(150 days)
No
The summary mentions "computerized 3-dimensional image processing" and "heart catalogs containing a variety of heart models," but does not explicitly mention AI, ML, or related terms like neural networks or deep learning. The description of performance testing focuses on "reconstruction accuracy" using automated and manual methods, which doesn't necessarily imply AI/ML.
No.
The device is intended to record, analyze, store, and retrieve digital ultrasound images for computerized 3-dimensional image processing and calculate volumes and ejection fractions. It does not provide treatment or therapy.
Yes
The device is indicated for determining volumes and ejection fractions of heart chambers, which are key metrics used to diagnose cardiac conditions. This information is processed from ultrasound images, making it a tool used to aid in the diagnosis of a patient's medical condition.
No
The device description explicitly states it is an "adjunct to existing ultraging systems" and refers to the "VentriPoint Medical System" cleared under a previous 510(k). This indicates it is part of a larger system that includes hardware (the ultrasound system), not a standalone software-only 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+ processes and analyzes ultrasound images of the heart chambers. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to record, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing and to provide measurements of heart chamber volumes and ejection fractions. This is a diagnostic imaging analysis tool, not an in vitro test.
Therefore, the VMS+ falls under the category of a medical device that processes and analyzes medical images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IYN
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.
Mentions image processing
computerized 3-dimensional image processing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound images
Anatomical Site
Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA)
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
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.
Summary of Performance Studies
The VMS+, subject of this submission, did not require clinical studies to support the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
May 14, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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
2
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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3
Section 5: 510(k) Summary
| Date: | December 8, 2017 |
|---|---|
| Submitter: | VentriPoint, Inc. |
| 2 Sheppard Ave. East | |
| Toronto, Ontario | |
| Contact Person: | Desmond Hirson |
| Tel: 416-848-4156 | |
| Fax: 416-848-0709 | |
| Device Name: | Ventripoint Medical System Plus (VMS+) |
| Common Name: | Diagnostic Ultrasound Image Analysis System |
| Classification: | Regulatory Class: II |
| Review Category: Tier II | |
| Classification 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
4
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 Device
VentriPoint Medical System IS-1
(K150628) | Submission Device
VMS+ |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for Use | 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 3-dimensional
image processing.
The VMS system is indicated for
use where RV volumes and
ejection fractions are warranted or
desired. | 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 3-
dimensional 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. |
5
| 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 essential | |
| performance 3rd edition. | |
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General |
| requirements for basic safety and essential performance | |
| Collateral standard: Electromagnetic compatibility – | |
| Requirements and tests 2nd edition. | |
| ISO 14971:2007 | Medical devices – Application of risk management to |
| medical 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.
6
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.