Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes basic ECG signal processing and measurement, but there is no mention of AI or ML algorithms being used for analysis or interpretation. The analysis module provides "ECG measurement," which is a standard function of ECG devices and does not inherently imply AI/ML.

Therapeutic

No
The device is intended for acquiring, recording, and processing an electrocardiographic signal for transmission and review by a physician; it does not explicitly state an intention to treat or mitigate a disease or condition.

Diagnostic

Yes

The device is explicitly designed to acquire, record, and process an electrocardiographic signal to collect data for review by a physician, which is a step in the diagnostic process. While the device itself doesn't offer a diagnostic interpretation, it enables the collection of diagnostic data.

SaMD (Software as a Medical Device)

No

The device description explicitly lists and describes hardware components: "The QT ECG Recorder - Compact device that records 12-lead, resting electrocardiograms" and "The QT ECG Electrode Strip-Disposable, patented electrodes". While software is a component, it is not the sole component.

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 QT ECG System acquires, records, and processes an electrocardiographic signal. This is a measurement of the electrical activity of the heart, which is a physiological process happening within the body.
Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly measures electrical signals from the body surface.

Therefore, the QT ECG System falls under the category of a medical device that measures physiological signals, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on adult patients and pediatric patients age 18 - 22 years. It is designed to be used by a patient or other layperson in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.

Product codes

DXH

Device Description

The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The QT ECG system consists of 5 major components when using:

The QT ECG Recorder - Compact device that records 12-lead, resting electrocardiograms, then transmits the recorded data to a mobile device (smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile device (not included) is needed to operate the QT ECG Recorder, and to send the recoded rhythm strip to a cardiologist or licensed physician for review.
. The QT ECG Electrode Strip-Disposable, patented electrodes that are prepositioned on a self-adhesive strip
. The QT ECG App — Software that lets the user uses their mobile device to operate the QT ECG recorder. Once an ECG recording is done, the data is auto uploaded to the cloud for analysis.
. Analysis - The analysis module provides ECG measurement from the collected data.
. Web Service - The web service provides an interface for communication.

The recorded ECG data is saved temporarily on the mobile device until it is transferred via the Internet to the cloud server. The QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is intended for use on adults and pediatric patients to acquire ECG signals to be transmitted wirelessly via Bluetooth to a mobile device, and then over the Internet to a web service. The QT ECG System is designed to be used by a patient to record and transmit ECG data to a physician's office, hospital or other medical receiving center for review.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Chest, arm and lower belly

Indicated Patient Age Range

adult patients and pediatric patients age 18 – 22 years

Intended User / Care Setting

a patient or other layperson in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities)

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Three Clinical and Usability Tests have been conducted on the subject device.

Study One is a clinical study that to present the equivalence of QT ECG to the reference device, Philips PageWriter ECG system. In conclusion, we achieved both objectives, reached the pre-determined acceptance criteria for electrode fit of 90% or more of the unselected population aged 18 to 75 years old, and 90% or higher rate of equivalence in clinical interpretation from patients aged 18 to 75 years old between Philips PageWriter and QT ECG in this study.

Study Two & Three are human factor and usability studies that conducted to test the Human Factor and Usability of QT ECG used by laypeople in home environments/ non-healthcare environment, and conducted with healthcare workers who have experience working at non-acute healthcare facilities to validate its use with nursing home staff respectively. In conclusion, we achieved the objectives in this study, and addressed all the human factor and usability issues identified.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

90% or more of the unselected population aged 18 to 75 years old for electrode fit.
90% or higher rate of equivalence in clinical interpretation from patients aged 18 to 75 years old.

Predicate Device(s)

K113514

Reference Device(s)

K113144

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a stylized depiction of human figures, while the FDA logo features the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side-by-side, indicating a connection between the two organizations.

May 4, 2018

QT Medical, Inc. Ruey-Kang Chang Chief Executive Offier 1001 W. Carson Street Suite U Torrance, California 90502

Re: K180157

Trade/Device Name: QT ECG Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH Dated: March 31, 2018 Received: April 4, 2018

Dear Ruey-Kang Chang:

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 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);

1

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M. A. Willemsen

for 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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Indications for Use

510(k) Number (if known)

K180157

Device Name QT ECG

Indications for Use (Describe)

The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on adult patients and pediatric patients age 18 - 22 years. It is designed to be used by a patient or other layperson in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K180157

QT Medical, Inc. QT ECG

510(k) SUMMARY

5.1	Type of Submission:	Traditional
5.2	Date of Summary:	04/27/2018
5.3	Submitter:	QT Medical, Inc.
	Address:	1001 W Carson Street, Suite U, Torrance, CA,
90502, U.S.A.
	Phone:	1-424-558-3500
	Fax:	1-310-755-3108
	Contact:	Ruey-Kang Chang
(rk.chang@qtmedical.com)

5.4 Identification of the Device:

Proprietary/Trade name:	QT ECG
Classification Product Code:	DXH
Regulation Number:	870.2920
Regulation Description:	Telephone electrocardiograph
transmitter and receiver
Review Panel:	Cardiovascular
Device Class:	II

5.5 Identification of the Predicate Device:

Predicate Device Name:	Smartheart
Manufacturer:	SHL Telemedicine International Ltd.
Classification Product Code:	DXH
Regulation number:	870.2920
Device Class:	II
510(k) Number:	K113514

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5.6	Identification of the Reference Device:
	Predicate Device Name:	PageWriter TC70
	Manufacturer:	Philips Medical Systems International
BV
	Classification Product Code:	DPS
	Regulation number:	870.2340
	Device Class:	II
	510(k) Number:	K113144

5.7 Indications for Use / Intended Use of the Device

Indication for Use:

The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on adult patients and pediatric patients age 18 -22 years. It is designed to be used by a patient or other layperson in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), to record and transmit a 12-lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.

Intended Use:

The QT ECG System is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The QT ECG System is designed to be used by a patient or another layperson or a healthcare worker to transmit a 12lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving center.

5.8 Device Description

The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG)

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system with Bluetooth connectivity. The OT ECG system consists of 5 major components when using:

The QT ECG Recorder - Compact device that records 12-lead, resting electrocardiograms, then transmits the recorded data to a mobile device (smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile device (not included) is needed to operate the QT ECG Recorder, and to send the recoded rhythm strip to a cardiologist or licensed physician for review.
. The QT ECG Electrode Strip-Disposable, patented electrodes that are prepositioned on a self-adhesive strip
. The QT ECG App — Software that lets the user uses their mobile device to operate the QT ECG recorder. Once an ECG recording is done, the data is auto uploaded to the cloud for analysis.
. Analysis - The analysis module provides ECG measurement from the collected data.
. Web Service - The web service provides an interface for communication.

The recorded ECG data is saved temporarily on the mobile device until it is transferred via the Internet to the cloud server. The OT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is intended for use on adults and pediatric patients to acquire ECG signals to be transmitted wirelessly via Bluetooth to a mobile device, and then over the Internet to a web service. The QT ECG System is designed to be used by a patient to record and transmit ECG data to a physician's office, hospital or other medical receiving center for review.

5.9 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device. QT ECG.

. Biocompatibility
- In Vitro Cytotoxicity Test
- White Rabbit Skin Irritation Test
- Skin Sensitization Study (Maximization Test)

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510(k) Summary K180157

QT Medical, Inc. QT ECG

. Software Validation
Electromagnetic compatibility and electrical safety .
- Electrical Safety Test
- EMC Test
- Electrical Safety in Home Healthcare Environment
- Safety and Essential Performance of Electrocardiographs
- Battery Safety Test i
. Performance & Shelf life

All the test results demonstrate QT ECG meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

The list of standards that claim compliance:

| Testing Item | FDA recognition
number | Standards and regulations applied |
|--------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bio-
compatibility | 2-220 | ISO 10993-1: 2009, Biological Evaluation Of Medical Devices

Part 1: Evaluation And Testing Within A Risk Management
Process [Including: Technical Corrigendum 1 (2010)] |
| | 2-222 | ISO 10993-2:2006, Biological evaluation of medical devices --
Part 2: Animal welfare requirements. |
| | 2-245 | ISO 10993-5:2009, Biological evaluation of medical devices --
Part 5: Tests for in vitro cytotoxicity. |
| | 2-153 | ANSI/AAMI/ISO 10993-5:2009/(R)2014, Biological
Evaluation Of Medical Devices - Part 5: Tests For In Vitro
Cytotoxicity. |
| | 2-174 | ISO 10993-10:2010, Biological evaluation of medical devices --
Part 10: Tests for irritation and skin sensitization. |
| | 2-191 | ISO 10993-12:2012, Biological evaluation of medical devices --
Part 12: Sample preparation and reference materials. |
| | 2-198 | ANSI/AAMI/ISO 10993-12:2012, Biological Evaluation Of
Medical Devices - Part 12: Sample Preparation And Reference |
| | | Materials. |
| Software | 13-79 | IEC 62304:2006+AMD1:2015, Medical device software -
Software life cycle processes. |
| | 5-40 | ISO 14971:2007, Medical devices - Application of risk
management to medical devices. |
| | 3-105 | IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25:
Particular requirements for the basic safety and essential
performance of electrocardiographs. |
| Electromagnetic
Compatibility
and Electrical
Safety | - | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.
2:2007 + A1:2012, Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance. |
| | - | ANSI/AAMI ES60601-1: 2005 / A2:2010, Medical electrical
equipment - Part 1: General requirements for basic safety and
essential performance. |
| | 19-8 | IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance
Collateral standard: Electromagnetic compatibility. |
| | 19-14 | IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11:
General requirements for basic safety and essential performance
Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home
healthcare environment. |
| | 3-105 | IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25:
Particular requirements for the basic safety and essential
performance of electrocardiographs. |
| | 19-13 | IEC 62133:2012, Secondary cells and batteries containing
alkaline or other non-acid electrolytes - Safety requirements for
portable sealed secondary cells, and for batteries made from
them, for use in portable applications |

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5.10 Clinical and Usability Testing

Three Clinical and Usability Tests have been conducted on the subject device.

Study One is a clinical study that to present the equivalence of OT ECG to the reference device, Philips PageWriter ECG system. In conclusion, we achieved both objectives, reached the pre-determined acceptance criteria for electrode fit of 90% or more of the unselected population aged 18 to 75 years old, and 90% or higher rate of equivalence in clinical interpretation from patients aged 18 to 75 years old between Philips PageWriter and QT ECG in this study.

Study Two & Three are human factor and usability studies that conducted to test the Human Factor and Usability of OT ECG used by laypeople in home environments/ non-healthcare environment, and conducted with healthcare workers who have experience working at non-acute healthcare facilities to validate its use with nursing home staff respectively. In conclusion, we achieved the objectives in this study, and addressed all the human factor and usability issues identified.

5.11 Substantial Equivalence Determination

The QT ECG submitted in this 510(k) file is substantially equivalent in intended use, technology/mechanism of action, safety and performance to the cleared device, Smartheart (K113514). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

Item	Subject device	Predicate device
Manufacturer	QT Medical, Inc.	SHL Telemedicine
International, Ltd.	Substantial equivalence
determination
Trade Name	QT ECG	Smartheart

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510(k) No.	K180157	K113514
Product Code	DXH	DXH	Identical
Regulation
Number	870.2920	870.2920	Identical
Intended Use	The QT ECG System is
intended to condition an
electrocardiographic signal so
that it can be transmitted
digitally via Bluetooth
technology and cell-phone or
communication device to a
remote location. The QT ECG
System is designed to be used
by a patient or another
layperson or a healthcare
worker to transmit a 12-lead
ECG and rhythm strip in near
real-time to enable review at a
physician's office, hospital or
other medical receiving	The Smartheart device is
intended to condition an
electrocardiographic signal so
that it can be transmitted
digitally via Bluetooth
technology and cell-phone or
communication device to a
remote location. The
Smartheart device is designed
to be used by a patient to
transmit a 12 lead EGG and
rhythm strip in real-time to
enable review at a physician's
office, hospital or other
medical receiving center.	Equivalent
The QT ECG System
differs in that it specifies
patient types as
recommended in FDA
Class II Special Controls
Guidance Document:
Electrocardiograph
Electrodes (July 21, 2011).
The intended patient
population is similar to
that of the predicate.
QT ECG's intended users
include patients
themselves, and other
laypersons with similar
backgrounds as the adult
patients that use the
Smartheart .
Other differences in
wording are for
clarification and convey
the same meaning. The
differences in indications
for use do not change the
intended use of the device
to acquire and transmit
12-lead ECG signals from
	The QT ECG System is
intended to acquire, record and
process an electrocardiographic
signal so that it can be
transmitted digitally via
Bluetooth technology to a
cell-phone or mobile device,
then to a remote location. The
QT ECG System is indicated
for use on adult patients and
pediatric patients age 18 – 22
years. It is designed to be used
Indications for
Use
	by a patient or other layperson
in the home, or by healthcare
workers in non-acute care
clinical facilities (such as
nursing homes, skilled nursing
facilities), to record and
transmit a 12-lead ECG and
rhythm strip in near real-time
to enable review at a
physician's office, hospital or
other medical receiving
centers.	For the device features	patients in the home.
Mechanism of
Action	The ECG signals are acquired
via the QT ECG Electrode
Strip attached to the patient.
The Electrode Strip then
transfers the ECG signals to the
QT ECG Recorder that it is
plugged into. Then, the
Recorder sends the ECG data
via Bluetooth to the App for
display. The analysis module
provides ECG measurement
from the collected data. Using
an algorithm to detect the
positions of feature points such
as P, Q, R, S, T. Then, calculate
the eight measurements
according to their definitions.
And then, transmit the data to a
physician's office, hospital or
other medical receiving	Electrode belt and recorder are
applied to patient. ECG is
acquired and transmitted to a
mobile device using Bluetooth.
Mobile application running on
the device displays the ECG
signal and transmits it to a
remote location for subsequent
clinician assessment.	Equivalent
There are no significant
differences in the
mechanism of action for
both devices.
	for review.
Technology
Overview	The QT ECG Electrode
Strip with 10 electrode
contacts (chest/right and
left arm/left lower belly), 4
sizes available Handheld, battery powered
recorder Records 12-lead ECG Bluetooth data transmission Mobile Application running
on mobile device	Electrode belt with 16
electrode contacts (belt
chest/housing chest), 1 belt
size with small - extra-large
sizing Waist (square) and right arm
(round) electrodes with
leadwire Handheld, battery powered
recorder Records 12-lead ECG Bluetooth data transmission Mobile Application running
on mobile device	Equivalent
Both devices use electrode
components with
pre-placed electrodes,
Bluetooth transmission
and a mobile device.
They have similar
technology to acquire,
record and transmit the
ECG signal.
User Interface	Recorder - on/off button,
status LEDs Electrode Strip (4 sizes
available: S, M, L, XL) Right arm (RA), left arm
(LA) and left lower belly
(LL) Mobile Device running the
QT ECG App	Recorder - on/off button,
heart shaped indicator light Electrode Belt (adjustable
to 4 chest sizes: S, M, L,
XL) Right arm (RA), left arm
(LA) and waist electrodes
(LL) Mobile Device running
Smartheart mobile
application	Equivalent
Both devices include a
recorder with attached
electrode. Both devices
interface with a mobile
device running a mobile
application. QT ECG
includes RA, LA and LLelectrodes as part of the
electrode strip whereas the
Smartheart has separate
wires that connect these
electrodes to the recorder.
It does not affect the safety
and performance.
Anatomical
Location	Chest, arm and lower belly	Chest, armpit and waist	Equivalent
Both devices align
			electrodes over standard
ECG acquisition sites RA,
LA, LL, V1 – V6
		For the specifications
Sterile	No	No	Identical
			Equivalent
			Both recorders can be used
			multiple times per patient
			or with multiple patients,
			with cleaning between
			each use. The Smartheart
Single-Use	No (recorder)	No (recorder and electrode)	electrode belt can also be
	Yes (electrode)		cleaned and used multiple
			times and by multiple
			users. The QT ECG
			System uses a single-use
			disposable electrode that is
			not cleaned between uses.
Record Time	10 seconds	30 seconds	Equivalent
			Both devices have
			sufficient record time. In
			general, 10 seconds is
			sufficient for ECG
			diagnosis, and the subject
			device meets the
			performance requirements.
Recorder Input
Impedance	6.875MΩ	Meets IEC 60601-2-25: 2011	Equivalent
		which means at least 2.5MΩ	Both devices meet
			standards for input
			impedance. The QT ECG
			has a higher input
			impedance; thus it may

Recorder
Amplifier	CMRR: 97db min

Frequency response:
0.05~150Hz | CMRR: 80db min

A1:2012
ANSI/AAMI ES60601-1: 2005 | EN 60601-1:2006
EN 60601-1-2:2007
EN 60601-1-11:2010
IEC 60601-2-25:2011 | Equivalent
The QT ECG meets
current versions of
standards. |
| | IEC 60601-1-2:2014
IEC 60601-1-11:2015
IEC 60601-2-25:2011 | | |
| Mobile
application | Compatibility: iOS 10 or later;
Android 5.0 or later. | Compatibility: iOS 6.0 or later;
Android | Equivalent
Both devices work on
commonly available
mobile technology. |
| Mobile device | The app works on Phone:
iPhone 6
iPhone 6 Plus
iPhone 6s
iPhone 6s Plus
iPhone 7
iPhone 7 Plus
Google Pixel
Samsung Galaxy A7
LG G5
on Tablet:
iPad Air (or later)
iPad Air 2
iPad Mini 2 (or later)
iPad Mini 3
iPad Mini 4
HTC nexus 9
Samsung Galaxy Tab S2 | The app works on both iOS and
Android devices:
iPhone 3Gs, iPhone 4,
iPhone 4s, iPhone 5,
iPhone 5s, iPhone 6,
Samsung Galaxy S II,
Samsung Galaxy S,
Samsung Galaxy S III,
Samsung Galaxy S4,
Samsung Galaxy S5,
Samsung Galaxy Ace,
Samsung Galaxy Ace 2,
Samsung Galaxy Note,
Samsung Galaxy Note II,
Samsung Galaxy Note III,
Samsung Galaxy Nexus,
S.Galaxy S III Mini,
Samsung Galaxy W,
LG Optimus 4X HD,
LG Optimus L7,
LG Optimus Black,
LG Optimus Sol,
LG Optimus Sol ,
LG Prada 3.0 ,
LG Optimus 2X , | Equivalent
Both devices work on
commonly available
mobile technology. |

10

11

12

13

14

15

16

17

LG Google Nexus 4 ,
LG Optimus 2X ,
Motorola Defy Plus ,
Motorola Defy ,
Motorola RAZR XT910 ,
Motorola Atrix 2 ,
Motorola Atrix 4G ,
Motorola MILESTONE ,
HTC ONE X , HTC One S ,
HTC One V , HTC Desire C ,
HTC Sensation XL ,
HTC Sensation XE,
HTC Desire,
HTC Incredible S ,
HTC Sensation ,
HTC Desire V ,
HTC EVO 3D ,
HTC Desire S ,
HTC Desire HD ,
Sony Xperia Sola ,
Sony Xperia P ,
Sony Xperia U ,
Sony Xperia S ,
Sony Xperia Go ,
Sony Xperia PLAY ,
Sony Xperia Neo L ,
Sony XPERIA X10 ,
Sony Xperia Neo V ,
Sony Xperia Neo ,
Sony XPERIA ARC

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5.12 Similarity and Difference

The QT ECG has been compared with "Smartheart". The subject device has same intended use, technology/mechanism of action, safety and performance as the predicate device. Although there are some specifications that are different between two devices, the software validation, performance test and clinical/usability studies have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.

5.13 Conclusion

After analyzing non-clinical laboratory studies, clinical trials and safety testing data, it can be concluded that the QT ECG is substantially equivalent to the predicate device.