

510(k) Premarket Notification Submission

: :

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.9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Patricia TaigeRegulatory Affairs LeaderGE Medical Systems Information Technologies, Inc.Phone:(414) 721-3222Fax: (414) 721-3863
Secondary Contact Person:	Joe LucasRegulatory Affairs LeaderGE Medical Systems Information Technologies, Inc.Phone:(414) 721-2593Fax: (414) 721-3863
Device:	Trade Name: MAC 5500 HD ECG Analysis-System.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 Computer21 CFR 870.2920 Telephone ElectrocardiographTransmitter and Receiver	DQKDXH
Predicate Device(s):	K073625 MAC 5500 ECG Analysis System
Device Description:	The MAC 5500 HD and MAC 3500 ECG Analysis Systems aredesigned to acquire, analyze, display, and record ECG signals fromsurface ECG electrodes. The devices consist of two basiccomponents: the processing unit and the patient acquisition module.The MAC 5500 HD and MAC 3500 can deliver 3, 6, 12, or 15 leadECG's, including interpretive analysis and 12 or 15 lead ECG's on full-size reports. In addition MAC 5500 HD can deliver vector loops andcan be upgraded to provide software analysis options such as highresolution signal averaging of QRS and P wave portions of theelectrocardiogram.The MAC 5500 HD acquires ECG data using the external CAM HDpatient data acquisition module. By placing the data acquisitiondevice closer to the patient, signal fidelity is improved and noise isreduced: MAC 3500 has the patient data acquisition moduleintegrated into the main device.The MAC 5500 HD and MAC 3500 incorporate an alphanumerickeyboard for patient demographics and other data entry, a full VGAgraphics 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

Image /page/1/Picture/1 description: I am sorry, but there is no discernible information in the image to provide a description.

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:

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

ﺗﻮ

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K110266 P3/3

GE Healthcare

ి

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

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 (800) 638-2041 or (301) 796-7100 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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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circle. There are decorative swirls or flourishes around the letters, adding to the logo's distinctive appearance. The logo is black and white.

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

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).