(557 days)
No
The device description explicitly states that the ECG signal is "not intended for automated analysis" and is "solely intended for manual interpretation." There is no mention of AI or ML in the document.
No
The device is described as an ECG monitoring device intended for capturing and storing ECG information for later viewing and interpretation by healthcare professionals. It does not provide any treatment or therapeutic intervention.
Yes
Explanation: The device captures continuous electrocardiogram (ECG) information from patients with various symptoms, and this data is then reviewed by healthcare professionals for later viewing and manual interpretation to potentially identify cardiac issues. This data collection and interpretation for medical insights classify it as a diagnostic device.
No
The device description explicitly states it consists of a rechargeable and reusable ECG sensor with Bluetooth technology and a single-use electrode and hydrogel patch, in addition to the optional mobile platform app. This indicates the device includes hardware components beyond just software.
No, 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 QOCA Portable ECG Monitoring Device captures and records electrical activity of the heart (ECG) directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to capture continuous ECG information for later viewing and manual interpretation by healthcare professionals. This is a physiological measurement, not an in vitro test.
The device is a physiological monitoring device, specifically an ECG recorder.
N/A
Intended Use / Indications for Use
The QOCA Portable ECG Monitoring Device is intended to capture continuous electrocardiogram (ECG) information for long-term (up to 14 days). It is indicated for use on adult patients 21 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. ECG and heart rate data are stored in the device for later viewing by healthcare professionals.
Product codes (comma separated list FDA assigned to the subject device)
DSH, DXH
Device Description
The QOCA Portable ECG Monitoring Device consists of 3 parts: a rechargeable and reusable ECG sensor with Bluetooth technology, a single-use electrode and hydrogel patch, and an optional mobile platform app (QOCA ecg App).
The QOCA Portable ECG Monitoring Device provides a continuous, single-channel recording for up to 14 days. The QOCA Portable ECG Monitoring Device records ECG without patient interaction, and patients have the option of pressing the power button on the ECG sensor to trigger an event record. Patients can also choose to use the QOCA Portable ECG Monitoring Device along with a mobile platform app so that the event trigger can be triggered with the App and the data can be transmitted via BLE from the ECG sensor to the mobile platform for display.
The subject device provides operational alarms such as lead off detection and battery monitoring. The operational alarms display on both the sensor and QOCA ecg App to inform the patient of the operation status of the sensor. The subject device does not provide any alarms based on physiological data setting.
After the recording period (up to 14 days) ends, the patient returns to his/her healthcare provider, and the data stored in the sensor can be transferred to the computer by connecting with a USB cable and viewed with QOCA ecg Reader, a non-device MDDS for displaying data.
The device is intended to be used on general care patients who are 21 years of age or older. This device is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis. This device is not intended to be used for real-time and/or continuous patient monitoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left upper chest
Indicated Patient Age Range
adult patients 21 years or older
Intended User / Care Setting
Healthcare Professionals / Ambulatory
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)
Bench testing, biocompatibility, packaging testing, shelf life, and electromagnetic compatibility testing were conducted to assure the performance and safety of the subject device. These tests were performed in accordance with the following FDA recognized standards:
- ISO 10993-1 5th Edition 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 3rd Edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 3rd Edition 2010-08-01, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ANSI AAMI EC12: 2000/(R)2015, Disposable ECG electrodes
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Ed. 4.0 2014-02, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Ed. 2.0 2015-01, 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
- IEC 60601-2-47 Ed. 2.0 2012-02, Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software – Software life cycle processes
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
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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.
August 2, 2022
Quanta Computer Inc. Vivian Yang Regulatory Affairs Specialist No. 188, Wenhua 2nd Road, Guishan District Taoyuan City, 33377 Taiwan
Re: K210179
Trade/Device Name: QOCA Portable ECG Monitoring Device Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: June 27, 2022 Received: July 1, 2022
Dear Vivian Yang:
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. You must comply with all the Act's
1
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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)
Device Name
QOCA Portable ECG Monitoring Device
Indications for Use (Describe)
The QOCA Portable ECG Monitoring Device is intended to capture continuous electrocardiogram (ECG) information for long-term (up to 14 days). It is indicated for use on adult patients 21 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety, ECG and heart rate data are stored in the device for later viewing by healthcare professionals.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Quanta Computer Inc. The logo consists of a blue letter Q on the left, with three red lines inside the Q. To the right of the Q is the text "Quanta Computer Inc." in black font. The logo is simple and modern, and the text is clear and easy to read.
510(k) Summary
5.1 General Information
| Applicant: | Quanta Computer Inc. |
|---|---|
| Address | No. 188, Wenhua 2nd Rd., Guishan Dist., Taoyuan City 33377, Taiwan (R.O.C) |
| Contact Person: | Vivian Yang |
| Contact Information: | vivian.yang@quantatw.com |
| +886-3327-2345 ext. 12928 | |
| Date Prepared: | January 19, 2021 |
5.2 Device Information
| Trade Name: | QOCA Portable ECG Monitoring Device |
|---|---|
| Common Name: | Ambulatory ECG Device |
| Classification Name: | Recorder, Magnetic Tape, Medical |
| Regulation Number: | 870.2800 |
| Product Code: | DSH, DXH |
5.3 Predicate Device
| Trade Name: | ZIO® SkyRunner (SR) Electrocardiogram (ECG)
Monitoring Service |
|-------------------------|-------------------------------------------------------------------|
| Premarket Notification: | K143513 |
| Classification Name: | Recorder, Magnetic Tape, Medical |
| Regulation Number: | 870.2800 |
| Product Code: | DSH, DQK, DXH |
5.4 Device Description
The QOCA Portable ECG Monitoring Device consists of 3 parts: a rechargeable and reusable ECG sensor with Bluetooth technology, a single-use electrode and hydrogel patch, and an optional mobile platform app (QOCA ecg App).
The QOCA Portable ECG Monitoring Device provides a continuous, single-channel recording for up to 14 days. The QOCA Portable ECG Monitoring Device records ECG without patient interaction, and patients have the option of pressing the power button on the ECG sensor to trigger an event record. Patients can also choose to use the QOCA Portable ECG Monitoring Device along with a mobile platform app so that the event trigger
4
Image /page/4/Picture/0 description: The image shows the logo for Quanta Computer Inc. The logo consists of a stylized letter "Q" in blue and red, followed by the company name in black, sans-serif font. The "Q" is made up of a blue circle with three red horizontal lines inside.
K210179
can be triggered with the App and the data can be transmitted via BLE from the ECG sensor to the mobile platform for display.
The subject device provides operational alarms such as lead off detection and battery monitoring. The operational alarms display on both the sensor and QOCA ecg App to inform the patient of the operation status of the sensor. The subject device does not provide any alarms based on physiological data setting.
After the recording period (up to 14 days) ends, the patient returns to his/her healthcare provider, and the data stored in the sensor can be transferred to the computer by connecting with a USB cable and viewed with QOCA ecg Reader, a non-device MDDS for displaying data.
The device is intended to be used on general care patients who are 21 years of age or older. This device is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software. The ECG signal recorded by this device is not intended for automated analysis. This device is not intended to be used for real-time and/or continuous patient monitoring.
5.5 Indications for Use
The QOCA Portable ECG Monitoring Device is intended to capture continuous electrocardiogram (ECG) information for long-term (up to 14 days). It is indicated for use on adult patients 21 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. ECG and heart rate data are stored in the device for later viewing by healthcare professionals.
| Predicate device | Subject device | |
|---|---|---|
| Product Name | Zio SkyRunner(SR) | |
| Electrocardiogram (ECG) | ||
| Monitoring Service | QOCA Portable ECG | |
| Monitoring Device | ||
| K number | K143513 | |
| Indications for Use | The Zio SR ECG | |
| Monitoring Service is | ||
| intended to capture, | ||
| analyze, and report | ||
| symptomatic and/or | The QOCA Portable ECG | |
| Monitoring Device is | ||
| intended to capture | ||
| continuous | ||
| electrocardiogram (ECG) |
5.6 Comparison of Physical and Technological Characteristics with the Predicate Device
5
| Image: Quanta Computer Inc. logo | K21017 | |
|---|---|---|
| continuous | ||
| electrocardiogram (ECG) | ||
| information for long-term | ||
| (up to 14 days). It is | ||
| indicated for use on adult | ||
| patients 18 years or older | ||
| who may be asymptomatic | ||
| or who may suffer from | ||
| transient symptoms such as | ||
| palpitations, shortness of | ||
| breath, dizziness, light- | ||
| headedness, pre-syncope, | ||
| syncope, fatigue, or anxiety. | ||
| The reported ECG metrics | ||
| include single-lead analysis | ||
| on a beat by beat basis, | ||
| heart rate measurement and | ||
| rhythm analysis. The report | ||
| does not contain diagnostic | ||
| interpretation; the reported | ||
| analysis is provided for | ||
| review by the intended user | ||
| to render a diagnosis based | ||
| on clinical judgement and | ||
| experience. | information for long-term | |
| (up to 14 days). It is | ||
| indicated for use on adult | ||
| patients 21 years or older | ||
| who may be asymptomatic | ||
| or who may suffer from | ||
| transient symptoms such as | ||
| palpitations, shortness of | ||
| breath, dizziness, light- | ||
| headedness, pre-syncope, | ||
| syncope, fatigue, or anxiety. | ||
| ECG and heart rate data are | ||
| stored in the device for later | ||
| viewing by healthcare | ||
| professionals. | ||
| Product Code | DSH, DQK, DXH | DSH, DXH |
| Intended Users | Healthcare Professionals | Identical |
| Patient Populations | General care, non-pediatric | General care adult patient |
| (21 years of age or older) | ||
| Environment | Ambulatory | Identical |
| Placement | Left upper chest | Identical |
| Reuse or single use | Single-use | Reusable ECG device and |
| Single-use body patch | ||
| Duration | 14 days | Up to 14 days |
| Size | Device: 1325114 mm | Device: 35358.85 mm |
| Weight: 24.7g | Patch: 13081.81.2 mm | |
| Weight: 19.5 g | ||
| Signal Transmission | BLE to gateway | BLE to mobile platform |
| Operating Temperature | 5-40°C | 5-45°C |
| IP rating | IPX4 | IP26 |
| Electrical Safety | Conformed to IEC 60601-1 | Identical |
| EMC | Conformed to IEC 60601-1-2 | Identical |
| Biocompatibility | Conformed to ISO 10993-1 | Identical |
| Performance | Conformed to IEC 60601-2-47 | Identical |
6
Quanta Computer Inc.
5.7 Summary of Performance Data
Quanta Computer Inc. (Quanta Computer) follows the requirement in 21 CFR 820.30 Design Controls and completed bench testing, biocompatibility, packaging testing, shelf life, and electromagnetic compatibility testing were conducted to assure the performance and safety of the subject device. These tests were performed in accordance with the following FDA recognized standards:
- ISO 10993-1 5th Edition 2018-08, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5 3rd Edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 3rd Edition 2010-08-01, Biological evaluation of medical devices Part ● 10: Tests for irritation and skin sensitization
- ANSI AAMI EC12: 2000/(R)2015, Disposable ECG electrodes
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and ● A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2 Ed. 4.0 2014-02, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Ed. 2.0 2015-01, 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
7
Image /page/7/Picture/0 description: The image shows the logo for Quanta Computer Inc. The logo consists of a blue circle with three red horizontal lines inside it. The text "Quanta Computer Inc." is written in bold black letters to the right of the logo.
the home healthcare environment
- IEC 60601-2-47 Ed. 2.0 2012-02, Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- ANSI IEEE C63.27-2017 American National Standard for Evaluation of Wireless ● Coexistence
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software – Software life cycle processes
5.8 Conclusion
Based on the comparison of physical and technical characteristics and the performance data, the subject device is as safe and effective as the predicate device. While the subject device does not provide an analysis report, it presents the complete recorded data for the healthcare professional to review, and this difference does not affect the safety or effectiveness. In conclusion, the subject device, OOCA Portable ECG Monitoring Device, is substantially equivalent to the predicate device.