(487 days)
Not Found
No
The summary describes a device for recording and storing ECG signals and displaying heart rate. It does not mention any analysis or interpretation of the ECG data using AI or ML. The data is transferred to an app for display and potential review by a cardiologist.
No
The device is described as an ECG recorder for monitoring and data collection, which is then to be referred to a cardiologist for diagnosis. It does not provide any treatment or therapy.
No
The device records and stores ECG measurements and displays real-time heart rate. The user can transfer data to an app and print the ECG for a cardiologist to "refer and diagnose," indicating the device itself does not perform the diagnosis.
No
The device description explicitly states it is a "wristband as wearable style" and describes hardware components like "dry electrode," "build-in memory," and "BLE" for data transfer. It also mentions electrical safety and EMC tests, which are hardware-related.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The MiCor A100 Wearable ECG Recorder directly measures electrical signals from the user's body (ECG) through electrodes on the wrist. It does not analyze samples taken from the body.
- Intended Use: The intended use is to record and monitor cardiac function based on the electrical activity of the heart, not to analyze biological samples.
Therefore, the device falls under the category of a medical device that performs a physiological measurement, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DPS
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.
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
adult
Intended User / Care Setting
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
at home health care
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)
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 I
- . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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, 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);
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
MiCor A100 Wearable ECG Recorder Appendix 8 - 510(k) Summary
Appendix 8
510(k) Summary
4
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 |
5
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.
6
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.
7
| 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 intended | ||
| for recording and transmission of user's | ||
| ECG signal simultaneously. Users with | ||
| implanted pacemaker are not | ||
| recommended to use this device. | ||
| Mechanism of | ||
| action | MiCor A100 Wearable ECG recorder | |
| is a non-invasive, wearable type ECG | ||
| recorder. It allows user to measure and | ||
| record electrical activities of the heart | ||
| anywhere and anytime. | ||
| Electrical signals of the heart can be | ||
| obtained using one finger places on | ||
| MiCor A100 wearable ECG recorder | ||
| by dry conducting electrodes (Lead 1 | ||
| ECG). It will record 30 seconds of the | ||
| ECG signal (to measure cardiac | ||
| activities), unlike traditional ECG | ||
| device which requires at least 3 | ||
| electrodes. The electrical signal goes | ||
| filters then comes out the useful ECG | ||
| data and recorder in the device. | ReadMyHeart (K042814) is a handheld, | |
| personalized use, dry electrode and | ||
| affordable ECG recording device that | ||
| records user's cardiac functions for | ||
| daily health check. | ||
| It takes ECG signals of user/patient | ||
| with thumbs press on electrode at | ||
| ReadMyHeart gently. The device will | ||
| record user's ECG signal for 30 | ||
| seconds, and automatically stores the | ||
| last 15 seconds signals into the build-in | ||
| memory, while three parameters | ||
| measured, mainly, Heart Rate (HR), ST | ||
| segment and QRS interval of cardiac | ||
| ECG signal, displays on LCD of the | ||
| device. | ||
| Users may activate the device to acquire | ||
| ECG Lead I information voluntarily and | ||
| mutually. | ||
| Technology | ||
| ECG type | Lead 1 | Lead 1 |
| Specification | ||
| Input impedance | > 10 M - Ohm | > 10 Mohm |
| Input dynamic | ||
| range | +/- 200 mV | +/-2 mV |
| Bandwidth | 0.1 - 40Hz | 0.15-40 Hz |
| CMRR | ||
| (Common Mode | ||
| Rejection 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 device | ||
| connection & data | ||
| display | Mobile application (APP) of | |
| smartphone | PC | |
| Input | Dry conduction electrodes | Dry conduction electrodes and/or |
| external auxiliary electrodes | ||
| Output / Data | ||
| transfer | Bluetooth | USB interface |
| Power supply | Non-replaceable internal | |
| Lithium 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 | – |