MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System

K221321 · Ge Medical Systems Information Technologies, Inc. · DPS · Oct 18, 2022 · Cardiovascular

Device Facts

• Record ID: K221321
• Device Name: MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MAC 5 Resting ECG Analysis System is a non-invasive prescription device. · The device is indicated for use to acquire, analyze, display and print electrocardiograms. · The device is indicated for use to provide interpretation of the data for consideration by a physician. · The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. · The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data. · The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

Device Story

Mobile electrocardiograph system; acquires, analyzes, displays, and prints 3, 6, or 12-lead ECG signals from surface electrodes. Used in clinical settings (hospitals, medical facilities) by physicians or trained personnel. Device features integrated acquisition module and digital processing. Connects via wired LAN or WiFi to cardiology information systems (e.g., GEHC MUSE) for workflow integration. Provides interpretive analysis via 12SL algorithm. Output includes ECG waveforms and interpretive reports for physician review to aid clinical decision-making. Benefits include standardized ECG interpretation and efficient data management. Optional trolley for mobility; some models (Lite) lack integrated printers, supporting network printing instead.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including risk analysis, design reviews, software lifecycle validation, unit-level testing, system integration, and safety/performance verification against voluntary standards (ANSI/AAMI ES60601-1).

Technological Characteristics

Mobile ECG system; 8.9-10 inch LCD display; thermal dot array recorder (optional); wired/WiFi connectivity. Complies with ANSI/AAMI ES60601-1. Frequency response 0.04-300Hz. Software-based 12SL analysis algorithm (v24).

Indications for Use

Indicated for adult and pediatric (birth through 21 years of age) patients requiring non-invasive ECG acquisition, analysis, display, and printing in clinical settings. Not for use as a sole means of diagnosis; requires physician overread.

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 7 Resting ECG Analysis System (K203786)

Reference Devices

• ELI 380 12 lead Resting ECG (K142105)
• MAC VU 360 (K173830)

Submission Summary (Full Text)

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October 18, 2022

GE Medical Systems Information Technologies, Inc. Honghong Yang Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, Wisconsin 53226

## Re: K221321

Trade/Device Name: MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, DQK, DXH Dated: September 16, 2022 Received: September 20, 2022

Dear Honghong Yang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K221321

Device Name

MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System

Indications for Use (Describe)

The MAC 5 Resting ECG Analysis System is a non-invasive prescription device.

· The device is indicated for use to acquire, analyze, display and print electrocardiograms.

· The device is indicated for use to provide interpretation of the data for consideration by a physician.

· The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.

· The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.

· The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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GE Healthcare 510(k) Premarket Notification Submission

# 510(k) Summary

#### I. SUBMITTER

GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226

## Primary Contact Person:

Honghong Yang Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Telephone: [phone] Fax: [phone] E-mail: [e-mail]

Secondary Contact Person: Michael F. Petrini Executive, Regulatory Affairs - Life Care Solutions GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, Wisconsin 53226 Phone: [phone] Fax: [phone] E-mail: [e-mail]

## Date 510(k) Summary was Prepared: April 29, 2022

#### II. DEVICE

| Device Trade Name: | MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name: | Electrocardiograph |
| Classification Names | 21 CFR 870.2340 – Electrocardiograph<br>21 CFR 870.1425 – Programmable Diagnostic Computer<br>21 CFR 870.2920 – Telephone Electrocardiograph Transmitter and Receiver |
| Regulatory Class: | II |
| Product Code: | DPS, DQK and DXH |

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GE Healthcare 510(k) Premarket Notification Submission

| Predicate Device(s): | MAC 7 Resting ECG Analysis System (K203786) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Device: | ELI 380 12 lead Resting ECG (K142105) |
| Device Description: | The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG<br>Analysis System is a mobile electrocardiograph designed to<br>acquire, analyze, display, and record ECG signals from surface<br>ECG electrodes. |
| | The device can capture 3, 6, or 12 lead electrocardiograms,<br>provide interpretive analysis, and print reports. |
| | The device can connect to a network, either through a wired<br>LAN connection or via wireless WiFi access points. Once on<br>the network, the device can optionally interface with<br>cardiology information systems such as the GEHC MUSE®<br>system to participate in a complete electrocardiology<br>workflow. |
| | The device provides state-of-the-art information technology<br>security features and a contemporary user interface. Mobility is<br>provided via an optional trolley. |
| Indications for Use: | The MAC 5 Resting ECG Analysis System is a non-invasive<br>prescription device. |
| | • The device is indicated for use to acquire, analyze, display<br>and print electrocardiograms.<br>• The device is indicated for use to provide interpretation of the<br>data for consideration by a physician.<br>• The device is indicated for use in a clinical setting, by a<br>physician or by trained personnel who are acting on the orders<br>of a licensed physician. It is not intended as a sole means of<br>diagnosis.<br>• The interpretations of ECG offered by the device are only<br>significant when used in conjunction with a physician overread<br>as well as consideration of all other relevant patient data.<br>• The device is indicated for use on adult and pediatric (birth<br>through 21 years of age) populations |

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Technology: The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite employs the same fundamental scientific technology, basic design, construction, materials, energy source, control mechanism, and operating principles as the predicate device MAC 7 in acquiring, analyzing, recording, displaying and printing ECG data for both adult and pediatric populations. The basic system prints 3, 6 or 12 leads of ECG and provides optional transmission and reception of ECG data to and from a central ECG cardiovascular information system. The system can be upgraded with software options, such as communication options which is similar to the predicate device. The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System is similar to the MAC 7 Resting ECG Analysis System, K203786, in the technology of downloading

> cardiovascular information system (e.g. MUSE) as well as supporting ECG reports in PDF. Both are able to use WiFi communication.

orders and patient demographics from a central ECG

## Determination of Substantial Equivalence:

The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is substantially equivalent to the predicate MAC 7 Resting ECG Analysis System (K203786) and the reference device ELI 380 - 12 Lead Resting ECG(K142105) as described in the following table:

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| Specification | Predicate Product:<br>MAC 7 Resting ECG Analysis<br>System (K203786) | Proposed Product:<br>MAC 5 A4/ MAC 5 A5/ MAC 5<br>Lite Resting ECG Analysis System | Discussion of Differences |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | The MAC 7 Resting ECG<br>Analysis System is intended to<br>acquire, analyze, display, and<br>record electrocardiographic<br>information from adult or<br>pediatric populations. Basic<br>system delivers 3, 6, or 12 lead<br>ECG's and interpretive analysis.<br>Transmission and reception of<br>ECG data and other clinical data<br>to and from a central clinical<br>information system is optional.<br><br>The MAC 7 ECG Analysis<br>System is intended to be used<br>under the direct supervision of a<br>licensed healthcare practitioner,<br>by trained operators in a<br>hospital, medical professional's<br>facility or wherever ECG testing<br>is performed. | The MAC 5 Resting ECG<br>Analysis System is intended to<br>acquire, analyze, display, and<br>record electrocardiographic<br>information from adult or<br>pediatric populations. Basic<br>system delivers 3, 6, or 12 lead<br>ECG's and interpretive analysis.<br>Transmission and reception of<br>ECG data and other clinical data<br>to and from a central clinical<br>information system is optional.<br><br>The MAC 5 ECG Analysis<br>System is intended to be used<br>under the direct supervision of a<br>licensed healthcare practitioner,<br>by trained operators in a hospital,<br>medical professional's facility or<br>wherever ECG testing is<br>performed. | Identical |
| Indications<br>for Use | The MAC 7 Resting ECG<br>Analysis System is a non-<br>invasive prescription device.<br>• The device is indicated for use<br>to acquire, analyze, display and<br>print electrocardiograms.<br>• The device is indicated for use<br>to provide interpretation of the<br>data for consideration by a<br>physician.<br>• The device is indicated for use<br>in a clinical setting, by a<br>physician or by trained<br>personnel who are acting on the<br>orders of a licensed physician. It<br>is not intended as a sole means<br>of diagnosis.<br>• The interpretations of ECG<br>offered by the device are only<br>significant when used in<br>conjunction with a physician<br>over-read as well as<br>consideration of all other<br>relevant patient data.<br>• The device is indicated for use<br>on adult and pediatric (birth<br>through 21 years of age)<br>populations. | The MAC 5 Resting ECG<br>Analysis System is a non-invasive<br>prescription device.<br>• The device is indicated for use<br>to acquire, analyze, display and<br>print<br>electrocardiograms.<br>• The device is indicated for use<br>to provide interpretation of the<br>data for consideration by a<br>physician.<br>• The device is indicated for use<br>in a clinical setting, by a<br>physician or by trained personnel<br>who are acting on the orders of a<br>licensed physician. It is not<br>intended as a sole means of<br>diagnosis.<br>• The interpretations of ECG<br>offered by the device are only<br>significant when used in<br>conjunction with a physician<br>over-read as well as consideration<br>of all other relevant patient data.<br>• The device is indicated for use<br>on adult and pediatric (birth<br>through 21 years of age)<br>populations. | Identical |
| Specification | Predicate Product:<br>MAC 7 Resting ECG Analysis<br>System (K203786) | Proposed Product:<br>MAC 5 A4/ MAC 5 A5/ MAC 5<br>Lite Resting ECG Analysis System | Discussion of Differences |
| Contraindications | This MAC 7 Resting ECG<br>Analysis System is not intended<br>in the following manner:<br>• During patient transport<br>• With high-frequency surgical<br>units<br>• As an intra-cardiac application<br>• As a sole means of diagnosis<br>• As a vital signs physiological<br>monitor | This MAC 5 Resting ECG<br>Analysis System is not intended<br>in the following manner:<br>• During patient transport<br>• With high-frequency surgical<br>units<br>• As an intra-cardiac application<br>• As a sole means of diagnosis<br>• As a vital signs physiological<br>monitor | Identical |
| Patient<br>Population | Adult and pediatric (birth<br>through 21 years of age)<br>populations | Adult and pediatric (birth through<br>21 years of age) populations | Identical |
| Environment<br>of Use | Intended to be used under the<br>direct supervision of a licensed<br>healthcare practitioner in a<br>hospital or medical<br>professional's facility by trained<br>operators | Intended to be used under the<br>direct supervision of a licensed<br>healthcare practitioner in a<br>hospital or medical professional's<br>facility by trained operators | Identical |
| Patient<br>Acquisition<br>Circuitry | Acquisition module integrated in<br>the device and digitalizing<br>functions provided by the device<br>itself. | Acquisition module integrated in<br>the device and digitalizing<br>functions provided by the device<br>itself. | Identical |
| Interpretive<br>ECG<br>Analysis | Yes | Yes | Identical |
| Critical<br>Values | Critical Test Values identified<br>and indicated:<br>- Dialog Box<br>- Printed Report<br>User acknowledgement required<br>to clear notification | Critical Test Values identified<br>and indicated:<br>- Dialog Box<br>- Printed Report<br>User acknowledgement required<br>to clear notification | Identical |
| ECG<br>Pacemaker<br>Detection | Pacemaker pulses are detected<br>digitally and maintained in a<br>separate printable and viewable<br>channel from the ECG<br>waveform. All recorded leads<br>are examined for pace pulse<br>presence.<br>For the acquisition module<br>integrated in the device,<br>software instructs 12SL to<br>disable digital<br>detection/reconstruction and<br>accept all pace detections from<br>acquisition module. | Pacemaker pulses are detected<br>digitally and maintained in a<br>separate printable and viewable<br>channel from the ECG waveform.<br>All recorded leads are examined<br>for pace pulse presence. The<br>separate pacemaker pulses<br>channel is configurable for enable<br>and disable. It is enabled by<br>default.<br>For the acquisition module<br>integrated in the device, software<br>instructs 12SL to disable digital<br>detection/reconstruction and<br>accept all pace detections from<br>acquisition module. | Substantially<br>Equivalent<br>The pacemaker pulses<br>channel can be turned<br>off by the user,<br>according to preference.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Specification | Predicate Product:<br>MAC 7 Resting ECG Analysis<br>System (K203786) | Proposed Product:<br>MAC 5 A4/ MAC 5 A5/ MAC 5<br>Lite Resting ECG Analysis System | Discussion of Differences |
| Display<br>type, size,<br>resolution,<br>and<br>information | 10 inch diagonal LCD, 1280 x<br>800 text and waveforms. | 8.9 inch diagonal LCD, 892 x 558<br>text and waveforms. | Substantially<br>Equivalent<br>A more compact display<br>is offered; there is no<br>change to displayed<br>information.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Battery<br>Operation | Yes. Battery is rechargeable and<br>user replaceable. | Yes. Battery is rechargeable and<br>user replaceable,<br>a more compact battery is<br>provided for the proposed<br>compact design. | Substantially<br>Equivalent.<br>A compact battery for<br>the proposed device.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Recorder<br>Method | Thermal dot array | - Thermal dot array<br>- MAC 5 Lite: Offered without<br>an integrated printer | - Identical for MAC 5 A4<br>and MAC 5 A5 which<br>support thermal printing.<br>MAC 5 Lite offered<br>without an integrated<br>printer.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Thermal<br>Paper size | A4 or Letter format, thermal<br>paper Z-fold | - models with printers, A4,<br>A5, Letter format, or<br>thermal paper Z-fold | Substantially<br>Equivalent<br>Only different thermal<br>paper from predicate<br>device.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Specification | Predicate Product:<br>MAC 7 Resting ECG Analysis<br>System (K203786) | Proposed Product:<br>MAC 5 A4/ MAC 5 A5/ MAC 5<br>Lite Resting ECG Analysis System | Discussion of Differences |
| Network<br>Printer<br>Option | Not supported. | Support to print the report via the<br>network printer. | The contents of the<br>network printer reports<br>are the same as thermal<br>printer reports.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Pharmacy<br>Option | Not supported. | New data entry feature<br>convenience to enter clinical trial<br>data along with the patient data<br>which could be included in the<br>report. | The new data entry<br>feature is for<br>convenience of<br>additional data appended<br>to the record; it is<br>available on similar<br>devices as a user<br>preference.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Interpretatio<br>n Statements | Provides interpretive statements<br>from the 12SLTM analysis<br>algorithm (v23.1) for 10 seconds<br>ECG. | Provides interpretive statements<br>from the 12SLTM analysis<br>algorithm (v24) for 10 seconds<br>ECG. | Substantially<br>Equivalent<br>No changes to the<br>interpretive statements<br>of the 12SLTM analysis<br>algorithm (v24) under<br>K141963 and compared<br>to the predicate device.<br>The changes introduced<br>with the 12SLTM (v24)<br>do not impact the ECG<br>analysis (measurement<br>or accuracy) of the<br>algorithm.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |
| Specification | Predicate Product:<br>MAC 7 Resting ECG Analysis<br>System (K203786) | Proposed Product:<br>MAC 5 A4/ MAC 5 A5/ MAC 5<br>Lite Resting ECG Analysis System | Discussion of Differences |
| Dimensions<br>and Weight | 40 x 32 x 21 cm,<br>5.2 Kg | - MAC 5 A4: 31.5 x 36.0 x<br>11.4 cm,<br>3.6 Kg<br>- MAC 5 A5: 31.5 x 26.0 x<br>10.8 cm,<br>3.0 Kg<br>- MAC 5 Lite: 30.9 x 26.0 x<br>8.4 cm,<br>2.0 Kg | Substantially<br>Equivalent<br>The proposed product<br>has a more compact<br>design from predicate<br>device.<br>GE Healthcare considers<br>the MAC 5 to<br>be substantially<br>equivalent to the<br>predicate device |

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| Specification | Reference device:<br>ELI 380<br>K142105 | Proposed<br>MAC 5 A4/ MAC 5<br>A5/ MAC 5 Lite<br>Resting ECG<br>Analysis System | Discussion of Differences |
|-----------------------|-----------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Frequency<br>Response | 0.05-300Hz | 0.04-300Hz | Substantially equivalent<br>The 300Hz filter is being added to the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG. The 300Hz frequency response feature is substantially equivalent to the reference device, ELI 380. The technology for the delivery of 300Hz low pass filter, is not novel or new to the Resting ECG. The 300Hz filter feature is available for pediatric patients. The addition of 300Hz low-pass filter will present waveforms with high frequency elements. Verification evidence demonstrates that the performance and specifications of the 300Hz filter feature on the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System are equivalent to those on the ELI 380. The 300 Hz filter feature on the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System does not differ in its technological characteristics, function, or performance and therefore, it is substantially equivalent.<br><br>The lower limit of 0.04Hz frequency bandwidth is identical to the predicate device, MAC 7 therefore, it is substantial equivalent<br><br>The 300Hz bandwidth feature for MAC 5 shall include the MAC 7 (K203786) and MAC VU 360 (K173830) as a bundle as they all developed on the same software platform. Verification evidence demonstrates that the performance and specifications of the 300Hz filter feature on the MAC 7 and MAC VU 360 are equivalent to the MAC 5. |

## Substantial Equivalence to the reference device, ELI 380 (K142105)

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| Performance Standards: | The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG<br>Analysis System complies with the<br>voluntary consensus standard ANSI/AAMI ES60601-<br>1:2005/(R)2012 and its relevant collateral and particular<br>standards. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG<br>Analysis System and its applications<br>comply with voluntary standards. The following quality<br>assurance measures were applied to the development of the<br>system:<br>- Risk Analysis<br>- Required Reviews<br>- Design Reviews<br>- Software Development Lifecycle<br>- Testing on unit level<br>- Integration testing (System verification)<br>- Performance testing (Verification)<br>- Safety testing (Verification) |
| Summary of Clinical Tests: | The subject of this premarket submission, MAC 5 Resting<br>ECG Analysis System, did not require clinical studies to<br>support substantial equivalence. |
| Conclusion: | GE Healthcare considers the MAC 5 A4/ MAC 5 A5/ MAC<br>Lite Resting ECG Analysis System to be as safe, as effective,<br>and perform as well as the legally marketed predicate device<br>MAC 7 Resting ECG Analysis System. |