(294 days)
Not Found
No
The summary explicitly states that the heart rate variability (HRV) analysis is "only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis." There are no mentions of AI, ML, or related concepts.
No.
The device is intended for recording, recalling, storing, and transferring ECG signals for home health care use to help with healthcare management and reference for healthcare professionals. It also provides a parameter of heart rate variability (HRV) as a mathematical analysis, but it explicitly states that it is "not intended to produce any interpretation of those measurements or any kind of diagnosis." While it aids in health management and provides data that could be used for diagnosis, it does not itself provide therapy or diagnosis, which are characteristic of a therapeutic device.
No
The text explicitly states multiple times that "This device is not intended to substitute for a hospital diagnostic ECG device" and "is not intended to produce any interpretation of those measurements or any kind of diagnosis."
No
The device description explicitly states "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." This indicates a physical hardware component with electrodes for ECG acquisition, not a software-only device.
Based on the provided text, the CheckMyHeart Plus device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The CheckMyHeart Plus records electrical signals from the body's surface (ECG).
- The intended use and device description clearly state it records and stores ECG signals. This is a physiological measurement, not an analysis of a biological sample.
- The device description explicitly states it provides a mathematical analysis of HRV but is "not intended to produce any interpretation of those measurements or any kind of diagnosis." This further reinforces that it's a data collection and storage device, not a diagnostic tool that analyzes biological samples.
Therefore, the CheckMyHeart Plus falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
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.
Standard accessories:
- A. CheckMyHeart Plus Heart rate Variability (HRV) analysis Software CD X 1
- B. USB Cable X 1
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
adults above 21 years old
Intended User / Care Setting
home health care use
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)
The following performance data were provided in support 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.
- B. Electrical safety and electromagnetic compatibility (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
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 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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
Plus (CMH 4.0) | READMYHEART
(RMH3.0) | Similarity | Difference |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The device is
intended for home
use by users who
might have transient
symptoms that may
suggest cardiac
conduction
abnormity or by
users who want to
monitor the cardiac
function for HOME
HEALTH CARE
from Lead I ECG
signal. ECG
acquisition and
transmission is
voluntary and
mutually activated
by the user. The
intended users are
adults above 20
years old. This
device is not
intended for use as
precisely diagnostic | Both CheckMyHeart
Plus and
READMYHEART
are
electrocardiographic
monitor for
recording and
displaying real-time
ECG data for the
purpose of home
health care use. The
users for
CheckMyHeart Plus
and
READMYHEART
can measure the
parameter of heart
rate variability
(HRV) in RR
interval. Their target
population aims to
the adults above 20
years old who might
experience cardiac
conduction | Originally,
READMYHEART
can only let users
to see the outcome
of measurement on
the computer with
proper software
installation.
CheckMyHeart
Plus is basically an
upgrade model of
READMYHEART.
The upgrade
feature in
CheckMyHeart is
to show the user
real-time signal
output on the
screen of the
device. |
| | | | |
| 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. | tool. This device is
also not intended for
recording and
transmission of
user's ECG signal
simultaneously. 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.
The device detects
the appearance of
irregular heart beat
(IHB) during
measurement, and
gives a warning
signal with the
reading once the
irregular heartbeat is
detected. Users with
implanted
pacemaker are not | abnormity or by
adult users whenever
they want to have
routine checks. They
both are not
intended to
substitute for a
hospital diagnostic
ECG device.
All the materials,
components, energy
source and features
are the same in
CheckMyHeart Plus
and
READMYHEART | |
- A.
6
7
| recommended to use
| this device. | ||
|---|---|---|
| ------------------------------------ | -- | -- |
B. Technological Characteristics
| Item | CheckMyHeart
Plus (CMH 4.0) | READMYHEA
RT (RMH3.0) | Similarity | Difference |
|------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------|------------|
| Input impedance | > 20 M Ohm | > 10M
Ohm | | Yes |
| Input dynamic
range | +/- 3 mV | +/- 2 mV | | Yes |
| Bandwidth | 0.1 - 40 Hz | 0.15 ~ 40
Hz | Yes | |
| CMRR
(Common Mode
Rejection Ratio) | > 95 dB | > 60 dB | | Yes |
| A/D conversion | 12 bits | 12 bits | Yes | |
| Sampling Rate | 250 samples/sec | 250
samples/sec | Yes | |
| Measurement
Time | 300 seconds | 300seconds | Yes | |
| Display | 240×128
Dot-matrix LCD
display | LCD
display
panel | Yes | |
| Input | Dry conduction
electrodes | Dry
conduction
electrodes
and/or
external
auxiliary
electrodes
and
conductive
adhesive
ECG pads | Yes | |
| Output | USB interface | USB
interface | Yes | |
| Power Supply | 1.5V (AAA) x 2 | 1.5V | Yes | |
8
| (AAA) x 2 | ||||
|---|---|---|---|---|
| Product Size | 124 × 78 × 24 | |||
| mm | 120 × 80 × | |||
| 20 mm | Yes | |||
| Weight | 150 g excluding | |||
| batteries | 116g | |||
| excluding | ||||
| 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 | ||
| (10°C ~ | Yes | |||
| temperature | (10°C ~ 40°C) | 40°C) | ||
| Humidity | 25%~95% | 25%~95% | Yes | |
| Measurement Range | ||||
| Average Heart | ||||
| Rate | 45 to 180 bpm | 45 to 180 | ||
| 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
Plus (CMH 4.0) | READMY
HEART
(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 | EN61000-4-3 :2006+A2:2010 | Pass | Pass |
C. Safety
9
| | Susceptibility
Measurement(
RS) | EN60601-1-2:2015 | | |
|---|-------------------------------------------------------|--------------------------------------|------|------|
| 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 |
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 | |
| Plus (CMH 4.0) | READMY | |||
| HEART | ||||
| (RMH3.0) | ||||
| 1 | Indication of | |||
| inoperable | ||||
| ELECTROCARDIOG | ||||
| RAPH | 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 | IEC60601-2-25:2011 | Pass | Pass |
D. Performance Characteristics
10
| | frequency(impulse)
response | | | |
|----|--------------------------------|--------------------|------|------|
| 9 | Linearity and dynamic
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.