(71 days)
Not Found
Unknown
While the device performs automated analysis of echocardiographic images, the summary does not explicitly mention the use of AI or ML algorithms. The description focuses on "automated analyses" and comparisons to existing methods like Visual Estimation and Velocity Vector Imaging (VVI), which are not necessarily AI/ML based. There is no mention of training or test sets in the context of model development, which is typical for AI/ML submissions.
No
The device is intended for non-invasive processing of echocardiographic images to assist clinicians in cardiac evaluation, not for providing therapy.
Yes
This device is intended for "non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation." This evaluation assists clinicians in cardiac evaluations, matching 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 any accompanying hardware or hardware components being part of the device itself. The predicate devices are also described as software applications or workplaces.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the software processes already acquired echocardiographic images. This means it analyzes data that has been generated by another medical device (the echocardiograph) and is not directly interacting with biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Device Description: The description reinforces that it analyzes echocardiographic patient examination DICOM movies. Again, this is processing existing image data.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with any biological samples. IVDs are designed to perform tests on biological specimens.
- Focus on Image Processing: The description explicitly mentions "processing of already acquired echocardiographic images." This is characteristic of medical image analysis software, not IVDs.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This is typically done by examining specimens derived from the human body.
This device falls under the category of medical image analysis software, which is a type of medical device, but not an IVD. It assists clinicians in interpreting existing medical images.
N/A
Intended Use / Indications for Use
DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The LVivo 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. It also has the ability to measure strain
Mentions image processing
DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
echocardiographic images
Anatomical Site
left ventricular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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 this study, the performance of LVivoSG was compared with conventional methods used for SG function evaluation in echocardiography, including manual evaluation by sonographers and visual estimation by physicians. In the blinded clinical trial, ultrasound clips of 100 subjects were evaluated with the LVivo 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2016
Diacardio, Ltd. % Mr. George Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue SOMERSET MA 02726
Re: K161382
Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 14, 2016 Received: May 18, 2016
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 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 (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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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), 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. 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)
K161382
Device Name
LVivo Software Application
Indications for Use (Describe)
DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
rescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
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- (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 1. (b) Manufacturer DiACardio, Ltd. Address: HaEnergia Street 77 Be'er Street, Israel Mfa. Phone: Tel.: +972 77 7648318 Contact Person: Mrs. Michal Yaacobi Date: July 21, 2016 2. Picture Archiving Device- classified as Class 2 LLZ, Regulation Number 21 Device & Classification CFR 892.2050 LVivo Software Application Name: Predicate Devices: K072090- Siemens Medical Solution SYNGO Auto Left Heart and VVL 3. Clinical Feature K091286- Siemens Medical Solution SYNGO US Workplace K130779- DiaCardio's LVivoEF Software Application 4. Description: The LVivo 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. It also has the ability to measure strain 5. Intended Use: DiaCardio's L Vivo 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 With respect to technology and intended use, DiaCardio's LVivo Software Technological Application is substantially equivalent to its predicate devices. Based upon the outcomes from clinical trials, DiaCardio believes that their device does Characteristics: not raise additional safety of efficacy concerns. At the end of this summary, a comparison table is provided.
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- Clinical Tests: In this study, the performance of LVivoSG was compared with conventional methods used for SG function evaluation in echocardiography, including manual evaluation by sonographers and visual estimation by physicians. In the blinded clinical trial, ultrasound clips of 100 subjects were evaluated with the LVivo 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 0.8) was for mid segments of all walls, while low correlation (R