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 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 recommended to use this device.

Device Description

ReadMyHeart 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 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. The device also detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis when recording the signal for 180 seconds. The HRV is not intended to produce any interpretation of those measurements or any kind of diagnosis. User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually. Furthermore, ReadMyHeart (Model RMH3.0) is modified and has generally the same design from DailyCare BioMedical Inc.'s prior device – ReadMyHeart (RMH2.0, K042814).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the ECG parameters algorithm and hardware design in this device (ReadMyHeart RMH 3.0) are exactly the same as in the predicate device (ReadMyHeart RMH2.0, K042814), thus no clinical validation for ECG parameters was required for the RMH 3.0.

Therefore, the acceptance criteria and performance reported mainly pertain to the irregular heartbeat (IHB) detection function.

Metric / Feature	Acceptance Criteria (Implied)	Reported Device Performance
ECG Parameters Accuracy	Substantial equivalence to predicate device (RMH2.0)	Algorithms and hardware are "exactly the same" as RMH2.0.
Irregular Heartbeat (IHB) Detection Performance	Meets requirements based on comparison study.	Performance tested with MIT-IBH database and simulators, and "meets the requirements."
Heart Rate Variability (HRV) Analysis Accuracy	(Not applicable for clinical validation/diagnosis)	Mathematical analysis only, "not intended to produce any interpretation... or diagnosis."
Safety & EMC Conformance	Conforms to IEC 60601-2-25, IEC 60601-1, IEC 60601-1-2.	Device conforms to stated applicable standards.
Performance Conformance	Conforms to IEC 60601-2-47 and IEC 60601-2-51 (voluntarily).	Device conforms to stated applicable standards.
Environment Tests	Complies with safety requirements.	Tested to comply with safety requirements.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated, but the "MIT-IBH database" was used. The exact number of recordings or patients from this database used for testing is not specified.
Data Provenance: The "MIT-IBH database" (likely referring to the MIT-BIH Arrhythmia Database) is a publicly available database of physiological recordings. It contains recordings from various medical centers in Boston and other locations. It is a retrospective dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not explicitly stated for the irregular heartbeat detection study. However, the MIT-BIH Arrhythmia Database is well-annotated by experts in cardiology, often physicians and technicians specialized in ECG interpretation.

4. Adjudication method for the test set:

Not explicitly stated, but for the MIT-BIH Arrhythmia Database, the ground truth annotations were established through an expert review process, typically involving multiple cardiologists or highly trained technicians converging on a consensus.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
The study described is a comparison of the device's IHB detection function against a database and simulators, not a study involving human readers with and without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance evaluation was done for the irregular heartbeat detection function. The device's algorithm was tested against the MIT-IBH database and simulators.

7. The type of ground truth used:

For the irregular heartbeat detection, the ground truth was derived from the expert annotations/consensus within the "MIT-IBH database" (likely the MIT-BIH Arrhythmia Database), which is based on expert cardiological interpretation of ECGs.

8. The sample size for the training set:

Not explicitly stated. Given that the ECG parameters algorithm is "exactly the same" as the predicate device (RMH2.0), the training would have occurred for that prior version. For the IHB detection, if the algorithm was trained on the MIT-IBH database, the training split size separate from the test set is not specified.

9. How the ground truth for the training set was established:

Not explicitly stated. Assuming the IHB algorithm was developed or refined using data from the MIT-BIH Arrhythmia Database, the ground truth for the training set would also have been established through expert annotations/consensus on ECG waveforms within that database.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K050620 p.1/3" in a handwritten style. The text appears to be a code or identifier, possibly related to document management or archiving. The "p.1/3" likely indicates that this is page 1 of a 3-page document. The handwriting is clear and legible, making the text easily readable.

Image /page/0/Picture/2 description: The image shows the logo for DailyCare BioMedical. The logo features a stylized figure of a person with outstretched arms above the letter "D". To the right of the figure is the text "DailyCare" in a bold, sans-serif font. Below "DailyCare" is the word "BioMedical" in a smaller font.

ReadMyHeart (Model RMH 3.0) Premarket Notification

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

1.0 Submitter's Indentification:
Submitter's Name:	DailyCare BioMedical Inc.
Address:	8F, 25-3, Ji-Lin Road, Chungli 320, Taiwan
TEL:	+886-3-2621688
FAX:	+886-3-2617688
Contact:	Mr. Daniel J. H. Chang

2.0 Device Name:

Trade Name:	ReadMyHeart - Model RMH3.0
Common Name:	Handheld ECG monitor
Classification Name:	Electrocardiograph (per 21 CFR 870.2340)
3.0 Classification:	Class II
4.0 Predicate Device:	This predicate device is ReadMyHeart (RMH2.0, K042814)marketed by DailyCare BioMedical Inc.

5.0 Intended Use:

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 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

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Image /page/1/Picture/1 description: The image contains a logo for DailyCafe BioMedical. The logo features a stylized letter D with a person figure inside the curve of the D. To the right of the D is the text "DailyCafe" in a bold font, with "BioMedical" in a smaller font underneath. To the right of the logo is the word "ReadM".

ReadMyHeart (Model RMH 3.0) Premarket Notification

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 recommended to use this device.

6.0 Device Description:

The device also detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.

This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis when recording the signal for 180 seconds. The HRV is not intended to produce any interpretation of those measurements or any kind of diagnosis.

User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

Furthermore, ReadMyHeart (Model RMH3.0) is modified and has generally the same design from DailyCare BioMedical Inc.'s prior device – ReadMyHeart (RMH2.0, K042814).

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Image /page/2/Picture/1 description: The image shows the logo for DailyCare BioMedical. The logo features a stylized letter "D" with a human figure integrated into the design. The text "DailyCare" is written in a stylized font, with "BioMedical" appearing in smaller letters below it.

ReadMyHeart (Model RMH 3.0) Premarket Notification

7.0 Performance Summary:

In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards include

All Safety test according to IEC 60601-2-25 & IEC 60601-1,

- EMC tests according to IEC 60601-1-2
- Performance tests according to IEC 60601-2-47 and IEC 60601-2-51 voluntarily.
- Environment tests are tested to comply with the safety requirements. Furthermore, the performance is tested with MIT-IBH database and simulators and meets the requirements.

Discussion of Clinical Test performed: 8.0

Since the ECG parameters algorithm and hardware design in this device is exactly the same as in the predicate device, ReadMyHeart (RMH2.0, K042814), no clinical validation for ECG parameters is required. Instead, we conducted a simulator and MIT database comparison study for the function of irregular heartbeat detection. Furthermore, HRV is only the mathematical analysis of heart beat and is not shown safe and effectiveness and has not been approved by FDA for a specific clinical diagnosis in any devices, so that is for reference only, therefore, no clinical validation is required for HRV.

9.0 Conclusions:

ReadMyHeart (Model RMH3.0) is a modification from predicate device ReadMyHeart (RMH2.0, K042814). It has generally the same technological characteristics and intended use. Moreover, bench testing contained in this submission supplied demonstrates that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the ReadMyHeart (Model RMH 3.0) is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2005

0 5 10 15

Dailycare Biomedical, Inc. c/o Mr. Daniel J. H. Chang Senior Engineer 8F, 25-3, Ji-Lin Road Chungli 320 TAIWAN

Re: K050620

ReadMyHeart model RMH 3.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: June 29, 2005 Received: June 29, 2005

Dear Mr. Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 5 IQC) premanted is substantially equivalent (for the indications
referenced above and have determined the consected in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug. commerce prior to May 28, 1970, the chacinent and othe provisions of the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject of the genirst for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mendo requirements
devices, good manufacturing practice, labeling, and prohibitions against mishranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations allec may be subject to such additional colubis. Existing migor regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In be found in the Code of I cacial regarations).
publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Daniel J. H. Chang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou that I Dr intribution that your device complies with other requirements of the Act that i DA has made a coulations administered by other Federal agencies. You must of any I cateral statures and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 6077, and if a regulation (21 CFR Part 820); and if applicable, the electronic form in the quany by by count (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) This letter wifi anon yourse of substantial equivalence of your device of your device to a legally prematics notification. "The sclassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific aarroliance at (240) 276-0295 Also, please note the regulation entitled, eoniation of Office or Course to premarket notification" (21CFR Part 807.97) you may obtain. Whisoralianing of responsibilities under the Act may be obtained from the Other general mironmation and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimmofor

Brand D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

(DailyCare BioMedical Inc.)

Indications for Use:

atten is a personal single lead Electrocardiograph monitor for home health care use. The device is intended for self-testing by users who might experience transient symptoms that may suggest cardiac conduction abnormity or by users whenever desired as routine recordings may begg and mutually activated by the user and the intended users are adults above 20 years oid.

The user is normally not required to apply electrode on body. Two electrodes integrated within the device are provided. The user has to press his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary rosera the =================================================================================================================================================================== recommended to use auxiliary external electrode for HRV analysis. I

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.

shirts 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.

Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alummer

scular Devices 510(k) Number_

Page _ 1_ of _1

Regulation Number and Section

§ 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).