(192 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 infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as 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 OT ECG system is a non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The OT ECG system consists of 5 major components:
- ·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, then send the recorded data via cloud to a certified medical professional for review.
- . Analysis - The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, ORS duration, etc.
- . 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 infants, children and adults 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.
The provided text is a 510(k) Summary for the QT Medical, Inc. QT ECG device (K220795). This document primarily focuses on establishing substantial equivalence to a predicate device (K180157) and outlines various non-clinical testing performed to show safety and performance. However, it does not contain the detailed clinical study information typically required to describe acceptance criteria and the study that proves the device meets those criteria for an AI/ML enabled medical device.
The document states:
- "All the test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria and indication for use, and is substantially equivalent to the predicate device." (Page 5)
- "Although there are some different specifications between two devices, the software validation, performance test and usability test 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 also undergone all safety and performance tests, and the results complied with the test requests." (Page 14)
These statements indicate that acceptance criteria exist and were met through testing. However, the document lists these tests as "Non-clinical Testing" including biocompatibility, software validation, cybersecurity, electromagnetic compatibility, electrical safety, performance (of electrode and recorder, durability, wireless interference), and human factors (usability). These are engineering and regulatory compliance tests, not a clinical study proving diagnostic or predictive performance against specific clinical acceptance criteria for an AI/ML algorithm's output.
The device description on page 5 explicitly mentions:
- "Analysis - The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc."
- "The QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function." (Page 5)
This indicates that the "Analysis module" performs basic ECG measurements (e.g., intervals, durations) but does not provide diagnostic interpretations or AI-driven insights that would require validation through a clinical study with expert ground truth. The device's function is data acquisition and transmission, not automated diagnosis or interpretation. Therefore, a clinical study of the device's diagnostic performance, as might be done for an AI/ML device that provides interpretations, is not described because it appears not to be within the scope of this device's intended use or capabilities.
Given the information provided in the document, I cannot create the requested table or answer most of the questions because the device does not include an AI/ML component for diagnostic interpretation and the detailed clinical study information is not present. The "performance test" mentioned in the non-clinical testing section likely refers to technical specifications for ECG signal acquisition and transmission, not clinical outcome or interpretative accuracy.
Therefore, the following table and answers are based on the absence of such information in the provided document, reflecting that this device's clearance did not hinge on an AI/ML diagnostic performance study.
Acceptance Criteria and Device Performance (Based on available information)
The provided submission does not detail acceptance criteria related to AI/ML diagnostic performance as the device's "Analysis module" performs raw ECG measurement without interpretation or diagnostic capabilities. The acceptance criteria mentioned are general for device functionality, safety, and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criterion (if available from this document) | Reported Device Performance (if available from this document) |
|---|---|---|
| AI/ML Diagnostic/Interpretative Performance | Not applicable; device performs measurement, not interpretation. | Not applicable; device performs measurement, not interpretation. |
| Biocompatibility | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Software Validation & Cybersecurity | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Electromagnetic Compatibility & Electrical Safety | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Performance (general device) | - (Met predefined criteria for electrode, recorder, durability, measurement, wireless interference) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Human Factors (Usability) | - (Met predefined criteria) | "test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria." |
| Substantial Equivalence | Demonstrated equivalence to K180157 | "QT ECG is substantially equivalent to the predicate device." |
Answers to Specific Questions (Based on available information):
-
A table of acceptance criteria and the reported device performance:
(See table above. Note: This device is not described as having an AI/ML diagnostic component, so the clinical performance criteria typically associated with such devices are not present.) -
Sample sizes used for the test set and the data provenance:
The document mentions general "validation activities" and "performance tests" but does not specify sample sizes for test sets related to clinical performance or diagnostic accuracy. The data provenance (e.g., country of origin, retrospective/prospective) for any specific performance testing is also not provided. The testing described appears to be primarily engineering and regulatory compliance testing rather than clinical study data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable/Not provided. Since the device states it "does not make any interpretation" and "does not have diagnostic alarm function," there's no indication that expert-established ground truth for diagnostic or interpretative performance was required or used in this submission. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Not provided. No clinical diagnostic test set or adjudication method is described in this document. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was done or described. The device does not appear to provide AI assistance for human interpretation, as its analysis module only provides measurements, not interpretations. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone diagnostic performance study was done or described as the device's analysis module explicitly states it "does not make any interpretation." -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided regarding diagnostic ground truth, for reasons stated above. The ground truth for the non-clinical performance tests would be defined by engineering standards and specifications. -
The sample size for the training set:
Not applicable/Not provided. As the device's "Analysis module" performs measurements rather than AI-driven interpretations, there's no mention of a training set for a machine learning algorithm. -
How the ground truth for the training set was established:
Not applicable/Not provided. (See answer to question 8).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 26, 2022
QT Medical, Inc. Jackal Chen Department Director 1360 Valley Vista Drive. Suite 203 Diamond Bar, California 91765
Re: K220795
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: August 25, 2022 Received: August 29, 2022
Dear Jackal Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220795
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 infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing facilities), to record and transmit a 12lead 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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Traditional 510(k) 510(k) Summary
510(k) SUMMARY
- Type of Submission: Traditional 5.1
- Date of Summary: 03/07/2022 5.2
| 5.3 Submitter: | QT MEDICAL, Inc. |
|---|---|
| Address: | 1360 Valley Vista Drive, Suite 203, Diamond Bar,CA 91765, US |
| Phone: | 1-909-323-0007 |
| Fax: | 1-310-755-3108 |
| Representative: | Ruey-Kang Chang, CEO(rk.chang@qtmedical.com) |
Identification of the Device: 5.4
| 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 |
ર્ રંડ Identification of the Predicate Device:
| Predicate Device Name: | QT ECG |
|---|---|
| Manufacturer: | QT MEDICAL, Inc. |
| Classification Product Code: | DXH |
| Regulation number: | 870.2920 |
| Device Class: | II |
| 510(k) Number: | K180157 |
5.6 Indications for 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
{4}------------------------------------------------
Traditional 510(k) 510(k) Summary
to a remote location. The OT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults 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 OT 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 OT ECG System is designed to be used by an adult 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 center.
5.7 Device Description
The OT ECG system is a non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The OT ECG system consists of 5 major components:
- ·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, then send the recorded data via cloud to a certified medical professional for review.
- . Analysis - The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, ORS duration, etc.
- . 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
{5}------------------------------------------------
Traditional 510(k) 510(k) Summary
not have diagnostic alarm function. The QT ECG System is intended for use on infants, children and adults 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.
5.8 Non-clinical Testing
A series of validation activities were conducted on the subject device, QT ECG.
- . Biocompatibility
- in vitro cytotoxicity test -
- white rabbit skin irritation test -
- skin sensitization study (maximization test)
- . Software validation and cybersecurity evaluation
- . Electromagnetic compatibility and electrical safety
- electrical safety test -
- external defibrillation assessment -
- The system is not defibrillation-proof. The defibrillation safety assessment manifests that the patient's safety is assured.
- -EMC test
- cable performance test
- electrical safety in home healthcare environment
- battery safety test
- . Performance
- performance test of electrode and the recorder -
- durability and measurement test of the system -
- wireless interference test -
- Human Factor (Usability) .
All the test results demonstrate OT ECG meets the requirements of its pre-defined acceptance criteria and indication for use, and is substantially equivalent to the predicate device.
The list of claimed standards and regulations for compliance:
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| Testing Item | FDA Recognition No. | Standards and Regulations Applied |
|---|---|---|
| Biocompatibility | - | Good Laboratory Practice for Nonclinical Laboratory Studies. Title 21 of the U.S. Code of Federal Regulations,Part 58 United States Food and Drug Administration. |
| - | Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process". | |
| 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. | |
| 2-245 | ANSI/AAMI/ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For InVitro Cytotoxicity. | |
| 2-174 | ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skinsensitization. | |
| 2-191 | ISO 10993-12:2012, Biological evaluation of medical devices -- Part 12: Sample preparation and referencematerials. | |
| 2-191 | ANSI/AAMI/ISO 10993-12:2012, Biological Evaluation Of Medical Devices - Part 12: Sample PreparationAnd Reference Materials. | |
| SoftwareValidation andCybersecurityEvaluation | - | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: 2005. |
| - | Guidance on Off-The-Shelf Software Use in Medical Devices: 2019. | |
| - | Guidance for content of Premarket Submissions for Management of Cybersecurity in Medical Devices: 2014. | |
| 13-79 | IEC 62304:2006+AMD1:2015, Medical device software - Software life cycle processes. | |
| 5-125 | ISO 14971:2019, Medical devices - Application of risk management to medical devices. | |
| 3-105 | ANSI/AAMI/IEC 60601-2-25:2011/(R)2016, Medical electrical equipment - Part 2-25: Particular requirementsfor the basic safety and essential performance of electrocardiographs. | |
| Guidance on Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-PoweredMedical Devices: 2016. | ||
| ElectromagneticCompatibilityand ElectricalSafety | 19-4 | ANSI/AAMI ES60601-1: 2005 / A2:2010, Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance. |
| 19-8 | IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral standard: Electromagnetic compatibility. | |
| 19-14 | IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety andessential performance - Collateral standard: Requirements for medical electrical equipment and medicalelectrical 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 safetyand essential performance of electrocardiographs. | |
| 19-13 | IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells, and for batteries made from them, for use in portableapplications. | |
| Performance | 3-52 | |
| 19-13 | IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells, and for batteries made from them, for use in portableapplications. | |
| Human Factor |
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Traditional 510(k) 510(k) Summary
Substantial Equivalence Determination 5.9
The QT ECG submitted in this 510(k) file is compared with the cleared device, former QT ECG (K180157). Differences between the devices are cited as below, and other technological specifications are all the same as that of K180157. The patient population is extended,
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Traditional 510(k) 510(k) Summary
| Item | Subject device | Predicate device | Substantial equivalencedetermination |
|---|---|---|---|
| Brand Name | QT ECG | QT ECG | |
| Model Name | PCA 500 | - | |
| 510(k) No. | (to be assigned) | K180157 | |
| Indications forUse | The QT ECG System is intended to acquire,record and process an electrocardiographicsignal so that it can be transmitted digitallyvia Bluetooth technology to a cell-phone ormobile device, then to a remote location. TheQT ECG System is indicated for use oninfants, children and adults. It is designed tobe operated by adults in the home, or byhealthcare workers in non-acute care clinicalfacilities (such as nursing homes, skillednursing facilities), to record and transmit a12-lead ECG and rhythm strip in nearreal-time to enable review at a physician'soffice, hospital or other medical receivingcenters. | The QT ECG System is intended to acquire,record and process an electrocardiographicsignal so that it can be transmitted digitally viaBluetooth technology to a cell-phone or mobiledevice, then to a remote location. The QT ECGSystem is indicated for use on adult patients andpediatric patients age 18 – 22 years. It isdesigned to be used by a patient or otherlayperson in the home, or by healthcare workersin non-acute care clinical facilities (such asnursing homes, skilled nursing facilities), torecord and transmit a 12-lead ECG and rhythmstrip in near real-time to enable review at aphysician's office, hospital or other medicalreceiving centers. | EquivalentBoth devices are designed toacquire, record and process anelectrocardiographic signal.The difference in patient populationhas been evaluated, verified &validated, and the difference inwording is to specify the user moreclearly.Above all, it does not raise newissues of SE. |
so the risk management and verification & validation activities in our design and development control process are all completed.
{9}------------------------------------------------
| QT MEDICAL, Inc. |
|---|
| QT ECG |
Traditional 510(k)
510(k) Summary
| 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 an adult 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 center. | 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 center. | EquivalentThe intended use for both devices is the same.The difference in wording is to specify the user more clearly, and it does not raise new issues of SE. |
|---|---|---|---|
| Type of protectionagainst electricalshock | Type: CF; non-defibrillator proof | IdenticalBoth devices do not have the defibrillation-proof specification and both devices have stated warning on labeling to control the relevant risk. | |
| Recorder storageand transporttemperature | -25°C~70°C | -20°C~40°C | EquivalentThe storage and transport condition has been tested and met its pre-defined criteria, and it does not raise new issues of SE. |
| Electrode Stripsizes | 7 sizes: S, M, L, XL for adults,1, 2 ,3 for pediatrics | 4 sizes: S, M, L ,XL for adults | EquivalentThe performance of new strips for pediatrics has been tested and met |
| its pre-defined criteria, and it doesnot raise new issues of SE. | |||
| Electrode Stripmaterials incontact with thehuman body | Hydrogel, andMedical grade tape | Hydrogel, andMedical grade tape | IdenticalBoth devices use the same materialson the electrode strip in contactwith the human body. |
| Electrode Stripshelf life | 3 year | 1 year | EquivalentThe extended shelf life has beentested and met its pre-definedcriteria, and it does not raise newissues of SE. |
| Electrode Stripstorage andtransportationtemperature | 5°C~30°C | 5°C~27°C | EquivalentThe storage condition has beentested and met its pre-definedcriteria, and it does not raise newissues of SE. |
| Electrode Stripoperationtemperature | 5°C~30°C | < 32°C | EquivalentThe operation condition has beentested and met its pre-definedcriteria, and it does not raise newissues of SE. |
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Traditional 510(k) 510(k) Summary
{11}------------------------------------------------
Traditional 510(k)
510(k) Summary
| Item | Subject device | Predicate device | |
|---|---|---|---|
| Brand Name | QT ECG | QT ECG | Substantial equivalence |
| Model Name | PCA 500 | determination | |
| 510(k) No. | (to be assigned) | K180157 | |
| App modules | add Configuration module | • Recorder control module• ECG data module• User/Patient identification module | EquivalentThe added or modified moduleshave been tested and met itspre-defined criteria, and it does notraise new issues of SE. |
| Web Servicemodules | change User management module toAuthentication moduleadd RBAC module, Organizationmodule, and Configuration module | • User management module• ECG data storage module• Report module | |
| Analysis modules | add Pre-processing module and Noisedetection module | Measurement module | |
| Mobile | on Phone: | iOS 10 or later; | |
| application | iPhone 11 Pro Max (iOS 13.5) | Android 5.0 or later. | |
| Mobile device | iPhone 11 Pro (iOS 13.5) | on Phone: | EquivalentThe mobile device compatibility has been tested and met its pre-defined criteria, and it does not raise new issues of SE. |
| iPhone 11 (iOS 13.5) | iPhone 6, 6 Plus, 6s, 6s Plus | ||
| iPhone XS Max (iOS 13.5) | iPhone 7, 7 Plus | ||
| iPhone XS (iOS 13.5) | Google Pixel | ||
| iPhone XR (iOS 13.5) | Samsung Galaxy A7 | ||
| iPhone X (iOS 13.5) | LG G5 | ||
| iPhone 8/ 8 Plus (iOS 13.5) | |||
| iPhone 7/ 7 Plus (iOS 13.5) | on Tablet: | ||
| iPhone 6S/ 6S Plus (iOS 13.5) | iPad Air (or later) | ||
| iPhone 6/ 6 Plus (iOS 12.4.7) | iPad Air 2 | ||
| iPhone SE (iOS 13.5) | iPad Mini 2 (or later) | ||
| iPhone SE 2 (iOS 13.5) | iPad Mini 3 | ||
| iPod touch (6th) (iOS 12.4.7) | iPad Mini 4 | ||
| Samsung Galaxy S9 (Android 9) | HTC nexus 9 | ||
| Samsung Galaxy S9+ (Android 9) | Samsung Galaxy Tab S2 | ||
| Samsung Galaxy S8 (Android 9) | |||
| Samsung Galaxy S8+ (Android 9) | |||
| LG G7 (Android 8.0.0) | |||
| LG G6 (Android 8.0.0) | |||
| LG G5 (Android 8.0.0) | |||
| Google Pixel 2 (Android 10) | |||
| Google Pixel 2 XL (Android 10) | |||
| Google Pixel (Android 10) | |||
| Google Pixel XL (Android 10) | |||
| on Tablet: | |||
| iPad 7th/2019 (iOS 13.5) | |||
| iPad 6th/2018 (iOS 13.5) | |||
| iPad 5th/2017 (iOS 13.5) | |||
| iPad mini 5 (iOS 13.5) | |||
| iPad mini 4 (iOS 13.5) | |||
| iPad mini 3 (iOS 12.4.7) | |||
| QT MEDICAL, Inc.QT ECG | Traditional 510(k)510(k) Summary | ||
| iPad mini 2 (iOS 12.4.7) | |||
| iPad Air 2 (iOS 13.5) | |||
| iPad Air 1 (iOS 12.4.7) | |||
| Samsung Tab S4 (Android 9) | |||
| Samsung Tab S3 (Android 9) | |||
| Samsung Tab S2 (Android 7.0) | |||
| Samsung Tab A 10.1" 2019 (Android 9) | |||
| Lenovo Tab 4 8 Plus (Android 8.1.0) | |||
| Asus Zenpad 3s 10 (Android 7.0) | |||
| Asus Zenpad 3 8.0 (Android 7.0) |
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Traditional 510(k) 510(k) Summary
{13}------------------------------------------------
{14}------------------------------------------------
5.10 Similarity and Difference
The QT ECG has been compared with former "QT ECG". The subject device has similar indications for use, same technology/mechanism of action, and similar safety and performance as the predicate device. The patient population is extended to infant and children in the subject device, which is operated through 3 new sizes Electrode Strip.
Although there are some different specifications between two devices, the software validation, performance test and usability test 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 also undergone all 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.
5.11 Conclusion
After analyzing all testing data and comparing with predicated device, 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).