LVivo Seamless

K212466 · Dia Imaging Analysis, Ltd. · QIH · Dec 9, 2021 · Radiology

Device Facts

• Record ID: K212466
• Device Name: LVivo Seamless
• Applicant: Dia Imaging Analysis, Ltd.
• Product Code: QIH · Radiology
• Decision Date: Dec 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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 and Age >18.

Device Story

LVivo Seamless v2.0 is a standalone software application operating offline on a server within a healthcare environment. It receives ultrasound examinations in DICOM format from ultrasound devices. The system automatically selects appropriate clips for Ejection Fraction (EF) and Global Longitudinal Strain (GLS) evaluation. It activates the FDA-cleared LVivo EF and LVivo Strain modules to perform automated analysis. Results are transmitted to the PACS for review by a healthcare professional. The device assists clinicians in evaluating cardiac function by providing automated measurements, which are used to support clinical decision-making. The primary benefit is the automated, non-invasive assessment of cardiac parameters, potentially improving workflow efficiency and consistency in cardiac ultrasound analysis.

Clinical Evidence

Validation study used 100 patient examinations (age >18). The system successfully identified 4CH, 2CH, and 3CH clips in 95% of cases. GLS measurements were compared against GE's Automated Functional Imaging (AFI) as the reference standard. Results showed a correlation of 0.88, mean accuracy of -1.4% ± 3.93% (Bland-Altman), sensitivity of 0.90, and specificity of 0.83, using a normal/abnormal threshold of -18%.

Technological Characteristics

Standalone software application; runs on Windows-based servers; processes DICOM ultrasound clips; utilizes automated image selection and analysis modules (LVivo EF and LVivo Strain); supports manual editing of results; integrates with PACS; offline processing architecture.

Indications for Use

Indicated for non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters of cardiac structure and function in patients >18 years old with suspected disease.

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 Seamless (K202546)

Reference Devices

• LVivo Software Application (K210053)

Submission Summary (Full Text)

{0}------------------------------------------------

December 9, 2021

Image /page/0/Picture/1 description: The image contains 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 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 Senior Project Manager Medicsense USA 291 Hillside Avenue SOMERSET, MASSACHUSETTS 02726

Re: K212466

Trade/Device Name: LVivo Seamless v2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 8, 2021 Received: November 10, 2021

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 (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

{1}------------------------------------------------

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 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 (OS) 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, Division 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

Device Name DiA LVivo Seamless

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 and Age >18.

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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]<br>https://www.upwork.com/freelancers/~0196e832ca4b82a2f3?viewMode=1 | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | December 7, 2021 | |
| 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 Seamless | |
| 3. | Predicate Device: | K202546 LVivo Seamless (Reference Device K210053) | |
| 4. | Description: | The LVivo Seamless is a standalone application that extends the LVivo<br>Platform and runs offline on a server in a healthcare environment. The<br>system accepts echo examinations in DICOM format that are sent from an<br>Ultrasound device and automatically selects the adequate clips for EF and<br>GLS evaluation. After the clip selection, the LVivo Seamless activates the<br>FDA cleared LVivo EF and LVivo Strain modules which perform automatic<br>evaluation. The results are sent to the PACS and are evaluated by a<br>healthcare professional. | |
| 5. | Indications for<br>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 and Age>18 | |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to technology and intended use, DiA's LVivo Seamless is<br>substantially equivalent to its predicate device. Based upon the outcomes<br>from the risk analysis and Performance Testing Evaluation, DiA believes<br>that the modification of the predicate device does not raise additional safety<br>of efficacy concerns. The following comparison table depicts the changes. | |
| | Submitted Device | Predicate Device | Reference Device |
| Features/Characteristics | LVivo Seamless | LVivo Seamless | LVivo Software<br>Application |
| Product Code | same | QiH | QiH |
| Indication for Use | DiA's LVivo platform is<br>intended for non-invasive<br>processing of ultrasound<br>images to detect,<br>measure, and<br>calculate relevant<br>medical parameters<br>of structures and<br>function of patients with<br>suspected disease and<br>Age>18 | 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. | 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 | LVivo EF, LVivo Strain | LVivo EF | LVivo EF, LVivo SG<br>(LVivo SWM & LVivo<br>Strain), LVivo SAX,<br>LVivo RV and LVivo<br>Bladder |
| Automation | same | yes | yes |
| Manual Adjustment | same | yes | yes |
| Bi plane EF evaluation | same | yes | yes |
| Simultaneous 2CH and<br>4CH evaluation | same | yes | yes |
| Off-line EF evaluation<br>using DICOM clips of any<br>vendor | same | yes | yes |
| Automated ED and ES<br>frames selection | same | yes | yes |
| Dynamic left ventricular | same | yes | yes |
| Manual editing by<br>user capability | Same, added editing<br>capabilities to the<br>output results | yes | yes |
| | | | |
| | | | |
| | | | |
| Visually confirm EF | same | yes | yes |
| Automated rejection of<br>false results | same | yes | yes |
| Volume calculation by<br>standard Simpson's<br>method of discs | same | yes | yes |
| Volume curve<br>calculation | same | yes | yes |
| EF results presentation | same | yes | yes |
| Enables calculation EF<br>results for different<br>cycle | same | yes | yes |
| Algorithm | same | same | yes |
| Calculation speed | same | yes | yes |
| Capability or a part of a<br>bigger package (device)<br>for LV function<br>evaluation | same | yes | yes |
| Segmental Longitudinal<br>Strain Measure | yes | no | yes |
| Global Longitudinal<br>Strain (GLS) Measure | yes | Yes (from LVivo<br>EF module) | yes |
| GLS calculation per view | yes | no | no |
| Operating System | Windows | Windows | Windows/Linux<br>(with Android<br>option for LVivo<br>EF) |
| 510(k) # | K212466 | K202546 | K210053 |

{4}------------------------------------------------

{5}------------------------------------------------

{6}------------------------------------------------

- 7. Performance A summary of the Performance Evaluation, which was based upon well-Evaluation: established test methods, demonstrated conformity to the intended use. Success criteria:
1. Correct identification of 4ch and 2ch and 3ch views in 90% of the examinations

2. Correlation of 80% between GLS by AFI and GLS by LVivo Seamless

100 patient examinations were used for the validation. Inclusion criteria: Age>18, examinations in which GLS results by Automated Functional Imaging (AFI .GE) were available. No exclusion criteria were applied. The system was able to recognize all three 4CH, 2CH and 3CH clips in 95% of the examinations. The measurements by LVivo Strain running offline on the automatically selected clips were compared to the measurements done routinely in the Echo lab by AFI. The GLS by LVivo Strain was compared to GLS by AFI. Statistical analysis was done by Correlation, Bland-Altman:

| Measurement | Accuracy<br>(Mean±1.96STD) | Data Range | Correlation |
|-------------|----------------------------|------------|-------------|
| GLS | -1.4% ± 3.93% | -4% - -24% | 0.88 |

sensitivity and specificity and of 0.90, and 0.83 respectively. The Normal\Abnormal threshold used for GLS was -18%

- 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 GLS Module, 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 Seamless is substantially equivalent to the predicate device.