LVIVO EF SYSTEM

K130779 · Diacardio, Ltd. · LLZ · Aug 15, 2013 · Radiology

Device Facts

• Record ID: K130779
• Device Name: LVIVO EF SYSTEM
• Applicant: Diacardio, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

LVivo EF Software Application processes pre-acquired echocardiographic DICOM movies; performs fully automated analysis of left ventricular (LV) function; utilizes two orthogonal planes (four-chamber and two-chamber views) to evaluate global ejection fraction (EF); assists clinicians in cardiac evaluation; intended for clinical use.

Clinical Evidence

Blinded clinical trial of 83 subjects comparing LVivoEF system to manual biplane method (MBP) and visual estimation. Primary endpoint met with a Pearson correlation coefficient for biplane EF of r=0.88 (p<0.0001).

Technological Characteristics

Software-based image processing application for DICOM echocardiographic movies. Operates on standard computing hardware. Automated analysis of LV function using 4CH and 2CH views.

Indications for Use

Indicated for non-invasive processing of echocardiographic images to detect, measure, and calculate left ventricular wall for left ventricular function evaluation to assist clinicians in cardiac evaluation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Siemens Medical Solution SYNGO Auto Left Heart and VVL Clinical Feature (K072090)
• Philips Ultrasound, Inc. QLAB 2D Cardiac Quantification Plug-In (K070792)

Submission Summary (Full Text)

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K130779

## 510(k) Summary of Safety & Effectiveness

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1. (a) | Submitter<br>Address: | George J. Hattub<br>MedicSense, USA<br>291 Hillside Avenue<br>Somerset, MA 02726<br>www.medicsense.com |
|--------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer<br>Address: | AUG 1 5 2013<br>DiACardio, Ltd.<br>Meytag High-Tech Ventures<br>P.O. Box 12, Katzrin, Israel 12900 |
| | Mfg. Phone: | Tel.: [phone] |
| | Contact Person: | Mrs. Michal Yaacobi |
| | Date: | May 5, 2013 |
| 2. | Device &<br>Classification<br>Name: | Picture Archiving Device- classified as Class 2 LLZ, Regulation Number 21<br>CFR 892.2050<br>LVivo EF Software Application |
| 3. | Predicate Devices: | K072090- Siemens Medical Solution SYNGO Auto Left Heart and VVL<br>Clinical Feature<br>K070792- Philips Ultrasound, Inc. QLAB 2D Cardiac Quantification Plug-In |
| 4. | Description: | The LVivoEF System analyzes echocardiographic patient examination<br>DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated<br>using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH)<br>views, to provide fully automated analyses of LV function from the echo<br>examination movies. |
| 5. | Intended Use: | DiaCardio's LVivo EF Software Application is intended for non-invasive<br>processing of already acquired echocardiographic images in order to detect,<br>measure, and calculate the left ventricular wall for left ventricular function<br>evaluation. This measurement can be used to assist the clinician in a<br>cardiac evaluation. |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to technology and intended use, DiaCardio's LVivo EF<br>Software Application is substantially equivalent to its predicate devices.<br>Based upon the outcomes from clinical trials, DiaCardio believes that their<br>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<0001).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 15, 2013

DiaCardio. Ltd c/o George Hattub MedicSense, USA 291 Hillside Ave. SOMERSET. MA 02726

Re: K130779

> 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

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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 [phone] or [phone] 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 [phone] or [phone] 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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