VentriPoint Medical System

K150628 · Ventripoint, Inc. · IYN · May 22, 2015 · Radiology

Device Facts

• Record ID: K150628
• Device Name: VentriPoint Medical System
• Applicant: Ventripoint, Inc.
• Product Code: IYN · Radiology
• Decision Date: May 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Software as a Medical 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.

Device Story

VMS is an adjunct to existing ultrasound systems; records 2D cardiac ultrasound sequences with transducer position tracking. User identifies anatomic landmarks; data transmitted via secure internet to VMS server. Server uses Knowledge Based Reconstruction (KBR) to assemble 3D right ventricle model. Results returned to VMS system for clinician review. Used in clinical settings to assist in RV volume and ejection fraction assessment. Benefits include non-invasive 3D cardiac analysis.

Clinical Evidence

No new clinical trials conducted. Substantial equivalence supported by prior clinical testing in PAH patients (K140153) comparing KBR-derived volumes to cardiac MRI, and robust bench testing of the new RV catalog to verify reconstruction accuracy.

Technological Characteristics

Windows-based analysis system; utilizes freehand scanning with pulsed DC 6DOF magnetic tracking. Integrates real-time video capture and external ECG trigger. Employs Knowledge Based Reconstruction (KBR) database for 3D assembly. Complies with UL 60601-1 and UL 60601-2. Connectivity via secure internet for server-side processing.

Indications for Use

Indicated for patients requiring right ventricle (RV) volume and ejection fraction evaluation. No specific age or gender restrictions stated.

Regulatory Classification

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.

Predicate Devices

• VentriPoint Medical System (K140153)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 101<br>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)

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| Parameters | VentriPoint Medical System | VentriPoint Medical System |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Expanded Use | K140153 |
| Indications for<br>Use | The VMS system is an adjunct to<br>existing ultrasound imaging systems and<br>is intended to record, analyze, store and<br>retrieve digital ultrasound images for<br>computerized 3-dimensional image<br>processing.<br>The VMS system is indicated for use<br>where RV volumes and ejection<br>fractions are warranted or desired. | The VMS system is an adjunct to<br>existing ultrasound imaging systems and<br>is intended to record, analyze, store and<br>retrieve digital ultrasound images for<br>computerized 3-dimensional image<br>processing. The VMS system is used to<br>record a sequence of conventional<br>cardiac 2-D ultrasound images with the<br>transducer position recorded for each<br>image acquired to compute right<br>ventricular volumes and ejection<br>fraction. Specific anatomic landmarks<br>identified by the product user are<br>transmitted by secure internet<br>connection to a VMS server where 3-D<br>assembly of the right ventricle in adult<br>patients with Pulmonary Arterial<br>Hypertension takes place using<br>Knowledge Based Reconstruction<br>(KBR). The results are then returned to<br>the VMS system for display and further<br>consideration or evaluation by the<br>product user. |
| Freehand<br>scanning device | Yes | Yes |
| RV volume<br>measurement | Yes | Yes |
| 3-D<br>Reconstruction | Knowledge Based Reconstruction<br>database | Knowledge Based Reconstruction<br>database |
| Software Based<br>Analysis Tool | Yes | Yes |
| UL 60601-1 | Yes | Yes |
| UL 60601-2 | Yes | Yes |
| Windows® OS<br>based analysis<br>system | Yes | Yes |
| Real-time Video<br>Capture card | Yes | Yes |
| External ECG<br>trigger | Yes | Yes |
| Pulsed DC 6DOF<br>magnetic tracking<br>system | 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)