(86 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Smartheart device, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format. However, it does outline the overall performance and equivalence claim.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "clearly demonstrate that the Smartheart device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns." |
| Effective 12-lead ECG transmitter | "The results of the study clearly confirmed the efficacy of the Smartheart as a 12 lead ECG transmitter." |
| Compliance with standards | Tested according to IEC 60601-2-51:2005, IEC 60601-2-25 (1993) +A1:1999 (and others not fully listed). |
| Substantial Equivalence to Predicate Device (CardioSenC™ K080047) | "The Smartheart device has similar intended use and technological concepts as the market-cleared CardioSenC™." |
| Digital signal transmission | "The Smartheart is capable of transmitting the electrocardiographic signal digitally so it can be forwarded to a remote location as the market-cleared CardioSenC™." |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions a "usability study" but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The text mentions that the Smartheart is designed to enable review at a "physician's office, hospital or other medical receiving center" by a "certified medical professional capable of interpreting the results." However, it does not specify the number or qualifications of experts used to establish ground truth specifically for the usability study mentioned.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method used for the test set in the usability study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Therefore, no effect size for human readers with and without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study
The text describes the Smartheart as a device that transmits ECG signals for professional review. It does not describe a standalone (algorithm only) performance study or an AI component that would necessitate such a study. The device's function is data acquisition and transmission, not automated interpretation.
7. Type of Ground Truth Used
Based on the device's intended use to transmit ECGs for review by "certified medical professionals," the ground truth for evaluating the device's efficacy in data acquisition and transmission would likely be expert medical interpretation of the transmitted ECGs. However, the text does not explicitly state how ground truth was established for the usability study. Given the nature of the device, it would involve comparison of the transmitted ECGs to a reference standard (e.g., simultaneously acquired "gold standard" ECGs) and/or expert review of the quality and interpretability of the transmitted signals.
8. Sample Size for the Training Set
The provided text does not mention a training set or its sample size. This is consistent with the device being a data acquisition and transmission tool rather than an AI-powered diagnostic algorithm requiring a training phase for its core function.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned (since the device is a transmitter, not an AI interpreter), this information is not applicable and not provided in the text.
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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
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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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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
§ 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).