(150 days)
The VMS+ is an adjunct to existing ultraging 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 VentriPoint Medical System was cleared under 510(k) K150628 for use in right ventricle evaluation where RV volumes and ejection fractions are warranted or desired. This current submission is intended to expand system use to Left ventricle (LV), Right Atrium (RA), and Left Atrium (LA) volumes and ejection fractions. LV, RA, LA evaluation is accomplished by the addition of KBR heart catalogs containing a variety of heart models for each chamber. VMS+ employs the same fundamental scientific technology to that of the cleared device.
The provided text describes the Ventripoint Medical System Plus (VMS+) and its substantial equivalence to a predicate device, the Ventripoint Medical System (K150628). The submission aims to expand the system's use from only the right ventricle (RV) to include the left ventricle (LV), right atrium (RA), and left atrium (LA) volumes and ejection fractions.
However, the document explicitly states that "The VMS+, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This means that a clinical study proving the device meets specific acceptance criteria for clinical performance as an AI-powered diagnostic tool was not conducted or submitted for this particular expansion of indications for use. The focus of the provided text is on demonstrating substantial equivalence based on technological characteristics and the performance of its "catalogs" for LV, LA, and RA evaluation through bench testing.
Therefore, many of the requested elements for describing clinical acceptance criteria and a study proving their fulfillment cannot be directly extracted from the provided text for the expanded indications.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for LV, LA, and RA volume/ejection fraction measurement are not explicitly stated or reported.
The document mentions "Performance bench testing of the LV, LA, and RA catalogues was completed to verify suitability for left ventricle, left atrium, and right atrium evaluation. Testing of the LV, LA, and RA catalogs consisted of a robust series of automated and manual testing to verify reconstruction accuracy."
However, the results of this testing, in terms of quantitative performance against specific criteria, are not detailed in this submission summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Performance bench testing" but does not specify a "test set" in the context of human subject data, nor does it provide details on sample size, or data provenance. This is consistent with the statement that clinical studies were not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as a clinical test set with expert-established ground truth is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study is mentioned or described in the provided text. The device is described as an "adjunct to existing ultraging systems" and a "computerized 3-dimensional image processing" system, implying it's a tool for measurement rather than an AI for interpretation that would typically require MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Performance bench testing of the LV, LA, and RA catalogues... to verify reconstruction accuracy" could be considered a form of standalone performance evaluation for the reconstruction accuracy component. However, the quantitative results and the specific methodology are not detailed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "reconstruction accuracy" bench testing, the ground truth would likely be a known, precisely measured physical model or a highly accurate reference standard within the testing environment. The text does not specify the exact nature of this ground truth.
8. The sample size for the training set
The device uses "KBR heart catalogs containing a variety of heart models for each chamber." This refers to a "Knowledge Based Reconstruction database." The sample size or specific details of this "training set" (in the machine learning sense) are not provided. The term "catalogs" suggests a collection of models used by the system for its reconstruction process, rather than a dynamically trained AI model in the contemporary sense.
9. How the ground truth for the training set was established
The text states the device uses a "Knowledge Based Reconstruction database" for its 3-D reconstruction. For such a system, the "ground truth" for building these "heart catalogs" would typically involve precise anatomical measurements from a diverse set of real hearts (cadaveric, surgical, or high-fidelity imaging such as MRI/CT) to create a statistical model or library of normal and abnormal heart shapes and sizes. However, the specific methodology for establishing this ground truth for the KBR catalogs is not detailed in the provided document.
Summary regarding acceptance criteria and study details based solely on the provided text:
The submission for the VMS+ expanding its indications to LV, LA, and RA did not include clinical studies demonstrating performance against specific clinical acceptance criteria. The basis for substantial equivalence for these new indications rested on the device employing the "same fundamental scientific technology" as the cleared predicate and undergoing "Performance bench testing... to verify reconstruction accuracy" for the new LV, LA, and RA catalogs. No specific quantitative targets or results from this bench testing are provided in this summary, nor are details on the test set, ground truth derivation, or expert involvement for clinical validation.
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May 14, 2018
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Ventripoint Diagnostics, Ltd. % Desmond Hirson VP Development and Operations 2 Sheppard Avenue East, Suite 605 Toronto, Ontario M2N 5Y7 CANADA
Re: K173810
Trade/Device Name: Ventripoint Medical System Plus (VMS+) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: April 11, 2018 Received: April 13, 2018
Dear Desmond Hirson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173810
Device Name
Ventripoint Medical System Plus (VMS+)
Indications for Use (Describe)
The VMS+ is an adjunct to existing ultraging 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.
| 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) |
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Section 5: 510(k) Summary
| Date: | December 8, 2017 |
|---|---|
| Submitter: | VentriPoint, Inc.2 Sheppard Ave. EastToronto, Ontario |
| Contact Person: | Desmond HirsonTel: 416-848-4156Fax: 416-848-0709 |
| Device Name: | Ventripoint Medical System Plus (VMS+) |
| Common Name: | Diagnostic Ultrasound Image Analysis System |
| Classification: | Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology |
| Ultrasonic Pulsed Doppler Imaging System 892 1550 90-JYM |
A. Legally Marketed Predicate Device
The Ventripoint Medical System Plus (VMS+) is an adjunct system to existing ultrasound imaging systems with accessories and proprietary software. It is substantially equivalent to Ventripoint Medical System (K150628).
B. Device Description
The VentriPoint Medical System was cleared under 510(k) K150628 for use in right ventricle evaluation where RV volumes and ejection fractions are warranted or desired. This current submission is intended to expand system use to Left ventricle (LV), Right Atrium (RA), and Left Atrium (LA) volumes and ejection fractions. LV, RA, LA evaluation is accomplished by the addition of KBR heart catalogs containing a variety of heart models for each chamber. VMS+ employs the same fundamental scientific technology to that of the cleared device.
C. Intended Use
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VMS+ Ventripoint Medical System 510(k) Submission
The VMS+ 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+ 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.
D. Substantial Equivalence
The Ventripoint Medical System Plus (VMS+) is a system with accessories and proprietary software. It is substantially equivalent to Ventripoint Medical System IS-1 (K150628).
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
| Feature/Characteristic | Predicate DeviceVentriPoint Medical System IS-1(K150628) | Submission DeviceVMS+ |
|---|---|---|
| IntendedUse/Indications for Use | The VMS System is an adjunct toexisting ultrasound imagingsystems and is intended to record,analyze, store and retrieve digitalultrasound images forcomputerized 3-dimensionalimage processing.The VMS system is indicated foruse where RV volumes andejection fractions are warranted ordesired. | The VMS+ system isan adjunct to existingultrasound imagingsystems and isintended to record,analyze, store andretrieve digitalultrasound images forcomputerized 3-dimensional imageprocessing.The VMS+ system isindicated for usewhere Left Ventricle(LV), Right Ventricle(RV), Left Atrium (LA),and Right Atrium (RA)volumes and ejectionfractions are warrantedor desired. |
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| Freehand scanning device | ||
|---|---|---|
| RV volume measurement | Yes | Yes |
| 3-D Reconstruction | Knowledge Based Reconstruction database | Knowledge Based Reconstruction database |
| Software Based Analysis Tool | Yes | Yes |
| UL 60601-1 | Yes | Yes |
| UL 60601-2 | Yes | Yes |
| Windows OS based analysis system | Yes | Yes |
| Real-time Video Capture card | Yes | Yes |
| External ECG trigger | Yes | Yes |
| Pulsed DC 6DOF magnetic tracking system | Yes | Yes |
E. Non-Clinical Tests
The device has been evaluated for electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The systems comply with the following voluntary standards:
| Reference No. | Title |
|---|---|
| IEC 60601-1 | IEC 60601-1, Medical electrical equipment – Part 1:General requirements for basic safety and essentialperformance 3rd edition. |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essential performanceCollateral standard: Electromagnetic compatibility –Requirements and tests 2nd edition. |
| ISO 14971:2007 | Medical devices – Application of risk management tomedical devices |
Performance bench testing of the LV, LA, and RA catalogues was completed to verify suitability for left ventricle, left atrium, and right atrium evaluation. Testing of the LV, LA, and RA catalogs consisted of a robust series of automated and manual testing to verify reconstruction accuracy.
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VMS+ Ventripoint Medical System 510(k) Submission
F. Clinical Tests
The VMS+, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
G. Conclusion
Device Similarities
Intended use and other key features are consistent with traditional clinical practice and FDA guidance. The VMS+ product conforms to applicable medical device safety standards and compliance is verified through independent evaluation. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards.
Safety and Effectiveness
The VMS+ system is a non-invasive, non-significant risk technology.
The LV. LA. and RA catalogs do not raise different questions of safety or effectiveness that were not applicable to the predicate device. Ventripoint Diagnostics Ltd. believes that the VMS+ is as safe and effective as the predicate device.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.