(416 days)
Not Found
No
The document describes a device with basic sensor measurements and data communication, with no mention of AI, ML, or related concepts.
No
The device is described as a medical and non-medical monitor designed for self-testing, with features like ECG, heart rate, and temperature measurement, which are diagnostic or monitoring functions rather than therapeutic.
Yes
This device is designed for self-testing and measures physiological parameters like ECG, heart rate, and body temperature, which are used to assess a patient's health status, thus serving a diagnostic purpose. The mention of its ability to "communicate measured data... to a PC with a receiving medical Application such as PMP4" further supports its role in health monitoring and diagnosis.
No
The device description explicitly states it contains sensors, electrodes, an LCD, buttons, and a USB connector, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the HealthePod is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HealthePod's Functionality: The HealthePod measures physiological parameters directly from the body (ECG, heart rate, body temperature) and tracks physical activity (pedometer, calorie meter). It does not analyze samples taken from the body.
The device is described as a "medical device designed for self-testing" and a "medical and non-medical monitor." Its features are focused on monitoring vital signs and activity, not on analyzing biological samples.
N/A
Intended Use / 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 ●
Product codes
DXH, FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing by patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: 972-8-9484044 |
| E-mail: | galex@cardguard.com |
| Device | |
| Trade Name: | HealthePod |
| Classification: | Transmitters and receivers, electrocardiograph, telephone |
| Product Code: | DXH Cardiovascular transmitters and receivers, FLL Thermometer electronic, clinical |
| 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
1
HealthePod 510(k) Summary of Safety and Effectiveness
ﻨ ﺑﻬ
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.
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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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