(105 days)
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.
The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) 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.
This document describes the 510(k) Pre-market Notification for the QT ECG device. The purpose of the submission is to demonstrate substantial equivalence to a predicate device, Smartheart (K113514).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" for the entire device in a pass/fail format for all aspects. Instead, acceptance criteria are generally implied by adherence to recognized standards for non-clinical testing and by specific objectives for the clinical and usability studies.
However, a comparison table (pages 9-18) details the subject device's features against the predicate device, indicating "Equivalent" or "Identical" for most aspects, and elaborating on differences that do not raise new issues of substantial equivalence. For performance, the clinical study's objectives serve as acceptance criteria.
Clinical Study Acceptance Criteria & Performance:
| Acceptance Criteria (from "Study One") | Reported Device Performance (from "Study One") |
|---|---|
| 1. Electrode fit: 90% or more of the unselected population aged 18 to 75 years old. | "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" |
| 2. Equivalence in clinical interpretation: 90% or higher rate of equivalence in clinical interpretation from patients aged 18 to 75 years old between Philips PageWriter and QT ECG. | "we achieved both objectives... 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." |
Non-Clinical Testing Acceptance Criteria & Performance:
For non-clinical tests (Biocompatibility, Software Validation, EMC, Electrical Safety, Performance & Shelf life), the acceptance criteria are implicitly defined by compliance with the listed FDA-recognized standards (ISO 10993 series, IEC 62304, ISO 14971, IEC 60601 series, IEC 62133). The document states:
- "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." (Page 6)
- The tables listing the standards (pages 6-7) serve as the acceptance criteria for these categories.
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Study (Study One): The document does not explicitly state the sample size (number of patients) used in Study One. It mentions "unselected population aged 18 to 75 years old."
- Data Provenance: The document does not specify the country of origin for the clinical study data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Clinical Study (Study One): The document mentions "clinical interpretation from patients... between Philips PageWriter and QT ECG." This implies that the interpretation of the ECGs from both devices was performed by experts, and their interpretations were compared to establish equivalence. However, the exact number of experts, their qualifications (e.g., "radiologist with 10 years of experience"), or how their interpretations formed a ground truth are not detailed in this document.
4. Adjudication Method for the Test Set:
- The document does not describe the adjudication method (e.g., 2+1, 3+1, none) used for the clinical interpretations in Study One.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document does not indicate that an MRMC comparative effectiveness study was done to measure human reader improvement with AI assistance. The clinical study aimed to show equivalence in clinical interpretation between the QT ECG and a reference device (Philips PageWriter), not the impact of AI assistance on human readers.
6. Standalone (Algorithm Only) Performance:
- The document does not present a standalone performance study of the algorithm without human-in-the-loop. The device's "Analysis module" provides "ECG measurement" (e.g., P, Q, R, S, T points and eight measurements), but its performance (e.g., accuracy against a reference standard) is not described as a standalone evaluation. The overall equivalence is based on the system's ability to produce interpretable ECGs.
7. Type of Ground Truth Used:
- Clinical Study (Study One): The ground truth for evaluating clinical interpretation equivalence was based on the interpretation of ECGs from a reference device (Philips PageWriter ECG system) compared to the QT ECG system. This suggests a comparative ground truth rather than an independent "gold standard" such as pathology or outcomes data.
- Non-Clinical Testing: Ground truth is established by adherence to the performance requirements outlines in the listed FDA-recognized standards (e.g., IEC 60601-2-25:2011 for basic safety and essential performance of electrocardiographs).
8. Sample Size for the Training Set:
- The document does not specify a sample size for a training set. This submission is for a device that acquires, records, and processes ECG signals for transmission and review, implying that the primary "analysis module" performs measurements rather than complex diagnostic AI that typically requires large training datasets. If an algorithm was trained, the details are not provided here.
9. How the Ground Truth for the Training Set Was Established:
- As no training set sample size is provided, the method for establishing its ground truth is also not described in this document.
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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 (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)
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 electrocardiographtransmitter 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 InternationalBV | |
| 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 recognitionnumber | 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 ManagementProcess [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, BiologicalEvaluation Of Medical Devices - Part 5: Tests For In VitroCytotoxicity. | |
| 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 OfMedical 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 riskmanagement to medical devices. | |
| 3-105 | IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25:Particular requirements for the basic safety and essentialperformance of electrocardiographs. | |
| ElectromagneticCompatibilityand ElectricalSafety | - | 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 essentialperformance. |
| - | ANSI/AAMI ES60601-1: 2005 / A2:2010, Medical electricalequipment - Part 1: General requirements for basic safety andessential 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 electricalequipment and medical electrical systems used in the homehealthcare environment. | |
| 3-105 | IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25:Particular requirements for the basic safety and essentialperformance of electrocardiographs. | |
| 19-13 | IEC 62133:2012, Secondary cells and batteries containingalkaline or other non-acid electrolytes - Safety requirements forportable sealed secondary cells, and for batteries made fromthem, 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 TelemedicineInternational, Ltd. | Substantial equivalencedetermination |
| Trade Name | QT ECG | Smartheart |
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| 510(k) No. | K180157 | K113514 | |
|---|---|---|---|
| Product Code | DXH | DXH | Identical |
| RegulationNumber | 870.2920 | 870.2920 | Identical |
| Intended Use | The QT ECG System isintended to condition anelectrocardiographic signal sothat it can be transmitteddigitally via Bluetoothtechnology and cell-phone orcommunication device to aremote location. The QT ECGSystem is designed to be usedby a patient or anotherlayperson or a healthcareworker to transmit a 12-leadECG and rhythm strip in nearreal-time to enable review at aphysician's office, hospital orother medical receiving | The Smartheart device isintended to condition anelectrocardiographic signal sothat it can be transmitteddigitally via Bluetoothtechnology and cell-phone orcommunication device to aremote location. TheSmartheart device is designedto be used by a patient totransmit a 12 lead EGG andrhythm strip in real-time toenable review at a physician'soffice, hospital or othermedical receiving center. | EquivalentThe QT ECG Systemdiffers in that it specifiespatient types asrecommended in FDAClass II Special ControlsGuidance Document:ElectrocardiographElectrodes (July 21, 2011).The intended patientpopulation is similar tothat of the predicate.QT ECG's intended usersinclude patientsthemselves, and otherlaypersons with similarbackgrounds as the adultpatients that use theSmartheart .Other differences inwording are forclarification and conveythe same meaning. Thedifferences in indicationsfor use do not change theintended use of the deviceto acquire and transmit12-lead ECG signals from |
| The QT ECG System isintended to acquire, record andprocess an electrocardiographicsignal so that it can betransmitted digitally viaBluetooth technology to acell-phone or mobile device,then to a remote location. TheQT ECG System is indicatedfor use on adult patients andpediatric patients age 18 – 22years. It is designed to be used | |||
| Indications forUse | |||
| by a patient or other laypersonin the home, or by healthcareworkers in non-acute careclinical facilities (such asnursing homes, skilled nursingfacilities), to record andtransmit a 12-lead ECG andrhythm strip in near real-timeto enable review at aphysician's office, hospital orother medical receivingcenters. | For the device features | patients in the home. | |
| Mechanism ofAction | The ECG signals are acquiredvia the QT ECG ElectrodeStrip attached to the patient.The Electrode Strip thentransfers the ECG signals to theQT ECG Recorder that it isplugged into. Then, theRecorder sends the ECG datavia Bluetooth to the App fordisplay. The analysis moduleprovides ECG measurementfrom the collected data. Usingan algorithm to detect thepositions of feature points suchas P, Q, R, S, T. Then, calculatethe eight measurementsaccording to their definitions.And then, transmit the data to aphysician's office, hospital orother medical receiving | Electrode belt and recorder areapplied to patient. ECG isacquired and transmitted to amobile device using Bluetooth.Mobile application running onthe device displays the ECGsignal and transmits it to aremote location for subsequentclinician assessment. | EquivalentThere are no significantdifferences in themechanism of action forboth devices. |
| for review. | |||
| TechnologyOverview | The QT ECG ElectrodeStrip with 10 electrodecontacts (chest/right andleft arm/left lower belly), 4sizes available Handheld, battery poweredrecorder Records 12-lead ECG Bluetooth data transmission Mobile Application runningon mobile device | Electrode belt with 16electrode contacts (beltchest/housing chest), 1 beltsize with small - extra-largesizing Waist (square) and right arm(round) electrodes withleadwire Handheld, battery poweredrecorder Records 12-lead ECG Bluetooth data transmission Mobile Application runningon mobile device | EquivalentBoth devices use electrodecomponents withpre-placed electrodes,Bluetooth transmissionand a mobile device.They have similartechnology to acquire,record and transmit theECG signal. |
| User Interface | Recorder - on/off button,status LEDs Electrode Strip (4 sizesavailable: S, M, L, XL) Right arm (RA), left arm(LA) and left lower belly(LL) Mobile Device running theQT ECG App | Recorder - on/off button,heart shaped indicator light Electrode Belt (adjustableto 4 chest sizes: S, M, L,XL) Right arm (RA), left arm(LA) and waist electrodes(LL) Mobile Device runningSmartheart mobileapplication | EquivalentBoth devices include arecorder with attachedelectrode. Both devicesinterface with a mobiledevice running a mobileapplication. QT ECGincludes RA, LA and LLelectrodes as part of theelectrode strip whereas theSmartheart has separatewires that connect theseelectrodes to the recorder.It does not affect the safetyand performance. |
| AnatomicalLocation | Chest, arm and lower belly | Chest, armpit and waist | EquivalentBoth devices align |
| electrodes over standardECG 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 InputImpedance | 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 | |||
| RecorderAmplifier | CMRR: 97db minFrequency response:0.05~150Hz | CMRR: 80db minFrequency response:0.05~150Hz | have better ability to drivethe whole circuit and toresist environmentalinterference.EquivalentBoth devices sufficientlyreject common modesignal. |
| Recorder ECGDataTransmission | 10 seconds of continuousrhythm strip (lead II);2.5 seconds of leads: I, II, V1,V2, V3, V4, V5, V6. III, AVR,AVL and AVF are calculated atthe receiver | 12 seconds of continuousrhythm strip (lead II);2.5 seconds of leads: I, II, V1,V2, V3, V4, V5, V6.III, AVR,AVL and AVF are calculated atthe receiver | EquivalentBoth devices acquiresufficient amount ofrhythm strip anddiagnostic leads. |
| RecorderCalibration | Automatic – on power on,2mVp-p 2Hz Square wave | Automatic – on power on,2mVp-p 2Hz Square wave | Identical |
| RecorderCurrent Drain | Transmission: 180 mA max.Shutdown mode: < 1μΑ.Idle mode: 40mA typical | Transmission: 180 mA max.Shutdown mode: < 1μA.Idle mode: 40mA typical | Identical |
| RecorderBluetooth(for ECG datatransmit) | Class II | Class II | Identical |
| RecorderBattery | Rechargeable lithium battery(3.7 V) | AAA lithium (1.5 V) batteries | EquivalentBoth devices run onbattery during operation.QT ECG' battery meetsthe requirement of IEC62133. |
| Recorder | 17 hours of continuous | 6 hours of continuous | Equivalent |
| BatteryOperating Time | recording and transmission24 hours of normal use (use:standby = 1:5) with newbattery | recording and transmission | Both devices have morebattery time than neededto record an ECG. |
| Recorder ACPower | Battery charger can beconnected (not duringrecording)Output: 5V, 1AInput 90 - 264 Vrms, 47~63 Hz | Not used | EquivalentQT ECG passed the test ofelectrical safety; therefore,the difference would notaffect the safety andperformance. |
| RecorderBatterycharging time(typical) | 1.5 hour | Not applicable | EquivalentQT ECG meets therequirements of IEC60601-1 & IEC 62133;therefore, the differencewould not affect the safetyand performance. |
| Type ofprotectionagainstelectrical shock | Type: CF,non-defibrillator proof | Type: CF,non-defibrillator proof | Identical |
| RecorderStoragetemperature | -20°C~40°C | -25°C~70°C | EquivalentNarrowed storagetemperature rangeeliminates the risk to thedevice integrity fromlithium-ion battery. Thus,the subject device is safeas the predicate. |
| Electrode StripStoragetemperature | 5 °C ~27 °C | -25°C~70°C | EquivalentThe storage range of QTECG electrode strip is |
| smaller, but the differencewould not affect the safetyand performance. | |||
| Storage relativehumidity | 10% – 93%Non-condensing | 10% – 93%Non-condensing | Identical |
| Storageatmosphericpressure | 700 hPa – 1060 hPa | 700 hPa – 1060 hPa | Identical |
| Operatingtemperature | 5~40°C | 5~40°C | Identical |
| Operatingrelativehumidity | 15% – 93%Non-condensing | 15% – 93%Non-condensing | Identical |
| Operatingatmosphericpressure | 700 hPa – 1060 hPa | 700 hPa – 1060 hPa | Identical |
| RecorderPhysicalDimension | 72.00 x 68.02 x 18.60 (mm) | 110 x 85 x 15 (mm) | EquivalentBoth devices are small,hand-held sizes. Thedifference would not affectthe safety andperformance. |
| RecorderWeight | 67g (with battery) | 110g (without batteries) | EquivalentBoth devices are small andlight weight; the differencewould not affect the safetyand performance. |
| ElectricalSafety TestingPassed | IEC 60601-1:2005+CORR.1:2006+ CORR. 2:2007+ A1:2012ANSI/AAMI ES60601-1: 2005 | EN 60601-1:2006EN 60601-1-2:2007EN 60601-1-11:2010IEC 60601-2-25:2011 | EquivalentThe QT ECG meetscurrent versions ofstandards. |
| IEC 60601-1-2:2014IEC 60601-1-11:2015IEC 60601-2-25:2011 | |||
| Mobileapplication | Compatibility: iOS 10 or later;Android 5.0 or later. | Compatibility: iOS 6.0 or later;Android | EquivalentBoth devices work oncommonly availablemobile technology. |
| Mobile device | The app works on Phone:iPhone 6iPhone 6 PlusiPhone 6siPhone 6s PlusiPhone 7iPhone 7 PlusGoogle PixelSamsung Galaxy A7LG G5on Tablet:iPad Air (or later)iPad Air 2iPad Mini 2 (or later)iPad Mini 3iPad Mini 4HTC nexus 9Samsung Galaxy Tab S2 | The app works on both iOS andAndroid 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 , | EquivalentBoth devices work oncommonly availablemobile technology. |
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| 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.
§ 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).