HEALTHEPOD

K083174 · Card Guard Scientific Survival , Ltd. · DXH · Dec 17, 2009 · Cardiovascular

Device Facts

• Record ID: K083174
• Device Name: HEALTHEPOD
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Dec 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The HealthePod is a medical device designed for self-testing. It comprises the following medical features: - ECG 1-lead . - Heart rate . - Body temperature ●

Device Story

HealthePod is a handheld, patient-operated monitor for self-testing. Device utilizes two dry electrodes on its PCB to capture 1-lead ECG signals and heart rate; includes a sensor for body temperature measurement. Data is transmitted via USB to a PC running receiving software (e.g., PMP4) for display and review. Intended for home use by patients to monitor cardiovascular and temperature parameters. Healthcare providers access the transmitted data via the PC application to support clinical decision-making. Device features an LCD, three buttons, and non-medical functions (pedometer, calorie meter, alarm) not subject to FDA clearance.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and adherence to safety standards for medical electrical equipment.

Technological Characteristics

Handheld device with LCD, three buttons, and USB connectivity. Features two dry electrodes for ECG sensing. Complies with EN 60601-1 (safety), EN 60601-1-2 (EMC), and EN 60601-1-4 (programmable medical systems).

Indications for Use

Indicated for self-testing by patients for monitoring of 1-lead ECG, heart rate, and body temperature.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Predicate Devices

• Card Guard CG-2206 (K963725)
• Card Guard PMP4 SelfCheck ECG (K042254)
• TaiDoc Technology Corporation Clever TD-1112 IR thermometer (K061800)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Card Guard Scientific Survival LTD. The words "CARD GUARD" are in bold, black letters, with a line underneath. Below the line, the words "Scientific Survival LTD" are in a smaller font. To the right of the words is a black line that resembles an EKG.

November 09 2009

### 1. GENERAL

| Submitter | Card Guard Scientific Survival Ltd., |
|-----------------|----------------------------------------------------------------------------------------------------------------------|
| Address | 2 Pekeris St. P.O.B. 527 Rehovot 76100, Israel |
| Contact: | Alex Gonorovsky, RA Manager |
| Phone: | 972-8-9484019 Fax: [phone] |
| E-mail: | [e-mail] |
| Device | |
| Trade Name: | HealthePod |
| Classification: | Transmitters and receivers, electrocardiograph, telephone |
| Product Code: | DXH Cardiovascular transmitters and receivers, FLL Thermometer electronic, clinical<br>electrocardiograph, telephone |
| Regulation No: | 21 CFR 870.2920 |
| Class: | II |

# 2. DEVICE DEFINITION

The Card Guard® CG-1411USB HealthePod is a medical and non-medical monitor designed for self-testing by patients. It contains 4 sensors designed to execute the following features:

- . ECG 1-lead
- . Heart rate
- . Ambient temperature
- Body temperature .
- Pedometer walking steps and walking distance, .
- Calorie Meter .
- Stopwatch, Count down, Alarm clock .
- Date/Time .

Note: The following HealthePod non-medical functions are not subject to FDA clearance: Ambient temperature, Pedometer, Calorie Meter, Stopwatch, Count down, Alarm clock and Date/Time.

HealthePod can communicate measured data and patient information to a PC with a receiving medical Application such as PMP4. Two dry electrodes are assembled on the device PCB. It features an LCD, three buttons and a USB connector for communication with PC.

# 3. REFERENCED STANDARDS

The HealthePod meets the requirements of the following standards:

EN ISO 9001: Quality management systems - Requirements; December 2000

EN ISO 13485: Quality systems - Medical devices; August 2000

EN ISO 14971: Medical devices – application of risk management to medical devices; March 2001

EN 60601-1: Medical electrical equipment; Part 1: General requirements for safety; Sept. 2002

EN 60601-1-2: Medical electrical equipment; Part 1: 2. Collateral Std: EMC; requirements and tests; 2001

EN 60601-1-4: Medical electrical equipment; Part 1: 4. Collateral Std: Programmable el. medical systems; 2001

EN 980: Graphical symbols for use in the labeling of medical devices; August 2003

EN 1041: Terminology, Symbols and Information provided with Medical Devices; Information supplied by the manufacturer with medical devices; April 1998

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#### HealthePod 510(k) Summary of Safety and Effectiveness

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## 4. SUBSTANTIAL EQUIVALENCE

The clearance for the HealthePod is sought on the grounds of its claimed substantial equivalence (SE) to the following predicate devices:

- Card Guard's CG-2206 K963725 for the one lead feature and similarity in electronic design. 1.
- Card Guard's PMP4 SelfCheck ECG K042254 for the over-the-counter distribution business 2. method when the PMP4 SelfCheck ECG is set to its one lead configuration.
- TaiDoc Technology Corporation Clever TD-1112 IR thermometer K061800 3.

# 5. CONCLUSIONS

CARD GUARD

80 17 D

The HealthePod constitutes a safe and reliable device. Its material composition and operation present no adverse health effect or safety risks when used as intended. The device is as safe, as effective and performs as well as or better than its cleared predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, possibly symbolizing health and well-being. The overall design is simple and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Card Guard Scientific Survival, Ltd. c/o Mr. Alex Gonorovsky Manager, Regulatory Affairs 2 Pekeris St, Science Park Rehovot Israel 76100

DEC 1 7 2009

Re: K083174

Trade Name: Health-ePod Dated: August 5, 2009 Received: August 10, 2009

Dear Mr. Gonorovsky: Re: K083174 Trade/Device Name: Health-ePod Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: Class II Product Code: DXH, FLL Dated: November 9, 2009 Received: November 12, 2009

Dear Mr. Gonorovsky:

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.

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Page 2 – Mr. Alex Gonorovsky

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.

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 (OS) 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/ReportaProblem/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/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): KO83174 Device Name: HealthePod Indications for Use:

> The HealthePod is a medical device designed for self-testing. It comprises the following medical features:

- ECG 1-lead .
- Heart rate .
- Body temperature ●

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _区 (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
(Posted November 13, 2003)
510(k) Nurnber K083174

Page 1 of 1

(Posted November 13, 2003)

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