Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes "interpretive analysis" but does not mention AI, ML, or any related technologies. The performance studies section focuses on standard software and system testing, not AI/ML model validation.

Therapeutic

No
The device is described as an "ECG Analysis System" that acquires, analyzes, displays, and prints electrocardiograms to provide interpretation of data for consideration by a physician. It is a diagnostic device, not a therapeutic one.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the device is indicated to "acquire, analyze, display and print electrocardiograms" and to "provide interpretation of the data for consideration by a physician", although it also clarifies that it is "not intended as a sole means of diagnosis." The "Device Description" further elaborates that it can "provide interpretive analysis". These functions indicate its role in assisting with a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes," indicating it includes hardware components for signal acquisition and recording.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
Device Function: The MAC 5 Resting ECG Analysis System acquires, analyzes, displays, and prints electrocardiograms. This involves measuring electrical activity of the heart directly from the patient's body using surface electrodes. This is an in vivo measurement, not an in vitro test on a sample.
Intended Use: The intended use clearly states it's for acquiring and analyzing ECGs from patients, not for testing biological samples.

Therefore, the MAC 5 Resting ECG Analysis System is a medical device, but it falls under the category of devices that perform measurements directly on the patient, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 over-read 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.

Product codes

DPS, DQK, DXH

Device Description

The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device can capture 3, 6, or 12 lead electrocardiograms, provide interpretive analysis, and print reports. The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow. The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and pediatric (birth through 21 years of age) populations.

Intended User / Care Setting

In a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The subject of this premarket submission, MAC 5 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K203786

Reference Device(s)

K142105

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: +86 13915289019 Fax: +86 0510-85226688 E-mail: Honghong.yang@ge.com

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: +1-360-9283 Fax: +1-414-721-3864 E-mail: michael.petrini@ge.com

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
21 CFR 870.1425 – Programmable Diagnostic Computer
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
Analysis System is a mobile electrocardiograph designed to
acquire, analyze, display, and record ECG signals from surface
ECG electrodes.
	The device can capture 3, 6, or 12 lead electrocardiograms,
provide interpretive analysis, and print reports.
	The device can connect to a network, either through a wired
LAN connection or via wireless WiFi access points. Once on
the network, the device can optionally interface with
cardiology information systems such as the GEHC MUSE®
system to participate in a complete electrocardiology
workflow.
	The device provides state-of-the-art information technology
security features and a contemporary user interface. Mobility is
provided via an optional trolley.
Indications for 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

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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:
MAC 7 Resting ECG Analysis
System (K203786) | Proposed Product:
MAC 5 A4/ MAC 5 A5/ MAC 5
Lite Resting ECG Analysis System | Discussion of Differences |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The MAC 7 Resting ECG
Analysis System is intended to
acquire, analyze, display, and
record electrocardiographic
information from adult or
pediatric populations. Basic
system delivers 3, 6, or 12 lead
ECG's and interpretive analysis.
Transmission and reception of
ECG data and other clinical data
to and from a central clinical
information system is optional.

The MAC 7 ECG Analysis
System is intended to be used
under the direct supervision of a
licensed healthcare practitioner,
by trained operators in a
hospital, medical professional's
facility or wherever ECG testing
is performed. | The MAC 5 Resting ECG
Analysis System is intended to
acquire, analyze, display, and
record electrocardiographic
information from adult or
pediatric populations. Basic
system delivers 3, 6, or 12 lead
ECG's and interpretive analysis.
Transmission and reception of
ECG data and other clinical data
to and from a central clinical
information system is optional.

The MAC 5 ECG Analysis
System is intended to be used
under the direct supervision of a
licensed healthcare practitioner,
by trained operators in a hospital,
medical professional's facility or
wherever ECG testing is
performed. | Identical |
| Indications
for Use | The MAC 7 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
over-read 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. | 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
over-read 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. | Identical |
| Specification | Predicate Product:
MAC 7 Resting ECG Analysis
System (K203786) | Proposed Product:
MAC 5 A4/ MAC 5 A5/ MAC 5
Lite Resting ECG Analysis System | Discussion of Differences |
| Contraindications | This MAC 7 Resting ECG
Analysis System is not intended
in the following manner:
• During patient transport
• With high-frequency surgical
units
• As an intra-cardiac application
• As a sole means of diagnosis
• As a vital signs physiological
monitor | This MAC 5 Resting ECG
Analysis System is not intended
in the following manner:
• During patient transport
• With high-frequency surgical
units
• As an intra-cardiac application
• As a sole means of diagnosis
• As a vital signs physiological
monitor | Identical |
| Patient
Population | Adult and pediatric (birth
through 21 years of age)
populations | Adult and pediatric (birth through
21 years of age) populations | Identical |
| Environment
of Use | Intended to be used under the
direct supervision of a licensed
healthcare practitioner in a
hospital or medical
professional's facility by trained
operators | Intended to be used under the
direct supervision of a licensed
healthcare practitioner in a
hospital or medical professional's
facility by trained operators | Identical |
| Patient
Acquisition
Circuitry | Acquisition module integrated in
the device and digitalizing
functions provided by the device
itself. | Acquisition module integrated in
the device and digitalizing
functions provided by the device
itself. | Identical |
| Interpretive
ECG
Analysis | Yes | Yes | Identical |
| Critical
Values | Critical Test Values identified
and indicated:

Dialog Box
Printed Report
User acknowledgement required
to clear notification | Critical Test Values identified
and indicated:
Dialog Box
Printed Report
User acknowledgement required
to clear notification | Identical |
| ECG
Pacemaker
Detection | Pacemaker pulses are detected
digitally and maintained in a
separate printable and viewable
channel from the ECG
waveform. All recorded leads
are examined for pace pulse
presence.
For the acquisition module
integrated in the device,
software instructs 12SL to
disable digital
detection/reconstruction and
accept all pace detections from
acquisition module. | Pacemaker pulses are detected
digitally and maintained in a
separate printable and viewable
channel from the ECG waveform.
All recorded leads are examined
for pace pulse presence. The
separate pacemaker pulses
channel is configurable for enable
and disable. It is enabled by
default.
For the acquisition module
integrated in the device, software
instructs 12SL to disable digital
detection/reconstruction and
accept all pace detections from
acquisition module. | Substantially
Equivalent
The pacemaker pulses
channel can be turned
off by the user,
according to preference.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Specification | Predicate Product:
MAC 7 Resting ECG Analysis
System (K203786) | Proposed Product:
MAC 5 A4/ MAC 5 A5/ MAC 5
Lite Resting ECG Analysis System | Discussion of Differences |
| Display
type, size,
resolution,
and
information | 10 inch diagonal LCD, 1280 x
800 text and waveforms. | 8.9 inch diagonal LCD, 892 x 558
text and waveforms. | Substantially
Equivalent
A more compact display
is offered; there is no
change to displayed
information.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Battery
Operation | Yes. Battery is rechargeable and
user replaceable. | Yes. Battery is rechargeable and
user replaceable,
a more compact battery is
provided for the proposed
compact design. | Substantially
Equivalent.
A compact battery for
the proposed device.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Recorder
Method | Thermal dot array | - Thermal dot array
MAC 5 Lite: Offered without
an integrated printer | - Identical for MAC 5 A4
and MAC 5 A5 which
support thermal printing.
MAC 5 Lite offered
without an integrated
printer.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Thermal
Paper size | A4 or Letter format, thermal
paper Z-fold | - models with printers, A4,
A5, Letter format, or
thermal paper Z-fold | Substantially
Equivalent
Only different thermal
paper from predicate
device.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Specification | Predicate Product:
MAC 7 Resting ECG Analysis
System (K203786) | Proposed Product:
MAC 5 A4/ MAC 5 A5/ MAC 5
Lite Resting ECG Analysis System | Discussion of Differences |
| Network
Printer
Option | Not supported. | Support to print the report via the
network printer. | The contents of the
network printer reports
are the same as thermal
printer reports.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Pharmacy
Option | Not supported. | New data entry feature
convenience to enter clinical trial
data along with the patient data
which could be included in the
report. | The new data entry
feature is for
convenience of
additional data appended
to the record; it is
available on similar
devices as a user
preference.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Interpretatio
n Statements | Provides interpretive statements
from the 12SLTM analysis
algorithm (v23.1) for 10 seconds
ECG. | Provides interpretive statements
from the 12SLTM analysis
algorithm (v24) for 10 seconds
ECG. | Substantially
Equivalent
No changes to the
interpretive statements
of the 12SLTM analysis
algorithm (v24) under
K141963 and compared
to the predicate device.
The changes introduced
with the 12SLTM (v24)
do not impact the ECG
analysis (measurement
or accuracy) of the
algorithm.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |
| Specification | Predicate Product:
MAC 7 Resting ECG Analysis
System (K203786) | Proposed Product:
MAC 5 A4/ MAC 5 A5/ MAC 5
Lite Resting ECG Analysis System | Discussion of Differences |
| Dimensions
and Weight | 40 x 32 x 21 cm,
5.2 Kg | - MAC 5 A4: 31.5 x 36.0 x
11.4 cm,
3.6 Kg
MAC 5 A5: 31.5 x 26.0 x
10.8 cm,
3.0 Kg
MAC 5 Lite: 30.9 x 26.0 x
8.4 cm,
2.0 Kg | Substantially
Equivalent
The proposed product
has a more compact
design from predicate
device.
GE Healthcare considers
the MAC 5 to
be substantially
equivalent to the
predicate device |

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| Specification | Reference device:
ELI 380
K142105 | Proposed
MAC 5 A4/ MAC 5
A5/ MAC 5 Lite
Resting ECG
Analysis System | Discussion of Differences |
|-----------------------|-----------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Frequency
Response | 0.05-300Hz | 0.04-300Hz | Substantially equivalent
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.

The lower limit of 0.04Hz frequency bandwidth is identical to the predicate device, MAC 7 therefore, it is substantial equivalent

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
Analysis System complies with the
voluntary consensus standard ANSI/AAMI ES60601-
1:2005/(R)2012 and its relevant collateral and particular
standards. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG
Analysis System and its applications
comply with voluntary standards. The following quality
assurance measures were applied to the development of the
system:

Risk Analysis
Required Reviews
Design Reviews
Software Development Lifecycle
Testing on unit level
Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification) |
| Summary of Clinical Tests: | The subject of this premarket submission, MAC 5 Resting
ECG Analysis System, did not require clinical studies to
support substantial equivalence. |
| Conclusion: | GE Healthcare considers the MAC 5 A4/ MAC 5 A5/ MAC
Lite Resting ECG Analysis System to be as safe, as effective,
and perform as well as the legally marketed predicate device
MAC 7 Resting ECG Analysis System. |