(301 days)
Not Found
Yes
The summary explicitly mentions "Al software" in the User Validation section.
No.
The Ventripoint VMS+ 4.0 system is a medical imaging device used for diagnosis and analysis of cardiac function, not for direct treatment or therapy.
Yes
The VMS+ 4.0 system is described as a medical imaging device that assists clinicians in evaluating cardiac function and calculates volumes and ejection fractions, which are used to assess the state of a patient’s health and aid in diagnosis.
No
The device description explicitly states that the VMS+ system includes a hardware stand with a computer, position sensors, and software. This indicates it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The VMS+ 4.0 system is a medical imaging device that processes and analyzes ultrasound and MRI images of the heart. It does not analyze biological samples from the patient.
- Intended Use: The intended use is to record, analyze, store, and retrieve digital ultrasound images for 3D processing and to calculate heart chamber volumes and ejection fractions. This is a diagnostic imaging application, not an in vitro diagnostic test.
Therefore, the VMS+ 4.0 system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
No
The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", meaning the letter does not confirm PCCP authorization.
Intended Use / Indications for 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.
Product codes
QIH, LLZ
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) (heart chambers)
Indicated Patient Age Range
Not Found
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: 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.
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 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.
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 AI software, which should only be viewed as a first guess 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
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.
1
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.
2
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,
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
3
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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. |
| 18 Hook Ave, Unit 101 | |
| Toronto Ontario M6P 1T4 | |
| Canada | |
| Contact Person: | Aaron Zhang |
| RA/QA Manager | |
| azhang@ventripoint.com | |
| Tel: 416-848-4156 | |
| Device Name | Ventripoint Medical System Plus (VMS+) 4.0 |
| Classification: | Regulatory Class: II |
| Review Category: Tier II | |
| Classification Panel: Radiology | |
| Regulation Number: 892.2050 | |
| Classification Product Code: QIH | |
| 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 |
| Review Category: Tier II | |
| Classification Panel: Radiology | |
| 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.
5
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.
6
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.
7
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
Ventripoint Medical
System Plus (VMS+)
3.0 (K191493) | Subject Device
Ventripoint Medical
System Plus (VMS+)
4.0 | Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The VMS+ 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+ 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 VMS+ 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+ 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. | Same |
| Technological Characteristics | | | |
| Software based
analysis tool | Yes | Yes | Same |
| Knowledge-Based
Reconstruction
Algorithm | Yes | Yes | Same |
| 3D Visualization | Generates a 3D
surface model of the
4 chambers and | Generates a 3D
surface model of the 4
chambers and | Same |
| Feature/Characteristic | Predicate Device
Ventripoint Medical
System Plus (VMS+)
3.0 (K191493) | Subject Device
Ventripoint Medical
System Plus (VMS+)
4.0 | Comparison |
| | accompanying
volume
measurement. | accompanying volume
measurement. | |
| Measurements | End-systolic volumes
(EDV, ESV), Ejection
Fractions (EF), Stroke
Volumes and Cardiac
Outputs | End-systolic volumes
(EDV, ESV), Ejection
Fractions (EF), Stroke
Volumes and Cardiac
Outputs. | Same |
| Acquisition Workflow | Executing on a
computer, processes
data acquired by the
sensor system in
conjunction with the
output from the
ultrasound
equipment, to enable
tracking of anatomic
landmark points from
the 2D images and
conversion of those
points into 3D data
points. | Executing on a
computer, processes
data acquired by the
sensor system in
conjunction with the
output from the
ultrasound equipment,
to enable tracking of
anatomic landmark
points from the 2D
images and conversion
of those points into 3D
data points. | Same |
| Points placement | Requires placement
of anatomic
landmarks on the 2D
images. On-screen
guide is provided to
user for point
placement first
guesses. User must
manually adjust first
guess point
placements as
required.
Landmarks are then
used to build an
accurate 3D
constructed shape
mesh (defined by
vertices, edges, and
faces). | Requires placement of
anatomic landmarks on
the 2D images. On-
screen guide is
provided to user for
point placement first
guesses. Alternatively,
automated point
placement first guesses
can be generated via a
button press. User
must manually adjust
first guess point
placements as
required.
Landmarks are then
used to build an
accurate 3D
constructed shape
mesh (defined by
vertices, edges, and
faces). | VMS+ 4.0 is equivalent
to VMS+ 3.0. The
automated control point
first guess placement is
added to improve user
workflow efficiency.
Users must still
modify/confirm control
point placement after
an automated first
guess.
Internal user validation
of the final location of
control points using the
on-screen guide versus
automated first
guesses was assessed.
Additionally, verification
tests were performed
against doctors' point
placement.
Thus, the difference
does not raise different
questions of safety and
effectiveness. |
| Feature/Characteristic | Predicate Device
Ventripoint Medical
System Plus (VMS+)
3.0 (K191493) | Subject Device
Ventripoint Medical
System Plus (VMS+)
4.0 | Comparison |
| Location of KBR
catalogue | Knowledge-based
reconstruction located
locally on the system,
which accepts the 3D
data points generated
through the use of the
position sensor
system and provides
the computation
engine for generating
a 3D surface
construction of the
four chambers and
accompanying
volume measurement
and ejection fractions
of the four chambers
of the four chambers
of the heart, either at
end-diastolic and/or
end-systolic. | Knowledge-based
reconstruction located
locally on the system,
which accepts the 3D
data points generated
through the use of the
position sensor system
and provides the
computation engine for
generating a 3D
surface construction of
the four chambers and
accompanying volume
measurement and
ejection fractions of the
four chambers of the
four chambers of the
heart, either at end-
diastolic and/or end-
systolic. | Same |
| Software application
types | Console (system) and
Workstation
(standalone) | Console (system) and
Workstation
(standalone) | Same |
| Hardware data
acquisition system | Touchscreen for
image capture, a
video-input connector
to receive image data
from an ultrasound
machine, off-the-shelf
real-time video
capture card to
receive image data
from an ultrasound
machine, and 3D
positional tracking
system to receive
position and
orientation
information. | Touchscreen for image
capture, a video-input
connector to receive
image data from an
ultrasound machine,
off-the-shelf real-time
video capture card to
receive image data
from an ultrasound
machine, and 3D
positional tracking
system to receive
position and orientation
information. | Same |
| Feature/Characteristic | Predicate Device
Ventripoint Medical
System Plus (VMS+)
3.0 (K191493) | Subject Device
Ventripoint Medical
System Plus (VMS+)
4.0 | Comparison |
| 3D tracking/positional
system | Magnetic-based; free-
hand scanning;
consisting of
mechanical arm,
transmitter,
ultrasound transducer
sensor, and
associated
electronics. | Magnet-free; free-hand
scanning; consisting of
ultrasound transducer
sensor,
transmitter/sensor on
patient, and associated
electronics. | VMS+ 4.0 is equivalent
to VMS+ 3.0 with the
only difference being
that the magnet has
been removed from
transmitter/sensor as
an improvement. The
way in which the device
operates remains the
same; both systems
are free-hand scanning.
In addition, the
performance of the new
device is the same as
the predicate device.
Thus, the difference
does not raise different
questions of safety and
effectiveness. |
| Patient contacting
components | Surface device; intact
skin; A-limited (