(294 days)
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.
CheckMyHeart Plus is intended to record, recall, store and 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 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.
This document describes the CheckMyHeart Plus device and its substantial equivalence to the predicate device, READMYHEART (RMH3.0), as part of a 510(k) submission (K172778). The key focus is on demonstrating that the new device meets the same safety and performance standards as the predicate.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for CheckMyHeart Plus are based on meeting the same safety and performance standards as its predicate device, READMYHEART, and demonstrating that any differences do not raise new concerns regarding safety and efficacy. The reported performance of CheckMyHeart Plus is consistently "Pass" for all tested criteria, matching the predicate device.
Here's a table summarizing the performance characteristics where both devices were tested against IEC60601-2-25:2011:
| No. | Name of Test | Standard | CheckMyHeart Plus (CMH 4.0) | READMYHEART (RMH3.0) |
|---|---|---|---|---|
| 1 | Indication of inoperable ELECTROCARDIOGRAPH | IEC60601-2-25:2011 | Pass | Pass |
| 2 | Goldberger and Wilson LEADS | IEC60601-2-25:2011 | Pass | Pass |
| 3 | Input impedance | IEC60601-2-25:2011 | Pass | Pass |
| 4 | COMMON MODE 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 response (HF)-A | IEC60601-2-25:2011 | Pass | Pass |
| 8 | Low frequency (impulse) response | IEC60601-2-25:2011 | Pass | Pass |
| 9 | Linearity and dynamic range | IEC60601-2-25:2011 | Pass | Pass |
| 10 | Recording Speed | IEC60601-2-25:2011 | Pass | Pass |
Additionally, both devices passed the following safety tests:
| No | Name of Test | Standard | CheckMyHeart Plus (CMH 4.0) | READMYHEART (RMH3.0) |
|---|---|---|---|---|
| 1 | Radiated Emission Measurement | EN55011 :2009+A1:2010 Class B | Pass | Pass |
| 2 | Electrostatic Discharge Immunity Test (ESD) | EN61000-4-2 :2009 EN60601-1-2 :2015 | Pass | Pass |
| 3 | Radiated Susceptibility Measurement (RS) | EN61000-4-3 :2006+A2:2010 EN60601-1-2:2015 | Pass | Pass |
| 4 | Power Frequency Magnetic Field (Magnetic) | EN61000-4-8:2010 EN60601-1-2:2015 | Pass | Pass |
| 5 | Biocompatible evaluation | ISO 10993-1:2009/AC:2010 | Pass | Pass |
Study Details
The provided document describes a "substantial equivalence determination" based on a comparison between the new device (CheckMyHeart Plus) and a legally marketed predicate device (READMYHEART, Model RMH3.0, K050620). The study does not involve clinical trials with human subjects to evaluate diagnostic performance in a clinical setting. Instead, it relies on demonstrating that the new device's technical specifications and test results meet recognized industry standards and are comparable to those of the predicate.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in terms of patient data for evaluating diagnostic performance. The tests conducted are primarily engineering and hardware/software verification, typically performed on the device itself or in laboratory settings. There is no mention of patient data or its provenance for these performance and safety tests. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. The study is not evaluating diagnostic accuracy against a ground truth established by medical experts. It's a technical and regulatory comparison against standards and a predicate device. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no 'test set' requiring adjudication by experts for diagnostic performance. -
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 or conducted. The device (CheckMyHeart Plus) is for recording, recall, storage, and transfer of Lead I ECG signals for home health care use. It provides a parameter of heart rate variability (HRV) but is explicitly not intended to produce any interpretation of those measurements or any kind of diagnosis. Therefore, it does not involve AI for interpretation or human readers needing assistance. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone performance evaluation was done in the sense that the device's technical specifications and functionalities were tested as an independent unit against engineering standards. However, it's crucial to reiterate that this device is for recording and displaying ECG data, not for automated diagnosis or interpretation. The document explicitly states it "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." -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the safety and performance tests listed (e.g., input impedance, COMMON MODE REJECTION, frequency response), the "ground truth" is defined by the technical specifications and limits set forth in the referenced international standards (e.g., IEC60601-2-25:2011). The tests verify if the device's measured parameters fall within these predefined acceptable ranges. -
The sample size for the training set:
Not applicable. The document does not describe the development of an artificial intelligence (AI) algorithm that would require a 'training set' of medical data. The device's functionality is based on established electrocardiograph principles and hardware/software engineering. -
How the ground truth for the training set was established:
Not applicable, as no training set for an AI algorithm is mentioned or implied.
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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.
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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
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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.
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FORM FDA 3881 (8/14)
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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 |
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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.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE
| CheckMyHeartPlus (CMH 4.0) | READMYHEART(RMH3.0) | Similarity | Difference |
|---|---|---|---|
| CheckMyHeart Plusis intended to record,recall, store andtransfer single leadelectrocardiographicmonitor forrecording anddisplaying real-timeECG data for homehealth care use. Theintended users areadults above 21years old who mightexperience transientsymptoms that maysuggest cardiacconductionabnormity or byadult users wheneverthey want to haveroutine checks. Thisdevice is notintended tosubstitute for ahospital diagnostic | The device isintended for homeuse by users whomight have transientsymptoms that maysuggest cardiacconductionabnormity or byusers who want tomonitor the cardiacfunction for HOMEHEALTH CAREfrom Lead I ECGsignal. ECGacquisition andtransmission isvoluntary andmutually activatedby the user. Theintended users areadults above 20years old. Thisdevice is notintended for use asprecisely diagnostic | Both CheckMyHeartPlus andREADMYHEARTareelectrocardiographicmonitor forrecording anddisplaying real-timeECG data for thepurpose of homehealth care use. Theusers forCheckMyHeart PlusandREADMYHEARTcan measure theparameter of heartrate variability(HRV) in RRinterval. Their targetpopulation aims tothe adults above 20years old who mightexperience cardiacconduction | Originally,READMYHEARTcan only let usersto see the outcomeof measurement onthe computer withproper softwareinstallation.CheckMyHeartPlus is basically anupgrade model ofREADMYHEART.The upgradefeature inCheckMyHeart isto show the userreal-time signaloutput on thescreen of thedevice. |
| ECG device. ECGacquisition andtransmission can bevoluntarily andmutually activatedby the adult users forthe purpose ofhealthcaremanagement andreference forhealthcareprofessionals. Thisdevice provides aparameter of heartrate variability(HRV) in RRinterval which isonly mathematicalanalysis and is notintended to produceany interpretation ofthose measurementsor any kind ofdiagnosis. | tool. This device isalso not intended forrecording andtransmission ofuser's ECG signalsimultaneously. Thisdevice provides aparameter of heartrate variability(HRV) in RRinterval which isonly mathematicalanalysis and is notintended to produceany interpretation ofthose measurementsor any kind ofdiagnosis.The device detectsthe appearance ofirregular heart beat(IHB) duringmeasurement, andgives a warningsignal with thereading once theirregular heartbeat isdetected. Users withimplantedpacemaker are not | abnormity or byadult users wheneverthey want to haveroutine checks. Theyboth are notintended tosubstitute for ahospital diagnosticECG device.All the materials,components, energysource and featuresare the same inCheckMyHeart PlusandREADMYHEART |
- A.
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| recommended to usethis device. | ||
|---|---|---|
| ------------------------------------ | -- | -- |
B. Technological Characteristics
| Item | CheckMyHeartPlus (CMH 4.0) | READMYHEART (RMH3.0) | Similarity | Difference |
|---|---|---|---|---|
| Input impedance | > 20 M Ohm | > 10MOhm | Yes | |
| Input dynamicrange | +/- 3 mV | +/- 2 mV | Yes | |
| Bandwidth | 0.1 - 40 Hz | 0.15 ~ 40Hz | Yes | |
| CMRR(Common ModeRejection Ratio) | > 95 dB | > 60 dB | Yes | |
| A/D conversion | 12 bits | 12 bits | Yes | |
| Sampling Rate | 250 samples/sec | 250samples/sec | Yes | |
| MeasurementTime | 300 seconds | 300seconds | Yes | |
| Display | 240×128Dot-matrix LCDdisplay | LCDdisplaypanel | Yes | |
| Input | Dry conductionelectrodes | Dryconductionelectrodesand/orexternalauxiliaryelectrodesandconductiveadhesiveECG pads | Yes | |
| Output | USB interface | USBinterface | Yes | |
| Power Supply | 1.5V (AAA) x 2 | 1.5V | Yes |
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| (AAA) x 2 | ||||
|---|---|---|---|---|
| Product Size | 124 × 78 × 24mm | 120 × 80 ×20 mm | Yes | |
| Weight | 150 g excludingbatteries | 116gexcludingbatteries | 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(10°C ~ | Yes | |
| temperature | (10°C ~ 40°C) | 40°C) | ||
| Humidity | 25%~95% | 25%~95% | Yes | |
| Measurement Range | ||||
| Average HeartRate | 45 to 180 bpm | 45 to 180bpm | 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 | CheckMyHeartPlus (CMH 4.0) | READMYHEART(RMH3.0) |
|---|---|---|---|---|
| 1 | RadiatedEmissionMeasurement | EN55011 :2009+A1:2010Class B | Pass | Pass |
| 2 | ElectrostaticDischargeImmunityTest(ESD) | EN61000-4-2 :2009EN60601-1-2 :2015 | Pass | Pass |
| 3 | Radiated | EN61000-4-3 :2006+A2:2010 | Pass | Pass |
C. Safety
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| SusceptibilityMeasurement(RS) | EN60601-1-2:2015 | |||
|---|---|---|---|---|
| 4 | PowerFrequencyMagneticField(Magnetic) | EN61000-4-8:2010EN60601-1-2:2015 | Pass | Pass |
| 5 | Biocompatibleevaluation | 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 | CheckMyHeartPlus (CMH 4.0) | READMYHEART(RMH3.0) |
| 1 | Indication ofinoperableELECTROCARDIOGRAPH | IEC60601-2-25:2011 | Pass | Pass |
| 2 | Goldberger andWilson LEADS | IEC60601-2-25:2011 | Pass | Pass |
| 3 | Input impedance | IEC60601-2-25:2011 | Pass | Pass |
| 4 | COMMON MODEREJECTION | 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 | Frequencyresponse(HF)-A | IEC60601-2-25:2011 | Pass | Pass |
| 8 | Low | IEC60601-2-25:2011 | Pass | Pass |
D. Performance Characteristics
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| frequency(impulse)response | ||||
|---|---|---|---|---|
| 9 | Linearity and dynamicrange | 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
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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
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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.
§ 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).