(487 days)
The device is intended for use by users who have transient symptoms that may suggest cardiac conduction abnormalities or by users who wants to monitor the cardiac function at home health care from Lead 1 ECG signal.
ECG acquisition and transmission is voluntary and mutually activated by the user. The intend users are adult.
The device is design to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time.
Users with implanted pacemaker are not recommended to use this device.
MiCor A100 Wearable ECG Recorder is an easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of users' heart rhythm. ECG acquisition and transmission is voluntary and mutually activated by the user. The intended users are adult. The device is designed to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time. Users with implanted pacemaker are not recommended to use this device.
The device is the wristband as wearable style. It is smaller and light weight, dry electrode and affordable ECG recording device. Its primary function is recording ECG signal of user/patient with one finger press on top of ECG plate of device. The device will record the user/patient ECG signal for 30 seconds and automatically store into build-in memory, meanwhile, the device also display the real time heart rate. The device can store 30 sets of ECG signal (30 seconds / set of data), then user can transfer ECG signal data from device to APP of the iPhone via BLE. The APP can display ECG of each recording ECG signal. And user can print the ECG and let his Cardiologist to refer and diagnose.
The provided document is a 510(k) summary for the MiCor A100 Wearable ECG Recorder. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was subjected to various non-clinical tests and "All the test results demonstrate that MiCor A100 Wearable ECG Recorder meets the requirements of its pre-defined acceptance criteria". However, the specific quantitative acceptance criteria or the detailed reported performance metrics (e.g., accuracy, sensitivity, specificity, or specific values for electrical parameters) for the MiCor A100 are not explicitly provided in the summary.
The summary lists several tests:
- Reliability Test
- Biocompatibility Test (Cytotoxicity, Skin Sensitization, Skin Irritation)
- Software Validation
- Electrical Safety and EMC Tests
- Performance Test (IEC 60601-2-47: 2012)
- Usability Test
For the Performance Test, it references IEC 60601-2-47: 2012, which would contain the standard's acceptance criteria for electrocardiographs. Without the full test report, the specific results against these criteria are not detailed in this summary.
The table below shows the specifications declared for the MiCor A100, which can be implicitly considered as performance characteristics for which the device meets acceptance:
| Performance Characteristic | Acceptance Criteria (Implicit from Specification) | Reported Device Performance (MiCor A100) |
|---|---|---|
| Input impedance | > 10 Mohm | > 10 M - Ohm |
| Input dynamic range | +/- 200 mV | +/- 200 mV |
| Bandwidth | 0.1 - 40 Hz | 0.1 - 40 Hz |
| CMRR | > 60 dB | > 60 dB |
| A/D conversion | 16 bit | 16 bit |
| Sampling rate | 250 samples/sec | 250 samples/sec |
| Measurement time | 30 seconds | 30 seconds |
| Storage ECG data | 30 measurements | 30 measurements |
| Average heart rate | 30 to 240 bpm | 30 to 240 bpm |
2. Sample Size Used for the Test Set and Data Provenance
The document is a 510(k) summary for establishing substantial equivalence through non-clinical testing. It explicitly states under "5.9 Clinical Testing": "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no "test set" of patient data for clinical performance evaluation. The "sample size" would refer to the number of devices tested during the non-clinical evaluations listed. The document does not specify the number of devices used for these non-clinical tests.
- Sample Size for Test Set: Not applicable as no clinical test data was used for substantial equivalence. For non-clinical tests, the sample size of devices is not specified.
- Data Provenance: Not applicable as no clinical data was used. The non-clinical tests were conducted by the manufacturer, MiTAC International Corp., based in Taiwan.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test data was used, there was no ground truth based on patient data established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study or any clinical study was performed or referenced in this 510(k) summary. The evaluation focuses solely on non-clinical aspects and comparison to a predicate device.
6. Standalone Performance Study
A "standalone" performance in the context of an algorithm or AI would typically refer to its diagnostic accuracy without human intervention. Since this device is an ECG recorder, not an AI-driven interpretation system, the concept of a standalone algorithm performance in the diagnostic sense is not directly applicable. The device's performance tests (e.g., IEC 60601-2-47) evaluate its ability to accurately record ECG signals according to technical standards. The summary reports that these tests were conducted and met the predefined acceptance criteria, which can be considered its standalone technical performance.
7. Type of Ground Truth Used
For the non-clinical performance evaluations, the "ground truth" would be established by the technical standards (e.g., IEC 60601-2-47) and measurement equipment calibrated to those standards. There is no biological or expert-derived ground truth as no clinical data was used.
8. Sample Size for the Training Set
Not applicable. The MiCor A100 Wearable ECG Recorder is a data acquisition device, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
January 26, 2018
MiTAC International Corp. Yihao Huang Product Manager No. 200, Wen Hua 2nd Rd. Guishan Dist. Taoyuan City, 33383 Taiwan
Re: K162665
Trade/Device Name: MiCor A100 Wearable ECG Recorder Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 26, 2017 Received: December 29, 2017
Dear Yihao Huang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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Page 2 - Yihao Huang
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willehenne
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162665
Device Name MiCor A100 Wearable ECG Recorder Form Approved: OMB No. 0910-0120
Indications for Use (Describe)
The device is intended for use by users who have transient symptoms that may suggest cardiac conduction abnormalities or by users who wants to monitor the cardiac function at home health care from Lead 1 ECG signal.
ECG acquisition and transmission is voluntary and mutually activated by the user. The intend users are adult.
The device is design to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time.
Users with implanted pacemaker are not recommended to use this device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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MiCor A100 Wearable ECG Recorder Appendix 8 - 510(k) Summary
Appendix 8
510(k) Summary
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MiCor A100 Wearable ECG Recorder Appendix 8 - 510(k) Summary
510(k) Summary
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of Summary: | 01/17/2017 |
| 5.3 | Submitter: | MiTAC International CORP. |
| Address: | No. 200, Wen Hua 2nd Rd., Guishan Dist., | |
| Taoyuan City 33383, Taiwan (R.O.C.) | ||
| Phone: | + 886-3-396-2888 | |
| Fax: | + 886-3-396-1000 | |
| Contact: | YiHao Huang (yihao.huang@mic.com.tw) |
5.4 Identification of the Device:
| Proprietary/Trade name: | MiCor A100 Wearable ECG Recorder |
|---|---|
| Regulation Description: | Electrocardiograph |
| Review Panel: | Cardiovascular |
| Regulation Number: | 870.2340 |
| Device Class: | II |
| Product Code: | DPS |
રત્ત Identification of the Predicate Device:
| Predicate Device Name: | ReadMyHeart |
|---|---|
| Manufacturer: | DailyCare BioMedical Inc. |
| Regulation Number: | 870.2340 |
| Device Class: | II |
| Product Code: | DPS |
| 510(k) Number: | K042814 |
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5.6 Intended Use/ Indications for Use of the subject device
The device is intended for use by users who have transient symptoms that may suggest cardiac conduction abnormalities or by users who wants to monitor the cardiac function at home health care from Lead 1 ECG signal.
ECG acquisition and transmission is voluntary and mutually activated by the user. The intend users are adult.
The device is design to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time.
Users with implanted pacemaker are not recommended to use this device.
5.7 Device Description
MiCor A100 Wearable ECG Recorder is an easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of users' heart rhythm. ECG acquisition and transmission is voluntary and mutually activated by the user. The intended users are adult. The device is designed to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time. Users with implanted pacemaker are not recommended to use this device.
The device is the wristband as wearable style. It is smaller and light weight, dry electrode and affordable ECG recording device. Its primary function is recording ECG signal of user/patient with one finger press on top of ECG plate of device. The device will record the user/patient ECG signal for 30 seconds and automatically store into build-in memory, meanwhile, the device also display the real time heart rate. The device can store 30 sets of ECG signal (30 seconds / set of data), then user can transfer ECG signal data from device to APP of the iPhone via BLE. The APP can display ECG of each recording ECG signal. And user can print the ECG and let his Cardiologist to refer and diagnose.
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5.8 Non-clinical Testing
A series of safety and performance tests were conducted on the proposed device, MiCor A100 Wearable ECG Recorder.
- Reliability Test
- . Biocompatibility Test
- In Vitro Cytotoxicity Test
- Skin Sensitization Study (Maximization Test) –
- White Rabbit Skin Irritation Test ।
- . Software Validation
- . Electrical Safety and EMC Tests
- . Performance Test
- IEC 60601-2-47: 2012
- . Usability Test
All the test results demonstrate that MiCor A100 Wearable ECG Recorder meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device.
5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
Substantial Equivalence Determination 5.10
The MiCor A100 Wearable ECG Recorder has the same safety and performance claims, and similar technological characteristics to the predicate device, ReadMyHeart (K042814). A series of tests were performed and demonstrated substantial equivalence between the proposed and the predicate device. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.
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| Item | Proposed device | Predicate device |
|---|---|---|
| Proprietary name | MiCor A100 Wearable ECG Recorder | ReadMyHeart |
| 510(k) No. | - | K042814 |
| Intended use | The device is intended for use by users who have transient symptoms that may suggest cardiac conduction abnormalities or by users who wants to monitor the cardiac function at home health care from Lead 1 ECG signal.ECG acquisition and transmission is voluntary and mutually activated by the user. The intend users are adult.The device is design to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time.Users with implanted pacemaker are not recommended to use this device. | The device is a personal single lead Electrocardiograph monitor. The device is intended for self-testing by patients by recording 15 seconds of the first standard lead I of Electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician. The intended user are Users who are above 20 years old.The user is normally not required to apply electrode on the body. Two electrodes integrated within the device are provided. The user has to press his thumbs on the two electrodes in order record the ECG signal.The User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason.The recorded data can be downloaded to Personal Computer via USB interface port. This device is not intended for use as precisely diagnostic |
| tool. This device is also not intendedfor recording and transmission of user'sECG signal simultaneously. Users withimplanted pacemaker are notrecommended to use this device. | ||
| Mechanism ofaction | MiCor A100 Wearable ECG recorderis a non-invasive, wearable type ECGrecorder. It allows user to measure andrecord electrical activities of the heartanywhere and anytime.Electrical signals of the heart can beobtained using one finger places onMiCor A100 wearable ECG recorderby dry conducting electrodes (Lead 1ECG). It will record 30 seconds of theECG signal (to measure cardiacactivities), unlike traditional ECGdevice which requires at least 3electrodes. The electrical signal goesfilters then comes out the useful ECGdata and recorder in the device. | ReadMyHeart (K042814) is a handheld,personalized use, dry electrode andaffordable ECG recording device thatrecords user's cardiac functions fordaily health check.It takes ECG signals of user/patientwith thumbs press on electrode atReadMyHeart gently. The device willrecord user's ECG signal for 30seconds, and automatically stores thelast 15 seconds signals into the build-inmemory, while three parametersmeasured, mainly, Heart Rate (HR), STsegment and QRS interval of cardiacECG signal, displays on LCD of thedevice.Users may activate the device to acquireECG Lead I information voluntarily andmutually. |
| Technology | ||
| ECG type | Lead 1 | Lead 1 |
| Specification | ||
| Input impedance | > 10 M - Ohm | > 10 Mohm |
| Input dynamicrange | +/- 200 mV | +/-2 mV |
| Bandwidth | 0.1 - 40Hz | 0.15-40 Hz |
| CMRR(Common ModeRejection Ratio) | > 60 dB | > 60 dB |
| A/D conversion | 16 bit | 12 bit |
| Sampling rate | 250 samples/sec | 250 samples/sec |
| Measurement time | 30 seconds | 30 seconds |
| Storage ECG data | 30 measurements | 25 measurements |
| Feature | ||
| Use type | Wearable | handheld |
| Display on device | 72x32 Dot – OLED | LCD display |
| Other deviceconnection & datadisplay | Mobile application (APP) ofsmartphone | PC |
| Input | Dry conduction electrodes | Dry conduction electrodes and/orexternal auxiliary electrodes |
| Output / Datatransfer | Bluetooth | USB interface |
| Power supply | Non-replaceable internalLithium Ion battery / Rechargeable | 1.5 V (AAA) ×2 |
| Measurement range | ||
| Average heart rate | 30 to 240 bpm | 45 to 180 bpm |
| ST segment | – | -3 to +3 mm |
| QRS interval | – | < 0.20 sec |
| Size | ||
| Dimension | 45.6 x 21.4 x 11.3 (mm) | 12 x 8 x 2 cm |
| Weight | 24.5g | 116 g excluding batteries |
| Environmental conditions | ||
| Storagetemperature | -25 °C to 70 °C | -20 °C to 50 °C |
| Operatingtemperature | 5 °C to 45 °CECG plate: 46 °C (Max.) | 10 °C to 40 °C |
| Humidity | 10 % to 95 % | 25 % to 95 % |
| Atmospherepressure | 800 - 1013 hPa | – |
| Compliance | ||
| Test | IEC 60601-2-47 | IEC 60601-2-47IEC 60601-2-25 |
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5.11 Similarity and Difference
Although the specification and features are different between the proposed and the predicate device, they have the same safety and performance claims, and similar technological characteristics. The proposed device has been conducted on safety and performance tests, and the results complied with the test requests. After comparison analysis considering test results, the difference of the proposed and the predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in safety and performance claims.
5.12 Conclusion
After analyzing non-clinical studies and safety testing data, it can be concluded that MiCor A100 Wearable ECG Recorder is substantially equivalent to the predicate device.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).