(192 days)
Not Found
No
The document explicitly states that the analysis module provides measurements but "does not make any interpretation of the intervals provided based on factors such as heart rate, ORS duration, etc." This indicates a lack of interpretive algorithms, which would be a common application of AI/ML in ECG analysis. Furthermore, there is no mention of AI, ML, or related terms like deep learning or neural networks in the document.
No.
The device is intended for acquiring, recording, and transmitting ECG signals for review by a physician; it does not provide any therapeutic intervention or treatment.
No
The device acquires, records, and transmits electrocardiographic signals for review by a physician; it explicitly states that the "Analysis module... does not make any interpretation" and the device "does not have monitoring capabilities and does not have diagnostic alarm function," indicating it does not diagnose.
No
The device description clearly lists hardware components like the "QT ECG Recorder" and "The QT ECG Electrode Strip" as part of the system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The QT ECG System acquires, records, and transmits an electrical signal from the body (an electrocardiogram). It does not analyze or process biological specimens.
- Intended Use: The intended use is to provide ECG data for review by a physician, not to perform diagnostic tests on biological samples.
- Device Description: The components and function described are consistent with an ECG device, not an IVD.
Therefore, the QT ECG System falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on 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.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The QT 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infants, children and adults
Intended User / Care Setting
adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing facilities)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
- 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, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer Shih 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
2
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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3
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:
6
| 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 and | |
| testing 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 In | |
| Vitro Cytotoxicity. | ||
| 2-174 | ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin | |
| sensitization. | ||
| 2-191 | ISO 10993-12:2012, Biological evaluation of medical devices -- Part 12: Sample preparation and reference | |
| materials. | ||
| 2-191 | ANSI/AAMI/ISO 10993-12:2012, Biological Evaluation Of Medical Devices - Part 12: Sample Preparation | |
| And Reference Materials. | ||
| Software | ||
| Validation and | ||
| Cybersecurity | ||
| Evaluation | - | 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 requirements | |
| for the basic safety and essential performance of electrocardiographs. | ||
| Guidance on Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered | ||
| Medical Devices: 2016. | ||
| Electromagnetic | ||
| Compatibility | ||
| and Electrical | ||
| Safety | 19-4 | ANSI/AAMI ES60601-1: 2005 / A2:2010, Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance. | ||
| 19-8 | IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and | |
| essential performance - Collateral standard: Electromagnetic compatibility. | ||
| 19-14 | IEC 60601-1-11:2015, Medical electrical equipment - Part 1-11: General requirements for basic safety and | |
| essential performance - Collateral standard: Requirements for medical electrical equipment and medical | ||
| electrical systems used in the home healthcare environment. | ||
| 3-105 | IEC 60601-2-25:2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety | |
| and essential performance of electrocardiographs. | ||
| 19-13 | IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety | |
| requirements for portable sealed secondary cells, and for batteries made from them, for use in portable | ||
| applications. | ||
| Performance | 3-52 | |
| 19-13 | IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety | |
| requirements for portable sealed secondary cells, and for batteries made from them, for use in portable | ||
| applications. | ||
| Human Factor |
7
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,
8
Traditional 510(k) 510(k) Summary
| Item | Subject device | Predicate device | Substantial equivalence
determination |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brand Name | QT ECG | QT ECG | |
| Model Name | PCA 500 | - | |
| 510(k) No. | (to be assigned) | K180157 | |
| Indications for
Use | The QT ECG System is intended to acquire,
record and process an electrocardiographic
signal so that it can be transmitted digitally
via Bluetooth technology to a cell-phone or
mobile device, then to a remote location. The
QT ECG System is indicated for use on
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. | 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. | Equivalent
Both devices are designed to
acquire, record and process an
electrocardiographic signal.
The difference in patient population
has been evaluated, verified &
validated, and the difference in
wording is to specify the user more
clearly.
Above all, it does not raise new
issues 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. | Equivalent
The 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 protection
against electrical
shock | Type: CF; non-defibrillator proof | | Identical
Both devices do not have the defibrillation-proof specification and both devices have stated warning on labeling to control the relevant risk. |
| Recorder storage
and transport
temperature | -25°C70°C | -20°C40°C | Equivalent
The storage and transport condition has been tested and met its pre-defined criteria, and it does not raise new issues of SE. |
| Electrode Strip
sizes | 7 sizes: S, M, L, XL for adults,
1, 2 ,3 for pediatrics | 4 sizes: S, M, L ,XL for adults | Equivalent
The performance of new strips for pediatrics has been tested and met |
| | | | its pre-defined criteria, and it does
not raise new issues of SE. |
| Electrode Strip
materials in
contact with the
human body | Hydrogel, and
Medical grade tape | Hydrogel, and
Medical grade tape | Identical
Both devices use the same materials
on the electrode strip in contact
with the human body. |
| Electrode Strip
shelf life | 3 year | 1 year | Equivalent
The extended shelf life has been
tested and met its pre-defined
criteria, and it does not raise new
issues of SE. |
| Electrode Strip
storage and
transportation
temperature | 5°C30°C | 5°C27°C | Equivalent
The storage condition has been
tested and met its pre-defined
criteria, and it does not raise new
issues of SE. |
| Electrode Strip
operation
temperature | 5°C~30°C |