(145 days)
Yes
The summary explicitly states "Mentions AI, DNN, or ML: Yes".
No.
The device is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters; it does not provide therapy.
Yes
The device processes ultrasound images to detect, measure, and calculate medical parameters and evaluate cardiac (e.g., Global Ejection Fraction, RV function, strain) and bladder function, which are activities directly related to diagnosing disease or conditions.
Yes
The device description explicitly states it is a "platform" that "analyzes echocardiographic patient examination DICOM movies" and performs "fully automated analyses". The performance studies and key metrics focus on the software's ability to process images and calculate parameters, comparing its results to manual measurements or other software. There is no mention of any hardware component being part of the device itself, only that it processes images from an external source (ultrasound). The predicate and reference devices also include software applications.
Based on the provided information, the LVivo platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states "non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease." This describes a device that analyzes medical images obtained directly from the patient, not a device that analyzes samples (like blood, urine, or tissue) taken from the patient.
- Device Description: The description focuses on analyzing echocardiographic DICOM movies and ultrasound images of the bladder. This is consistent with image analysis, not in vitro testing.
- Input Imaging Modality: The input is Ultrasound, which is a non-invasive imaging technique applied to the patient.
- Anatomical Site: The anatomical sites mentioned are internal structures of the patient (Left Ventricular wall, Right Ventricular, Bladder, etc.).
- Performance Studies: The performance studies compare the device's measurements to manual measurements from the same imaging data, or to other image analysis methods. They do not involve analyzing patient samples.
In Vitro Diagnostics (IVDs) are defined as medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
The LVivo platform analyzes images of the patient, not samples from the patient. Therefore, it falls under the category of medical image analysis software, not an IVD.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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.
Product codes
QIH
Device Description
The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain and to evaluate the Right Ventricle and well as to measure the bladder.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Left Ventricle, Right Ventricle, Bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, Point of Care environment (for LVivo Bladder)
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
LVivoRV
- Study Type: Retrospective, single center study.
- Data Source: All examinations were retrospectively retrieved from the PACS systems available on site.
- Sample Size: Not explicitly stated, but examinations collected over a period of 22 months.
- Inclusion Criteria: RV Clips from 4CH and 4CH modified views that have 2-3 stable recorded beats. Dataset included only examinations in which measurements of TAPSE and S' were reported.
- Exclusion Criteria: Not explicitly stated, but implied by inclusion criteria.
- Annotation Protocol:
- EDA and ESA were measured by 2 sonographers by selection and manually tracing the ED and ES frames, and FAC results were calculated from the EDA and the ESA.
- TAPSE was measured by a sonographer using M-Mode and by an echo cardiologist using VVI.
- S' was measured by a sonographer using M-Mode and by an echo cardiologist using VVI.
- RV Strain was measured by echo cardiologist using VVI.
- The selected RV clips were anonymized and saved separately without the patient's details according to the patient number.
- LVivoRV evaluation was done by an automated batch processing after all data was ready and considered locked.
LVivoBladder
- Study Type: Retrospective, single center study.
- Data Source: All examinations were retrospectively retrieved from the PACS systems available in Terem's clinic.
- Sample Size: 226 bladder images (113 pairs).
- Inclusion Criteria: Cases with bladder volume reported, full sets of images (transverse and longitudinal views). Specifically, 80 consecutive bladder ultrasound examinations with bladder volume higher than 200ml and 80 consecutive bladder ultrasound examinations with bladder volume less than 200ml were extracted.
- Exclusion Criteria: Not explicitly stated, but filtering for cases with full sets of images implied.
- Annotation Protocol:
- Cases were filtered to include only those where bladder volume is reported.
- An expert sonographer reviewed extracted cases to include only cases with full sets of images.
- All images were anonymized by the study coordinator.
- Pairs of images for validation were selected to be most similar to those used for original reported measurements.
- For tests including post voiding good quality interpretable images, both pre-voiding and post-voiding images were used.
- An expert sonographer performed manual measurements of the bladder volume, acquiring the 3 dimensions (D1, D2, D3) from long and trans views. For standardization, the dimension measured by the expert in the long view was always marked from top right to bottom left of the image.
- The LVivo Bladder algorithm was applied by an automated batch processing on all pairs of trans and long views, configured to draw the dimension in the long view from top right to bottom left of the image for standardization.
Summary of Performance Studies
LVivoRV
- Study Type: Retrospective, single center study.
- Sample Size: Not explicitly stated for performance analysis, but data collected over 22 months.
- Key Metrics & Results:
- Primary endpoint (FAC): r=0.79, p200ml):** Kappa of 0.84 (excellent agreement).
- High agreement: 0.93.
- Sensitivity for differentiating post voiding volume (>200ml): 100.
- Specificity for differentiating post voiding volume (>200ml): 80.
- Correlation between automated and manual bladder volume calculation: r=0.94 (very high correlation).
- Key Results: The primary endpoint of comparing LVivo Bladder measurement of bladder volume to manual tracing was successfully met. Excellent agreement and very high sensitivity and specificity were achieved, particularly for differentiating relevant clinical thresholds. The algorithm was found to be very robust and accurate.
Key Metrics
LVivoRV
- Correlation (r)
- p-value
- Inter-observer reliability
- Intra-observer reliability
- 95% Confidence Interval (for intra-observer reliability)
LVivoBladder
- Kappa
- Agreement
- Sensitivity
- Specificity
- Correlation (r)
Predicate Device(s)
K132544 TomTec-Arena for RV Evaluation
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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June 23, 2020
Image /page/0/Picture/1 description: The image shows 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 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 % Mr. George J. Hattub Senior Staff Consultant Medicsense USA 291 Hillside Avenue SOMERSET MA 02726
Re: K200232
Trade/Device Name: LVivo Software Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: May 13, 2020 Received: May 18, 2020
Dear Mr. 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known) K200232
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.
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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K200232 510(k) Summary
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
-
- (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 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: June 21, 2020 Automated Radiological Image Processing Software- classified as Class 2 2. Device & QIH, Regulation Number 21 CFR 892.2050 Classification Name: LVivo Software Application Predicate Device: K132544 TomTec-Arena for RV Evaluation 3. Reference K161382 & K130779- DiaCardio's LVivo Software Application Devices: K180995 GE Viscan for Bladder and Android 4. Description: The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain and to evaluate the Right Ventricle and well as to measure the bladder. 5. DiA's LVivo platform is intended for non-invasive processing of ultrasound Intended Use: images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease 6. Comparison of With respect to technology and intended use, DiA's LVivo Software Application is substantially equivalent to its predicate devices. Based upon Technological Characteristics: the outcomes from clinical trials, DiA believes that their device does not raise additional safety of efficacy concerns. At the end of this summary, a comparison table is provided. 7. A summary of the clinical evaluation is provided on the proceeding pages. Clinical Tests:
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| Submitted Device | Predicate Device | |
|---|---|---|
| Features/Characteristics | LVivo | TomTec-Arena 1.0 K132544 |
| Product Code | QIH | LLZ |
| Intended Use | Calculate | |
| and measurement | ||
| of LV, RV and | ||
| Bladder | Calculation and | |
| measurement LV, RV, | ||
| fetal and abdomen | ||
| Indication for Use | DiA's 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. | Indication for use of Tom- | |
| Tec- Arena software are | ||
| diagnostic review, | ||
| quantification and reporting of | ||
| cardiovascular, fetal, and | ||
| abdominal structures and | ||
| functions of patients with | ||
| suspected disease. | ||
| Automation | yes | yes |
| Manual Adjustment | yes | yes |
| RV Calculation from | 2d | 3d |
| RV ED Volume | no | yes |
| FAC | yes | yes |
| ED Area | yes | no |
| EDVi | no | yes |
| ES Vol | no | yes |
| ES area | yes | no |
| EF | no | yes |
| SV | no | yes |
| TAPSE | yes | yes |
| Strain values free wall | yes | yes |
| Strain values septum | no | yes |
| S prime | yes | no |
| View | 4ch view | Multi 2d view |
| 510(k) # | K200232 | K132544 |
| Submitted Device | Reference Devices | |
| Features/Characteristics | LVivo | LVivo K130779 & K161382 |
| Product Code | QIH | LLZ |
| Indications For Use | DiA's 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. | DiaCardio's LVivo Software | |
| Application is intended for | ||
| non-invasive processing of | ||
| already acquired | ||
| echocardiographic images in | ||
| order to detect, measure, and | ||
| calculate the left ventricular | ||
| wall for left ventricular | ||
| function evaluation. This | ||
| measurement can be used to | ||
| assist the clinician in a | ||
| cardiac evaluation. | ||
| Modules | LVivo EF, LVivo SG, | |
| LVivo SAX, LVivo RV & | ||
| LVivo Bladder | LVivo EF, LVivo SG, LVivo | |
| SAX | ||
| Automation | Same | Fully Automated |
| Bi plane EF evaluation | Yes | Yes |
| Simultaneous 2CH | ||
| and 4CH evaluation | Yes | Yes |
| Off line EF | ||
| evaluation using | ||
| DICOM clips of any | ||
| vondar | Yes | Yes |
| Automated ED and | ||
| ES frames selection | Yes | Yes |
| Dynamic left ventricular | Yes. Frame by | |
| frame tracking | Yes. Frame by frame | |
| tracking | ||
| Manual editing by user | ||
| capability | Minimum of 7 border | |
| points manipulation | ||
| (dragging) and online | ||
| contour presentation. | ||
| Possible to apply to | ||
| any frame in the clip. | ||
| Border detection is | ||
| recalculation is | ||
| applied to the entire | ||
| clip. | Yes. 7 border points | |
| manipulation (dragging) and | ||
| online contour presentation. | ||
| Possible to apply to any | ||
| frame in the clip. | ||
| Border detection is | ||
| recalculation is applied to | ||
| the entire clip. | ||
| Visually confirm EF | Yes | Yes |
| Automated rejection | ||
| of false results | Yes | Yes |
| Volume calculation by | ||
| Simson's method of | ||
| discs | Yes | Yes |
| Volume curve | ||
| Presentation | Yes | Yes |
| EF results presentation | Displaying full clip with | |
| border tracking. And | ||
| table with results for | ||
| each cycle for selected | ||
| ED & ES frames for | ||
| each beat. | Displaying full clip with border | |
| tracking. And table with | ||
| results for each cycle for | ||
| selected ED & ES frames for | ||
| each beat. | ||
| Enables presentation EF | ||
| results for different cycle | Yes | Yes |
| Algorithm | Image segmentation for | |
| border detection | ||
| For the RV- Deep | ||
| Learning Technology | Image segmentation for | |
| border detection | ||
| From image processing | ||
| Calculation speed | Less than 1s per cycle | |
| for biplane evaluation | Less than 1s per cycle for | |
| biplane evaluation | ||
| Capability or a part of a | ||
| bigger package (device) | ||
| for LV function | ||
| evaluation | Yes | Yes |
| Segmental Longitudinal | ||
| Strain Measure | Yes | Yes |
| Global Longitudinal | ||
| Strain Measure | Yes | Yes |
| Segmental wall motion | ||
| evaluation | Yes | Yes |
| RV Evaluation | Yes | No |
| Bladder Measurement | Yes | No |
| Operating System | Windows/Linux (with | |
| Android Mobile | ||
| Option for LVivo EF) | Windows | |
| 510(k) # | K200232 | K130779 & K161382 |
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| Submitted Device | Reference Device | |
|---|---|---|
| Features/Characteristics | LVivo | Viscan K180995 |
| Indication for Use | DiA's 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. | Vscan Extend is a | |
| general-purpose | ||
| diagnostic ultrasound | ||
| imaging system for use | ||
| by qualified and trained | ||
| healthcare professionals | ||
| enabling visualization and | ||
| measurement of | ||
| anatomical structures and | ||
| fluid. The specific clinical | ||
| applications and exam | ||
| times include Cardiac, | ||
| Abdominal and Urology] | ||
| Automation | yes | yes |
| Calculate From Border | yes | yes |
| Display Calipers | yes | yes |
| Allow User to Adjust | ||
| Calibration | yes | yes |
| Present Volume | yes | yes |
| Present Diameter | yes | yes |
| Image processing | ||
| algorithm | yes | yes |
| Frame | Trans and Long | |
| View | Trans and Long View | |
| Operating System | Windows, | |
| Android Option | ||
| (With LVivo EF) | Android | |
| 510(k) # | K200232 | K180995 |
8
Clinical Summary -
LVivoRV
Technology
The LVivo RV, a part of the LVivo platform, is a decision support system that uses 2D echocardiographic examinations to automatically evaluate the Right Ventricular (RV) function from 4 chamber apical views (focused or modified). The LVivoRV utilizes clips in DICOM format from the apical 4CH view, focused or modified, as an input without any additional user input (such as selection of a starting frame or manual starting points as required by Epsilon). The Algorithm combines image processing and Deep Learning Neural Network (NN) for the RV analysis. The endocardial boundaries and the location of the anulus of the tricuspid valve are identified by the NN model. These boundaries are further enhanced and tracked using image processing methods that are already established in other approved modules of the LVivo Platform. The algorithm provides measurements of RV size and function: ESA, EDA, FAC, TAPSE S' and Free Wall Strain. There are 3D technologies available for RV evaluation, the most known is Image-Arena Platform by TomTec
Protocol:
In this presented clinical validation, the LVivoRV output for RV function was compared with conventional methods that are used in echocardiography for RV function evaluation (2D manual measurements by technicians and when relevant to M-Mode, doppler and VVI).
Study: Retrospective, single center study.
-
- All examinations were retrospectively retrieved from the PACS systems available on site. Examinations of patients referred to the echo unit who have had a standard echo examination were collected over a period of 22 months retrospectively according to the inclusion / exclusion criteria
-
- All examinations were performed as part of the routine and according to the ASE guidelines, using available ultrasound systems (EPIQ, Affinity, IE33, & Philips)
-
- Only RV Clips from 4CH and 4CH modified views that have 2-3 stable recorded beats were included. Also, the dataset included only examinations in which measurements of TAPSE and S' were reported
-
- The selected RV clips, were anonymized and saved separately without the patient's details according to the patient number
-
- conventional methods were used to evaluate RV function:
- EDA and ESA were measured by 2 sonographers by selection and manually tracing the ED and ES frames, and FAC results were calculated from the EDA and the ESA.
- TAPSE was measured by a sonographer using M-Mode and by an echo cardiologist using VVI.
- S' was measured by a sonographer using M-Mode and by an echo cardiologist using VVI.
- -RV Strain was measured by echo cardiologist using VVI
-
- LVivoRV evaluation was done by an automated batch processing after all data was ready and considered locked
-
- Manual measurements were compared to automated measurements according to statistical plan
9
Study Objectives
- Primary endpoint was to compare LVivoRV measurement of FAC to manual FAC measurement
- Secondary endpoints were: -
- to compare LVivoRV measurements to the manual measurements of EDA, ESA, TAPSE, S' and FREE WALL STRAIN
- To compare RV function by visual assessment to the categorized result from FAC, TAPSE, S' and STRAIN and
- To evaluate inter and intra observer variability.
Acceptance of the statistical data was 75% correlation between FAC by LVivoRV and the same measurements performed manually by sonographers. This value is based on statistical data reported by FDA cleared system for semi-automated RV function evaluation (Echolnsight by Epsilon)
Results and Conclusions
The results showed that the primary end point was successfully met with a very good correlation of FAC between LVivoRV and manual measurements (r=0.79, p