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.

Device Description

The VentriPoint Medical System was cleared under 510(k) K140153 for use in adult patients with Pulmonary Arterial Hypertension. This current submission is intended to expand system use to right ventricle evaluation where RV volumes and ejection fractions are warranted or desired in patients other than those diagnosed with PAH. Right ventricle evaluation is accomplished by the addition of a KBR heart catalog containing a variety of heart models that are not specific to PAH. All other system operational characteristics remain unchanged from the cleared device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the submission as an expansion of use for the VentriPoint Medical System (VMS) to include a new "RV catalog" for evaluating right ventricle volumes and ejection fractions in patients beyond those diagnosed with Pulmonary Arterial Hypertension (PAH). The primary claim is substantial equivalence to the previously cleared device (K140153).

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum accuracy percentages, specific Bland-Altman limits of agreement) for the expanded use. Instead, it relies on the comparison to the existing predicate device and the rigor of the nonclinical testing for the new RV catalog.

However, we can infer the guiding principle for acceptance:

Acceptance Criteria (Inferred)	Reported Device Performance
Premarket Notification K140153 (Predicate Device cleared for PAH patients): Substantial equivalence to Cardiac MRI for RV volumes and ejection fractions for PAH patients.	K140153 (Predicate): Demonstrated substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI in adult PAH patients. The document implies this performance was previously achieved and accepted.
Expanded Use (K150628 - All patients, not just PAH): Suitability for right ventricle evaluation (RV volumes and ejection fractions) in patients other than those diagnosed with PAH.	K150628 (New RV Catalog): "Performance bench testing of the RV catalog was completed to verify suitability for right ventricle evaluation where RV volumes and ejection fractions are warranted or desired in patients other than those diagnosed with PAH." Testing involved "a robust series of automated and manual testing to verify reconstruction accuracy." The document concludes: "Accuracy of the RV catalog was assessed through rigorous bench testing and has been cleared for use in Canada and Europe since April 2013." The device is deemed "substantially equivalent to the predicate device" and introduces "no new questions concerning safety or effectiveness."
New Safety or Effectiveness Concerns: The expanded use should not introduce new questions concerning safety or effectiveness.	"The RV catalog introduces no new questions concerning safety or effectiveness and is therefore substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set for K150628 (Expanded Use): The document states, "Performance bench testing of the RV catalog was completed..." and "Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy."
- Sample Size: The specific number of cases or data points used in this "robust series of automated and manual testing" for the RV catalog is not specified in the provided text.
- Data Provenance: This was nonclinical bench testing, meaning it likely involved simulated data, phantoms, or possibly previously acquired anonymized patient data used in a controlled laboratory setting. The document does not specify country of origin for this bench testing data. It is neither prospective nor retrospective clinical data.
Test Set for K140153 (Predicate Device Clinical Testing):
- Sample Size: The document refers to "Prior clinical testing was completed in adult Pulmonary Arterial Hypertension (PAH) patients which was the basis for pre-market notification K140153." The specific sample size for this clinical testing is not provided in this document.
- Data Provenance: This was "clinical testing" in "adult Pulmonary Arterial Hypertension (PAH) patients." The country of origin is not specified, and it would have been prospective or retrospective clinical data related to PAH patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

For K150628 (Bench Testing for New RV Catalog): The document mentions "automated and manual testing to verify reconstruction accuracy." It does not explicitly state the involvement of human experts for establishing ground truth during this specific bench testing. If manual verification was performed, it would imply human review, but the number and qualifications are not specified.
For K140153 (Clinical Testing for Predicate Device): The ground truth for the predicate device's clinical testing was "volumes derived from cardiac MRI." While cardiac MRI interpretation requires expert radiologists/cardiologists, the document does not specify the number of experts or their qualifications used to establish these MRI-derived ground truth values.

4. Adjudication Method:

For K150628 (Bench Testing for New RV Catalog): The document describes "robust series of automated and manual testing." An explicit adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in manual testing, if any, is not specified.
For K140153 (Clinical Testing for Predicate Device): Not specified.

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

No, a MRMC comparative effectiveness study was not explicitly mentioned or described for either the current submission (K150628) or the predicate (K140153) in the provided text.
- The K140153 clearance "demonstrated the substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI." This suggests a comparison of the algorithm's performance to a gold standard, rather than a study comparing human readers with and without AI assistance.
- For K150628, the justification for not conducting additional human clinical trials was that the RV catalog development was similar to the PAH catalog and that extensive bench testing was performed.

6. Standalone ("Algorithm Only") Performance Study:

Yes, standalone performance was implicitly studied.
- "Performance bench testing of the RV catalog was completed to verify suitability for right ventricle evaluation..." and "Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy." This describes evaluating the algorithm's output directly against some form of ground truth or benchmark during bench testing.
- Similarly, the K140153 clearance involving "substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI" represents a standalone performance evaluation of the algorithm against a clinical gold standard. The device's description clarifies it's "computerized 3-dimensional image processing" and uses "Knowledge Based Reconstruction (KBR)" via a server, indicating an algorithmic analysis.

7. Type of Ground Truth Used:

For K150628 (New RV Catalog Bench Testing): The ground truth for the bench testing was derived from methods used to "verify reconstruction accuracy" through "automated and manual testing." The exact nature (e.g., synthetic phantoms with known volumes, highly curated images with expert annotations) is not detailed, but it's related to the "Knowledge Based Reconstruction database."
For K140153 (Predicate Device Clinical Testing): The ground truth was volumes derived from cardiac MRI. Cardiac MRI is generally considered a gold standard for cardiac chamber volume measurements.

8. Sample Size for the Training Set:

The document mentions "Development of the RV catalog was conducted according to VentriPoint established procedures in the same way as the PAH catalog that was cleared as part of K140153." and refers to a "KBR heart catalog containing a variety of heart models."
The specific sample size of data used to train or develop the "KBR heart catalog" or "RV catalog" is not provided in the document.

9. How Ground Truth for Training Set Was Established:

The document mentions "Knowledge Based Reconstruction (KBR)" and the "KBR heart catalog." The KBR system fundamentally relies on a database of heart models. How these initial heart models and their associated ground truth (e.g., precise anatomical measurements, volumes) were established for the training/development of the original KBR system and the new RV catalog is not detailed in this summary. It would likely involve meticulously characterized anatomical data, potentially from diverse sources (e.g., cadaveric studies, high-resolution imaging modalities with expert segmentation).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 22, 2015

VentriPoint, Inc. % Mr. Jim Bodtke V.P. of Clinical Affairs and Development 1805 136th Place NE, Suite 101 BELLEVUE WA 98005

Re: K150628

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: March 9, 2015 Received: March 11, 2015

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Robert A Och

Robert Ochs. Ph.D. Acting 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): _ K150628

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 indicated for use where RV volumes and ejection fractions are warranted or desired.

Prescription Use (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)

Page __ of ___________________________________________________________________________________________________________________________________________________________________

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510(k) Summary or 510(k) Statement

510(k) Summarv 807.92(c)

SPONSOR

Section 5

807.92(a)(1)

Company Name:	VentriPoint, Inc.
Company Address	1805 136th Place NE, Suite 101Bellevue, WA 98005
Telephone:	206-283-0221
Fax:	425-747-4163
Contact Person:	Jim Bodtke

Summary Preparation Date: 9 March, 2015

DEVICE NAME

Trade Name:	VentriPoint Medical System IS-1
Common/Usual Name:	Diagnostic Ultrasound Image Analysis System
Classification Name:	Ultrasonic Pulsed Doppler Imaging System

PREDICATE DEVICE

Legally Marketed Equivalent Device
510(k) #	Product	Company
K140153	VentriPoint Medical System	VentriPoint, Inc

DEVICE DESCRIPTION

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 indicated for use where RV volumes and ejection fractions are warranted or desired.

807.92(a)(4)

807.92(a)(5)

807.92(a)(2)

807.92(a)(3)

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Parameters	VentriPoint Medical System	VentriPoint Medical System
510(k) Number	Expanded Use	K140153
Indications forUse	The VMS system is an adjunct toexisting ultrasound imaging systems andis intended to record, analyze, store andretrieve digital ultrasound images forcomputerized 3-dimensional imageprocessing.The VMS system is indicated for usewhere RV volumes and ejectionfractions are warranted or desired.	The VMS system is an adjunct toexisting ultrasound imaging systems andis intended to record, analyze, store andretrieve digital ultrasound images forcomputerized 3-dimensional imageprocessing. The VMS system is used torecord a sequence of conventionalcardiac 2-D ultrasound images with thetransducer position recorded for eachimage acquired to compute rightventricular volumes and ejectionfraction. Specific anatomic landmarksidentified by the product user aretransmitted by secure internetconnection to a VMS server where 3-Dassembly of the right ventricle in adultpatients with Pulmonary ArterialHypertension takes place usingKnowledge Based Reconstruction(KBR). The results are then returned tothe VMS system for display and furtherconsideration or evaluation by theproduct user.
Freehandscanning device	Yes	Yes
RV volumemeasurement	Yes	Yes
3-DReconstruction	Knowledge Based Reconstructiondatabase	Knowledge Based Reconstructiondatabase
Software BasedAnalysis Tool	Yes	Yes
UL 60601-1	Yes	Yes
UL 60601-2	Yes	Yes
Windows® OSbased analysissystem	Yes	Yes
Real-time VideoCapture card	Yes	Yes
External ECGtrigger	Yes	Yes
Pulsed DC 6DOFmagnetic trackingsystem	Yes	Yes

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

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NONCLINICAL TESTING

Performance bench testing of the RV catalog was completed to verify suitability for right ventricle evaluation where RV volumes and ejection fractions are warranted or desired in patients other than those diagnosed with PAH.

Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy.

CLINICAL TESTING

Prior clinical testing was completed in adult Pulmonary Arterial Hypertension (PAH) patients which was the basis for pre-market notification K140153. This clearance demonstrated the substantial equivalence of VentriPoint Knowledge Based Reconstruction (KBR) with volumes derived from cardiac MRI.

Development of the RV catalog was conducted according to VentriPoint established procedures in the same way as the PAH catalog that was cleared as part of K140153. Therefore additional human clinical trials were not warranted.

CONCLUSION

807.92(b)(3)

Device Similarities

The proposed expanded use of the VMS system is substantially equivalent to the predicate device. K140153. with the addition of a RV catalog that allows evaluation of RV volumes and ejection fractions in patients other than those diagnosed with PAH. All operational characteristics of the VMS system remain unchanged from the cleared device.

Safety and Effectiveness

The VMS system is a non-invasive, non-sigmificant risk technology. No adverse events were reported during previous clinical trials. Accuracy of the RV catalog was assessed through rigorous bench testing and has been cleared for use in Canada and Europe since April 2013. The RV catalog introduces no new questions concerning safety or effectiveness and is therefore substantially equivalent to the predicate device.

807.92(b)(1)

807.92(b)(2)

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.