(185 days)
Not Found
No
The description focuses on signal conditioning and transmission, with no mention of AI/ML for analysis or interpretation.
No.
The device is used to transmit an ECG signal for diagnostic interpretation, not to treat a condition.
No
The device is described as an ECG transmitter that conditions and transmits an electrocardiographic signal. It is intended to send real-time ECG data to a medical professional for interpretation, rather than performing the diagnosis itself. The performance studies mention compliance with "ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices)", but the device's function is purely data transmission, enabling diagnosis by a professional.
No
The device description explicitly states it is a "personal, battery powered, hand-held personal ECG transmitter," indicating it is a physical hardware device, not solely software.
Based on the provided information, the CardioSen'C device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- CardioSen'C Function: The CardioSen'C device conditions and transmits an electrocardiographic signal (ECG). An ECG is a recording of the electrical activity of the heart, which is obtained directly from the body surface using electrodes. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is to transmit the ECG signal to a remote location for interpretation by a medical professional. This is a diagnostic tool that works in vivo (within the living body) by capturing electrical signals, not in vitro (in glass/outside the body) by analyzing biological samples.
- Device Description: The description clearly states it's a "personal, battery powered, hand-held personal ECG transmitter." This aligns with a device that interacts with the body to capture a physiological signal.
- Performance Studies: The performance studies mentioned are related to standards for electrocardiographic devices and safety, not IVD-specific studies.
- Predicate Devices: The predicate devices listed are also ECG transmitters/recorders, not IVD devices.
In summary, the CardioSen'C device is a medical device used for capturing and transmitting physiological data (ECG) directly from the patient's body. This falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.
Product codes (comma separated list FDA assigned to the subject device)
DXH
Device Description
The CardioSen'C is a personal, battery powered, hand-held personal ECG transmitter, enabling an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location, to a physician's office, hospital or monitoring center. The ECG data can be transmitted in real time via two communication methods. The CardioSen'C produces an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The ECG data can also be transmitted digitally through the cellular network. Either one of these two transmissions methods permits the transfer of a 12-lead ECG and rhythm strip to the medical professional capable of interpreting the data.
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
Used by a patient to transmit to a physician's office, hospital or other medical receiving center.
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)
The CardioSen'C device has been tested according to various standards and guidance documents, such as ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices), IEC 60601-2-25 (1993) +A1:1999 requirements for the safety of electrocardiographs, etc. Further IVD study has shown that the system meets its design specifications and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 11 2008
Image /page/0/Picture/1 description: The image shows the logo for SHL TeleMedicine International Ltd. The logo features the letters "SHL" in a bold, sans-serif font, with a heart symbol incorporated into the design. Below the letters, the words "TeleMedicine International Ltd" are written in a smaller, sans-serif font.
510(K) SUMMARY
CardioSen'C
510(k) Number K 080047
| Applicant's Name: | SHL Telemedicine International Ltd.
90 Igal Alon St.
Tel Aviv 67891
ISRAEL
Tel (972)3-561-2212
Fax (972)3-624-2414 |
| ------------------- | ----------------------------------------------------------------------------------------------------------------------------------- |
|---|
- Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
- Trade Name: CardioSen'C
- Classification: Name: Telephone electrocardiograph transmitter and receiver Product Code: DXH Regulation No: 21 CFR 870.2920 Class: II Panel: Cardiovascular
Device Description: The CardioSen'C is a personal, battery powered, hand-held personal ECG transmitter, enabling an individual to immediately transmit a 12-lead ECG and a rhythm strip from a remote location, to a physician's office, hospital or monitoring center.
The ECG data can be transmitted in real time via two communication methods. The CardioSen'C produces an ECG frequency modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The ECG data can also be transmitted digitally through the cellular network. Either one of these two transmissions methods permits the transfer of a 12-lead ECG and rhythm strip to the medical professional capable of interpreting the data.
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Intended Use Statement:
The CardioSen'C device is intended to condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.
Predicate Devices:
The CardioSen'C is substantially equivalent to the following predicate devices:
- CardioBeeper ® CB 12/12, 12 Lead Personal ECG Transmitter, . cleared under K002310;
- River 1, ECG Event Recorder and Transmitter, cleared under . K063609.
Performance Data:
The CardioSen'C device has been tested according to various standards and guidance documents, such as ANSI/AAMI EC11-1991 (Diagnostic Electrocardiographic Devices), IEC 60601-2-25 (1993) +A1:1999 requirements for the safety of electrocardiographs, etc. Further IVD study has shown that the system meets its design specifications and is safe and effective for its intended use.
Conclusions:
The CardioSen'C device has the same intended use and is capable of transmitting the electrocardiographic signal acoustically via customary telephones as the CardioBeeper® CB 12/12. Further, the CardioSen'C can transmit digitally over cellular network to a remote location as the River -1 device. The results of tests studies and analyses performed with the CardioSen'C device demonstrate that the CardioSen'C device is as safe and effective as its predicate devices without raising any new safety and\or effectiveness concerns.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 11 2008
SHL TeleMedicine International LTD c/o Qsite Mr. Yoram Levy 31 Haavoda St. Binyamina, 30500 ISRAEL
Re: K080047
CardioSens'C Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: June 22, 2008 Received: June 27, 2008
Dear Mr. Levy:
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.
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 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 – Mr. Yoram Levy
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); labcling (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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Qamde
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 STATEMENT
510(k) Number (if known):
Device Name:
CardioSen'C
Indications for Use:
The CardioSen'C device intended to is condition an electrocardiographic signal so that it can be transmitted acoustically via telephone and/or digitally over cellular network to a remote location. The CardioSen'C device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to a physician's office, hospital or other medical receiving center.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of Cardiovascular, Respiratory and Neurological Devices 510(k) Number
ces
(Division Sign-Off)
Division of Cardiovascular Devices
Section 1 - Page 2 CardioSen'C - 510k Notifica