READMYHEART, MODEL RMH3.0

K050620 · Dailycare Biomedical, Inc. · DPS · Jul 14, 2005 · Cardiovascular

Device Facts

• Record ID: K050620
• Device Name: READMYHEART, MODEL RMH3.0
• Applicant: Dailycare Biomedical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Indications for Use

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 Story

Handheld, dry-electrode ECG monitor for home use; records Lead I ECG signals via thumb-press electrodes or optional auxiliary external electrode. Device records 30-second segments; stores last 15 seconds in internal memory. Measures Heart Rate (HR), ST segment, and QRS interval; displays on LCD. Detects irregular heartbeats (IHB) and provides warning signal. Calculates Heart Rate Variability (HRV) via RR interval analysis. Data transferable to PC via USB for printing and long-term tracking. Operated by patient; intended for routine health checks or transient symptom monitoring. Not a diagnostic tool; not for simultaneous transmission. Benefits include convenient, affordable, personalized cardiac function tracking.

Clinical Evidence

Bench testing only. No clinical validation performed. Performance verified using MIT-IBH database and simulators. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-47, and IEC 60601-2-51.

Technological Characteristics

Handheld ECG monitor; dry electrode sensing; internal battery powered. Dimensions/form factor: handheld. Connectivity: USB for PC data transfer. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-25, IEC 60601-2-47, IEC 60601-2-51 (performance). Software: embedded firmware for signal processing and parameter calculation.

Indications for Use

Indicated for adults >20 years old for home health care monitoring of Lead I ECG signals. Intended for users with transient symptoms suggesting cardiac conduction abnormality or for routine cardiac function monitoring. Contraindicated for users with implanted pacemakers.

Regulatory Classification

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.

Predicate Devices

• ReadMyHeart (RMH2.0, K042814)

Submission Summary (Full Text)

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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: | [phone] |
| FAX: | [phone] |
| 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)<br>marketed by DailyCare BioMedical Inc. |

#### 5.0 Intended Use:

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

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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:

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).

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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 [phone] 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 [phone] or [phone] 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_

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