(43 days)
Not Found
Unknown
The description mentions "Knowledge Based Reconstruction expert system," which could potentially involve AI/ML techniques, but the summary does not explicitly state the use of AI, ML, or related terms like DNN.
No.
The device is described as a diagnostic system intended to analyze, store, and retrieve ultrasound images to compute right ventricular volumes and ejection fraction, which supports clinical decision making. It does not provide therapy.
Yes
The device description explicitly states, "The VentriPoint Diagnostic System is a client/server platform..." and its intended use is to compute right ventricular volumes and ejection fraction, and display results for "further consideration or evaluation by the product user," supporting "clinical decision making."
No
The device description explicitly states it is a "cart based system consisting of CE Marked off-the-shelf subassemblies" and includes a "3-D tracking system connected to the ultrasound transducer," indicating it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The VMS system processes and analyzes digital ultrasound images, which are generated by an external imaging system and represent anatomical structures within the body. It does not directly interact with or analyze biological samples.
The device's function is focused on image processing, 3D reconstruction, and quantitative measurement of anatomical structures based on imaging data, which falls under the category of medical imaging analysis software or systems, not IVDs.
N/A
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 used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.
Product codes (comma separated list FDA assigned to the subject device)
IYN
Device Description
The VentriPoint Diagnostic System is a client/server platform consisting of the VentriPoint Medical System (client) and VentriPoint Services (server). The VentriPoint Medical System (VMS) is a cart based system consisting of CE Marked off-the-shelf subassemblies which accepts the digital video output from any 2-D ultrasound machine.
A 3-D tracking system is connected to the ultrasound transducer using a custom sleeve. This system provides 3-D spatial coordinates for the 2-D images. After recording the 2-D images and associated 3-D spatial coordinates. a trained medical professional uses the VMS graphical user interface to place a series of points on the 2-D images corresponding to selected anatomical structures. Those points. along with their 3-D spatial coordinates, are sent by secure internet connection to the VentriPoint Services.
The VentriPoint Services use a Knowledge Based Reconstruction expert system to convert those 3-D points into a dense 3-D model of the right ventricle and sends the model back to the VMS system where the results are displayed on the screen. This initial rendering is reviewed for accuracy by the product user. The border contours generated from the previously placed points are displayed and may be adjusted by the user to achieve a precise fit. Improvements are made by adding, deleting or moving points on the image slices where needed. after which the information is sent by secure internet connection to the VentriPoint Services to be reconstructed. The review and reconstruction process may be repeated until the user is satisfied that the best contour fit has been made.
Once the 3-D model has been approved by credentialed site personnel, quantitative right ventricle measurements are reported. The data produced by VMS is intended to support qualified licensed medical professionals in clinical decision making when used in conjunction with other patient test information.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
right ventricle (cardiac)
Indicated Patient Age Range
Adult
Intended User / Care Setting
qualified licensed medical professionals
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
A clinical study of 75 consenting adults with Pulmonary Arterial Hypertension was conducted to assess the accuracy of right ventricle (RV) volumes and ejection fraction (EF) obtained with the VMS system. Standard of care cardiac magnetic resonance imaging (MRI) was used for comparison. Analysis of the patient imaging data was completed by independent imaging core labs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: Performance bench testing of the VentriPoint Medical System (VMS) was completed to verify accuracy of the PAH reconstruction catalog. Testing of the PAH catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy.
Clinical Testing: A clinical study of 75 consenting adults with Pulmonary Arterial Hypertension was conducted to assess the accuracy of right ventricle (RV) volumes and ejection fraction (EF) obtained with the VMS system. Standard of care cardiac magnetic resonance imaging (MRI) was used for comparison. Analysis of the patient imaging data was completed by independent imaging core labs. A thorough analysis of the core lab results and sources of variability indicates that the VMS system is an accurate method of measuring RV volume and EF when compared with MRI analyzed using Simpson's method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
RV volume
ejection fraction
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K140153
MAR - 6 2014
510(k) Summary : Section 5
510(k) Summary 807.92(c)
SPONSOR
807.92(a)(1)
, .
| Company Name: | VentriPoint. Inc. |
|---|---|
| Company Address | 24 Roy Street, #445 |
| Seattle, WA 98109 | |
| Telephone: | 206-283-0221 |
| Fax: | None |
| Contact Person: | Jim Bodtke |
Summary Preparation Date: 22 January 2014
DEVICE NAME
510(k) #
| Trade Name: | VentriPoint Medical System IS-1 |
|---|---|
| Common/Usual Name: | Diagnostic Ultrasound Image Analysis System |
| Classification Name: | Ultrasonic Pulsed Doppler Imaging System |
Product
Echo-Scan with Freehand Scanning
PREDICATE DEVICE
Legally Marketed Equivalent Device
Company Acuson SC2000TM Ultrasound System Siemens Medical Solutions, Inc
807.92(a)(4)
807.92(a)(3)
TomTec Imaging Systems GmbH
DEVICE DESCRIPTION
The VentriPoint Diagnostic System is a client/server platform consisting of the VentriPoint Medical System (client) and VentriPoint Services (server). The VentriPoint Medical System (VMS) is a cart based system consisting of CE Marked off-the-shelf subassemblies which accepts the digital video output from any 2-D ultrasound machine ..
A 3-D tracking system is connected to the ultrasound transducer using a custom sleeve. This system provides 3-D spatial coordinates for the 2-D images. After recording the 2-D images and associated 3-D spatial coordinates. a trained medical professional uses the VMS graphical user interface to place a series of points on the 2-D images corresponding to selected anatomical structures. Those points. along with their 3-D spatial coordinates, are sent bv secure internet connection to the VentriPoint Services.
The VentriPoint Services use a Knowledge Based Reconstruction expert system to convert those 3-D points into a dense 3-D model of the right ventricle and sends the model back to the VMS svstem where the results are displayed on the screen. This initial rendering is reviewed for accuracy by the product user. The border contours generated from the previously placed points are displayed and may be adjusted by the user to achieve a precise fit. Improvements are made
807.92(a)(2)
510(k) Summa
1
by adding. deleting or moving points on the image slices where needed. after which the information is sent by secure internet connection to the VentriPoint Services to be reconstructed. The review and reconstruction process may be repeated until the user is satisfied that the best contour fit has been made.
Once the 3-D model has been approved by credentialed site personnel, quantitative right ventricle measurements are reported. The data produced by VMS is intended to support qualified licensed medical professionals in clinical decision making when used in conjunction with other patient test information.
DEVICE INTENDED 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 used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.
| Parameters | VentriPoint Medical
System | Siemens SC2000 | TomTec Echo-Scan |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K102017 | K963807 |
| 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 used to record a
sequence of conventional
cardiac 2-D ultrasound
images with the transducer
position recorded for each
image acquired to compute
right ventricular volumes
and ejection fraction.
Specific anatomic
landmarks identified by the
product user are
transmitted by secure
internet connection to a | The SC2000 ultrasound
imaging system is intended
for the following
applications: Cardiac, Neo-
natal and Fetal Cardiac,
Pediatric, Transesophageal,
Adult Cephalic, Peripheral
Vessel, Intraoperative
Neurological, Musculo-
skeletal Conventional, and
Musculo-skeletal
Superficial applicatioris.
The system also provides
the ability to measure
anatomical structures and
calculation packages that
provide information to the
clinician that may be used
adjunctively with other
medical data obtained by a
physician for clinical
diagnosis purposes. | Echo-Scan™ is intended to
acquire, analyze, store and
retrieve digital ultrasound
images for computerized 3-
dimensional and 4-
dimensional (dynamic 3-D)
image processing. It is an
add-on accessory for
existing ultrasound
imaging systems, and is
intended to control position
and movement of
ultrasound transducers for
the systematic acquisition
of 2 dimensional image
slices throughout a volume
of interest. The Echo-Scan
acquires sets of 2D images
and stores them digitally in
the TomTec standard 3D
image file format for
subsequent 3D |
| | VMS server where 3-D
assembly of the right
ventricle in adult patients
with Pulmonary Arterial
Hypertension takes place
using Knowledge Based
Reconstruction (KBR). The
results are then returned to
the VMS system for
display and further
consideration or evaluation
by the product user. | | tomographic reconstruction
and surface rendering with
either the Echo-Scan or
Echo-View. It is intended
as a general purpose digital
3D ultrasound image
processing tool for
cardiology, radiology,
neurology,
gastroenterology, urology,
surgery, obstetrics and
gynecology. The TomTec
Freehand Scanning Device
is intended for acquiring a
sequence of conventional
2D ultrasound images with
transducer position
recorded for each image
acquired. The resulting
image data set is intended
for storage in the TomTec
standard 3D image file
format for subsequent 3D
tomographic image
reconstruction. |
| Freehand
scanning device | Yes | Yes | Yes |
| RV volume
measurement | Yes | Yes | Yes |
| 3-D
Reconstruction | Knowledge Based
Reconstruction database | Knowledge Based
Reconstruction database
(only Velocity Vector
Imaging (VVI) component) | Automated border
detection algorithms |
| Software Based
Analysis Tool | Yes | Yes | Yes |
| UL 60601-1 | Yes | Yes | Yes |
| UL 60601-2 | Yes | Yes | unknown |
| Windows® OS
based analysis
system | Yes | Yes | Yes |
| Real-time Video
Capture card | Yes | Yes | Yes |
| External ECG
trigger | Yes | Yes | Yes |
| Pulsed DC 6DOF
magnetic tracking | Yes | No | Yes |
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
807.92(a)(5)
2
22
3
| I
MADIGULER
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
was been been and consisted. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | and in color contraction of the consisted by and the compress on of the minister and the many of the many of the many of the many of the many of the many of the many of the m | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
стания в при при свое при при ставительные в свъ страниции в страниции в с седь полности в с седь полности в с седь полнения. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comments of the first of the first and the first and the first and the first and the first and the first and the first and the first and the first and the first and the first | | | |
NONCLINICAL TESTING
Performance bench testing of the VentriPoint Medical System (VMS) was completed to verify accuracy of the PAH reconstruction catalog.
Testing of the PAH catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy.
CLINICAL TESTING
A clinical study of 75 consenting adults with Pulmonary Arterial Hypertension was conducted to assess the accuracy of right ventricle (RV) volumes and ejection fraction (EF) obtained with the VMS system. Standard of care cardiac magnetic resonance imaging (MRI) was used for comparison.
Analysis of the patient imaging data was completed by independent imaging core labs. A thorough analysis of the core lab results and sources of variability indicates that the VMS system is an accurate method of measuring RV volume and EF when compared with MRI analyzed using Simpson's method.
CONCLUSION
807.92(b)(3)
Similarities with the Predicate Devices
The VMS system is substantially equivalent to the predicate devices in the ability to generate 3-D reconstructions of the cardiac right ventricle from a series of 2-D ultrasound images.
Specifically, the VMS system is substantially equivalent to the Siemens Acuson SC2000 in the use of a knowledge based reconstruction database (the SC2000 Velocity Vector Imaging (VVI) component).
The VMS system is substantially equivalent to the TomTec Echo-Scan in technological characteristics that include:
- PC with Microsoft Windows® OS. .
- . video capture card.
- tracking device. and .
- ECG trigger mechanism .
The TomTec Echo-Scan and VMS system share the following common traits:
- Allow for 3-D freehand ultrasound scanning, .
- . Employs an off-the-shelf, strategically positioned, electromagnetic field generator along with a field disturbance sensor firmly attached to the ultrasound transducer in order to enable high precision positional information for each scan plane, and
- As with the VMS product, the TomTec Echo-Scan enables a 3-D reconstruction of . cardiac chambers using 2-D ultrasound images and precision of all selected data points in space to accomplish the intended clinical use.
807.92(b)(1)
807.92(b)(2)
4
Difference with the Predicate Devices
The difference between the VMS system and the TomTec Echo-Scan is how the 3-D Reconstruction takes place. The VMS system uses a Knowledge Based Reconstruction database as does the Siemens Acuson SC2000 while the TomTec Echo-Scan uses Automated Border Detection Algorithms.
Safety and effectiveness
The VMS system is a non-invasive, non-significant risk technology. No adverse events were reported during the clinical trial. Effectiveness was assessed through bench and clinical performance testing using a standard of care method as a comparator. The VMS system introduces no new questions concerning safety or effectiveness and is therefore substantially equivalent to the predicate devices.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure, with three flowing lines representing the human form. The graphic is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 6, 2014
Ventripoint, Inc. % Mr. Jim Bodtke V.P. of Clinical Affairs 24 Roy Street, #445 SEATTLE WA 98109
Re: K140153
Trade/Device Name: Ventripoint Medical System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: II Product Code: IYN Dated: January 22, 2014 Received: January 22, 2014
Dear Mr. Bodtke:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHO1Tices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Section 4 Indications for Use Statement
Indications for Use
510(k) Number (if known): _ K140153
Device Name: VentriPoint Medical System
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 used to record a sequence of conventional cardiac 2-D ultrasound images with the transducer position recorded for each image acquired to compute right ventricular volumes and ejection fraction. Specific anatomic landmarks identified by the product user are transmitted by secure internet connection to a VMS server where 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension takes place using Knowledge Based Reconstruction (KBR). The results are then returned to the VMS system for display and further consideration or evaluation by the product user.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OVID)
Smh.7)
Page 1 of 1
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) ======================================================================================================================================================================= K140153
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