(144 days)
Unknown
The summary mentions "automated analysis" and "algorithm processed automatically," which could potentially involve AI/ML, but it does not explicitly state the use of AI, ML, or related terms like deep learning or neural networks. The description of performance studies focuses on statistical correlations and Bland-Altman analysis, which are common for comparing automated measurements to manual ones, but don't inherently confirm AI/ML use. Without explicit mention or further details on the "algorithm," it's impossible to definitively confirm AI/ML.
No
The device is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters to aid in diagnosis, not to provide therapy.
Yes
The device processes ultrasound images to detect, measure, and calculate medical parameters and function of patients with suspected disease, which directly support diagnosis.
Yes
The device description explicitly states that the LVivo platform is a "software system for automated analysis of ultrasound examinations." It processes DICOM movies and does not mention any associated hardware components that are part of the device itself.
Based on the provided information, the LVivo platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside of the body (in vitro).
- LVivo's Function: The LVivo platform processes ultrasound images acquired non-invasively from the patient's body. It analyzes these images to measure and calculate medical parameters. This process does not involve testing biological samples taken from the patient.
Therefore, the LVivo platform falls under the category of medical imaging software or a medical device that processes imaging data, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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. In addition, it has the ability to provide Quality Score feedback.
Product codes
OIH
Device Description
The LVivo platform is a software system for automated analysis of ultrasound examinations. Automated analysis of echocardiographic examinations is done using DICOM movies. The LVivo platform supports global and segmental evaluation of the left ventricle (LV) of the heart. The global LV function is evaluated from two of the apical views: four-chamber (4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV function is done from three apical views 4CH, 2CH and three chamber (3CH) and supports wall motion evaluation and strain. LVivo CE-EF (Contrast EF) extends the current toolbox of the LVivo platform by providing the ability to process Ultrasonic DICOM images which acquire by Ultrasound Equipment in which the patient was prescribed a contras agent. In addition to the LV analysis, the cardiology toolbox includes a module for automated evaluation of the Right Ventricular function. The LVivo platform includes one additional non-cardiac module for the measurement of the bladder volume.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound images, Ultrasonic DICOM images
Anatomical Site
left ventricle (LV) of the heart, Right Ventricular, bladder
Indicated Patient Age Range
Age ranged from 20 to 100 years of aqe. For 47 patient exams collected from Beth Israel, Soroka and Hadassah the average age was 66±16.4 years old, average BMI was 28±8, range 13 to 56. For 47 patients reported from UCMC the average age was 63±15.8 years old, average BMI was 31.98, range 17.9 to 54.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Of the 101 patient exams that were included in the study, the algorithm processed automatically 91/101 (90%) of the exams. The final ground truth was comprised of the measurements by the 3 sonographers. No further changes by the cardiologist to the measurements were needed following the cardiologist's review.
Summary of Performance Studies
Performance Evaluation: A summary of the Performance Evaluation, which was based upon wellestablished test methods, demonstrated conformity to the intended use.
The overall patient population included 58% patients with Normal LV function 2% patients with preserved LV function and 40% patients with Abnormal LV function, among them 10% with mildly impaired LV function, 14% with moderately impaired LV function and 16% with Severely impaired LV function. LV was enlarged in 26% of the patients. 32% of the patients had LV hypertrophy.
Gender and Age were available for 94 (93%) of the patients. 52/94 (55%) were female and 59/94 male (62%). Age ranged from 20 to 100 years of aqe. For 47 patient exams collected from Beth Israel, Soroka and Hadassah the average age was 66±16.4 years old, average BMI was 28±8, range 13 to 56. For 47 patients reported from UCMC the average age was 63±15.8 years old, average BMI was 31.98, range 17.9 to 54. Race information was available for total of 69/101 (69%) patient examinations collected from US, among them 21/69 (30%) were indicated as Black or African Americans, 46/69 (67%) were indicated as white and 2/69 (3%) were Asian.
Of the 101 patient exams that were included in the study, the algorithm processed automatically 91/101 (90%) of the exams. The final ground truth was comprised of the measurements by the 3 sonographers. No further changes by the cardiologist to the measurements were needed following the cardiologist's review. The automated results were compared to the ground truth. The comparison between automated results and manual measurements for EDV, ESV and EF for A4CH, A2CH views separately and biplane (BP) are presented below (BA=Bland-Altman):
EDV 4CH correlation of r=0.96, CI [0.94, 0.97] was obtained between automated and manual results, BA: -2.68ml, LOA (-36.02, 30.66).
ESV 4CH correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -3.87ml, LOA (-25.58, 17.82).
EF 4CH correlation of r=0.95, CI [0.93, 0.97] was obtained between automated and manual results, BA: 1.26% points, LOA (-8.42, 10.96).
EDV 2CH correlation of r=0.96, CI [0.94, 0.97] was obtained between automated and manual results, BA: -5.69 ml, LOA (-36.02, 24.44)
ESV 2CH correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -3.87ml, LOA (-25.58, 17.82).
EF 2CH correlation of r=0.93, CI [0.90, 0.95] was obtained between automated and manual results, BA: -0.54% points, LOA (-12.18, 11.1)
BP EDV correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -4.1ml. LOA (-29.04, 20.84).
BP ESV correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -2.77ml. LOA (-19.67, 14.13), BA: 0.39% points, LOA (-8.26, 9.05).
BP EF correlation of r=0.96, Cl [0.94, 0.97] was obtained between automated and manual results, BA: 0.39% points, LOA (-8.26, 9.05)
Key Metrics
EDV 4CH correlation of r=0.96, CI [0.94, 0.97]
ESV 4CH correlation of r=0.98, CI [0.97, 0.99]
EF 4CH correlation of r=0.95, CI [0.93, 0.97]
EDV 2CH correlation of r=0.96, CI [0.94, 0.97]
ESV 2CH correlation of r=0.98, CI [0.97, 0.99]
EF 2CH correlation of r=0.93, CI [0.90, 0.95]
BP EDV correlation of r=0.98, CI [0.97, 0.99]
BP ESV correlation of r=0.98, CI [0.97, 0.99]
BP EF correlation of r=0.96, Cl [0.94, 0.97]
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 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
March 3, 2025
Re: K243235
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: OIH Dated: February 3, 2025 Received: February 3, 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 Re"). 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
2
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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director 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)
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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K243235 510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter
Address: | George J. Hattub
Medicsense USA LLC
291 Hillside Avenue
Somerset, MA 02726
ghattub@comcast.net |
|--------|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | DiA Imaging Analysis Ltd
HaEnergia Street 77
Beer-Sheva, Israel 8470912 |
| | Mfg. Phone: | Tel.: +972 77 7648318 |
| | Contact Person: | Mrs. Michal Yaacobi |
| | Date: | February 28, 2025 |
| 2. | Device &
Classification
Name: | Medical Image Management and Processing System -
classified as Class 2 QIH, Regulation Number 21 CFR 892.2050
LVivo Software Application |
| 3. | Predicate Device:
Reference Device: | LVivo Software Application: K240553
ASUSON Sequoia and Select Diagnostic Ultrasound System: K232145 |
| 4. | Description: | The LVivo platform is a software system for automated analysis of
ultrasound examinations. Automated analysis of echocardiographic
examinations is done using DICOM movies. The LVivo platform supports
global and segmental evaluation of the left ventricle (LV) of the heart. The
global LV function is evaluated from two of the apical views: four-chamber
(4CH) and two-chamber (2CH) by ejection fraction (EF). The segmental LV
function is done from three apical views 4CH, 2CH and three chamber
(3CH) and supports wall motion evaluation and strain. |
| | | LVivo CE-EF (Contrast EF) extends the current toolbox of the LVivo platform
by providing the ability to process Ultrasonic DICOM images which acquire
by Ultrasound Equipment in which the patient was prescribed a contras
agent. |
| | | In addition to the LV analysis, the cardiology toolbox includes a module for
automated evaluation of the Right Ventricular function. The LVivo platform
includes one additional non-cardiac module for the measurement of the
bladder volume. |
| 5. | Indications for
Use: | LVivo platform is intended for non-invasive processing of ultrasound
images to detect, measure, and calculate relevant medical parameters of |
5
structures and function of patients with suspected disease. In addition, it has the ability to provide Quality Score feedback.
-
- 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 Contrast EF 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 | |
| Application | LVivo Software Application | |
| Product Code | same | QIH |
| Indication for Use | same | 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. In | ||
| addition, it has the ability to | ||
| provide Quality Score | ||
| feedback. | ||
| Modules | LVivo CE-EF, LVivo | |
| EF, LVivo PLAX, LVivo | ||
| SG, LVivo SAX, LVivo | ||
| RV, LVivo Seamless, | ||
| LVivo IQS and LVivo | ||
| Bladder | LVivo EF, LVivo PLAX, LVivo | |
| SG, LVivo SAX, LVivo RV, | ||
| LVivo Seamless, LVivo IQS | ||
| and LVivo Bladder | ||
| Automation | same | yes |
| Manual Adjustment | same | yes |
| Bi plane EF evaluation | same | yes |
| Simultaneous 2CH and | ||
| 4CH evaluation | same | yes |
| Off-line LV RV and | ||
| Bladder evaluation using | ||
| DICOM clips of any | ||
| vendor | same | yes |
| Automated ED and ES | ||
| frames selection | same | yes |
| Dynamic left ventricular | same | yes |
| Manual editing by | ||
| user capability | same | yes |
| Visually confirm | ||
| results | same | yes |
| Automated rejection | ||
| of false results | same | yes |
| Volume calculation by | ||
| standard Simpson's | ||
| method of discs for EF | same | yes |
| Volume curve | ||
| Presentation | same | yes |
| EF, Strain, SWM, RV, | ||
| SAX, Bladder results | ||
| presentation | same | yes |
| Enables presentation of | ||
| cardiac function results | ||
| for different cycles | same | yes |
| Algorithm | Added Support | |
| for Contrast EF | yes | |
| Calculation speed | same | yes |
| Capability or a part of a | ||
| bigger package (device) | ||
| for LV function | ||
| evaluation and Bladder | same | yes |
| Segmental Longitudinal | ||
| Strain Measure | same | yes |
| Global Longitudinal | ||
| Strain Measure | same | yes |
| Segmental wall motion | ||
| evaluation | same | yes |
| Operating System | Window 10 or | |
| higher | Windows/Linux | |
| 510(k) # | K243235 | K240553 |
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Performance Evaluation:
A summary of the Performance Evaluation, which was based upon wellestablished test methods, demonstrated conformity to the intended use.
The overall patient population included 58% patients with Normal LV function 2% patients with preserved LV function and 40% patients with Abnormal LV function, among them 10% with mildly impaired LV function, 14% with moderately impaired LV function and 16% with Severely impaired LV function. LV was enlarged in 26% of the patients. 32% of the patients had LV hypertrophy.
Gender and Age were available for 94 (93%) of the patients. 52/94 (55%) were female and 59/94 male (62%). Age ranged from 20 to 100 years of aqe. For 47 patient exams collected from Beth Israel, Soroka and Hadassah the average age was 66±16.4 years old, average BMI was 28±8, range 13 to 56. For 47 patients reported from UCMC the average age was 63±15.8 years old, average BMI was 31.98, range 17.9 to 54. Race information was available for total of 69/101 (69%) patient examinations collected from US, among them 21/69 (30%) were indicated as Black or African Americans, 46/69 (67%) were indicated as white and 2/69 (3%) were Asian.
Of the 101 patient exams that were included in the study, the algorithm processed automatically 91/101 (90%) of the exams. The final ground truth was comprised of the measurements by the 3 sonographers. No further changes by the cardiologist to the measurements were needed following the cardiologist's review. The automated results were compared to the ground truth. The comparison between automated results and manual measurements for EDV, ESV and EF for A4CH, A2CH views separately and biplane (BP) are presented below (BA=Bland-Altman):
EDV 4CH correlation of r=0.96, CI [0.94, 0.97] was obtained between automated and manual results, BA: -2.68ml, LOA (-36.02, 30.66).
ESV 4CH correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -3.87ml, LOA (-25.58, 17.82).
EF 4CH correlation of r=0.95, CI [0.93, 0.97] was obtained between automated and manual results, BA: 1.26% points, LOA (-8.42, 10.96).
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EDV 2CH correlation of r=0.96, CI [0.94, 0.97] was obtained between automated and manual results, BA: -5.69 ml, LOA (-36.02, 24.44)
ESV 2CH correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -3.87ml, LOA (-25.58, 17.82).
EF 2CH correlation of r=0.93, CI [0.90, 0.95] was obtained between automated and manual results, BA: -0.54% points, LOA (-12.18, 11.1)
BP EDV correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -4.1ml. LOA (-29.04, 20.84).
BP ESV correlation of r=0.98, CI [0.97, 0.99] was obtained between automated and manual results, BA: -2.77ml. LOA (-19.67, 14.13), BA: 0.39% points, LOA (-8.26, 9.05).
BP EF correlation of r=0.96, Cl [0.94, 0.97] was obtained between automated and manual results, BA: 0.39% points, LOA (-8.26, 9.05)
-
- 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 modified device. Therefore. DiA Imaging Analysis has concluded that the modified LVivo Software Application is substantially equivalent to its predicate device.