(86 days)
Not Found
No
The description focuses on signal acquisition and transmission, with no mention of AI/ML for analysis or interpretation.
No
The device is described as conditioning and transmitting ECG signals for review by a medical professional. Its stated purpose is diagnostic (providing data for interpretation), not therapeutic (treating or alleviating a medical condition).
Yes
The device is intended to condition an electrocardiographic signal for transmission so it can be reviewed by a medical professional, which is a step in the diagnostic process. It collects physiological data (ECG) that is then interpreted to assess a patient's health status.
No
The device description explicitly states it is a "hand-held battery powered, 12 lead ECG and rhythm strip device with Bluetooth connection" that "acquires ECG data via attached electrodes," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, the Smartheart device 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.
- Smartheart Function: The Smartheart device acquires and transmits an electrocardiographic (ECG) signal. This is a measurement of the electrical activity of the heart, which is a physiological signal, not a sample taken from the body for analysis.
- Intended Use: The intended use is to transmit the ECG signal for review by a medical professional, not to perform a diagnostic test on a biological sample.
Therefore, the Smartheart device falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at 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 Smartheart is a personal, hand-held battery powered. 12 lead ECG and rhythm strip device with Bluetooth connection. The Smartheart acquires ECG data via attached electrodes. The Smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.
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 data for review at 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)
Usability study: SHL Telemedicine has conducted a usability study designed to test the effectiveness of the Smartheart device as a 12 lead ECG transmitter. The results of the study clearly confirmed the efficacy of the Smartheart as a 12 lead ECG transmitter.
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
KI13514 PI/>
FEB 2 2 2012
Image /page/0/Picture/2 description: The image shows a logo for SHL Telemedicine. The logo consists of the letters "SHL" stacked on top of the word "telemedicine". The letters "SHL" are in a bold, sans-serif font, and the word "telemedicine" is in a smaller, italicized font. There are horizontal lines above and below the letters "SHL".
510(K) SUMMARY
Smartheart
510(k) Number K
Applicant's Name: SHL Telemedicine International Ltd. 90 Yigal Alon Street 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: Smartheart
Preparation Date November 20, 2011
Name: Telephone electrocardiograph transmitter and receiver Classification: Product Code: DXH Regulation No: 21 CFR 870.2920 Class: II Panel: Cardiovascular
- Device Description: The Smartheart is a personal, hand-held battery powered. 12 lead ECG and rhythm strip device with Bluetooth connection. The Smartheart acquires ECG data via attached electrodes. The Smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.
Intended Use Statement:
.
The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.
Section 3 - Page 2 Smartheart - 510k Notification
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Image /page/1/Picture/1 description: The image shows a logo for SHL Telemedicine. The logo consists of the letters "SHL" stacked on top of the word "Telemedicine". There are two horizontal lines above the letters "SHL" and one horizontal line below the letters "SHL" and above the word "Telemedicine".
Predicate Devices:
The Smartheart is substantially equivalent to the following predicate device:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| CardioSenC™ | K080047 | Jul 11, 2008 |
Performance Standards:
The Smartheart device has been tested according to various standards and guidance documents, such as IEC 60601-2-51:2005 (Essential performance, of recording and analyzing single channel and multichannel electrocardiographs), IEC 60601-2-25 (1993) +A1:1999 (requirements for the safety of electrocardiographs), etc.
Usability study:
SHL Telemedicine has conducted a usability study designed to test the effectiveness of the Smartheart device as a 12 lead ECG transmitter. The results of the study clearly confirmed the efficacy of the Smartheart as a 12 lead ECG transmitter.
Conclusions:
The Smartheart device has similar intended use and technological concepts as the market-cleared CardioSen'CTM. The Smartheart is capable of transmitting the electrocardiographic signal digitally so it can be forwarded to a remote location as the market-cleared CardioSen'C™. The results of tests, analyses, and studies performed with the Smartheart device clearly demonstrate that the Smartheart device is as safe and effective as its predicate device without raising any new safety and\or effectiveness concerns.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to promoting health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
C
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 2 2012
SHL Telemedicine International, Ltd. c/o Mr. Yoram Levy Osite 31 Haavoda St. Binyamina, Israel 30500
K113514 Re:
Trade/Device Name: Smartheart Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: Class II (two) Product Codes: DXH Dated: November 20, 2011 Received: November 28, 2011
Dear Mr. Levy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerosale) to regard) the enactment date of the Medical Device Amendments, or to commerce pror to may 2011 devices mat have been require approval of a premarket approval application (PMA). and Costicle Act (110) that the novice, subject to the general controls provisions of the Act. The I va may, morelore, mains of the Act include requirements for annual registration, listing of general controls provision 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), if your device is classified (600 above) as is is is is a major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised hat I Driv issuality a your device complies with other requirements of the Act that I Dri has Inado a averalations administered by other Federal agencies. You must
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Page 2 - Mr. Yoram Levy
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/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.
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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Image /page/4/Picture/0 description: The image shows a logo with the letters "SHL" stacked on top of each other. Below the letters, the word "Telemedicine" is written in a smaller font. The logo appears to be for a telemedicine company called SHL Telemedicine.
INDICATIONS FOR USE STATEMENT
KIT 351 H 510(k) Number (if known):
Device Name:
Smartheart
Indications for Use:
The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician's office, hospital or other medical receiving center.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
er Use
part 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
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K113514
Section 1 - Page 2 Smartheart - 510k Notification