INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0

K062894 · Dailycare Biomedical, Inc. · DPS · Feb 8, 2007 · Cardiovascular

Device Facts

• Record ID: K062894
• Device Name: INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
• Applicant: Dailycare Biomedical, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor which the 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. The user presses his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason.

Device Story

Handheld, single-lead ECG monitor for home use; records cardiac signals via integrated dry electrodes (thumb-press) or optional auxiliary external electrode. Device displays real-time ECG waveform for 30 seconds; automatically stores last 15 seconds of signal. Measures Heart Rate (HR), ST segment, and QRS interval. Data transferred to PC via USB for printing and long-term tracking using GUI software. Operated by adult users for self-monitoring; data intended for healthcare professional reference. Benefits include convenient, routine cardiac health management and symptom tracking. Not a diagnostic tool; not for simultaneous recording and transmission.

Clinical Evidence

No clinical data. Performance verified via bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-25), EMC (IEC 60601-1-2), and performance standards (IEC 60601-2-47, IEC 60601-2-51). Device performance validated using MIT-IBH database and simulators.

Technological Characteristics

Handheld, battery-powered, single-lead ECG monitor. Features integrated dry electrodes. Connectivity via USB for PC data transfer. Conforms to IEC 60601-1, 60601-1-2, 60601-2-25, 60601-2-47, and 60601-2-51. Software-based signal processing for HR, ST segment, and QRS interval calculation.

Indications for Use

Indicated for adult users for home health care use to record and display real-time ECG data. Intended for self-testing by adults experiencing transient symptoms suggesting cardiac conduction abnormality or for routine checks. 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)
• Omron HCG-801 Portable ECG Monitor (K060766)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image contains a logo for "DailyCare BioMedical". The logo features a stylized letter "D" with two figures above it, one larger and one smaller. To the right of the "D" is the word "DailyCare" in a sans-serif font, with "BioMedical" in a smaller font below it. The overall design is simple and modern.

Premarket Notification of InstantCheck RTD-ECG monitor

8 2007 FEB

# 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 |

#### Device Name: 2.0

| Trade Name: | InstantCheck RTD-ECG Monitor |
|----------------------|------------------------------------------|
| Common Name: | Handheld ECG monitor |
| Classification Name: | Electrocardiograph (per 21 CFR 870.2340) |

- Class II 3.0 Classification:
- ReadMyHeart (RMH2.0) (K042814) 4.0 Predicate Device: Omron HCG-801 Portable ECG Monitor (K060766)

#### 5.0 Intended Use:

The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor which the 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.

The user presses his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason.

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Premarket Notification of InstantCheck RTD-ECG monitor

## 6.0 Indications for Use:

The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks.

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.

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 external electrode provided separately if thumb pressing is not convenient for reason. The recorded data can be downloaded to Personal Computer via USB interface port.

#### 7.0 Device Description:

The InstantCheck RTD-ECG monitor is a new model of handheld ECG monitors series of DailyCare BioMedical Inc. InstantCheck RTD-ECG is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions and displays the data in a clear and precise waveform for daily health check. It takes ECG signals of users by thumbs pressing gently on electrodes which are integrated on the device. InstantCheck RTD-ECG can record real-time display the user's ECG data for about 30 seconds, and automatically store the last 15 seconds signals into the build-in memory. While three parameters were measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, will be displayed on LCD display of the device.

User may also record ECG data 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

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## Premarket Notification of InstantCheck RTD-ECG monitor

GUI software provided separately, data stored in InstantCheck RTD-ECG can be printed for analysis, and for long-term tracking. InstantCheck RTD-ECG is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

InstantCheck RTD-ECG is not intended for use as a substitution of precise 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.

#### 8.0 Non-Clinical Performance Summary:

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

* Electrical 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.

* Environment tests are tested to comply with the safety requirements.

*The performance is also tested with MIT-IBH database and simulators.

### Discussion of Clinical Test performed: 9.0

InstantCheck RTD-ECG has the same fundamental scientific technology as the original cleared device, ReadMyHeart. Clinical validation for ECG parameters is not required.

### 10.0 Conclusions:

In order to benefit the public health and healthcare professionals, the InstantCheck RTD-ECG has simple, friendly software user interface. It has similar technological characteristics as previously cleared ReadMyHeart. The InstantCheck RTD-ECG demonstrates essential safety and effective to the users.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### FEE 8 2007

DailyCare BioMedical Inc. c/o Mr. Daniel J.H. Chang 8F, 25-3, Ji-Lin Road Chungli 320, Taiwan

Re: K062894

Trade Name: InstantCheck RTD-ECG Monitor, Model RMH4.0 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: September 27, 2006 Received: January 9, 2007

Dear Mr. Chang:

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 misburnelijng and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA 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 if the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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### Page 2 - Mr. Chang

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

B.F. Zimmerman 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

K062894 510(k) Number (if known):

Device Name: __InstantCheck RTD-ECG monitor (DailyCare BioMedical Inc.)

Indications for Use:

The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks.

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.

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 external electrode provided separately if thumb pressing is not convenient for reason. The recorded data can be downloaded to Personal Computer via USB interface port.

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)

B. Hamamoto

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