(301 days)
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.
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.
Here's a summary of the acceptance criteria and study information for the Ventripoint Medical System Plus (VMS+) 4.0, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | System performs as intended and meets specifications/requirements. | "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." |
| Bench Testing | Substantial equivalence in performance specifications to the previously cleared device. | "Predefined acceptance criteria were applied during testing and were met." |
| Software V&V | Software performs as intended, conforms to user needs/intended uses, and requirements are consistently fulfilled. | "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 & EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards. | "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 Performance (Point Localization) | User performance for final point localization using VMS+ 4.0 is at least as good as the predicate (VMS+ 3.0). | "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." |
| Cybersecurity | All existing vulnerabilities discovered and addressed; device is cyber safe. | "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." |
| Technological Characteristics (Modified Features) | Overall performance remains the same as the predicate with acceptable results. | "These proposed modifications are verified to ensure overall performance remains the same as the predicate with acceptable results." (Referring to the automated control point first guess and magnet-free tracking system changes) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the user validation study, 160 ultrasound images of the right ventricle were used.
- Data Provenance: Not explicitly stated for the ultrasound images used in the user validation. The document is from Canada (Ventripoint Diagnostics Ltd. is based in Toronto, ON, Canada), but the country of origin of the patient data is not specified. The studies are implicitly retrospective for the user validation ("160 ultrasound images...").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The text mentions "expert consensus region" for anatomical points, implying multiple experts, but does not provide an exact number.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set
- Adjudication Method: "Expert consensus region" is mentioned for the user validation study on anatomical point placement. This suggests that the ground truth for point localization was established by consensus among experts, but the specific method (e.g., 2+1, 3+1) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: The document describes an "internal user validation study" comparing user performance with VMS+ 4.0 to the predicate (VMS+ 3.0). This is a form of comparative effectiveness study involving human readers.
- Effect Size of Human Reader Improvement: The study demonstrated 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." It also notes that the automated point placement feature's accuracy was not evaluated and should only be viewed as a "first guess." Therefore, the improvement is primarily in workflow efficiency for initial point placement, not necessarily improved accuracy of human readers with AI vs. without AI, as users still manually adjust. The text implies no negative impact on the final accuracy achieved by human users.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No standalone (algorithm-only) performance study is explicitly described for the new automated first guess feature's accuracy. The document states: "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." Performance is measured based on the user's final placement after adjustment.
7. Type of Ground Truth Used
- Ground Truth Type: For the user validation study, the ground truth for anatomical point placement was an "expert consensus region." For the overall system performance, the ground truth for volume measurements and ejection fractions would likely be derived from the KBR algorithm's established accuracy against other modalities (like MRI), which is the basis of the VMS+ system itself, but this is not specifically described for the 4.0 version's validation directly.
8. Sample Size for the Training Set
- Training Set Sample Size: Not explicitly mentioned in the provided text. The VMS+ system uses a "database of MRI heart shape catalogs" for its Knowledge-Based Reconstruction (KBR) algorithm, but the size of this database (training set for the KBR) is not specified for VMS+ 4.0 or its predicate.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: The KBR algorithm references a "database of MRI heart shape catalogs." This implies that the ground truth for the training of the KBR algorithm (which reconstructs the heart's shape) is derived from MRI data, generally considered a gold standard for cardiac chamber quantification. However, the specific methodology for collecting and verifying this MRI data for the KBR training is not detailed for this device submission.
{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 101Toronto Ontario M6P 1T4Canada |
| Contact Person: | Aaron ZhangRA/QA Managerazhang@ventripoint.comTel: 416-848-4156 |
| Device Name | Ventripoint Medical System Plus (VMS+) 4.0 |
| Classification: | Regulatory Class: IIReview Category: Tier IIClassification Panel: RadiologyRegulation Number: 892.2050Classification Product Code: QIHSecondary 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: IIReview Category: Tier IIClassification Panel: RadiologyRegulation 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 DeviceVentripoint MedicalSystem Plus (VMS+)3.0 (K191493) | Subject DeviceVentripoint MedicalSystem Plus (VMS+)4.0 | Comparison |
|---|---|---|---|
| Indications for Use | The VMS+ is anadjunct to existingultrasound imagingsystems and isintended to record,analyze, store andretrieve digitalultrasound images forcomputerized 3-dimensional imageprocessing.The VMS+ isindicated for usewhere Left Ventricle(LV), Right Ventricle(RV), Left Atrium(LA), and RightAtrium (RA) volumesand ejection fractionsare warranted ordesired. | The VMS+ is anadjunct to existingultrasound imagingsystems and isintended to record,analyze, store andretrieve digitalultrasound images forcomputerized 3-dimensional imageprocessing.The VMS+ is indicatedfor use where LeftVentricle (LV), RightVentricle (RV), LeftAtrium (LA), and RightAtrium (RA) volumesand ejection fractionsare warranted ordesired. | Same |
| Technological Characteristics | |||
| Software basedanalysis tool | Yes | Yes | Same |
| Knowledge-BasedReconstructionAlgorithm | Yes | Yes | Same |
| 3D Visualization | Generates a 3Dsurface model of the4 chambers and | Generates a 3Dsurface model of the 4chambers and | Same |
| Feature/Characteristic | Predicate DeviceVentripoint MedicalSystem Plus (VMS+)3.0 (K191493) | Subject DeviceVentripoint MedicalSystem Plus (VMS+)4.0 | Comparison |
| accompanyingvolumemeasurement. | accompanying volumemeasurement. | ||
| Measurements | End-systolic volumes(EDV, ESV), EjectionFractions (EF), StrokeVolumes and CardiacOutputs | End-systolic volumes(EDV, ESV), EjectionFractions (EF), StrokeVolumes and CardiacOutputs. | Same |
| Acquisition Workflow | Executing on acomputer, processesdata acquired by thesensor system inconjunction with theoutput from theultrasoundequipment, to enabletracking of anatomiclandmark points fromthe 2D images andconversion of thosepoints into 3D datapoints. | Executing on acomputer, processesdata acquired by thesensor system inconjunction with theoutput from theultrasound equipment,to enable tracking ofanatomic landmarkpoints from the 2Dimages and conversionof those points into 3Ddata points. | Same |
| Points placement | Requires placementof anatomiclandmarks on the 2Dimages. On-screenguide is provided touser for pointplacement firstguesses. User mustmanually adjust firstguess pointplacements asrequired.Landmarks are thenused to build anaccurate 3Dconstructed shapemesh (defined byvertices, edges, andfaces). | Requires placement ofanatomic landmarks onthe 2D images. On-screen guide isprovided to user forpoint placement firstguesses. Alternatively,automated pointplacement first guessescan be generated via abutton press. Usermust manually adjustfirst guess pointplacements asrequired.Landmarks are thenused to build anaccurate 3Dconstructed shapemesh (defined byvertices, edges, andfaces). | VMS+ 4.0 is equivalentto VMS+ 3.0. Theautomated control pointfirst guess placement isadded to improve userworkflow efficiency.Users must stillmodify/confirm controlpoint placement afteran automated firstguess.Internal user validationof the final location ofcontrol points using theon-screen guide versusautomated firstguesses was assessed.Additionally, verificationtests were performedagainst doctors' pointplacement.Thus, the differencedoes not raise differentquestions of safety andeffectiveness. |
| Feature/Characteristic | Predicate DeviceVentripoint MedicalSystem Plus (VMS+)3.0 (K191493) | Subject DeviceVentripoint MedicalSystem Plus (VMS+)4.0 | Comparison |
| Location of KBRcatalogue | Knowledge-basedreconstruction locatedlocally on the system,which accepts the 3Ddata points generatedthrough the use of theposition sensorsystem and providesthe computationengine for generatinga 3D surfaceconstruction of thefour chambers andaccompanyingvolume measurementand ejection fractionsof the four chambersof the four chambersof the heart, either atend-diastolic and/orend-systolic. | Knowledge-basedreconstruction locatedlocally on the system,which accepts the 3Ddata points generatedthrough the use of theposition sensor systemand provides thecomputation engine forgenerating a 3Dsurface construction ofthe four chambers andaccompanying volumemeasurement andejection fractions of thefour chambers of thefour chambers of theheart, either at end-diastolic and/or end-systolic. | Same |
| Software applicationtypes | Console (system) andWorkstation(standalone) | Console (system) andWorkstation(standalone) | Same |
| Hardware dataacquisition system | Touchscreen forimage capture, avideo-input connectorto receive image datafrom an ultrasoundmachine, off-the-shelfreal-time videocapture card toreceive image datafrom an ultrasoundmachine, and 3Dpositional trackingsystem to receiveposition andorientationinformation. | Touchscreen for imagecapture, a video-inputconnector to receiveimage data from anultrasound machine,off-the-shelf real-timevideo capture card toreceive image datafrom an ultrasoundmachine, and 3Dpositional trackingsystem to receiveposition and orientationinformation. | Same |
| Feature/Characteristic | Predicate DeviceVentripoint MedicalSystem Plus (VMS+)3.0 (K191493) | Subject DeviceVentripoint MedicalSystem Plus (VMS+)4.0 | Comparison |
| 3D tracking/positionalsystem | Magnetic-based; free-hand scanning;consisting ofmechanical arm,transmitter,ultrasound transducersensor, andassociatedelectronics. | Magnet-free; free-handscanning; consisting ofultrasound transducersensor,transmitter/sensor onpatient, and associatedelectronics. | VMS+ 4.0 is equivalentto VMS+ 3.0 with theonly difference beingthat the magnet hasbeen removed fromtransmitter/sensor asan improvement. Theway in which the deviceoperates remains thesame; both systemsare free-hand scanning.In addition, theperformance of the newdevice is the same asthe predicate device.Thus, the differencedoes not raise differentquestions of safety andeffectiveness. |
| Patient contactingcomponents | Surface device; intactskin; A-limited (<24h) | Surface device; intactskin; A-limited (<24h) | Same |
| 3D Echo and MRIfunctionality | Can import 3D echoand MRI studies forvolumetric analysis. | Can import 3D echo andMRI studies forvolumetric analysis. | Same |
| Software controls | The softwarecomponents areresponsible forproviding the userwith controls formanaging thehardware operation,capturing ultrasoundimages, marking upimages with keyanatomical features,invoking thereconstructionalgorithm, displayingthe resultingconstruction andgenerating thecorresponding report. | The softwarecomponents areresponsible forproviding the user withcontrols for managingthe hardware operation,capturing ultrasoundimages, marking upimages with keyanatomical features,invoking thereconstructionalgorithm, displayingthe resultingconstruction andgenerating thecorresponding report. | Same |
| Power requirements | Power requirements:AC :100V- 240V,Frequenzy:50-60Hz | Power requirements:AC :100V- 240V,Frequenzy:50-60Hz | Same |
| Image data format | Original VMS+ andDICOM format | Original VMS+ andDICOM format | Same |
{8}------------------------------------------------
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.
{9}------------------------------------------------
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.
{10}------------------------------------------------
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.
{11}------------------------------------------------
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.
§ 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).