LVivo Seamless

K202546 · Dia Imaging Analysis, Ltd. · QIH · Sep 29, 2020 · Radiology

Device Facts

• Record ID: K202546
• Device Name: LVivo Seamless
• Applicant: Dia Imaging Analysis, Ltd.
• Product Code: QIH · Radiology
• Decision Date: Sep 29, 2020
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

LVivo Seamless is a standalone software application operating on a server within a healthcare environment. It receives ultrasound examinations in DICOM format from ultrasound devices; automatically selects adequate clips for Ejection Fraction (EF) evaluation; and triggers the FDA-cleared LVivo EF module for automated analysis. The system outputs results to the PACS for review by a healthcare professional. By automating clip selection and EF calculation, the device assists clinicians in assessing cardiac function. It is designed for offline use, removing manual adjustment and editing capabilities present in the predicate device to streamline the workflow. The device benefits patients by providing standardized, automated cardiac measurements to support clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluation based on established test methods demonstrated conformity to intended use and successful device performance.

Technological Characteristics

Standalone software application; runs on institutional servers; processes DICOM ultrasound clips; utilizes automated EF evaluation module; connectivity via DICOM standard; algorithm is identical to the predicate device.

Indications for Use

Indicated for patients with suspected disease requiring non-invasive ultrasound image processing for detection, measurement, and calculation of structural and functional medical parameters.

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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September 29, 2020

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: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym 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 MA 02726

Re: K202546

Trade/Device Name: LVivo Seamless Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: August 31, 2020 Received: September 2, 2020

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 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) K202546

Device Name LVivo Seamless

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.

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

K202546

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: | September 21, 2020 |
| 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 Seamless |
| 3. | Predicate Device: | K200232 LVivo Software Application |
| 4.<br>5. | Description:<br>Intended Use: | 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<br>evaluation. After the clip selection, the LVivo Seamless activates the FDA<br>cleared LVivo EF module which performs automatic evaluation. The results<br>are sent to the PACS and are evaluated by a healthcare professional.<br>LVivo platform is intended for non-invasive processing of ultrasound images |
| | | 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 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 |

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| | Submitted Device | Predicate Device |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Features/Characteristics | LVivo Seamless | LVivo Software<br>Application |
| Product Code | QiH | QIH |
| Indication for Use | 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 EF, LVivo SG,<br>LVivo SAX, LVivo RV &<br>LVivo Bladder |
| Automation | same | yes |
| Manual Adjustment | no | 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 | no | yes |
| Manual editing by<br>user capability | no | 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 | no | yes |
| EF results presentation | same | yes |
| Enables presentation EF<br>results for different<br>cycle | Same results are<br>presented for the<br>default beats | yes |
| Algorithm | same | 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 | no | yes |
| Global Longitudinal<br>Strain Measure | same | yes |
| Segmental wall motion<br>evaluation | no | yes |
| Operating System | same | Windows/Linux<br>(with Android<br>option for LVivo<br>EF |
| 510(k) # | Pending | K200232 |

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

8. Conclusion: The Intended Use and the technological characteristics in the current device are the same as those in the predicate device, and the minor changes from the predicate device, including the offline application in the institutional server and changes in the user input on the final images, 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 that LVivo Seamless software is substantially equivalent to the predicate device.