(72 days)
No
The document describes "computerized 3-dimensional image processing" and "Knowledge Based Reconstruction (KBR)" using a "heart catalog" and "heart models," but it does not explicitly mention AI, ML, deep learning, or any related terms. The description of the technology aligns more with traditional image processing and model-based reconstruction techniques rather than AI/ML.
No
The device is intended to record, analyze, store, and retrieve digital ultrasound images for computerized 3-dimensional image processing, and for right ventricle evaluation to determine RV volumes and ejection fractions. It does not provide any form of therapy.
No
The VMS system is described as an "adjunct to existing ultrasound imaging systems" intended to "record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing" to evaluate RV volumes and ejection fractions. It provides measurements and analysis based on images, rather than directly diagnosing a disease or condition. While the information it provides can be used in a diagnostic process, the device itself performs image processing and measurement, functioning more as a measurement and image analysis tool.
No
The device description refers to the "VentriPoint Medical System" and mentions it is an "adjunct to existing ultrasound imaging systems," implying it is a system that includes hardware components beyond just software. The submission is for an expansion of use for an already cleared system (K140153), which is described as a "system," not solely software.
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 system processes digital ultrasound images of the right ventricle. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use is to record, analyze, store, and retrieve ultrasound images for 3D processing and to evaluate RV volumes and ejection fractions. This is an imaging-based analysis, not a diagnostic test performed on a biological sample.
Therefore, the VMS system falls under the category of medical imaging devices, not in vitro diagnostics.
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 indicated for use where RV volumes and ejection fractions are warranted or desired.
Product codes
IYN
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasound
Anatomical Site
Right Ventricle (RV)
Indicated Patient Age Range
Adult
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
Testing of the RV catalog consisted of a robust series of automated and manual testing to verify reconstruction accuracy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
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.
1
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
2
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 ___________________________________________________________________________________________________________________________________________________________________
3
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 101 |
| Bellevue, 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
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.
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)
4
| Parameters | VentriPoint Medical System | VentriPoint Medical System |
|---|---|---|
| 510(k) Number | Expanded Use | K140153 |
| 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 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. | ||
| Freehand | ||
| scanning device | Yes | Yes |
| 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 |
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
5
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)