LVivo Software Application

K200232 · Dia Imaging Analysis, Ltd. · QIH · Jun 23, 2020 · Radiology

Device Facts

• Record ID: K200232
• Device Name: LVivo Software Application
• Applicant: Dia Imaging Analysis, Ltd.
• Product Code: QIH · Radiology
• Decision Date: Jun 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended 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.

Device Story

LVivo is a software platform for automated analysis of echocardiographic and abdominal ultrasound DICOM images. It processes 2D ultrasound clips to evaluate cardiac function (LV, RV) and bladder volume. For cardiac analysis, it uses deep learning and image processing to identify endocardial boundaries and valve annuli, calculating parameters like ejection fraction (EF), strain, and TAPSE. For bladder analysis, it segments contours from sagittal and transverse views to calculate volume. Used in clinical or point-of-care settings, the software provides automated measurements that assist clinicians in cardiac evaluation and bladder volume assessment. It supports manual adjustments of contours or calipers. By providing rapid, automated quantification, it aids clinical decision-making, such as assessing RV function or determining the need for catheterization based on post-void residual volume.

Clinical Evidence

Retrospective clinical validation for LVivoRV and LVivoBladder. LVivoRV study (n=22 months of exams) compared automated FAC to manual measurements, showing strong correlation (r=0.79, p<0.0001). EDA/ESA correlations were r=0.92/0.93. LVivoBladder study (n=226 images) compared automated volume to manual tracing, achieving high correlation (r=0.94) and excellent agreement (Kappa 0.84) for the 200mL threshold (100% sensitivity, 80% specificity).

Technological Characteristics

Software-based image processing platform. Operates on Windows/Linux (with Android mobile option for LVivo EF). Uses deep learning neural networks and active contour algorithms for image segmentation and border detection. Inputs: DICOM ultrasound clips. Outputs: Automated measurements of cardiac (LV/RV) and bladder parameters. Connectivity: Standalone software application. No specific hardware materials; software-only device.

Indications for Use

Indicated for patients with suspected disease requiring non-invasive ultrasound image processing for detection, measurement, and calculation of medical parameters related to cardiac structures/function (LV, RV) and bladder volume.

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

• TomTec-Arena for RV Evaluation (K132544)

Reference Devices

• DiaCardio's LVivo Software Application (K161382)
• DiaCardio's LVivo Software Application (K130779)
• GE Viscan (K180995)

Submission Summary (Full Text)

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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

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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) 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:

- 1. (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.: [phone] 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<br>and measurement<br>of LV, RV and<br>Bladder | Calculation and<br>measurement LV, RV,<br>fetal and abdomen |
| Indication for Use | DiA's 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. | Indication for use of Tom-<br>Tec- Arena software are<br>diagnostic review,<br>quantification and reporting of<br>cardiovascular, fetal, and<br>abdominal structures and<br>functions of patients with<br>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<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. | DiaCardio's LVivo Software<br>Application is intended for<br>non-invasive processing of<br>already acquired<br>echocardiographic images in<br>order to detect, measure, and<br>calculate the left ventricular<br>wall for left ventricular<br>function evaluation. This<br>measurement can be used to<br>assist the clinician in a<br>cardiac evaluation. |
| Modules | LVivo EF, LVivo SG,<br>LVivo SAX, LVivo RV &<br>LVivo Bladder | LVivo EF, LVivo SG, LVivo<br>SAX |
| Automation | Same | Fully Automated |
| Bi plane EF evaluation | Yes | Yes |
| Simultaneous 2CH<br>and 4CH evaluation | Yes | Yes |
| Off line EF<br>evaluation using<br>DICOM clips of any<br>vondar | Yes | Yes |
| Automated ED and<br>ES frames selection | Yes | Yes |
| Dynamic left ventricular | Yes. Frame by<br>frame tracking | Yes. Frame by frame<br>tracking |
| Manual editing by user<br>capability | Minimum of 7 border<br>points manipulation<br>(dragging) and online<br>contour presentation.<br>Possible to apply to<br>any frame in the clip.<br>Border detection is<br>recalculation is<br>applied to the entire<br>clip. | Yes. 7 border points<br>manipulation (dragging) and<br>online contour presentation.<br>Possible to apply to any<br>frame in the clip.<br>Border detection is<br>recalculation is applied to<br>the entire clip. |
| Visually confirm EF | Yes | Yes |
| Automated rejection<br>of false results | Yes | Yes |
| Volume calculation by<br>Simson's method of<br>discs | Yes | Yes |
| Volume curve<br>Presentation | Yes | Yes |
| EF results presentation | Displaying full clip with<br>border tracking. And<br>table with results for<br>each cycle for selected<br>ED & ES frames for<br>each beat. | Displaying full clip with border<br>tracking. And table with<br>results for each cycle for<br>selected ED & ES frames for<br>each beat. |
| Enables presentation EF<br>results for different cycle | Yes | Yes |
| Algorithm | Image segmentation for<br>border detection<br>For the RV- Deep<br>Learning Technology | Image segmentation for<br>border detection<br>From image processing |
| Calculation speed | Less than 1s per cycle<br>for biplane evaluation | Less than 1s per cycle for<br>biplane evaluation |
| Capability or a part of a<br>bigger package (device)<br>for LV function<br>evaluation | Yes | Yes |
| Segmental Longitudinal<br>Strain Measure | Yes | Yes |
| Global Longitudinal<br>Strain Measure | Yes | Yes |
| Segmental wall motion<br>evaluation | Yes | Yes |
| RV Evaluation | Yes | No |
| Bladder Measurement | Yes | No |
| Operating System | Windows/Linux (with<br>Android Mobile<br>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<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. | Vscan Extend is a<br>general-purpose<br>diagnostic ultrasound<br>imaging system for use<br>by qualified and trained<br>healthcare professionals<br>enabling visualization and<br>measurement of<br>anatomical structures and<br>fluid. The specific clinical<br>applications and exam<br>times include Cardiac,<br>Abdominal and Urology] |
| Automation | yes | yes |
| Calculate From Border | yes | yes |
| Display Calipers | yes | yes |
| Allow User to Adjust<br>Calibration | yes | yes |
| Present Volume | yes | yes |
| Present Diameter | yes | yes |
| Image processing<br>algorithm | yes | yes |
| Frame | Trans and Long<br>View | Trans and Long View |
| Operating System | Windows,<br>Android Option<br>(With LVivo EF) | Android |
| 510(k) # | K200232 | K180995 |

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#### 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.

- 1. 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
- 2. All examinations were performed as part of the routine and according to the ASE guidelines, using available ultrasound systems (EPIQ, Affinity, IE33, & Philips)
- 3. 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
- 4. The selected RV clips, were anonymized and saved separately without the patient's details according to the patient number
- 5. 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
- 6. LVivoRV evaluation was done by an automated batch processing after all data was ready and considered locked
- 7. Manual measurements were compared to automated measurements according to statistical plan

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## 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<0.0001). RV Global function is evaluated by measuring EDA and calculating FAC accordingly. The values obtained automatically by the LVivoRV were compared to the average of the values obtained manually by the 2 sonographers.

The correlations between the sonographer's average for EDA and ESA and the LVivoRV EDA and ESA were excellent with r=0.92 and r=0.93 respectively (p<0.0001).

For the TAPSE, we saw that the correlation of the manual measurement using M-Mode was 0.62, similarly to the correlation found between VVI and M-Mode that was r=0.66. With these correlations, the LVivoRV performance is close to "real life" performance of VVI in compare to M-mode. When looking at the TAPSE correlation without 5 outlier cases, we got r=0.72. The Free Wall Strain correlation between 2D VVI and LVivoRV was evaluated and found to be a positive correlation of R=0.6. When omitting 6 outlier cases from the correlation analysis, we obtained r= 0.78.

The inter-observer reliability between readers within the same group was also tested. Interobserver reliability between sonographers for EDA. ESA and FAC was 0.85, 0.9 and 0.77 respectively (p<0.0001).

10 subjects were randomly chosen for the evaluation of the intra-observer reliability. The intraobserver reliability was evaluated for the 2 sonographers that reported measurable values using 2D and one physician that reported measurable values with VVI. The intra-observer correlation for FAC for sonographer1 was 0.95 [95%Cl: 0.80-0.98] and for sonographer 2 it was 0.94 [95%Cl: 0.72-0.98]. The intra-observer correlation for TAPSE for the physician used the VVI was 0.85 [95%CI: 0.40-0.96]

It is known that the conventional RV assessment is not perfect and has its own intermeasurement variabilityF, thus we don't expect a perfect agreement between the LVivoRV and currently used techniques. However, the differences between RV parameters obtained using the LVivoRV software and the conventional measurements were similar to the variability of the current conventional methods.

Overall, the correlation of the LVivoRV to acceptable used methods for RV evaluation was very good. The LVivoRV can use as a decision support system.

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# LVivoBladder

## Technology

The LVivo Bladder, a part of the LVivo platform, is a decision support system for automated Bladder Volume evaluation from ultrasound examinations.

The LVivo Bladder utilizes images in DICOM format. It automatically Identifies the bladder borders on the ultrasound scan and locates the calipers for measuring the bladder's 3 dimensions on the longitudinal and sagittal views, with a corresponding value for the 3 dimensions and for the bladder volume. The calipers can be changed by the sonographer to make adjustments if required.

This application automatically measures bladder volume by segmenting bladder contours from sagittal and transverse ultrasound views using a combination of machine learning and active contour

## Protocol:

In this clinical validation study the automated bladder volume measurements obtained by DiA's automated tool were compared to manual measurements obtained by an expert.

Study: Retrospective, single center study.

- 226 bladder images (113 pairs) were included 1.
- 2. All examinations were retrospectively retrieved from the PACS systems available in Terem's clinic. Since the data is retrospectively collected, all examinations are acquired as part of routine abdominal examinations, by qualified sonographers using available ultrasound systems (Siemens, Mindray). Collected data will be in DICOM format.
- 3. Since Abdominal tests do not necessarily include bladder volume measurements, the first step of data collection was filtering of the abdominal tests to include only cases where bladder volume is reported.
- 4. Assuming ~30% of tests with bladder volume examinations will not include full sets of images (as described in item 2 under 'exclusion criteria), 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 from the database
- 5. An expert sonographer reviewed extracted cases to include only cases with full sets of images (as described in the inclusion criteria)
- All images were anonymized by the study coordinator and were sent to the sponsor via 6. Dropbox. Patient details including demographic details were collected anonymously and reported as well in the excel sheet.
- 7. Since some of the tests included more than one long view image and more than one trans view image and since these images do not represent the images that were used to measure the volume in practice, the pairs of images that were selected for the validation were the ones that were most similar to the ones that appear in the biplane view from which the original reported measurements were obtained. The rest of the pairs were used for verification
- 8. In tests that included post voiding good quality interpretable images in addition to prevoiding images, both were used for the validation
- 9. After obtaining the required data set for the validation test, all pairs (trans and long views) were sent to an expert sonographer for manual measurements of the bladder volume, to acquire the 3 dimensions of the bladder in long and trans views (i.e. D1, D2 and D3). For standardization purposes the dimension measured by the expert in the long view was always marked from top right to bottom left of the image.
- 10. The LVivo Bladder algorithm was applied by an automated batch processing on all pairs of trans and long views. Here as well the algorithm was configured to draw the dimension in the long view from top right to bottom left of the image, for standardization purposes

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- 11. The calculated volume by the manual measurements was compared to the automated calculated volume by LVivo Bladder.
## Study Objectives

The clinical validation objective was to compare LVivo Bladder measurement of bladder volume to bladder volume by manual tracing.

Post Voiding Residual volume of 200mL indicates inadequate emptying and may be associated with catheter insertion. In Point of care settings, it is specifically important to evaluate whether the residual volume is lower or higher than this 200ml threshold, thus the method that was used to compare the automated and the manual methods were based on categorial evaluation of more/less than 200mL.

We expected to have a good agreement between the automated and the manual method (which is an accepted method for BV measurement) based on 200ml threshold, with kappa of at least 0.61 which is considered substantial agreement according to accepted Kappa interoperations.

## Results and Conclusions

The results showed that the primary end point was successfully met- excellent agreement between methods was obtained by differentiating between post voiding volume, which is considered to be large (200ml) and is indicative for catheter placement, with excellent Kappa of 0.84, as well as very high agreement (0.93) and high sensitivity and specificity (100 and 80 respectively). Excellent results were also obtained comparing automated bladder volume calculation by LVivo Bladder to volume calculated by manual tracing which is the routinely used method with very high correlation (r=0.94).

The LVivo Bladder can easily, accurately and automatically measure the bladder volume from 2D ultrasound. Such a tool addresses the need in rapid and accurate evaluation in the POC environment. The LVivo Bladder's algorithm was found to be very robust and accurate in automatically measure bladder volume.