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.

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 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.

AI/ML Overview

The VentriPoint Medical System (VMS) is intended to record, analyze, store, and retrieve digital ultrasound images for computerized 3-dimensional image processing. It is used to record a sequence of conventional cardiac 2-D ultrasound images with transducer position recorded to compute right ventricular volumes and ejection fraction. The system identifies anatomic landmarks, transmits them to a VMS server for 3-D assembly of the right ventricle in adult patients with Pulmonary Arterial Hypertension using Knowledge Based Reconstruction (KBR), and then returns the results for display and evaluation.

Here's an analysis of the acceptance criteria and study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity). However, the study aims to assess the accuracy of RV volumes and EF obtained with the VMS system compared to Cardiac Magnetic Resonance Imaging (MRI). The conclusion states that the VMS system is an accurate method of measuring RV volume and EF when compared with MRI analyzed using Simpson's method, implying that the performance met an internal or implicit accuracy standard.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Right Ventricular (RV) Volume	To be an accurate method when compared to MRI (Simpson's method)	Accurate method of measuring RV volume when compared with MRI
Ejection Fraction (EF)	To be an accurate method when compared to MRI (Simpson's method)	Accurate method of measuring EF when compared with MRI

2. Sample Size and Data Provenance for the Test Set

Sample Size: A clinical study was conducted with 75 consenting adults with Pulmonary Arterial Hypertension.
Data Provenance: The data was collected from prospective clinical study participants. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the study likely took place in the U.S. or under U.S. regulatory standards.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience). It mentions:

"Analysis of the patient imaging data was completed by independent imaging core labs." This implies that qualified professionals were involved in analyzing the MRI data for ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method beyond stating that "Analysis of the patient imaging data was completed by independent imaging core labs." This suggests that the core labs provided the ground truth measurements. It does not mention multiple readers, consensus meetings, or other specific adjudication processes like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this summary. The study focused on the standalone performance of the VMS system against a standard of care (MRI). The document does not describe human readers using the AI with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The clinical study assessed "the accuracy of right ventricle (RV) volumes and ejection fraction (EF) obtained with the VMS system" by comparing "Analysis of the patient imaging data... completed by independent imaging core labs" using Cardiac Magnetic Resonance Imaging (MRI) as the comparator. This indicates that the VMS system's output (an algorithm-driven result after user contouring) was directly compared to the ground truth.

7. Type of Ground Truth Used

The ground truth used was Cardiac Magnetic Resonance Imaging (MRI) analyzed using Simpson's method. MRI is considered a gold standard for cardiac chamber quantification.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for the training set for the Knowledge Based Reconstruction (KBR) expert system.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established for the Knowledge Based Reconstruction (KBR) system. It only states that the VMS system uses a "Knowledge Based Reconstruction expert system" and makes a comparison to Siemens' "Knowledge Based Reconstruction database (only Velocity Vector Imaging (VVI) component)." This implies that the KBR system would have been developed using a dataset with known RV volumes and EF values, likely derived from methods like MRI or other established volumetric measurements, but the specifics are not detailed.

Summary

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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, #445Seattle, WA 98109
Telephone:	206-283-0221
Fax:	None
Contact Person:	Jim Bodtke

Summary Preparation Date: 22 January 2014

DEVICE NAME

510(k) #

K102017

K963807

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

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

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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 MedicalSystem	Siemens SC2000	TomTec Echo-Scan
510(k) Number		K102017	K963807
Indications forUse	The VMS system is anadjunct to existingultrasound imagingsystems and is intended torecord, analyze, store andretrieve digital ultrasoundimages for computerized 3-dimensional imageprocessing. The VMSsystem is used to record asequence of conventionalcardiac 2-D ultrasoundimages with the transducerposition recorded for eachimage acquired to computeright ventricular volumesand ejection fraction.Specific anatomiclandmarks identified by theproduct user aretransmitted by secureinternet connection to a	The SC2000 ultrasoundimaging system is intendedfor the followingapplications: Cardiac, Neo-natal and Fetal Cardiac,Pediatric, Transesophageal,Adult Cephalic, PeripheralVessel, IntraoperativeNeurological, Musculo-skeletal Conventional, andMusculo-skeletalSuperficial applicatioris.The system also providesthe ability to measureanatomical structures andcalculation packages thatprovide information to theclinician that may be usedadjunctively with othermedical data obtained by aphysician for clinicaldiagnosis purposes.	Echo-Scan™ is intended toacquire, analyze, store andretrieve digital ultrasoundimages for computerized 3-dimensional and 4-dimensional (dynamic 3-D)image processing. It is anadd-on accessory forexisting ultrasoundimaging systems, and isintended to control positionand movement ofultrasound transducers forthe systematic acquisitionof 2 dimensional imageslices throughout a volumeof interest. The Echo-Scanacquires sets of 2D imagesand stores them digitally inthe TomTec standard 3Dimage file format forsubsequent 3D
	VMS server where 3-Dassembly of the rightventricle in adult patientswith Pulmonary ArterialHypertension takes placeusing Knowledge BasedReconstruction (KBR). Theresults are then returned tothe VMS system fordisplay and furtherconsideration or evaluationby the product user.		tomographic reconstructionand surface rendering witheither the Echo-Scan orEcho-View. It is intendedas a general purpose digital3D ultrasound imageprocessing tool forcardiology, radiology,neurology,gastroenterology, urology,surgery, obstetrics andgynecology. The TomTecFreehand Scanning Deviceis intended for acquiring asequence of conventional2D ultrasound images withtransducer positionrecorded for each imageacquired. The resultingimage data set is intendedfor storage in the TomTecstandard 3D image fileformat for subsequent 3Dtomographic imagereconstruction.
Freehandscanning device	Yes	Yes	Yes
RV volumemeasurement	Yes	Yes	Yes
3-DReconstruction	Knowledge BasedReconstruction database	Knowledge BasedReconstruction database(only Velocity VectorImaging (VVI) component)	Automated borderdetection algorithms
Software BasedAnalysis Tool	Yes	Yes	Yes
UL 60601-1	Yes	Yes	Yes
UL 60601-2	Yes	Yes	unknown
Windows® OSbased analysissystem	Yes	Yes	Yes
Real-time VideoCapture card	Yes	Yes	Yes
External ECGtrigger	Yes	Yes	Yes
Pulsed DC 6DOFmagnetic tracking	Yes	No	Yes

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

807.92(a)(5)

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IMADIGULERﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘwas 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)

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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.

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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.

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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

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Section 4 Indications for Use Statement

Indications for Use

510(k) Number (if known): _ K140153

Device Name: VentriPoint Medical System

Indications for Use:

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

Regulation Number and Section

§ 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.