(91 days)
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease and Age >18. In addition, it has the ability to provide Quality Score feedback.
The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart utilizing the apical views. Global LV function evaluation by ejection fraction (EF) is done based on two of the apical views: four-chamber (4CH) and two-chamber (2CH). Segmental LV function evaluation is done from three apical views 4CH, 2CH and three chamber (3CH) and supports segmental wall motion evaluation and strain. The LVivo platform supports also LV function evaluation from the parasternal views including global and segmental LV function analysis from the Short Axis (SAX) view and the global LV function analysis form the Parasternal Long Axis (PLAX) views.
In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.
The LVivo Platform includes also two additional configurations: LVivo Seamless for offline analysis based on automatically selected views and LVivo IQS for real-time quality feedback during image acquisition
Here's an analysis of the provided text to fulfill your request, broken down by the specified information points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the performance metrics (Specificity, Sensitivity, Accuracy, Correlation) in a pass/fail format prior to presenting the results. Instead, it presents the achieved performance. However, we can infer that the reported values are what the manufacturer considers acceptable for equivalence.
Inferred Acceptance Criteria (Based on Study Results):
| Parameter | Acceptance Criteria (Inferred) | Reported Performance (Main Study) | Reported Performance (Second Validation Set) |
|---|---|---|---|
| Specificity | > 79% | 79% | 82% |
| Sensitivity | > 82% | 82% | 82% |
| Accuracy | > 82% | 82% | 82% |
| Correlation (Pearson) | > 0.89 | 0.89 | 0.856 |
| ICC (GT vs LVivo SWM) | > 0.85 | 0.85 | Not reported for this set |
| Automated Analysis Success Rate | > 84% | 84% (139 out of 166 exams) | Not explicitly stated, 'n=78' implies successful processing |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Main Test Set:
- Sample Size: 170 echo exams.
- Data Provenance:
- 101 exams from a medical center in the US.
- 69 exams from two medical centers in Israel.
- Nature of Data: Retrospective (implied by the description "The exams were collected..." and subsequent analysis; not explicitly stated as prospective).
- Second Validation Set:
- Sample Size: 101 patients.
- Data Provenance: From a hospital in Taiwan.
- Nature of Data: Retrospective (implied).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Three cardiologists.
- Qualifications of Experts: Specializing in echo. (No further details on specific experience or certifications are provided).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: "WMSI average across three cardiologists specializing in echo." This indicates a consensus approach where the average of the three experts' interpretations formed the ground truth (e.g., if one expert was an outlier, their reading would still contribute to the average).
5. 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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted or reported.
- The study focuses on the standalone performance of the AI algorithm compared to expert-defined ground truth. It also shows the inter-expert variability (ICC between experts).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the reported performance metrics (Specificity, Sensitivity, Accuracy, Pearson Correlation, ICC) are for the standalone algorithm's performance against the established ground truth, without human intervention or assistance during the assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Expert consensus. Specifically, "WMSI average across three cardiologists specializing in echo."
8. The sample size for the training set
- Training Set Sample Size: The document does not provide the sample size for the training set. It only describes the validation sets.
9. How the ground truth for the training set was established
- Training Set Ground Truth: The document does not provide information on how the ground truth for the training set was established. It only details the ground truth establishment for the test/validation sets.
This analysis is based solely on the provided text. Any information not explicitly stated in the document cannot be inferred.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
DiA Imaging Analysis Ltd. % George Hattub Medical Device Regulatory Affairs Specialist Medicsense USA LLC 291 Hillside Avenue Somerset, Massachusetts 02726
March 17, 2025
Re: K243862
Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: February 21, 2025 Received: February 21, 2025
Dear George 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, PhD Assistant Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
LVivo Software Application
Indications for Use (Describe)
L Vivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease and Age >18. In addition, it has the ability to provide Quality Score feedback.
Type of Use (Select one or both, as applicable)
Prescription 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:
| 1. (a) | SubmitterAddress: | George J. HattubMedicsense USA LLC291 Hillside AvenueSomerset, MA 02726ghattub@comcast.net | Submitted Device | Predicate Device | |
|---|---|---|---|---|---|
| 1. (b) | ManufacturerAddress: | DiA Imaging Analysis LtdHaEnergia Street 77Beer-Sheva, Israel 8470912 | Features/Characteristics | LVivo Software Application | LVivo Software Application |
| Mfg. Phone: | Tel.: +972 77 7648318 | Product Code | same | QIH | |
| Contact Person: | Mrs. Michal Yaacobi | Indication for Use | LVivo platform is intendedfor non- invasiveprocessing of ultrasoundimages to detect,measure, andcalculate relevantmedical parameters ofstructures and function ofpatients with suspecteddisease and Age >18. Inaddition, it has the abilityto provide Quality Scorefeedback | LVivo platform is intended for non-invasive processingof ultrasound images to detect,measure, and calculate relevantmedical parameters of structuresand function of patients withsuspected disease. In addition, ithas the ability to provide QualityScore feedback | |
| Date: | March 16, 2025 | Modules | same | LVivo PLAX, LVivo IQS, LVivoEF, LVivo SG, LVivo SAX, LVivoRV, LVivo Seamless & LVivoBladder | |
| 2. | Device &ClassificationName: | Medical Image Management and Processing System -classified as Class 2 QIH, Regulation Number 21 CFR 892.2050LVivo Software Application | Automation | same | yes |
| 3. | Predicate Devices: | LVivo Software Application K240553 | Manual Adjustment | same | yes |
| 4. | Description: | The LVivo platform is a software system for automated analysis ofultrasound examinations. Automated analysis of echocardiographicexaminations is done using DICOM movies. The LVivo platform supportsglobal and segmental evaluation of the left ventricle (LV) of the heart utilizingthe apical views. Global LV function evaluation by ejection fraction (EF) isdone based on two of the apical views: four-chamber (4CH) and two-chamber (2CH). Segmental LV function evaluation is done from three apicalviews 4CH, 2CH and three chamber (3CH) and supports segmental wallmotion evaluation and strain. The LVivo platform supports also LV functionevaluation from the parasternal views including global and segmental LVfunction analysis from the Short Axis (SAX) view and the global LV functionanalysis form the Parasternal Long Axis (PLAX) views. | Bi plane EF evaluation | same | yes |
| In addition to the LV analysis, the cardiology toolbox includes a module forautomated evaluation of the Right Ventricular function. The LVivo platformincludes one additional non-cardiac module for the measurement of thebladder volume. | Simultaneous 2CH and4CH evaluation | same | yes | ||
| The LVivo Platform includes also two additional configurations: LVivoSeamless for offline analysis based on automatically selected views andLVivo IQS for real-time quality feedback during image acquisition | Off-line LV RV andBladder evaluationusing DICOM clips ofany vendor | same | yes | ||
| 5. | Indications forUse: | LVivo platform is intended for non-invasive processing of ultrasoundimages to detect, measure, and calculate relevant medical parameters of |
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structures and function of patients with suspected disease and Age>18. In addition, it has the ability to provide Quality Score feedback.
- Comparison of With respect to technology and intended use, DiA's LVivo Software Technological Application is substantially equivalent to its predicate devices. Based upon the outcomes from the risk analysis and Performance Testing Evaluation, Characteristics: DiA believes that the modification of LVivo SWM module of the LVivo Software Application predicate device does not raise additional safety of efficacy concerns. The following comparison table depicts the changes.
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| Automated ED and ES frames selection | same | yes |
|---|---|---|
| Manual ED and ES frames selection | same | yes |
| Dynamic left ventricular Manual editing by user capability | same | yes |
| Manual editing by user capability | same | yes |
| Visually confirm results | same | yes |
| Automated rejection of false results | same | yes |
| Volume calculation by standard Simpson's method of discs for | same | yes |
| Volume curve Presentation | same | yes |
| EF, Strain, SWM, RV, SAX, Bladder results presentation | same | yes |
| Enables presentation of cardiac function results for different Algorithm | same | yes |
| Algorithm | same | yes |
| Calculation speed | same | yes |
| Capability or a part of a bigger package (device) for LV function evaluation and Bladder | same | yes |
| Segmental Longitudinal Strain Measure | same | yes |
| Global Longitudinal Strain Measure | same | yes |
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| Segmental wallmotion evaluation | Yes. Based on thesame machinelearning algorithm,multiple rocessingsteps were addedand the calculatedfeatures revised | Yes. Based on a machinelearning algorithm. |
|---|---|---|
| Operating System | Same | Windows/Linux(WithAndroid option for LVivo EF |
| 510(k) # | Pending | K240553 |
Non-Clinical Performance Evaluation:
The proposed modification of LVivo software application was tested in accordance with DiA Imaging Analysis internal procedures. DiA imaging Analysis tested the subject devices per the following standards to ensure the continued safe and effective performance:
• IEC 62304:2006+A1:2015 CSV, Medical Device Software – Software Life-Cycle Processes
· IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices, 2015 + AMD 2020.
• IEC/TR80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software systems, software, and services information
Non-clinical verification testing was conducted to address the change and performance test data were provided to support the revision of the software application. The activities to assure the safe and effective performance of the software revision included, but are not limited to, the Requirements Review, Risk Analysis and System Testing.
Risk control measures are identified by the threat models and incorporated into the risk analysis process and SW design. The verification and validation testing including 3rd party libraries vulnerability assessment of the SW (SBOM) to ensure that cybersecurity related design requirement are implemented successfully. The company
has defined a Cybersecurity plan for ongoing cybersecurity maintenance.
7. Clinical
Performance Evaluation:
A summary of the Performance Evaluation, which was based upon well-established test methods, demonstrated conformity to the intended use.
The validation was done using 170 examinations echo exams acquired with GE and Philips ultrasound devices. The exams were collected in three medical centers, 101 exams from a medical center in US, 69 exams from two medical centers in Israel. The patient population included 66% male with mean age of 60.5 ±14.9 years. BMI information was available for the examination in US and was reported to be 30.9 ± 8.
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Global systolic LV function was normal in 48 (28%) of the patients. Regional wall motion abnormalities (RWMA) were indicated in over 73 (42.9%) patients. Inclusion criteria: Age ≥18, sinus rhythm without multiple premature beats. Examinations in which more than one third of the endocardium is not visible in a plane (2CH/4CH/3CH) and patients with LBBB were excluded from the study.
Ground truth was defined as WMSI average across three cardiologists specializing in echo.
Results
A total of 166 exams were processed, automated analysis was possible in 139 exams (84%). The Specificity and sensitivity of WMSI were 79% and 82% respectively and the accuracy was found to be 82%. The Pearson correlation coefficient between automatically calculated WMSI was 0.89
The ICC calculation to compare between the automated WMSI and ground truth, was based on the exams that were processed automatically by the algorithm. In the ICC calculation to compare between the three experts, all patients in which WMSI was provided in the ground truth from all three experts were included. The comparison for
| ICC | ||||
|---|---|---|---|---|
| GT vs LVivoSWM | Expert 1 vsExpert 2 | Expert 1 vsExpert 3 | Expert 2 vsExpert 3 | |
| WMSI | 0.85 | 0.64 | 0.74 | 0.81 |
WMSI is provided below:
ICC calculated between GT and LVivo SWM, and between each pair of experts.
The software was tested on additional data set of 101 patients collected from a hospital in Taiwan. The data was acquired with Philips ultrasound device.
The patient population consisted of 62% males, with a mean age of 70.1 ± 16 years (range: 29–99 years). The average BMI was 23 ± 3.7, ranging from 16 to 35. All patients were of Asian ethnicity. Based on the echo reports, 65 patients (64%) had normal LV function, 28 (28%) had mildly or moderately impaired LV function, and 8 (8%) had severely impaired LV function. 65 patients (64%) had LV hypertrophy; LV size was reported as dilated for 11 patients (11%). Regional wall motion abnormalities (RWMA) were indicated for 34 (33%) of the patients. The Specificity, sensitivity, accuracy and Pearson correlation were calculated. The analysis summary is provided in the table below:
| Parameter | Second Validation Set |
|---|---|
| ----------- | ----------------------- |
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| Specificity | 82% |
|---|---|
| Sensitivity | 82% |
| Accuracy | 82% |
| Correlation | 0.856 |
| n | 78 |
Specificity, Sensitivity accuracy and correlation between automated results and ground truth running on the second clinical validation set.
8 .
- Conclusion: The intended use and the technological characteristics in the current device are the same as those in the predicate device. Likewise, the modifications do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully verify the validated performance of the subject device. Therefore, DiA Imaging Analysis has concluded the LVivo Software Application is substantially equivalent to the predicate device.
§ 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).