LVivo Software Application

K240553 · Dia Imaging Analysis, Ltd. · QIH · Oct 4, 2024 · Radiology

Device Facts

• Record ID: K240553
• Device Name: LVivo Software Application
• Applicant: Dia Imaging Analysis, Ltd.
• Product Code: QIH · Radiology
• Decision Date: Oct 4, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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. In addition, it has the ability to provide Quality Score feedback.

Device Story

LVivo Software Application is a software system for automated analysis of DICOM ultrasound images. It processes echocardiographic movies to evaluate left ventricular (LV) function, including global and segmental function, wall motion, and strain. The platform supports multiple views: apical (4CH, 2CH, 3CH), parasternal short axis (SAX), and parasternal long axis (PLAX). It also includes modules for right ventricular (RV) function and bladder volume measurement. Used in clinical and point-of-care environments, the software provides automated measurements of LV size, wall thickness, and contraction parameters. Clinicians use these outputs to rapidly evaluate patient cardiac condition. The system allows for manual frame selection and editing to confirm results, aiding in clinical decision-making by providing objective, automated quantification of cardiac function.

Clinical Evidence

Clinical validation involved 121 patients (age ≥18, 60% male) undergoing routine transthoracic echocardiography. Primary endpoint: Fractional Shortening (FS) correlation ≥75% vs manual. Results: 82% of exams automatically analyzed; correlation r=0.79; sensitivity/specificity 85% (cutoff 28%). An additional 40-patient dataset (age 27-87, 67.5% male) validated the PLAX module. 90% of exams were automatically analyzed. Results showed strong agreement with sonographers for LVIDd (r=0.9), LVIDs (r=0.95), and LV Mass (r=0.94), with acceptable bias and limits of agreement.

Technological Characteristics

Software-based medical image management and processing system. Operates on Windows/Linux platforms. Utilizes automated image analysis algorithms for DICOM ultrasound clips. Features include automated ED/ES frame selection, volume calculation via Simpson's method of discs, and strain/wall motion evaluation. Connectivity via standard DICOM input. No hardware components; software-only device.

Indications for Use

Indicated for patients with suspected disease requiring non-invasive ultrasound image processing for structural and functional assessment. Applicable to adult patients (≥18 years) in clinical or point-of-care settings. Contraindications include patients with multiple premature beats or LBBB.

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 IQS (K222970)

Submission Summary (Full Text)

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October 4, 2024

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DiA Imaging Analysis Ltd. % George Hattub Medical Device Regulatory Affairs Specialist Medicsense USA LLC 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K240553

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: September 13, 2024 Received: September 13, 2024

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 (the 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.

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"

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(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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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 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-regulatory

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assistance/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,

Samuel Tike for

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team 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)

K240553

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. 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) | Submitter<br>Address: | George J. Hattub<br>Medicsense USA LLC<br>291 Hillside Avenue<br>Somerset, MA 02726<br>[e-mail] |
|--------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer<br>Address: | DiA Imaging Analysis Ltd<br>HaEnergia Street 77<br>Beer-Sheva, Israel 8470912 |
| | Mfg. Phone: | Tel.: [phone] |
| | Contact Person: | Mrs. Michal Yaacobi |
| | Date: | October 3, 2024 |
| 2. | Device &<br>Classification<br>Name: | Medical Image Management and Processing System -<br>classified as Class 2 QIH, Regulation Number 21 CFR 892.2050<br>LVivo Software Application |
| 3. | Predicate Devices: | LVivo IQS K222970 |
| 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 and the Parasternal Long Axis view<br>(PLAX).<br><br>LVivo PLAX extends the current toolbox of the LVivo platform, providing<br>automated calculation of LV size and function parameters from the PLAX<br>view, for cardiac function evaluation as part of the standard echocardiographic<br>assessment in Echo environment and point-of-care. The measurements from<br>the PLAX view add information about the contraction of the LV, its size and<br>wall thickness and can be used for rapid evaluation of the patient's condition<br>in the point-of-care.<br><br>In addition to the LV analysis, the cardiology toolbox includes a module for<br>automated evaluation of the Right Ventricular function and the LVivo<br>Seamless. The LVivo platform includes one additional non-cardiac module<br>for the measurement of the bladder volume. |

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- LVivo platform is intended for non-invasive processing of ultrasound 5. Indications for images to detect, measure, and calculate relevant medical parameters of Use: structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
- 6. Comparison of With respect to technology and intended use, DiA's LVivo Software Technological Application is substantially equivalent to its predicate devices. Based upon Characteristics: the outcomes from the risk analysis and Performance Testing Evaluation, DiA believes that the addition of LVivo PLAX module to the LVivo Software Application predicate device does not raise additional safety of efficacy concerns. The following comparison table depicts the changes.

| | Submitted Device | Predicate Device |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features/Characteristics | LVivo Software<br>Application | LVivo IQS |
| Product Code | same | QIH |
| Indication for Use | same | LVivo platform is<br>intended for non-<br>invasive processing<br>of ultrasound<br>images to detect,<br>measure, and<br>calculate relevant<br>medical parameters of<br>structures and<br>function of patients<br>with suspected<br>disease. In addition, it<br>has the ability to<br>provide Quality Score<br>feedback |
| Modules | LVivo PLAX, LVivo IQS,<br>LVivo EF, LVivo SG,<br>LVivo SAX, LVivo RV,<br>LVivo Seamless &<br>LVivo Bladder | LVivo IQS, LVivo EF,<br>LVivo SG, LVivo SAX,<br>LVivo RV, LVivo<br>Seamless and LVivo<br>Bladder |
| Automation | same | yes |
| Manual Adjustment | same | yes |
| Bi plane EF evaluation | same | yes |
| Simultaneous 2CH and<br>4CH evaluation | same | yes |
| Off-line LV RV and<br>Bladder evaluation using<br>DICOM clips of any<br>vendor | same | yes |
| Automated ED and ES<br>frames selection | same | yes |
| Manual ED and ES frames<br>selection | Added for the PLAX<br>view | no |
| Dynamic left ventricular | same | yes |
| Manual editing by<br>user capability | same | yes |
| Visually confirm<br>results | same | yes |
| Automated rejection<br>of false results | same | yes |
| Volume calculation by<br>standard Simpson's<br>method of discs for EF | same | yes |
| Volume curve<br>Presentation | same | yes |
| EF, Strain, SWM, RV,<br>SAX, Bladder results<br>presentation | same | yes |
| Enables presentation of<br>cardiac function results<br>for different cycles | same | yes |
| Algorithm | Added Support<br>for PLAX view | yes |
| Calculation speed | same | yes |
| Capability or a part of a<br>bigger package (device)<br>for LV function<br>evaluation and Bladder | 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 | K222970 |

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#### 7. Performance Evaluation:

A summary of the Performance Evaluation, which was based upon wellestablished test methods, demonstrated conformity to the intended use.

The clinical validation included a set of 121 patients referred for routine transthoracic echocardiography according to GCP standards. The population was comprised of 60% male, average age of 66.5 ±17. Inclusion criteria: Age ≥18. sinus rhythm without multiple premature beats. Patients with LBBB were excluded from the study. 49% had Normal global LV systolic function, 27% had dilated LV, 24% had LVH, 17% had CAD.

Acceptance criteria for Fractional Shortening (FS): correlation >=75% vs manual measurements.

## Results

A total of 99 exams (82%) were automatically analyzed. The correlation vs average manual measurements of two sonographers was r=0.79, the primary end point was met. Specificity and sensitivity using cutoff value of 28% were 85% and 85% respectively.

## Additional Dataset

An additional dataset, with exams collected from a USA based medical center, was used for LVivo PLAX validation. The data set included 40 patients with similar inclusion\exclusion criteria as described above. The patient population comprised 67.5% (27) male, average age was 60±14 ranging from 27 to 87 years of age. BMI measurement was available for 95% (38) of patients with an average BMI of 31.6± 9.1 ranging from 18.3 to 67.

16.67% (6) had normal systolic LV function, 25% (9) had a mildly impaired LV systolic function, 33.3% (12) were moderately impaired and additional 25% (9) were severely impaired. 25% (10) of patients had dilated LV size. 25% (10) have reported to have LV hypertrophy

The LVivo PLAX was applied automatically to the clips from the 40 exams. 90% of exams were automatically analyzed. Results acceptance considered bias and limits of agreement (LOA) as well as correlation for the calculated parameters. The results are provided below:

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## Results of Additional Dataset

| Measurements | Sonographers Agreement | LVivo PLAX vs Sonographers |
|--------------|------------------------|----------------------------|
| LVIDd | Corr: 0.95 | Corr:0.9. |
| | Bias: 0.12cm | Bias:0.3cm |
| | LOA: -0.71, 0.46 | LOA -0.2, 0.9 |
| LVIDs | Corr: 0.94 | Corr:0.95. |
| | Bias: -0.097cm | Bias:0.42cm |
| | LOA: -4.1, 3.9 | LOA -0.25, 1.1 |
| FS | Corr: 0.79 | Corr:0.74*. |
| | Bias: 1.75% | Bias:-4% |
| | LOA: -12.7, 16.2 | LOA -19.98, 11.96 |
| IVSD | Corr: 0.86 | Corr:0.72. |
| | Bias: -0.08 | Bias:-0.16cm |
| | LOA: -0.3, 0.17 | LOA -0.47, 0.13 |
| PWD | Corr: 0.73 | Corr: 0.68. |
| | Bias: 0.06cm | Bias:-0095cm |
| | LOA: -0.3, 0.4 | LOA -0.21, 0.4 |
| LV Mass | Corr: 0.9 | Corr:0.94. |
| | Bias: -10.43gr | Bias:9.14gr |
| | LOA: -88,68 | LOA -41.6, 59.88 |

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.