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 of patients and Age >18.

Device Description

The LVivo Seamless is a standalone application that extends the LVivo Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation or EF and Strain analysis by FDA cleared 30d party software. The results are sent to the PACS and are evaluated by a healthcare professional.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) submission summary for LVivo Seamless:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Meets Criterion?
85% of exams processed automatically based on correctly identified 4-chamber, 2-chamber, and 3-chamber views	84% of exams correctly identified 4, 2, and 3 chamber views	No (Slightly Short)
80% correlation between Ground Truth Biplane EF and automated Biplane EF results	Pearson's Correlation (r) = 0.95	Yes
80% correlation between Ground Truth GLS and automated GLS results	Pearson's Correlation (r) = 0.92	Yes

Note: While the "85% processed automatically" criterion was reported as 84% met, the FDA cleared the device, implying this slight discrepancy was acceptable, or perhaps the 84% refers specifically to the subset used for correlation analysis rather than automated processing success rate on all 166 exams. The document states "The analysis (...) results are provided for 139 exams (84%) in which the system correctly identified 4, 2 and 3 chamber views," which further implies 84% of the total 166 (139/166 = 83.7%) and this subset was then used for the correlation analyses.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 166 examinations (images/videos) were included in the validation. Analysis results for EF and GLS correlations were provided for 139 exams (84% of the total 166) where the system correctly identified all three heart chamber views (4, 2, and 3 chamber).
Data Provenance: The documents do not explicitly state the country of origin. However, the manufacturer is DiA Imaging Analysis Ltd (Beer-Sheva, Israel), suggesting the data could be from various international sources, potentially including Israel. The study type is not explicitly stated as retrospective or prospective, but given it's a validation study for an existing (modified) device, it's highly likely to be retrospective data collected from clinical archives.
- Sub-datasets based on equipment:
  - 71 exams: Acquired with EPIQ (Philips Healthcare).
  - 96 exams: Acquired with Vivid E95 (74%), Vivid S70 (12.5%), Vivid E9 (12%) (GE Healthcare).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth. It refers to "Ground Truth Biplane EF measurements" and "Ground Truth GLS measurements," implying expert consensus or established clinical measurements were used. It is standard practice in such studies for ground truth to be established by qualified cardiologists or echo sonographers.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (like 2+1 or 3+1). It states "Ground Truth" was established, which usually implies a single consensus reading or a process where discrepancies are resolved, but the specific process is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described. The study focused on demonstrating the device's performance against established ground truth measurements, not on how human readers' performance improved with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The reported performance metrics (correlation, Bland-Altman) are directly comparing the device's automated measurements (algorithm only) to the established ground truth. The description of "LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation" further supports this.

7. The Type of Ground Truth Used

The ground truth used was expert consensus/established clinical measurements for Biplane EF (Ejection Fraction) and GLS (Global Longitudinal Strain). The clinical context implies these values were derived from manual, expert measurements or calculations based on the ultrasound images, intended to be the gold standard against which the device's automated measurements were compared.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This submission focuses on the validation of the device's performance, not its development or training process.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established. Similar to point 8, this is typically part of the device development phase and not detailed in a 510(k) summary for validation.

Summary

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March 6, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K243331

Trade/Device Name: LVivo Seamless Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: February 13, 2025 Received: February 13, 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 (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.

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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 OS 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 (QS) 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 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

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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,

Samul 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)

K243331

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 of patients and Age >18.

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

K243331

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

1. (a) Submitter George J. Hattub Address: Medicsense USA LLC 291 Hillside Avenue Somerset, MA 02726 ghattub@comcast.net 1. (b) Manufacturer DiA Imaging Analysis Ltd Address: HaEnergia Street 77 Beer-Sheva, Israel 8470912 Mfg. Phone: Tel.: +972 77 7648318 Contact Person: Mrs. Michal Yaacobi Date: March 6, 2025 Device & Medical Image Management and Processing System -2. Classification classified as Class 2 QIH, Regulation Number 21 CFR 892.2050 Name: LVivo Seamless Predicate Device: K212466 LVivo Seamless 3. The LVivo Seamless is a standalone application that extends the LVivo 4. Description: Platform and runs offline on a server in a healthcare environment. The system accepts echo examinations in DICOM format that are sent from an Ultrasound device and automatically selects the adequate clips for EF and GLS evaluation. After the clip selection, the LVivo Seamless activates the FDA cleared LVivo EF and LVivo Strain modules which perform automatic EF and Strain evaluation or EF and Strain analysis by FDA cleared 30d party software. The results are sent to the PACS and are evaluated by a healthcare professional. 5. Indications for LVivo platform is intended for non-invasive processing of ultrasound images Use: to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease and Age>18. 6. Comparison of The difference between the subject device and the predicate device is that Technological in addition to the ability to use LVivo EF and LVivo Strain for automated EF Characteristics: and Strain analysis, it is now includes the ability to use Automated EF and automated Strain analysis by another FDA cleared 3rd party software. With respect to technology and intended use. DiA's LVivo Seamless is substantially equivalent to its predicate device. Based upon the outcomes from the risk analysis and Performance Testing Evaluation, DiA believes that the modification of the predicate device does not raise additional safety of efficacy concerns. The following comparison table depicts the changes.

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	Submitted Device	Predicate Device
Features/Characteristics	LVivo Seamless	LVivo Seamless
Product Code	same	QIH
Indication for Use	LVivo platform is intendedfor non-invasive processingof ultrasound images todetect, measure, andcalculate relevant medicalparameters of structures andfunction of patients withsuspected disease and Age>18.	LVivo platform is intendedfor non-invasiveprocessing of ultrasoundimages to detect,measure, andcalculate relevant medicalparameters of structuresand function of patientswith suspected diseaseand Age >18.
Modules	same	LVivo EF and LVivo Strain
Automation	same	yes
Manual Adjustment	same	yes
Bi plane EF evaluation	same	yes
Simultaneous 2CH and4CH evaluation	same	yes
Off-line EF evaluationusing DICOM clips ofany vendor	same	yes
Automated ED and ESframes selection	same	yes

Dynamic left ventricularManual editing byuser capability	same	yes
Manual editing byuser capability	same	yes
Visually confirm EF	same	yes
Automated rejection offalse results	same	yes
Volume calculation bystandard Simpson'smethod of discs	same	yes
Volume curvecalculation	same	yes
EF results presentation	same	yes
Enables calculation EFresults for differentcycle	same	yes
Algorithm	same	same
Calculation speed	same	yes
Capability or a part of abigger package(device) for LV functionevaluation	same	yes
Segmental LongitudinalStrain Measure	yes	yes
Global LongitudinalStrain (GLS) Measure	yes	yes
Operating System	Windows	Windows
Ability to activate 3rdparty Auto EF andAuto Strainapplications (TOMTEC)	yes	No
510(k) #	K242331	K212466

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7.	PerformanceEvaluation:	The agreement between the device's output and the ground truth iscomparable to the predicate device. A summary of the PerformanceEvaluation, which was based upon well-established test methods,demonstrated conformity to the intended use.Success criteria:
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1. 85% of the exams will be processed automatically based on correctly identified 4 chamber, 2 chamber and 3 chamber views
1. 80% correlation between the Ground Truth Biplane EF measurements and automated Biplane EF results.
1. 80% correlation between Ground Truth GLS measurements and automated GLS results

Total of 166 examinations were included in the validation: 71 exams acquired with EPIQ (Philips Healthcare). Age 61.0 ± 16.3, 53.5% male. BMI was 29.7 ± 6.6. 62.0% of the patients in this dataset were Black or African American. LV function was Normal in 64.8%. 7.0% of the patients had Mild LV dysfunction, 14.1% had Moderate LV dysfunction and 14.1% of the patients had severe LV dysfunction.

96 acquired with Vivid E95(74%), Vivid S70(12.5%), Vivid E9 (12%) (GE Healthcare). Average age was 64 ± 17 ranging from 25 to 92, 59% male. 51 patients (53%) had Normal LV systolic function, 45 patients (47%) had impaired LV function (21% severely impaired, 15% moderately impaired and 11% mildly impaired). For 90 patients (94%) BMI measurements were available and the average BMI was 26.6± 4.9, ranging from 17.8 to 45.4.

The analysis (e.g Pearson's Correlation and Bland Altman) results are provided for 139 exams (84%) in which the system correctly identified 4, 2

Measurement	Bland Altman: Mean,(LOA) (% points)	Data Range (%points)	Pearson'sCorrelation (r)
Biplane EF	1.22, (-8.49, 10.93)	8.8 - 73.6	0.95
GLS	-1.27 (-5.16, 2.62)	-3.35 - -25.41	0.92

and 3 chamber views:

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 ability to run TomTec Auto EF and Strain, 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.

Regulation Number and Section

§ 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).