QT ECG

K180157 · QT Medical, Inc. · DXH · May 4, 2018 · Cardiovascular

Device Facts

• Record ID: K180157
• Device Name: QT ECG
• Applicant: QT Medical, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: May 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

QT ECG is a handheld, cordless 12-lead ECG system. Input: ECG signals acquired via a disposable, pre-positioned electrode strip. Processing: Recorder transmits data via Bluetooth to a mobile device (smartphone/tablet) running the QT ECG App; data is uploaded to a cloud server for analysis. Output: ECG rhythm strip and measurements for clinician review. Used in home or non-acute clinical settings by patients, laypersons, or healthcare workers. The device lacks diagnostic alarms or continuous monitoring. Clinicians review transmitted data at remote medical centers to support clinical decision-making. Benefits include near real-time ECG access for patients outside traditional clinical environments.

Clinical Evidence

Clinical study (Study One) compared QT ECG to Philips PageWriter TC70 in patients aged 18-75. Achieved >90% electrode fit and >90% clinical interpretation equivalence. Human factor/usability studies (Study Two & Three) validated use by laypeople in home environments and healthcare workers in non-acute facilities.

Technological Characteristics

Handheld, battery-powered 12-lead ECG recorder with Bluetooth connectivity. Uses disposable electrode strips. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-25. Biocompatibility per ISO 10993. Software lifecycle per IEC 62304. Connectivity via mobile device to cloud web service.

Indications for Use

Indicated for adult patients and pediatric patients aged 18-22 years for the acquisition, recording, and transmission of 12-lead ECG and rhythm strips.

Regulatory Classification

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.

Predicate Devices

• Smartheart (K113514)

Reference Devices

• PageWriter TC70 (K113144)

Submission Summary (Full Text)

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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);

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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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,<br>90502, U.S.A. |
| | Phone: | 1-424-558-3500 |
| | Fax: | 1-310-755-3108 |
| | Contact: | Ruey-Kang Chang<br>([e-mail]) |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | QT ECG |
|------------------------------|----------------------------------------------------------|
| Classification Product Code: | DXH |
| Regulation Number: | 870.2920 |
| Regulation Description: | Telephone electrocardiograph<br>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<br>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<br>number | Standards and regulations applied |
|--------------------------------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bio-<br>compatibility | 2-220 | ISO 10993-1: 2009, Biological Evaluation Of Medical Devices<br>- Part 1: Evaluation And Testing Within A Risk Management<br>Process [Including: Technical Corrigendum 1 (2010)] |
| | 2-222 | ISO 10993-2:2006, Biological evaluation of medical devices --<br>Part 2: Animal welfare requirements. |
| | 2-245 | ISO 10993-5:2009, Biological evaluation of medical devices --<br>Part 5: Tests for in vitro cytotoxicity. |
| | 2-153 | ANSI/AAMI/ISO 10993-5:2009/(R)2014, Biological<br>Evaluation Of Medical Devices - Part 5: Tests For In Vitro<br>Cytotoxicity. |
| | 2-174 | ISO 10993-10:2010, Biological evaluation of medical devices --<br>Part 10: Tests for irritation and skin sensitization. |
| | 2-191 | ISO 10993-12:2012, Biological evaluation of medical devices --<br>Part 12: Sample preparation and reference materials. |
| | 2-198 | ANSI/AAMI/ISO 10993-12:2012, Biological Evaluation Of<br>Medical Devices - Part 12: Sample Preparation And Reference |
| | | Materials. |
| Software | 13-79 | IEC 62304:2006+AMD1:2015, Medical device software -<br>Software life cycle processes. |
| | 5-40 | ISO 14971:2007, Medical devices - Application of risk<br>management to medical devices. |
| | 3-105 | IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25:<br>Particular requirements for the basic safety and essential<br>performance of electrocardiographs. |
| Electromagnetic<br>Compatibility<br>and Electrical<br>Safety | - | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.<br>2:2007 + A1:2012, Medical electrical equipment - Part 1:<br>General requirements for basic safety and essential<br>performance. |
| | - | ANSI/AAMI ES60601-1: 2005 / A2:2010, Medical electrical<br>equipment - Part 1: General requirements for basic safety and<br>essential performance. |
| | 19-8 | IEC 60601-1-2: 2014, Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance<br>- Collateral standard: Electromagnetic compatibility. |
| | 19-14 | IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11:<br>General requirements for basic safety and essential performance<br>- Collateral standard: Requirements for medical electrical<br>equipment and medical electrical systems used in the home<br>healthcare environment. |
| | 3-105 | IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25:<br>Particular requirements for the basic safety and essential<br>performance of electrocardiographs. |
| | 19-13 | IEC 62133:2012, Secondary cells and batteries containing<br>alkaline or other non-acid electrolytes - Safety requirements for<br>portable sealed secondary cells, and for batteries made from<br>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<br>International, Ltd. | Substantial equivalence<br>determination |
| Trade Name | QT ECG | Smartheart | |

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