The device is a personal single lead Electrocardiograph monitor. The device is intended for self-testing by patients by recording 15 seconds of the first standard lead I of Electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician. The intended user are Users who are above 20 years old.

The user is normally not required to apply electrode on the body. Two electrodes integrated within the device are provided. The user has to press his thumbs on the two electrodes in order record the ECG signal.

The User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason.

The recorded data can be downloaded to Personal Computer via USB interface port. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device.

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 user/patient with thumbs press on electrode at ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. 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.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study for ReadMyHeart

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device conforms to applicable PREDICATE device standards and a comparison study was performed. It does not explicitly state quantitative acceptance criteria for the ReadMyHeart device itself, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating comparability to a predicate device and adherence to general safety and performance standards.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Electrical Standards Conformance:
- IEC 60601-2-25 (Safety for Electrocardiographs)	Conforms to "All Safety test according to IEC 60601-2-25"
- IEC 60601-1 (General Requirements for Basic Safety and Essential Performance)	Conforms to "All Safety test according to... IEC 60601-1"
Electromagnetic Compatibility (EMC) Standards Conformance:
- IEC 60601-1-2 (EMC Requirements)	Conforms to "EMC tests according to IEC 60601-1-2"
Performance Standards Conformance:
- IEC 60601-2-47 (Ambulatory Electrocardiographic Systems)	Conforms to "Performance tests according to IEC 60601-2-47"
Comparability to Predicate Device (ecg@home, K012012):	"The comparison study demonstrated that the recordings performed on the subjects using ReadMyHeart is highly comparable to those obtained with the hospital use common electrocardiograph recorder." (Note: The predicate device is ecg@home, but the comparison was made against a "hospital use common electrocardiograph recorder", which is implied to be equivalent to or better than the predicate's performance in a clinical setting). The device also "have the same intended use and similar technological characteristics as .cadingTrount [predicate device]." "any differences in (); in the surfacteristics do not raise and new questions of safety or effectiveness."

2. Sample Size for the Test Set and Data Provenance:

The document mentions "a comparison study with a hospital use common electrocardiograph recorder was performed," and "recordings performed on the subjects." However, it does not specify the sample size (number of subjects/cases) used for this comparison study.

The data provenance is implied to be clinical, as it states "recordings performed on the subjects" and compares against "a hospital use common electrocardiograph recorder." However, it does not explicitly state the country of origin nor whether it was retrospective or prospective. Given the nature of a comparison study for a new device, it would most likely be prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the comparison study. It only mentions that the recordings should be "analyzed by a trained physician" as part of the intended use, but this is not tied to the specifics of the validation study.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the comparison study's test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The comparison described is for the device's output (ECG recordings) against a standard hospital recorder, not for human readers with and without AI assistance. Therefore, no effect size for human reader improvement with AI is mentioned.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was implicitly done. The "comparison study with a hospital use common electrocardiograph recorder" assesses the performance of the ReadMyHeart device (algorithm + hardware) directly against a benchmark, independent of human interpretation as the primary outcome. The report claims "highly comparable" recordings.

7. Type of Ground Truth Used:

The ground truth used for the comparison study appears to be data obtained from a "hospital use common electrocardiograph recorder." This suggests that the standard hospital ECG served as the reference standard against which the ReadMyHeart's ECG recordings were compared. This could be considered a form of "reference device" or "clinical standard" ground truth.

8. Sample Size for the Training Set:

The document does not mention a training set, nor its sample size. The device is presented as a recording device, not one employing machine learning that typically requires a separate training phase. Its performance is validated through comparison to a standard, rather than through a machine learning model's training and testing regimen.

9. How the Ground Truth for the Training Set Was Established:

Since no training set is mentioned (as the device is not described as a machine learning system), the document does not describe how ground truth for a training set was established.

Summary

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K042814

JAN - 6 2005

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 Name:	DailyCare BioMedical Inc.
Address:	8F, 25-3, Ji-Lin Road, Chungli 320, Taiwan
Tel:	+886-3-2621688
Fax:	+886-3-2617688
Contact:	Mr. Jen-Hao Chang
E-Mail:	info@dcbiomed.com

2.0 Device Name
Trade Name:	ReadMyHeart
Common Name:	Handheld ECG monitor
Classification name:	Electrocardiograph

Class II 3.0 Classification:
The predicate device is the ecg@home(K012012 ) marketed by 4.0 Predicate Device: H&C MEDICAL DEVICES SPA.

ReadMyHeart is intended for use by users who have transient 5.0 Intended Use: symptoms that may suggest cardiac conduction abnormalities or by users who want to monitor the cardiac function for home health care from Lead | 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 also not intended for recording and transmission of user's ECG signal simultaneously.

This device is not intended for use as precisely diagnostic tool.

Users with implanted pacemaker are not recommended to use this device.

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6.0 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 user/patient with thumbs press on electrode at ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. 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 has similar general design with ecg@home(K012012 ) marketed by H&C MEDICAL DEVICES SPA.

In terms of operating specification, Safety & EMC requirements, the 7.0 Performance device conforms to applicable standards include Summary:
- · 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

Furthermore, A comparison study with a hospital use common electrocardiograph recorder was performed in order to validate the performance of ReadMyHeart.

The comparison study demonstrated that the recordings performed on the subjects using ReadMyHeart is highly comparable to those obtained with the hospital use common electrocardiograph recorder.

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Conclusions: 8.

.
cadMyHeart have the same intended use and similar technological characteristics as .cadingTrount http://www.bbcamers.com/call/CAL DEVICES SPA.. Moreover, bench testing of eog@nethed in this submission and clinical testing supplied demonstrate that any differences in (); in the surfacteristics do not raise and new questions of safety or effectiveness. Thus, the ReadMyHeart is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 6 2005

DailyCare BioMedical Inc. c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001

Re: K042814

Trade Name: ReadMyHeart Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: October 8, 2004 Received: October 12, 2004

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreated to togens and the Medical Device Amendments, or to commerce provision of May 20, 1970, in exactions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manel a e Act include requirements for annual registration, listing of general controls provisions of use tice, labeling, and prohibitions against misbranding 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 (600 a00 rols. Existing major regulations affecting your device can may be subject to back as a success Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Ms. Jennifer Reich

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Icase of advised that I Dri b 1858aa.co or device complies with other requirements of the Act that I DA has made a active and regulations administered by other Federal agencies. You must of any I catal statutes 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 CI It I art 607); and ime (21 CFR Part 820); and if applicable, the electronic form in the quanty by became (Sections 531-542 of the Act); 21 CFR 1000-1050. product launation control pro herring your device as described in your Section 510(k) I mis letter will and w yourse organization of substantial equivalence of your device to a legally prematics noticated.org The start and on on 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 arrestiation J at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMISOranding by reference to prescessonsibilities under the Act may be obtained from the Other general mionmation international 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,

Bhimmar 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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Indications for Use

510(k) Number (if known):_K042814

Device Name: ReadMyHeart DailyCare BioMedical Inc.

Indications For Use:

The User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason.

Prescription Use ______________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K0428/4
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(Division Sign-Off)
Division of Cardiovascular 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).