HEARTCHECK ECG PEN WITH GEMS HOME

K121009 · Cardiocomm Solutions, Inc. · DPS · May 17, 2012 · Cardiovascular

Device Facts

• Record ID: K121009
• Device Name: HEARTCHECK ECG PEN WITH GEMS HOME
• Applicant: Cardiocomm Solutions, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: May 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The HeartCheck ECG Pen with GEMS Home is a telemedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is not intended to substitute for a hospital diagnostic ECG test. The software and hardware are not intended for recording and transmission of user's ECG signal simultaneously. Patients with implanted pacemaker or defibrillator are not recommended to use this device. GEMS Home is a simple software user interface with ECG trace viewing function.

Device Story

Handheld ECG monitor; records single-channel cardiac event data; activated by user during symptomatic events. Device components: signal input, amplifier, CPU, display, power unit, storage chip on single PCB. Data transmitted via USB to PC running GEMS Home software. GEMS Home provides user interface for storage and viewing of ECG traces. Used by patients in everyday settings; data reviewed by physicians/health professionals for symptom confirmation. Benefits: captures real-time cardiac data otherwise difficult to record. Not a substitute for hospital diagnostic ECG.

Clinical Evidence

Bench testing only. Performance validated via Low Voltage Indication, Shock, Random Vibration, Sinusoidal Vibration, Heart Rate Accuracy (Shelf Life), and High/Low Temperature & Humidity tests. Compliance with IEC60601-1, IEC 60601-1-2, and AAMI EC38 demonstrated.

Technological Characteristics

Handheld ECG monitor; single PCB design; 2 AAA battery power; USB connectivity. Standards: IEC60601-1 (electrical safety), IEC 60601-1-2 (EMC), AAMI EC38. Software: GEMS Home PC-based interface for trace viewing.

Indications for Use

Indicated for adult patients to record, store, transfer, and display single-channel ECG waveforms during daily activities. Contraindicated for patients with implanted pacemakers or defibrillators. Not for simultaneous recording and transmission.

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

• Handheld ECG Monitor MD100 (K093872)
• HeartCheck Pen Handheld ECG with GEMS Home (K111159)

Submission Summary (Full Text)

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## 510(k) SUMMARY (as required by 807.92(c))

## Regulatory Correspondent: AJW Technology Consultants. Inc. 962 Allegro Lane Apollo Beach, FL 33572 Jon Ward [e-mail] Phone: [phone]F Fax: [phone] CardioComm Solutions, Inc. Submitter of 510(k): 201-3060 Cedar Hill Road Victoria, BC V8T 3J5 Mona Palfreyman [e-mail] Phone: [phone] Fax: [phone] Date of Summary: March 26, 2012 Trade/Proprietary Name: HeartCheck ECG Pen with GEMS Home Classification Name: Class II Product Code: DPS 870.2340 Regulation:

Intended Use:

The HeartCheck ECG Pen with GEMS Home is a telemedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is not intended to substitute for a hospital diagnostic ECG test. The software and hardware are not intended for recording and transmission of user's ECG signal simultaneously. Patients with implanted pacemaker or defibrillator are not recommended to use this device. GEMS Home is a simple software user interface with ECG trace viewing function.

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### Device Description:

The applicant device HeartCheck ECG Pen is a handheld device, which can record cardiac event data and display the data in a clear and precise waveform.

The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit and storage chip. They are all in one PCB that is designed and made by our manufacturing partner Beijing Choice Electronic Technologies.

The HeartCheck ECG Pen is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of HeartCheck ECG Pen has the feature of recording this real time data that is normally difficult to capture.

The applicant device has a "data upload" function which is controlled by hardware; it can transmit the data measured by the device to a computer via the USB port. The GEMS Home software is used to store and review the data collected by the HeartCheck ECG Pen Monitor. The GEMS Home software is installed onto the computer from a CD ROM by the user. The GEMS Home software CD ROM is an accessory of the applicant device.

The applicant device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor.

| Predicate Device(s): | Handheld ECG Monitor MD100 (K093872)<br>HeartCheck Pen Handheld ECG with GEMS Home<br>(K111159) |
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|----------------------|-------------------------------------------------------------------------------------------------|

#### Substantial Equivalence:

The proposed device is substantial equivalent to the Handheld ECG Monitor MD100 (K093872) and HeartCheck Pen Handheld ECG with GEMS Home (K111159) devices. The proposed device has a similar intended use, technological, and design characteristics as the predicate device. Any minor differences do not introduce new issues of safety or effectiveness.

#### Performance Testing:

The device complies with IEC60601-1, IEC 60601-1-2 and AAMI EC38 standards. A Low Voltage Indication Validation Test, Shock Test, Random Vibration Test, Sinusoidal vibration Test, Heart Rate Accuracy Test (Shelf Life) and High, low temperature & humidity Test were all performed on the applicant device to validate its performance.

#### Conclusion:

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The minor differences in the handheld ECG, do not introduce new issues of safety and efficacy. The HeartCheck ECG Pen with GEMS Home has been tested to demonstrate compliance with the FDA Guidance document for use as a handheld ECG, in FDA Classification Code DPS. All of the Testing performed are described and summarized in Sections 15, 17 and 18. These are the Biocompatibility, Electromagnetic Capability and Electrical Safety and Performance Testing Sections. All results demonstrate that the HeartCheck ECG Pen with GEMS Home is equivalent to the predicate device in capability and it meets all of the standard test requirements.

Therefore, the proposed HeartCheck ECG Pen with GEMS Home device is substantially equivalent to Beijing Choice Electronic Technologies - Handheld ECG Monitor MD100 (K093872), Beijing Choice Electronic Technologies - HeartCheck Pen handheld Heart Rhythm with GEMS Home (K111159). The proposed device has the same classification information, similar intended use and technological characteristics as compared to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 7 2012

Cardio Comm Solutions, Inc. c/o Ms. Mona Palfreyman Director of Customer Support & Quality Assurance 201-3060 Ceder Hill Road Victoria, BC V8T 3J5

Re: K121009

> Device Name: HeartCheck ECG Pen with GEMS Home Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 26, 2012 Received: April 3, 2012

Dear Ms. Palfreyman:

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.

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Page 2 – Ms. Mona Palfreyman

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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):

Device Name: HeartCheck ECG Pen with GEMS Home

The HeartCheck ECG Pen with GEMS Home is a telemedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is not intended to substitute for a hospital. diagnostic ECG test. The software and hardware are not intended for recording and transmission of user's ECG signal simultaneously. Patients with implanted pacemaker or defibrillator are not recommended to use this device. GEMS Home is a simple software user interface with ECG trace viewing function.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sian-Off) Division of Cardiovascular Devices

510(k) Number K121007