(557 days)
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.
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.
The provided text describes the QOCA Portable ECG Monitoring Device and its substantial equivalence to a predicate device, the ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service. However, it does not contain information about:
- Specific acceptance criteria values for device performance (e.g., accuracy percentages for heart rate detection or ECG capture).
- A clinical study performed to prove the device meets these criteria. The document explicitly states: "The ECG signal recorded by this device is not intended for automated analysis. This device is solely intended for manual interpretation of the recorded ECG and heart rate detection using the integrated software." This indicates that there was no algorithm with its own performance metrics validated.
- Sample sizes used for a test set, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, type of ground truth used for testing, training set sample size, or how ground truth was established for training data. These details are typically associated with clinical validation studies for AI/algorithm-driven devices, which this ECG monitoring device, as described, is not.
The document primarily focuses on demonstrating equivalence to a predicate device through physical and technical characteristics, as well as adherence to various safety and performance standards.
Here's a summary of the information that is present, organized as per your request where applicable, noting the absence of the requested details related to performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are provided in the document. The performance evaluation focuses on compliance with recognized medical device standards rather than algorithm-specific performance metrics.
| Acceptance Criteria (Not explicitly quantified in terms of algorithmic performance) | Reported Device Performance (Compliance with standards) |
|---|---|
| Biocompatibility | Conformed to ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Electrical Safety | Conformed to ANSI AAMI ES60601-1, IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Conformed to IEC 60601-1-2 |
| Home Healthcare Environment Requirements | Conformed to IEC 60601-1-11 |
| Ambulatory ECG System Performance | Conformed to IEC 60601-2-47 |
| Wireless Coexistence | Conformed to ANSI IEEE C63.27-2017 |
| Software Life Cycle Processes | Conformed to IEC 62304 |
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a clinical performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical performance study with expert-established ground truth is described.
4. Adjudication method for the test set
Not applicable. No clinical performance study involving adjudication of a test set is described.
5. 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 mentioned. The device's ECG data is intended for manual interpretation by healthcare professionals, and the device itself does not provide automated analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned. The device's ECG signal is "not intended for automated analysis" but for "manual interpretation."
7. The type of ground truth used
Not applicable. The document does not describe a performance study requiring ground truth for an algorithm.
8. The sample size for the training set
Not applicable. The device does not employ an AI algorithm requiring a training set, according to the provided text.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned for an AI algorithm.
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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
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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
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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
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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 ECGMonitoring Device |
| K number | K143513 | |
| Indications for Use | The Zio SR ECGMonitoring Service isintended to capture,analyze, and reportsymptomatic and/or | The QOCA Portable ECGMonitoring Device isintended to capturecontinuouselectrocardiogram (ECG) |
5.6 Comparison of Physical and Technological Characteristics with the Predicate Device
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| Image: Quanta Computer Inc. logo | K21017 | |
|---|---|---|
| continuouselectrocardiogram (ECG)information for long-term(up to 14 days). It isindicated for use on adultpatients 18 years or olderwho may be asymptomaticor who may suffer fromtransient symptoms such aspalpitations, shortness ofbreath, dizziness, light-headedness, pre-syncope,syncope, fatigue, or anxiety.The reported ECG metricsinclude single-lead analysison a beat by beat basis,heart rate measurement andrhythm analysis. The reportdoes not contain diagnosticinterpretation; the reportedanalysis is provided forreview by the intended userto render a diagnosis basedon clinical judgement andexperience. | information for long-term(up to 14 days). It isindicated for use on adultpatients 21 years or olderwho may be asymptomaticor who may suffer fromtransient symptoms such aspalpitations, shortness ofbreath, dizziness, light-headedness, pre-syncope,syncope, fatigue, or anxiety.ECG and heart rate data arestored in the device for laterviewing by healthcareprofessionals. | |
| 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 andSingle-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 |
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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
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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.
§ 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).