CheckMyHeart Plus

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the agency's acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 5, 2018 DailyCare Biomedical, Inc Ming Lee Management Representative 7f, No. 1, Ding-An Rd, Zhongli Dist. Taoyuan City, Taoyuan, Taiwan 320 Re: K172778 Trade/Device Name: CheckMyHeart Plus Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 5, 2018 Received: June 8, 2018 Dear Ming Lee: 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 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. Wilhelmen for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K172778 Device Name CheckMyHeart Plus ## Indications for Use (Describe) CheckMyHeart Plus is intended to record, recall, store and transfer Lead I ECG signals for home health care use. The intended users are adults above 21 years old. This device is not intended to substitute for a hospital diagnostic ECG device. This device is also not intended for recording and transmission of user's ECG signals simultaneously. 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) ## 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 Drug 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." FORM FDA 3881 (8/14) {3}------------------------------------------------ 510(k) Summary K172778 Page 1 of 10 # 510(k) Summary This 510 (K) summary is being submitted in accorndance with requirements of Title 21,CFR Section 807.92. 510(K) Number : K172778 | 1. | SUBMITTER | DAILYCARE BIOMEDICAL INC | |----|-----------------|------------------------------------------------------------| | | | 7f, No. 1, Ding-An Rd, Zhongli Dist. Taoyuan City | | | | Taoyuan, TAIWAN (CHINA) 320 | | | Contact Person: | Joanne Tsai, Regulatory Affairs Engineer | | | | Tel: +886-3-263-1168 ext.318 | | | | Fax: +886-3-462-7866 | | | | E-mail: ctsai@dcbiomed.com | | | Date Prepared: | May 18th, 2018 | | 2. | DEVICE | Name of Device: CheckMyHeart Plus | | | | Common or Usual Name: Electrocardiograph | | | | Model Number: CMH 4.0 | | | | Classification Name: Electrocardiograph (21 CFR | | | | 870.2340) | | | | Regulatory Class: II | | | | Product Code: DPS | | | | Review Panel: Cardiovascular | | 3. | PREDICATE | READMYHEART, MODEL RMH3.0, K050620 | | | DEVICE | | | 4. | DEVICE | CheckMyHeart Plus is intended to record, recall, store and | | | DESCRIPTION | transfer single lead electrocardiographic monitor for | | | | recording and displaying real-time ECG data for home | | | | health care use. The intended users are adults above 21 | | | | years old who might experience transient symptoms that | | | | may suggest cardiac conduction abnormity or by adult | {4}------------------------------------------------ users whenever they want to have routine checks. This device is not intended to substitute for a hospital diagnostic ECG device. ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis. CheckMyHeart Plus 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 users with thumbs press on electrode at CheckMyHeart Plus gently. The device will record user's ECG signal for 300 seconds, and automatically stores signals into the build-in memory. Standard accessories: - A. CheckMyHeart Plus Heart rate Variability (HRV) analysis Software CD X 1 - B. USB Cable X 1 - ડ. INDICATION FOR CheckMyHeart Plus is intended to record, recall, and store USE and transfer Lead I ECG signals for home health care use. The intended users are adults above 21 years old. This device is not intended to substitute for a hospital diagnostic ECG device. This device is also not intended for recording and transmission of user's ECG signals simultaneously. {5}------------------------------------------------ # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE | CheckMyHeart<br>Plus (CMH 4.0) | READMYHEART<br>(RMH3.0) | Similarity | Difference | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CheckMyHeart Plus<br>is intended to record,<br>recall, store and<br>transfer single lead<br>electrocardiographic<br>monitor for<br>recording and<br>displaying real-time<br>ECG data for home<br>health care use. The<br>intended users are<br>adults above 21<br>years old who might<br>experience transient<br>symptoms that may<br>suggest cardiac<br>conduction<br>abnormity or by<br>adult users whenever<br>they want to have<br>routine checks. This<br>device is not<br>intended to<br>substitute for a<br>hospital diagnostic | The device is<br>intended for home<br>use by users who<br>might have transient<br>symptoms that may<br>suggest cardiac<br>conduction<br>abnormity or by<br>users who want to<br>monitor the cardiac<br>function for HOME<br>HEALTH CARE<br>from Lead I ECG<br>signal. ECG<br>acquisition and<br>transmission is<br>voluntary and<br>mutually activated<br>by the user. The<br>intended users are<br>adults above 20<br>years old. This<br>device is not<br>intended for use as<br>precisely diagnostic | Both CheckMyHeart<br>Plus and<br>READMYHEART<br>are<br>electrocardiographic<br>monitor for<br>recording and<br>displaying real-time<br>ECG data for the<br>purpose of home<br>health care use. The<br>users for<br>CheckMyHeart Plus<br>and<br>READMYHEART<br>can measure the<br>parameter of heart<br>rate variability<br>(HRV) in RR<br>interval. Their target<br>population aims to<br>the adults above 20<br>years old who might<br>experience cardiac<br>conduction | Originally,<br>READMYHEART<br>can only let users<br>to see the outcome<br>of measurement on<br>the computer with<br>proper software<br>installation.<br>CheckMyHeart<br>Plus is basically an<br>upgrade model of<br>READMYHEART.<br>The upgrade<br>feature in<br>CheckMyHeart is<br>to show the user<br>real-time signal<br>output on the<br>screen of the<br>device. | | | | | | | ECG device. ECG<br>acquisition and<br>transmission can be<br>voluntarily and<br>mutually activated<br>by the adult users for<br>the purpose of<br>healthcare<br>management and<br>reference for<br>healthcare<br>professionals. This<br>device provides a<br>parameter of heart<br>rate variability<br>(HRV) in RR<br>interval which is<br>only mathematical<br>analysis and is not<br>intended to produce<br>any interpretation of<br>those measurements<br>or any kind of<br>diagnosis. | tool. This device is<br>also not intended for<br>recording and<br>transmission of<br>user's ECG signal<br>simultaneously. This<br>device provides a<br>parameter of heart<br>rate variability<br>(HRV) in RR<br>interval which is<br>only mathematical<br>analysis and is not<br>intended to produce<br>any interpretation of<br>those measurements<br>or any kind of<br>diagnosis.<br>The device detects<br>the appearance of<br>irregular heart beat<br>(IHB) during<br>measurement, and<br>gives a warning<br>signal with the<br>reading once the<br>irregular heartbeat is<br>detected. Users with<br>implanted<br>pacemaker are not | abnormity or by<br>adult users whenever<br>they want to have<br>routine checks. They<br>both are not<br>intended to<br>substitute for a<br>hospital diagnostic<br>ECG device.<br>All the materials,<br>components, energy<br>source and features<br>are the same in<br>CheckMyHeart Plus<br>and<br>READMYHEART | | - A. {6}------------------------------------------------ {7}------------------------------------------------ | recommended to use<br>this device. | | | |------------------------------------|--|--| |------------------------------------|--|--| #### B. Technological Characteristics | Item | CheckMyHeart<br>Plus (CMH 4.0) | READMYHEA<br>RT (RMH3.0) | Similarity | Difference | |------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------|------------| | Input impedance | > 20 M Ohm | > 10M<br>Ohm | | Yes | | Input dynamic<br>range | +/- 3 mV | +/- 2 mV | | Yes | | Bandwidth | 0.1 - 40 Hz | 0.15 ~ 40<br>Hz | Yes | | | CMRR<br>(Common Mode<br>Rejection Ratio) | > 95 dB | > 60 dB | | Yes | | A/D conversion | 12 bits | 12 bits | Yes | | | Sampling Rate | 250 samples/sec | 250<br>samples/sec | Yes | | | Measurement<br>Time | 300 seconds | 300seconds | Yes | | | Display | 240×128<br>Dot-matrix LCD<br>display | LCD<br>display<br>panel | Yes | | | Input | Dry conduction<br>electrodes | Dry<br>conduction<br>electrodes<br>and/or<br>external<br>auxiliary<br>electrodes<br>and<br>conductive<br>adhesive<br>ECG pads | Yes | | | Output | USB interface | USB<br>interface | Yes | | | Power Supply | 1.5V (AAA) x 2 | 1.5V | Yes | | {8}------------------------------------------------ | | | (AAA) x 2 | | | |----------------------------|------------------------------|--------------------------------|-----|-----| | Product Size | 124 × 78 × 24<br>mm | 120 × 80 ×<br>20 mm | | Yes | | Weight | 150 g excluding<br>batteries | 116g<br>excluding<br>batteries | | Yes | | Environnemental Conditions | | | | | | Storage | -4°F~122°F | -4°F~122°F | Yes | | | temperature | (-20°C~ 50°C) | (-20°C~ 50°C) | | | | Operating | 50°F~104°F | 50°F~104°F<br>(10°C ~ | Yes | | | temperature | (10°C ~ 40°C) | 40°C) | | | | Humidity | 25%~95% | 25%~95% | Yes | | | Measurement Range | | | | | | Average Heart<br>Rate | 45 to 180 bpm | 45 to 180<br>bpm | Yes | | The upgrade specifications in CheckMyHeart Plus are to enhance the quality of signals during the measurement as well as the upgrade improves the data presentation to the users. The difference of CheckMyHeart Plus and READMYHEART do not raise new concern on safety and efficacy. | No | Name of Test | Standard | CheckMyHeart<br>Plus (CMH 4.0) | READMY<br>HEART<br>(RMH3.0) | |----|-----------------------------------------------------|----------------------------------------|--------------------------------|-----------------------------| | 1 | Radiated<br>Emission<br>Measurement | EN55011 :2009+A1:2010<br>Class B | Pass | Pass | | 2 | Electrostatic<br>Discharge<br>Immunity<br>Test(ESD) | EN61000-4-2 :2009<br>EN60601-1-2 :2015 | Pass | Pass | | 3 | Radiated | EN61000-4-3 :2006+A2:2010 | Pass | Pass | # C. Safety {9}------------------------------------------------ | | Susceptibility<br>Measurement(<br>RS) | EN60601-1-2:2015 | | | |---|-------------------------------------------------------|--------------------------------------|------|------| | 4 | Power<br>Frequency<br>Magnetic<br>Field(Magnetic<br>) | EN61000-4-8:2010<br>EN60601-1-2:2015 | Pass | Pass | | 5 | Biocompatible<br>evaluation | ISO 10993-1:2009/AC:2010 | Pass | Pass | The safety tests of CheckMyHeart Plus and READMYHEART had been evaluated according to the same standards and the results of both devices passed the criteria. | D. Performance Characteristics | | | | | |--------------------------------|-------------------------------------------------------|--------------------|--------------------------------|-----------------------------| | No. | Name of Test | Standard | CheckMyHeart<br>Plus (CMH 4.0) | READMY<br>HEART<br>(RMH3.0) | | 1 | Indication of<br>inoperable<br>ELECTROCARDIOG<br>RAPH | IEC60601-2-25:2011 | Pass | Pass | | 2 | Goldberger and<br>Wilson LEADS | IEC60601-2-25:2011 | Pass | Pass | | 3 | Input impedance | IEC60601-2-25:2011 | Pass | Pass | | 4 | COMMON MODE<br>REJECTION | IEC60601-2-25:2011 | Pass | Pass | | 5 | Overload tolerance | IEC60601-2-25:2011 | Pass | Pass | | 6 | Baseline(Noise Level) | IEC60601-2-25:2011 | Pass | Pass | | 7 | Frequency<br>response(HF)-A | IEC60601-2-25:2011 | Pass | Pass | | 8 | Low | IEC60601-2-25:2011 | Pass | Pass | ### D. Performance Characteristics {10}------------------------------------------------ | | frequency(impulse)<br>response | | | | |----|--------------------------------|--------------------|------|------| | 9 | Linearity and dynamic<br>range | IEC60601-2-25:2011 | Pass | Pass | | 10 | Recording Speed | IEC60601-2-25:2011 | Pass | Pass | CheckMyHeart Plus and READMYHEART passed the same performance tests according to the same design of tests from the standards listed above. Both CheckMyHeart Plus and READMYHEART have shown the same efficacy. PERFORMANCE 7. The following performance data were provided in support DATA of the substantial equivalence determination. - A. Biocompatibility - CheckMyHeart Plus and READMYHEART have the same product design and technologies. The materials provided by the suppliers as well as the materials' compositions do not change. The incoming, in-process and final quality inspections all follow the same procedures. Overall, the production and inspection process control remains the same, which do not raise any biocompatibility risks. - Electrical safety and electromagnetic compatibility B. (EMC) Electrical safety and EMC tests were conducted on CheckMyHeart Plus and READMYHEART. CheckMyHeart Plus and READMYHEART complies with IEC 60601-1:2005/A1:2012, EN60601-1:2006/AC:2010 and EN60601-1:2006/A1:2013. - C. Software Verification and Validation Testing {11}------------------------------------------------ Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. The software is an accessory to CheckMyHeart Plus that has Moderate Level of Concern. - D. Standards complied - a. IEC 60601-2-25: 2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (Edition 2.0, 3-105) - b. ISO 10993-1: 2009 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)] (Fourth Edition 2009-10-15, 2-220) - c. EN 60601-1:2006+ A1:2013 Medical electrical equipment - Part 1: General requirement for safety - d. IEC 60601-1:2005+AMD1:2012 CSV Consolidated version Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - e. IEC 60601-1-2:2007 Medical electrical {12}------------------------------------------------ equipment. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests (Edition 3, 19-1) - f. ISO 14971: 2007 Medical Devices -Application of Risk Analysis Management to medical device. (Second Edition, 5-40) CONCLUSIONS CheckMyHeart Plus and READMYHEART both are 8. intended to provide user to monitor Lead I ECG signal and parameter of heart rate variability (HRV). Their technologies are similar and there is no extra concern and risks on safety and efficacy. The safety and efficacy tests on CheckMyHeart Plus and READMYHEART have demonstrated the same results. In conclusion, the results drawing from tests, validation and risk analysis, CheckMyHeart Plus and READMYHEART are the substantial equivalent.