LVivo Software Application

K210053 · Dia Imaging Analysis, Ltd. · QIH · Feb 5, 2021 · Radiology

Device Facts

• Record ID: K210053
• Device Name: LVivo Software Application
• Applicant: Dia Imaging Analysis, Ltd.
• Product Code: QIH · Radiology
• Decision Date: Feb 5, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K210053 · Feb 5, 2021	LVivo Software Application	Dia Imaging Analysis, Ltd.	Routine transthoracic echocardiography examinations from ambulatory and hospitalized patients	The retrospective dataset was used to validate the performance of the LVivo Software Application (EF, SWM, and GLS analysis) by comparing results against established reference standards.	Retrospective cohort; Routine clinical care; Echocardiography; Performance validation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Retrospective analysis of routine clinical data	Ambulatory and hospitalized patients referred for routine transthoracic echocardiography; age >18, in sinus rhythm; excluded patients with LBBB.; Sample Size: 100 patients (96 examinations for EF analysis; 98 examinations for SWM and GLS analysis)	Not applicable for this study	Biplane EF correlation, sensitivity, specificity, and kappa for EF; sensitivity for SWM and GLS.

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Ejection Fraction	Neural network	biplane EF correlation >=80%	—	—	—	100 ambulatory and hospitalized patients referred for routine transthoracic echocardiography	—
Global Longitudinal Strain	Neural network	cutoff value < -17, Sensitivity>=75% compared to ref WSMI	—	—	—	98 examinations from a data set of 100 ambulatory and hospitalized patients	—
Segmental Wall Motion	Neural network	Sensitivity >=75%	—	—	—	98 examinations from a data set of 100 ambulatory and hospitalized patients	—

Indications for Use

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

Device Story

LVivo platform is a software system for automated analysis of echocardiographic DICOM movies; supports global/segmental left ventricle (LV) function evaluation (ejection fraction, wall motion, strain) from apical (4CH, 2CH, 3CH) and parasternal short axis (SAX) views; includes right ventricular (RV) function and bladder volume modules. Operates on Windows/Linux/Android platforms. Software processes ultrasound inputs to automatically select end-diastolic/end-systolic frames, calculate volumes via Simpson's method of discs, and present results. Clinicians use output to assess cardiac function and bladder volume; manual editing/confirmation capabilities provided. Benefits include automated, standardized, and efficient analysis of ultrasound examinations.

Clinical Evidence

Bench testing and retrospective analysis of 100 ambulatory/hospitalized patients (59% male, mean age 60.6 ±17.7). 96 exams used for EF analysis; 98 for SWM/GLS. Acceptance criteria: biplane EF correlation ≥80%; GLS sensitivity ≥75% (cutoff < -17); SWM sensitivity ≥75%. Results demonstrated performance similar or superior to the predicate device.

Technological Characteristics

Software-based automated radiological imaging processing. Supports DICOM input. Operates on Windows, Linux, and Android platforms. Utilizes neural network-based algorithms for image analysis. Features include automated frame selection, Simpson's method of discs for volume calculation, and manual editing tools.

Indications for Use

Indicated for patients with suspected disease requiring non-invasive ultrasound image processing for structural and functional measurements. Excludes patients with multiple premature beats or LBBB. Age >18.

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

• LVivo Software Application (K200232)

Submission Summary (Full Text)

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February 5, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

DiA Imaging Analysis Ltd. % Mr. George J. Hattub Senior Project Manager Medicsense USA 291 Hillside Avenue SOMERSET MA 02726

Re: K210053

Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: OIH Dated: December 31, 2020 Received: January 8, 2021

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. 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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K210053

Device Name LVivo Software Application

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

K210053

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

| 1. (a) | Submitter Address: | George J. Hattub<br>Medicsense USA LLC<br>291 Hillside Avenue<br>Somerset, MA 02726<br>[e-mail]<br>https://www.upwork.com/freelancers/~0196e832ca4b82a2f3?viewMode=1 |
|--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer Address: | DiA Imaging Analysis Ltd<br>HaEnergia Street 77<br>Beer-Sheva, Israel 8470912 |
| | Mfg. Phone: | Tel.: [phone] |
| | Contact Person: | Mrs. Michal Yaacobi |
| | Date: | January 27, 2021 |
| 2. | Device &<br>Classification<br>Name: | Automated Radiological Imaging Processing Software - classified as Class 2<br>QIH, Regulation Number 21 CFR 892.2050<br>LVivo Software Application |
| 3. | Predicate Device: | K200232 LVivo Software Application |
| 4. | Description: | The LVivo platform is a software system for automated analysis of<br>ultrasound examinations. Automated analysis of echocardiographic<br>examinations is done using DICOM movies. The LVivo platform supports<br>global and segmental evaluation of the left ventricle (LV) of the heart. The<br>global LV function is evaluated from two of the apical views: four-chamber<br>(4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV<br>function is done from three apical views 4CH, 2CH and three chamber<br>(3CH) and supports wall motion evaluation and strain. The LVivo platform<br>supports also global and segmental evaluation of the LV from the<br>parasternal short axis (SAX) view. In addition to the LV analysis, the<br>cardiology toolbox includes a module for automated evaluation of the Right<br>Ventricular function. The LVivo platform includes one additional non-cardiac<br>module for the measurement of the bladder volume. |
| 5. | Intended Use: | LVivo platform is intended for non-invasive processing of ultrasound images<br>to detect, measure, and calculate relevant medical parameters of structures<br>and function of patients with suspected disease |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to technology and intended use, DiA's LVivo Software<br>Application is substantially equivalent to its predicate device. Based upon<br>the outcomes from the risk analysis and Performance Testing Evaluation,<br>DiA believes that the modification of the predicate device does not raise<br>additional safety of efficacy concerns. The following comparison table<br>depicts the changes. |

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| | Submitted Device | Predicate Device |
|-------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features/Characteristics | LVivo Software<br>Application | LVivo Software<br>Application |
| Product Code | same | QIH |
| Indication for Use | same | LVivo platform is<br>intended for non-<br>invasive processing of<br>ultrasound images to<br>detect, measure, and<br>calculate relevant<br>medical parameters of<br>structures and function<br>of patients with<br>suspected disease. |
| Modules | same | LVivo EF, LVivo SG,<br>LVivo SAX, LVivo RV &<br>LVivo Bladder |
| Automation | same | yes |
| Manual Adjustment | same | yes |
| Bi plane EF evaluation | same | yes |
| Simultaneous 2CH and<br>4CH evaluation | same | yes |
| Off-line EF evaluation<br>using DICOM clips of any<br>vendor | same | yes |
| Automated ED and ES<br>frames selection | same | yes |
| Dynamic left ventricular | same | yes |
| Manual editing by<br>user capability | same | yes |
| Visually confirm EF | same | yes |
| Automated rejection<br>of false results | same | yes |
| Volume calculation by<br>standard Simpson's<br>method of discs | same | yes |
| Volume curve<br>Presentation | same | yes |
| EF results presentation | same | yes |
| Enables presentation EF<br>results for different<br>cycle | same | yes |
| Algorithm | Modified in LVivo EF | yes |
| Calculation speed | same | yes |
| Capability or a part of a<br>bigger package (device)<br>for LV function | same | yes |
| Segmental Longitudinal<br>Strain Measure | same | yes |
| Global Longitudinal<br>Strain Measure | same | yes |
| Segmental wall motion<br>evaluation | same | yes |
| Operating System | same | Windows/Linux<br>(with Android<br>option for LVivo<br>EF |
| 510(k) # | Pending | K200232 |

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510k Notification: LVivo Software Application

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#### 7. Performance A summary of the Performance Evaluation, which was based upon well-Evaluation: established test methods, demonstrated conformity to the intended use.

A data set of 100 ambulatory and hospitalized patients referred for routine transthoracic echocardiography was previously collected according to GCP standards. The population was comprised of 59% male, mean age of 60.6 ±17.727. Inclusion criteria: age >18 in sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 27 patients had normal LV and 47 patients had coronary artery disease (CAD) function. Total of 96 examinations were used for the EF analysis (due to missing ref).

Acceptance criteria for EF analysis: biplane EF correlation >=80%, similar or better EF biplane results in terms of correlation, specificity, sensitivity, and kappa with respect to subject device.

For SWM and GLS analysis, a total of 98 examinations were used from the same data set (due to missing ref).

For GLS acceptance criteria: cutoff value < -17, Sensitivity>=75% compared to ref WSMI, similar or better results compared to subject device

For SWM acceptance criteria: Sensitivity >=75%, similar or better results compared to subject device

- 8. Conclusion: The Intended Use and the technological characteristics in the current device are the same as those in the predicate device, including the addition of the neural network, do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully support the device performance. Therefore, DiA Imaging Analysis concludes the LVivo Software Application is substantially equivalent to the predicate device.