(147 days)
Not Found
Unknown
The summary mentions "fully automated analyses" and "image processing," which are common applications of AI/ML in medical imaging. However, it does not explicitly state that AI or ML is used, nor does it provide details about training or test sets that would definitively confirm the use of these technologies.
No
The device is described as "non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation" and "can be used to assist the clinician in a cardiac evaluation." It provides measurements and analyses, but it does not directly treat or prevent a disease.
Yes
The device processes echocardiographic images to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation, which assists clinicians in cardiac evaluation. This process involves the analysis of medical data to draw conclusions about a patient's health status, fitting the definition of a diagnostic device.
Yes
The device is described as a "Software Application" that processes "already acquired echocardiographic images." There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided information, the DiaCardio's LVivo EF Software Application is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- LVivo EF Function: The LVivo EF software processes already acquired echocardiographic images. These images are generated from a non-invasive imaging modality (ultrasound) applied to the patient's body. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is to process images to assist a clinician in a cardiac evaluation, not to analyze biological samples.
Therefore, the LVivo EF software falls under the category of medical image analysis software, which is distinct from In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
DiaCardio's LVivo EF Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
Product codes
LLZ
Device Description
The LVivoEF System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Echocardiographic images (DICOM movies)
Anatomical Site
Left ventricular wall / LV function
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician, in a cardiac evaluation setting.
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
In the blinded clinical trial, ultrasound clips of 83 subjects were evaluated with the LVivoEF System. Average values were calculated for each variable measured by Manual Biplane Method (MBP) and Pearson correlation coefficients were calculated between MBP and LVivoEF results.
Summary of Performance Studies
Clinical Tests: In this study, the performance of LVivoEF was compared with conventional methods used for LV function evaluation in echocardiography, including manual evaluation by sonographers and visual estimation by physicians. In the blinded clinical trial, ultrasound clips of 83 subjects were evaluated with the LVivoEF System. Average values were calculated for each variable measured by Manual Biplane Method (MBP) and Pearson correlation coefficients were calculated between MBP and LVivoEF results. The primary end point defined for this study was met with a correlation coefficient calculated for biplane EF (r=0.88, p
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com |
|--------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | AUG 1 5 2013
DiACardio, Ltd.
Meytag High-Tech Ventures
P.O. Box 12, Katzrin, Israel 12900 |
| | Mfg. Phone: | Tel.: +972 77 7648318 |
| | Contact Person: | Mrs. Michal Yaacobi |
| | Date: | May 5, 2013 |
| 2. | Device &
Classification
Name: | Picture Archiving Device- classified as Class 2 LLZ, Regulation Number 21
CFR 892.2050
LVivo EF Software Application |
| 3. | Predicate Devices: | K072090- Siemens Medical Solution SYNGO Auto Left Heart and VVL
Clinical Feature
K070792- Philips Ultrasound, Inc. QLAB 2D Cardiac Quantification Plug-In |
| 4. | Description: | The LVivoEF System analyzes echocardiographic patient examination
DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated
using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH)
views, to provide fully automated analyses of LV function from the echo
examination movies. |
| 5. | Intended Use: | DiaCardio's LVivo EF Software Application is intended for non-invasive
processing of already acquired echocardiographic images in order to detect,
measure, and calculate the left ventricular wall for left ventricular function
evaluation. This measurement can be used to assist the clinician in a
cardiac evaluation. |
| 6. | Comparison of
Technological
Characteristics: | With respect to technology and intended use, DiaCardio's LVivo EF
Software Application is substantially equivalent to its predicate devices.
Based upon the outcomes from clinical trials, DiaCardio believes that their
device does not raise additional safety of efficacy concerns. |
| 7. | Clinical Tests: | In this study, the performance of LVivoEF was compared with conventional |
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methods used for LV function evaluation in echocardiography, including manual evaluation by sonographers and visual estimation by physicians. In the blinded clinical trial, ultrasound clips of 83 subjects were evaluated with the LVivoEF System. Average values were calculated for each variable measured by Manual Biplane Method (MBP) and Pearson correlation coefficients were calculated between MBP and LVivoEF results. The primary end point defined for this study was met with a correlation coefficient calculated for biplane EF (r=0.88, p Trade/Device Name: LVivo EF Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 9, 2013 Received: July 17, 2013
Dear Mr. Hattub:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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 or and I 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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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Page 2 - Mr. Hattub
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), picase go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/deliault.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,
Michael D. O'Hara for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130779
Device Name: LVivo EF Software Application
Indications for Use:
DiaCardio's LVivo EF Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
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 In Vitro Diagnostics and Radiological Health (OIR)
Hechert D. D'Huse
(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) __K130779
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