(416 days)
The HealthePod is a medical device designed for self-testing. It comprises the following medical features:
- ECG 1-lead .
- Heart rate .
- Body temperature ●
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 .
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.
The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone performance study with detailed acceptance criteria and results.
Based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided text. The document states that "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." This is a general statement of compliance and equivalence, not a table of specific performance metrics against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document does not describe any specific test set for performance evaluation, nor does it mention sample sizes, country of origin, or whether any testing was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. As there's no mention of a specific test set or ground truth establishment process, the number and qualifications of experts are not discussed.
4. Adjudication Method for the Test Set
This information is not provided. An adjudication method would typically be relevant for studies involving human interpretation or expert review, which is not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. The HealthePod is described as a self-testing device with sensors, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not explicitly detailed in terms of performance metrics. While the device is a "self-testing" unit, indicating standalone operation, the document doesn't present a standalone performance study with quantitative results against specific criteria. It implies that the functionality (ECG 1-lead, heart rate, body temperature) works as intended and is equivalent to predicate devices.
7. The Type of Ground Truth Used
This information is not provided. Since no specific performance study with a test set is outlined, the type of ground truth used to validate performance (e.g., expert consensus, pathology, outcomes data) is not mentioned. For a device measuring physiological parameters, ground truth would typically come from established medical devices or clinical observations.
8. The Sample Size for the Training Set
This information is not provided. The document does not describe the development or training of any algorithms, so there is no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. As there is no mention of a training set, the method of establishing its ground truth is also not discussed.
Summary of Device and Equivalence Claim (from the document):
The HealthePod is a medical and non-medical monitor designed for self-testing. Its medical features include:
- ECG 1-lead
- Heart rate
- Body temperature
The device sought clearance based on substantial equivalence to the following predicate devices:
- Card Guard's CG-2206 K963725 (for one-lead feature and electronic design similarity)
- Card Guard's PMP4 SelfCheck ECG K042254 (for over-the-counter distribution and one-lead configuration)
- TaiDoc Technology Corporation Clever TD-1112 IR thermometer K061800
The conclusion states that the "HealthePod constitutes a safe and reliable device... The device is as safe, as effective and performs as well as or better than its cleared predicate devices." This implies that the performance is considered acceptable because it meets or exceeds the performance of already cleared devices, but the specific studies and acceptance criteria for this device are not detailed.
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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: 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, clinicalelectrocardiograph, 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
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.
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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 (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
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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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§ 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).