Ventripoint Medical System Plus (VMS+) 4.0

K241222 · Ventripoint Diagnostics , Ltd. · QIH · Feb 26, 2025 · Radiology

Device Facts

• Record ID: K241222
• Device Name: Ventripoint Medical System Plus (VMS+) 4.0
• Applicant: Ventripoint Diagnostics , Ltd.
• Product Code: QIH · Radiology
• Decision Date: Feb 26, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.

Device Story

VMS+ 4.0 is a medical imaging system for cardiac function evaluation via 3D reconstruction of heart chambers. Input: 2D ultrasound images captured via free-hand scanning. Operation: Uses Knowledge-Based Reconstruction (KBR) algorithm, referencing MRI heart shape catalogs, to transform 2D ultrasound data into 3D models. Features user-driven anatomical control point placement, now with an optional automated 'first guess' feature; users must manually confirm/adjust points. Output: 3D surface models, volumetric data (EDV, ESV, EF, stroke volume, cardiac output), and clinical reports. Used in clinical settings by healthcare providers. Benefits: Provides detailed volumetric data for cardiac assessment. Hardware includes a computer, touchscreen, and position sensors for tracking transducer/patient movement. Workflow takes ~15 minutes.

Clinical Evidence

Bench testing only. Internal user validation study (n=160 ultrasound images of the right ventricle) compared user performance for final anatomical point localization between VMS+ 4.0 and the predicate. Results demonstrated that user performance for final point localization using VMS+ 4.0 was at least as good as the predicate. No clinical patient outcome data provided.

Technological Characteristics

System includes computer, touchscreen, and magnet-free 3D position tracking sensors. Employs Knowledge-Based Reconstruction (KBR) algorithm for 3D surface modeling. Connectivity: DICOM and VMS+ formats. Power: 100V-240V, 50-60Hz. Software: Console and standalone workstation versions. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients where LV, RV, LA, and RA volumes and ejection fractions are required. Used as an adjunct to existing ultrasound imaging systems.

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

• Ventripoint Medical System Plus (VMS+) 3.0 (K191493)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Ventripoint Diagnostics Ltd. % Zhang Cheng Regulatory Affairs and Quality Manager 18 Hook Ave, Unit 101 Toronto, ON M6P1T4 CANADA

February 26, 2025

Re: K241222

Trade/Device Name: Ventripoint Medical System Plus (VMS+) 4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: March 6, 2024 Received: June 3, 2024

Dear Zhang Cheng:

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 QS 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-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.

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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,

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

510(k) Number (if known) K241222

Device Name

Ventripoint Medical System Plus (VMS+) 4.0

Indications for Use (Describe)

The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.

The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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Image /page/4/Picture/0 description: The image contains the logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network or molecular structure with interconnected lines and colored nodes. To the right of the geometric design is the company name, "Ventripoint," in a blue, sans-serif font, with the words "Diagnostics Ltd." appearing in a smaller font size below.

# Section 5: Traditional 510(k) Summary

| Date: | January 17, 2025 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Ventripoint Diagnostics Ltd.<br>18 Hook Ave, Unit 101<br>Toronto Ontario M6P 1T4<br>Canada |
| Contact Person: | Aaron Zhang<br>RA/QA Manager<br>[e-mail]<br>Tel: [phone] |
| Device Name | Ventripoint Medical System Plus (VMS+) 4.0 |
| Classification: | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: Radiology<br>Regulation Number: 892.2050<br>Classification Product Code: QIH<br>Secondary Product Code: LLZ |

### A. Legally Marketed Predicate Device

| Device Name | Ventripoint Medical System Plus (VMS+) 3.0 |
|-----------------|--------------------------------------------------------------------------------------------------------------------|
| 510k Number: | K191493 |
| Common Name: | Radiological Image Processing System |
| Classification: | Regulatory Class: II<br>Review Category: Tier II<br>Classification Panel: Radiology<br>Regulation Number: 892.2050 |

### B. Device Description

The Ventripoint VMS+ 4.0 System is a medical imaging device designed to assist clinicians in evaluating cardiac function through 3D reconstruction of heart chambers. It uses a Knowledge-Based Reconstruction (KBR) algorithm to recreate the heart's shape by capturing 2D ultrasound images at specific angles and referencing a database of MRI heart shape catalogs. The reconstructed 3D heart models are used to calculate volumes of any of the four chambers at end-diastolic and/or end-systolic phases. The software can also be installed on a separate workstation to import 3D datasets, MRI studies, and VMS+ studies.

The system employs user-driven anatomical control point placement to generate 3D models. Users manually adjust control points based on an anatomical template aligned with the patient's ultrasound images. An edge detection algorithm refines these points to match detected anatomical boundaries, ensuring model precision.

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Image /page/5/Picture/0 description: The image contains the logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network of interconnected lines and nodes with different colored circles at some of the nodes. To the right of the geometric design is the company name, "Ventripoint," in a stylized, blue font. Below "Ventripoint" is the text "Diagnostics Ltd." in a smaller font size.

The VMS+ system includes a hardware stand with a computer, position sensors to track the 3D orientation of the ultrasound transducer and patient movement, and software to handle image capture, landmark placement, and reconstruction. By leveraging its sensor system and statistical shape analysis, the VMS+ transforms 2D ultrasound data into accurate 3D models. The workflow takes approximately 15 minutes and provides detailed volumetric data and reports for clinical review.

## C. Indication for Use

The indications for use for the subject device are the same as the predicate device.

The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3dimensional image processing.

The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and eiection fractions are warranted or desired.

## D. Verification and Validation Summary

The verification and validation of the existing and new features of the VMS+ demonstrate that the VMS+ 4.0 performs as intended, specifications conform to user needs and intended uses, and that the requirements implemented can be consistently fulfilled.

All test reports were successful according to the acceptance criteria. The verification and validation were performed with software versions and hardware units that are considered equivalent to the final version of the product, as warranted by 21 CFR 820.30(g) and with the user interface as planned for the release.

## E. Technological Characteristics

The subject device. VMS+ 4.0. has similar technological characteristics as the predicate device. VMS+ 3.0 (K191493) with regard to the intended use, indications for use, operational environment, software, operating system, operating principle, technology, and performance. The modifications to the hardware/software have been tested for safety and effectiveness and have been determined to be safe and effective.

## F. Performance Data

### Bench Testina

Performance bench testing of the modified device was completed to verify that the modified device was substantially equivalent in performance specifications to the previously cleared device. Predefined acceptance criteria were applied during testing and were met. The verification test results demonstrate that the system software performs as intended and all requirements are met.

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Image /page/6/Picture/0 description: The image shows the logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network of interconnected nodes and lines with different colored circles at some of the nodes. To the right of the geometric design is the company name, "Ventripoint," in a blue, sans-serif font, with the words "Diagnostics Ltd." in a smaller font size underneath.

#### Software Verification and Validation

Software verification and validation testing were conducted, and documentation was provides as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The software for this device was considered to have a basic documentation level since software failures or flaws are do not present a hazardous situation with a probable risk of death or serious injury to anyone within the environment of use.

The verification and validation of the existing and new features of the VMS+ 4.0 software demonstrate that the VMS+ 4.0 software performs as intended, specifications conform to user needs and intended uses, and that the requiremented can be consistently fulfilled.

All test reports were successful according to the acceptance criteria. The verification and validation were performed with software versions and hardware units that are considered equivalent to the final version of the product, as warranted by 21 CFR 820.30(g) and with the user interface as planned for the release.

#### Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the VMS+ 4.0 device. The system complies with the applicable requirements of IEC 60601-1 standard for safety and essential performance and IEC 60601-1-2 standard for electromagnetic compatibility.

#### User Validation

An internal user validation study was performed to demonstrate that the modified device does not negatively impact user performance for anatomical point processing. From 160 ultrasound images of the right ventricle, the study estimated the proportion of images for each software where all anatomical points within the image would be finalized, by the user, within its respective expert consensus region. The test criteria were met, demonstrating that user performance for final point localization using VMS+ 4.0 was at least as good as the predicate, when used by the same users for the same imaging set. However, the study did not evaluate accuracy of the initial point placed by the Al software, which should only be viewed as a first quess and used with caution.

### Cybersecurity

Cybersecurity testing was performed as recommended by FDA's Guidance for Industry and FDA Staff. "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". This included both internal cybersecurity validation and external penetration testing to ensure that any existing vulnerabilities were discovered and addressed, and that the device is cyber safe.

#### G. Safety and Effectiveness

VMS+ 4.0 is a non-invasive, non-significant risk technology. The modifications to the cleared VMS+ user interface, including GUI and position tracking system do not introduce new questions concerning safety or effectiveness and is therefore substantially equivalent to the predicate.

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Image /page/7/Picture/0 description: The image contains the logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network or interconnected nodes, with small colored spheres at some of the vertices. To the right of the geometric design is the company name, "Ventripoint," in a stylized, blue font. Below "Ventripoint" is the text "Diagnostics Ltd." in a smaller, sans-serif font, also in blue.

### H. Technological Characteristics

As shown in the device comparison below, the technological characteristics of the subject VMS+4.0 remain the same as the previously cleared device under K191493 . The similarities and differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the subject device relative to the predicate. Both the subject and predicate devices have the same intended an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3dimensional image processing. The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.

The only change in the VMS+ 4.0 software compared to the predicate is adding an additional method for placing the first guesses for anatomical control points that are updated to a final location manually by a user and minor hardware modification to remove magnet from the transmitter and sensor. The automated control point first guess feature only provides an alternate method for obtaining first guesses for the location of the control points and users are still expected to update control point location in the same manner as the predicate before being used for further analysis. These proposed modifications are verified to ensure overall performance remains the same as the predicate with acceptable results.

| Feature/Characteristic | Predicate Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>3.0 (K191493) | Subject Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>4.0 | Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The VMS+ is an<br>adjunct to existing<br>ultrasound imaging<br>systems and is<br>intended to record,<br>analyze, store and<br>retrieve digital<br>ultrasound images for<br>computerized 3-<br>dimensional image<br>processing.<br><br>The VMS+ is<br>indicated for use<br>where Left Ventricle<br>(LV), Right Ventricle<br>(RV), Left Atrium<br>(LA), and Right<br>Atrium (RA) volumes<br>and ejection fractions<br>are warranted or<br>desired. | The VMS+ is an<br>adjunct to existing<br>ultrasound imaging<br>systems and is<br>intended to record,<br>analyze, store and<br>retrieve digital<br>ultrasound images for<br>computerized 3-<br>dimensional image<br>processing.<br><br>The VMS+ is indicated<br>for use where Left<br>Ventricle (LV), Right<br>Ventricle (RV), Left<br>Atrium (LA), and Right<br>Atrium (RA) volumes<br>and ejection fractions<br>are warranted or<br>desired. | Same |
| Technological Characteristics | | | |
| Software based<br>analysis tool | Yes | Yes | Same |
| Knowledge-Based<br>Reconstruction<br>Algorithm | Yes | Yes | Same |
| 3D Visualization | Generates a 3D<br>surface model of the<br>4 chambers and | Generates a 3D<br>surface model of the 4<br>chambers and | Same |
| Feature/Characteristic | Predicate Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>3.0 (K191493) | Subject Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>4.0 | Comparison |
| | accompanying<br>volume<br>measurement. | accompanying volume<br>measurement. | |
| Measurements | End-systolic volumes<br>(EDV, ESV), Ejection<br>Fractions (EF), Stroke<br>Volumes and Cardiac<br>Outputs | End-systolic volumes<br>(EDV, ESV), Ejection<br>Fractions (EF), Stroke<br>Volumes and Cardiac<br>Outputs. | Same |
| Acquisition Workflow | Executing on a<br>computer, processes<br>data acquired by the<br>sensor system in<br>conjunction with the<br>output from the<br>ultrasound<br>equipment, to enable<br>tracking of anatomic<br>landmark points from<br>the 2D images and<br>conversion of those<br>points into 3D data<br>points. | Executing on a<br>computer, processes<br>data acquired by the<br>sensor system in<br>conjunction with the<br>output from the<br>ultrasound equipment,<br>to enable tracking of<br>anatomic landmark<br>points from the 2D<br>images and conversion<br>of those points into 3D<br>data points. | Same |
| Points placement | Requires placement<br>of anatomic<br>landmarks on the 2D<br>images. On-screen<br>guide is provided to<br>user for point<br>placement first<br>guesses. User must<br>manually adjust first<br>guess point<br>placements as<br>required.<br>Landmarks are then<br>used to build an<br>accurate 3D<br>constructed shape<br>mesh (defined by<br>vertices, edges, and<br>faces). | Requires placement of<br>anatomic landmarks on<br>the 2D images. On-<br>screen guide is<br>provided to user for<br>point placement first<br>guesses. Alternatively,<br>automated point<br>placement first guesses<br>can be generated via a<br>button press. User<br>must manually adjust<br>first guess point<br>placements as<br>required.<br>Landmarks are then<br>used to build an<br>accurate 3D<br>constructed shape<br>mesh (defined by<br>vertices, edges, and<br>faces). | VMS+ 4.0 is equivalent<br>to VMS+ 3.0. The<br>automated control point<br>first guess placement is<br>added to improve user<br>workflow efficiency.<br>Users must still<br>modify/confirm control<br>point placement after<br>an automated first<br>guess.<br>Internal user validation<br>of the final location of<br>control points using the<br>on-screen guide versus<br>automated first<br>guesses was assessed.<br>Additionally, verification<br>tests were performed<br>against doctors' point<br>placement.<br>Thus, the difference<br>does not raise different<br>questions of safety and<br>effectiveness. |
| Feature/Characteristic | Predicate Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>3.0 (K191493) | Subject Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>4.0 | Comparison |
| Location of KBR<br>catalogue | Knowledge-based<br>reconstruction located<br>locally on the system,<br>which accepts the 3D<br>data points generated<br>through the use of the<br>position sensor<br>system and provides<br>the computation<br>engine for generating<br>a 3D surface<br>construction of the<br>four chambers and<br>accompanying<br>volume measurement<br>and ejection fractions<br>of the four chambers<br>of the four chambers<br>of the heart, either at<br>end-diastolic and/or<br>end-systolic. | Knowledge-based<br>reconstruction located<br>locally on the system,<br>which accepts the 3D<br>data points generated<br>through the use of the<br>position sensor system<br>and provides the<br>computation engine for<br>generating a 3D<br>surface construction of<br>the four chambers and<br>accompanying volume<br>measurement and<br>ejection fractions of the<br>four chambers of the<br>four chambers of the<br>heart, either at end-<br>diastolic and/or end-<br>systolic. | Same |
| Software application<br>types | Console (system) and<br>Workstation<br>(standalone) | Console (system) and<br>Workstation<br>(standalone) | Same |
| Hardware data<br>acquisition system | Touchscreen for<br>image capture, a<br>video-input connector<br>to receive image data<br>from an ultrasound<br>machine, off-the-shelf<br>real-time video<br>capture card to<br>receive image data<br>from an ultrasound<br>machine, and 3D<br>positional tracking<br>system to receive<br>position and<br>orientation<br>information. | Touchscreen for image<br>capture, a video-input<br>connector to receive<br>image data from an<br>ultrasound machine,<br>off-the-shelf real-time<br>video capture card to<br>receive image data<br>from an ultrasound<br>machine, and 3D<br>positional tracking<br>system to receive<br>position and orientation<br>information. | Same |
| Feature/Characteristic | Predicate Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>3.0 (K191493) | Subject Device<br>Ventripoint Medical<br>System Plus (VMS+)<br>4.0 | Comparison |
| 3D tracking/positional<br>system | Magnetic-based; free-<br>hand scanning;<br>consisting of<br>mechanical arm,<br>transmitter,<br>ultrasound transducer<br>sensor, and<br>associated<br>electronics. | Magnet-free; free-hand<br>scanning; consisting of<br>ultrasound transducer<br>sensor,<br>transmitter/sensor on<br>patient, and associated<br>electronics. | VMS+ 4.0 is equivalent<br>to VMS+ 3.0 with the<br>only difference being<br>that the magnet has<br>been removed from<br>transmitter/sensor as<br>an improvement. The<br>way in which the device<br>operates remains the<br>same; both systems<br>are free-hand scanning.<br>In addition, the<br>performance of the new<br>device is the same as<br>the predicate device.<br>Thus, the difference<br>does not raise different<br>questions of safety and<br>effectiveness. |
| Patient contacting<br>components | Surface device; intact<br>skin; A-limited (<24h) | Surface device; intact<br>skin; A-limited (<24h) | Same |
| 3D Echo and MRI<br>functionality | Can import 3D echo<br>and MRI studies for<br>volumetric analysis. | Can import 3D echo and<br>MRI studies for<br>volumetric analysis. | Same |
| Software controls | The software<br>components are<br>responsible for<br>providing the user<br>with controls for<br>managing the<br>hardware operation,<br>capturing ultrasound<br>images, marking up<br>images with key<br>anatomical features,<br>invoking the<br>reconstruction<br>algorithm, displaying<br>the resulting<br>construction and<br>generating the<br>corresponding report. | The software<br>components are<br>responsible for<br>providing the user with<br>controls for managing<br>the hardware operation,<br>capturing ultrasound<br>images, marking up<br>images with key<br>anatomical features,<br>invoking the<br>reconstruction<br>algorithm, displaying<br>the resulting<br>construction and<br>generating the<br>corresponding report. | Same |
| Power requirements | Power requirements:<br>AC :100V- 240V,<br>Frequenzy:50-60Hz | Power requirements:<br>AC :100V- 240V,<br>Frequenzy:50-60Hz | Same |
| Image data format | Original VMS+ and<br>DICOM format | Original VMS+ and<br>DICOM format | Same |

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Image /page/8/Picture/0 description: The image shows the logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network of interconnected nodes and lines, with some nodes highlighted in orange, green, and blue. To the right of the geometric design is the company name, "Ventripoint," in a bold, blue font. Below "Ventripoint" is the text "Diagnostics Ltd." in a smaller, lighter blue font.

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Image /page/9/Picture/0 description: The image is a logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network of interconnected nodes and lines, with some nodes colored in orange, green, and blue. To the right of the geometric design is the company name, "Ventripoint," in a blue, sans-serif font, with the word "Diagnostics Ltd." appearing in a smaller font size below it.

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Image /page/10/Picture/0 description: The image shows the logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network of interconnected nodes and lines, with some nodes highlighted in orange, green, and blue. To the right of the geometric design is the company name, "Ventripoint," in a bold, blue font. Below "Ventripoint" is the text "Diagnostics Ltd." in a smaller, lighter blue font.

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Image /page/11/Picture/0 description: The image shows the logo for Ventripoint Diagnostics Ltd. The logo features a geometric design on the left, resembling a network or constellation with interconnected lines and colored dots. To the right of the geometric design is the company name, "Ventripoint," in a blue, sans-serif font, with "Diagnostics Ltd." in a smaller font size underneath.

# l. Substantial Equivalence Conclusion

The VMS+ 4.0 with accessories and proprietary software has been verified and validated according to Ventripoint procedures for product design and development. The information provided by Ventripoint in this Traditional 510(k) application supports the claim of substantial equivalence to the predicate device (K191493) with regard to both intended use and technological characteristics.