(147 days)
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.
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.
Here's a breakdown of the acceptance criteria and study details for the LVivo EF Software Application (K130779), based on the provided text:
Acceptance Criteria and Device Performance
The provided text only explicitly states one primary endpoint and the corresponding result. The exact acceptance criteria (i.e., the numerical threshold for success) are not explicitly stated, but the device's performance is reported to have met this primary endpoint.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong positive correlation between LVivoEF and Manual Biplane Method (MBP) for biplane Ejection Fraction (EF) | Pearson correlation coefficient (r) = 0.88, p < 0.0001 |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 83 subjects.
- Data Provenance: The text does not specify the country of origin of the data. It mentions "echocardiographic patient examination DICOM movies" and "ultrasound clips," implying clinical imaging data. The study is described as a "clinical trial," which typically implies prospective data collection, but it's not explicitly stated as prospective or retrospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth was established by "manual evaluation by sonographers and visual estimation by physicians." The number of sonographers or physicians is not specified, nor are their specific qualifications (e.g., years of experience).
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Adjudication method for the test set:
- The adjudication method is not explicitly stated. The text mentions "average values were calculated for each variable measured by Manual Biplane Method (MBP)," suggesting that multiple manual evaluations might have been averaged, but it doesn't detail a formal adjudication process (like 2+1 or 3+1).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not reported. The study compared the device's performance against conventional manual methods performed by sonographers and physicians, but it did not assess human reader performance with versus without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was performed. The "LVivoEF System" was evaluated against manual methods. The reported correlation coefficient (r=0.88) reflects the algorithm's performance in automatically calculating EF, which is a standalone assessment. The analysis was "fully automated."
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The type of ground truth used:
- The ground truth used was expert consensus/manual measurements. Specifically, it involved "manual evaluation by sonographers and visual estimation by physicians" using the "Manual Biplane Method (MBP)."
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The sample size for the training set:
- The document does not provide information about the sample size used for the training set.
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How the ground truth for the training set was established:
- The document does not provide information on how the ground truth for the training set was established, as the training set details are omitted.
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510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com |
|---|---|---|
| 1. (b) | ManufacturerAddress: | AUG 1 5 2013DiACardio, Ltd.Meytag High-Tech VenturesP.O. Box 12, Katzrin, Israel 12900 |
| Mfg. Phone: | Tel.: +972 77 7648318 | |
| Contact Person: | Mrs. Michal Yaacobi | |
| Date: | May 5, 2013 | |
| 2. | Device &ClassificationName: | Picture Archiving Device- classified as Class 2 LLZ, Regulation Number 21CFR 892.2050LVivo EF Software Application |
| 3. | Predicate Devices: | K072090- Siemens Medical Solution SYNGO Auto Left Heart and VVLClinical FeatureK070792- Philips Ultrasound, Inc. QLAB 2D Cardiac Quantification Plug-In |
| 4. | Description: | The LVivoEF System analyzes echocardiographic patient examinationDICOM movies for Global ejection fraction (EF) evaluation. EF is evaluatedusing two orthogonal planes, four-chamber (4CH) and two-chamber (2CH)views, to provide fully automated analyses of LV function from the echoexamination movies. |
| 5. | Intended Use: | DiaCardio's LVivo EF Software Application is intended for non-invasiveprocessing of already acquired echocardiographic images in order to detect,measure, and calculate the left ventricular wall for left ventricular functionevaluation. This measurement can be used to assist the clinician in acardiac evaluation. |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology and intended use, DiaCardio's LVivo EFSoftware Application is substantially equivalent to its predicate devices.Based upon the outcomes from clinical trials, DiaCardio believes that theirdevice 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 (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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§ 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).