MAC 800 Resting ECG Analysis System by GE MEDICAL SYSTEMS CHINA CO., LTD.

The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics and physician offices outreach centers to record ECG signals from surface electrodes.

The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.

The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode.

The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. 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 800 is provided to the customer for the convenience of automatic documentation.

Device Description

The MAC 800 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. The MAC 800 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. 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 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, 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 can print the resting ECG report via the external laser printer including USB laser printer and network laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to SD card/shared directory/FTP server as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 can be used as a portable unit.

AI/ML Overview

This document is a 510(k) premarket notification for the GE MAC 800 Resting ECG Analysis System (MAC 800V2). It largely focuses on demonstrating substantial equivalence to a predicate device (MAC 800V1) and other GE algorithms (MUSE and 12SL ECG Analysis Program), rather than presenting a standalone study with detailed acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, and ground truth establishment are not directly available in the provided text.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Device Performance (Not fully detailed as it's a substantial equivalence submission)

The document asserts "The design changes made have no effect on the device's ability to acquire and analyze ECG data" and that the MAC 800V2 is "as safe, as effective, and performance is substantially equivalent to the predicate devices." This implies that the acceptance criteria are met if the new device's performance is deemed equivalent to the previously cleared predicate.

Explicit Acceptance Criteria: Not stated for specific performance metrics in this document. The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device.

Reported Device Performance: Not quantified in this document. The document states that the proposed MAC 800V2 uses the "identical 12SL ECG algorithm (K060833)" and has "identical Resting ECG mode and Arrhythmia mode as the predicate MAC 800V1 (K090212)". This implies that the performance is expected to be the same as the predicate and the 12SL algorithm.

Acceptance Criteria	Reported Device Performance
Not explicitly stated for quantifiable device performance metrics in this 510(k) submission. Instead, the primary "acceptance criterion" is the demonstration of substantial equivalence to the predicate device and the use of identical, previously cleared algorithms and functionalities.	The MAC 800V2 employs the "identical 12SL ECG algorithm (K060833)" and provides "identical Resting ECG mode and Arrhythmia mode as the predicate MAC 800V1 (K090212)." Therefore, its performance is expected to be consistent with these previously cleared components.

Study Details (Based on available information)

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in this document, as a new clinical study to evaluate the device's performance against specific acceptance criteria was not required for this submission. The submission relies on substantial equivalence to previously cleared devices and algorithms.
- Data Provenance: Not specified. The document indicates that the 12SL ECG algorithm (K060833) is used, and the predicate device is MAC 800V1 (K090212). The performance of these previously cleared components would have been established in their respective submissions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified or applicable in this 510(k) submission, as it did not require new clinical studies. The ground truth for the 12SL ECG algorithm (K060833) would have been established during its original clearance process.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified or applicable, as no new clinical study was conducted for this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done for this specific submission. The document explicitly states: "The subject of this premarket submission, the proposed MAC 800V2 did not require clinical studies to support substantial equivalence." The device is an ECG analysis system, which may or may not involve AI in the way a modern "AI assistance" study would assess. The 12SL algorithm performs "interpretive analysis," which could be considered an automated interpretation, but the document does not focus on human reader improvement with or without this analysis in this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not explicitly described as a new standalone performance study for the MAC 800V2.
- However, the document states the device "uses identical 12SL ECG algorithm (K060833)." The 12SL algorithm itself is a standalone interpretive algorithm. Performance data for that algorithm would have been part of its original 510(k) submission (K060833). This current submission implicitly leverages the established standalone performance of the 12SL algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified for this submission. For ECG interpretation algorithms like 12SL, ground truth is typically established by expert consensus of cardiologists on ECG recordings, sometimes correlated with clinical outcomes or other diagnostic tests, as would have been done in the K060833 submission.
The sample size for the training set:
- Not specified in this document. This submission focuses on a new version of hardware/software based on existing algorithms. The training set for the underlying 12SL ECG algorithm (K060833) would have been described in its original submission.
How the ground truth for the training set was established:
- Not specified in this document. Similar to the test set, the ground truth for the training of the 12SL algorithm (K060833) would have been established through a rigorous process, likely involving expert cardiologists' interpretations and adjudication, as is standard for ECG algorithms.

Summary

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

December 3, 2014

GE Medical Systems China Co., Ltd. Kristin Pabst Regulatory Affairs Manager 9900 West Innovation Dr. Wauwatosa, Wisconsin 53226

Re: K142288

Trade/Device Name: MAC 800 Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: October 31, 2014 Received: November 3, 2014

Dear Kristin Pabst,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

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

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510(k) Number (if known):

Device Name: MAC 800 Resting ECG Analysis System

Indications for Use:

The MAC 800 is a portable ECG acquisition, analysis and recording system.

The MAC 800 is intended to be used under the direct supervision of a licensed healthcare practitioner.

The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.

The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode.

The arrhythmia detection portion of the MAC 800 is provided to the customer for the convenience of automatic documentation.

Contraindication:

The MAC 800 is not intended for use as a vital signs physiological monitor.

The MAC 800 is not intended for use during patient transport.

The MAC 800 is not suitable for intra cardiac application.

The MAC 800 is not designed to provide alarms for arrhythmia detection.

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)

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510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	August 13, 2014
Submitted:	Sun YanLiRegulatory Affairs ManagerGE MEDICAL SYSTEMS CHINA CO., LTD.No. 19 Changjiang Road National Hi-Tech Dev. ZoneWuxi, Jiangsu, China 214028
Primary Contact Person:	Kristin PabstRegulatory Affairs ManagerGE Medical Systems Information Technologies, Inc.Phone: (414) 721-3104Fax: (414) 721-3863E-mail: Kristin.Pabst@ge.com
Secondary Contact Person:	Douglas KentzRegulatory Affairs DirectorGE Medical Systems Information Technologies, Inc.Phone: 414 362-2038Fax: 414-262-2585E-mail: Douglas.kentz@ge.com
Device: Trade Name:	MAC 800 Resting ECG Analysis System
Common/Usual Name:	Electrocardiograph
Classification Names:	Electrocardiograph (21 CFR 870.2340 )
Product Code:	DPS
Predicate Device(s):	MAC 800 Resting ECG Analysis System, K090212MUSE Cardiology Information System K11013212SL ECG Analysis Program K060833
Device Description:	The MAC 800 ECG acquisition, analysis and recording systemcan print and display multiple leads of ECG data. The MAC 800will provide, in resting ECG mode, ECG quality informationusing the hookup advisor. The hookup advisor advises users ofpoor lead quality based on noise measurement It can be upgraded

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to provide options such as ECG measurement and interpretation with 12SL. 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.

Intended Use: The MAC 800 is a portable ECG acquisition, analysis and recording system.

The MAC 800 is intended to be used under the direct supervision of a licensed healthcare practitioner.

The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.

The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode.

The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. 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 800 is provided to

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the customer for the convenience of automatic documentation.

Contraindication:

The MAC 800 is not intended for use as a vital signs physiological monitor.

The MAC 800 is not intended for use during patient transport. The MAC 800 is not suitable for intra cardiac application. The MAC 800 is not designed to provide alarms for arrhythmia detection.

Technology: The proposed MAC 800V2 Resting ECG Analysis System is a system based on the predicate MAC 800V1 (K090212) with improvements to the user experience.

The proposed MAC 800V2 Resting ECG Analysis System uses the same modes of operation including Resting ECG mode and Arrhythmia mode to do different ECG examinations, and uses 12SL ECG algorithm (K060833) to do ECG analysis. The major workflow and User Interface does not change. The proposed MAC 800V2 Resting ECG Analysis System provides identical Resting ECG mode and Arrhythmia mode as the predicate MAC 800V1 (K090212), and uses identical 12SL ECG algorithm (K060833).

The proposed MAC 800V2 Resting ECG Analysis System employs the same fundamental scientific technology as the predicate MAC 800V1 (K090212).

The MAC 800V2 is nearly identical to the MAC 800V1 system, with the addition of the updates and features described in this submission.

The proposed MAC 800V2 Resting ECG Analysis System is as safe and effective as the predicate devices.

The following table includes comparison of the main features of the device, and includes the features that are different from the predicate. Additional comparison information can be found in Comparison Matrix in Section 12.1.

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Feature/Function	Proposed DeviceMAC 800 V2	Predicate DeviceMAC 800V1
Intended Use	MAC 800V2 intended use isthe same as predicate MAC800V1 with the exception ofaddition of expandeddescription to further clarifythe medical professional'sfacility environment toinclude clinics, physicianoffices outreach centers.The main features of thedevice including (but notlimited to) mechanicaldesign, OS, ECG systemperformance, signalacquisition and input, ECGmeasurement parameters,arrhythmia features andoptional software features areidentical with predicate MAC800V1..	MAC 800V1 intended use isthe same as proposed MAC800V2 with the exception ofMAC 800V2 expandeddescription to further clarify themedical professional's facilityenvironment to include clinics,physician offices outreachcenters.The main features of thedevice including (but notlimited to) mechanical design,OS, ECG system performance,signal acquisition and input,ECG measurement parameters,arrhythmia features andoptional software features areidentical with proposed MAC800V2..
USB Port	2 USB portsSupports English:Keyboard, barcode andmagnetic card reader, laserprinterSupports French German,Italian and Spanish keyboardsas well as USB WIFI card.	2 USB PortsSupports English:Keyboard, barcode andmagnetic card reader, laserprinterNot available
Supplies andAccessories	Supplies and accessoriessame as predicate except:Added a compact trolleyAdded USB WIFI card	Supplies and accessories sameas proposed except:Compact trolley not availableUSB WIFI card not available
	2 ECG electrodes and clipsremoved due to end of life
LCD panel	LED backlight to eliminateHg for RoHS compliance	CCFL backlight
Anti-drift system	ADS arrhythmia modeADS Rest mode	ADS Arrhythmia mode
DataTransmissionroutes	Wireless Lan datatransmission	Wireless Lan data transmissionnot available
	32 GB SD card.	2GB SD card
CommunicationProtocol	Same communicationprotocols as predicate except:	Same communication protocolsas proposed except:
	Added GE designed DCPprotocol to transfer ECG data.	GE designed DCP protocol totransfer ECG data not available
ExaminationOrder	Adds support fordownloading and managing	No support for downloadingand managing examination
	examination orders from theMUSE system	orders from MUSE system
Data Export	Adds support to export andauto-export data to a FTPserver	No support for export and auto-export data to FTPserver
	32 GB SD card	2GB SD card
Shared directorypassword/PDFfile naming/File	Supports alphanumericpassword for shared directory	Supports numeric password forshared directory
Management	Auto-naming and userconfigurable naming of PDFfiles	Auto-naming of PDF files
	Adds Preview to existing filemanagement functionality forenhanced data security anduser convenience.	Preview not available
Technique ofPrintout	USB laser printerNetwork laser printer	USB laser printer
	Printer minimum memorycapacity 8MB	Printer minimum memorycapacity 2MB
Report formats	Same report formats as	Same report formats as
for Laser Printer	predicate except:	proposed except:
	Adds 2 new ECG reportlayouts	2 new ECG report layouts notavailable
	Adds a waveform distanceauto-adjust for 12 leadprintouts to avoid waveformoverlap.	Waveform distance auto-adjustfor 12 lead printouts notavailable
Service Tool	Ability to test network	Ability to test network
	connection	connection
	Ping IP test has been addedfor service purpose only	Ping IP test not available
Clinical Trials	5 pharma setting groups peruser request	1 pharma setting group per userrequest
	Pop up message to notify"user ID already exists" whencreating a non-unique user IDfor clinical trial.	"User ID already exists" pop upmessage not supported
Enhanced Userexperience	Ability to enable/disableautomatic addition of leading"o" digits to patient ID entry	Not available
	Added printing of setupconfiguration file name inaddition to saving and setup	Printing of setup configurationfile name not supported.
	information content in a	Saving and set up information
	configuration file,	content in a configuration file
	Ability to configure tosynchronized clock when it hasnetwork connection to a timeserver.	Not available

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Determination of

Summary of Non-Clinical Tests:

Substantial Equivalence:

The following quality assurance measures were applied to the development of the system:

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Risk Analysis �
Requirements Reviews �
Design Reviews �
Testing on unit level (Module verification) �
Integration testing (System verification) �
Final acceptance testing (Validation) �
Performance testing (Verification) �
Safety testing (Verification) �

The MAC 800V2 has been thoroughly tested through verification of specifications and validation, including software validation. Verification of compliance with applicable voluntary standards has also been made to support safe use of the device in its intended environment.

The proposed MAC 800V2 and its applications were designed and tested for compliance to the following standards:

IEC 60601-1: 2005 + C1: 2006 + C2: 2007 Medical electrical equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-2-25: 2011- Medical electrical equipment, Part 2-25: Particular Requirements for the Basic Safety and Essential Performance of Electrocardiographs.
IEC 60601-1-2: 2007-Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
IEC 62304:2006, Medical devices - Medical device software -Software life cycle processes
IEC 62366: 2007-Medical devices-Application of usability engineering to medical device
ANSI/AAMI EC11: 1991/ (R2007)-Diagnostic Electrocardiographic Devices

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Summary of Clinical Tests:

The subject of this premarket submission, the proposed MAC 800V2 did not require clinical studies to support substantial equivalence.

Conclusion:

The design changes made have no effect on the device's ability to acquire and analyze ECG data. GE Medical Systems Information Technologies, Inc. considers the proposed MAC 800V2 to be as safe, as effective, and performance is substantially equivalent to the predicate devices.

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).