WebPAX

K152949 · Heart Imaging Technologies, LLC · LLZ · Aug 17, 2016 · Radiology

Device Facts

• Record ID: K152949
• Device Name: WebPAX
• Applicant: Heart Imaging Technologies, LLC
• Product Code: LLZ · Radiology
• Decision Date: Aug 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations. Due to special customer requirements based on the imaging modality and clinical focus, WebPAX can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use. Not intended for diagnostic use on mobile devices.

Device Story

WebPAX is a software-only PACS solution; server-side software installed on customer-supplied hardware/virtual machines; client-side accessed via standard web browsers (Chrome, Internet Explorer). Inputs: DICOM-compliant medical images. Processing: server manages/stores images; client-side modules perform image visualization, optimization, and post-processing (e.g., multi-planar reconstruction via WebGL, echocardiography/cardiovascular MRI measurements). Outputs: processed diagnostic images and quantitative measurements (volumes, mass, velocity, time-intensity curves). Used in clinical settings by physicians/technicians to assist in diagnosis and treatment planning. Benefits: provides comprehensive tools for image evaluation and post-processing across various modalities.

Clinical Evidence

Bench testing only. Software verification confirmed requirements met on Chrome and IE11. Software validation of image analysis (basic, echo, cardiovascular MR measurements) showed >98% accuracy compared to predicate measurements on identical DICOM datasets. Reader study (n=3 board-certified physicians) evaluated 3D post-processing using six clinical datasets; performance was comparable to predicate Siemens Leonardo workstation, with all scores rated 1 (Excellent) or 2 (Very good).

Technological Characteristics

Software-only PACS; server-client architecture. Connectivity: TCP/IP, DICOM standard (SCP/SCU). Visualization: WebGL-based 3D post-processing (MPR). Measurements: ROI-based area, grayscale, distance, angle, velocity, and time-intensity curve analysis. Platform: customer-supplied server/virtual machine; web browser client. Software: WebPAX 9.3.

Indications for Use

Indicated for physicians and healthcare professionals to view, optimize, and post-process diagnostic medical images for evaluation, diagnosis, or treatment planning. Not for primary interpretation of lossy compressed mammographic or digitized film screen images. Not for diagnostic use on mobile devices.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• LEONARDO syngo Cardiology Workstation (K042203)
• WebPAX (K051325)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

Auqust 17, 2016

Heart Imaging Technologies, LLC % Robert M. Judd, Ph.D. President 5003 Southpark Drive, Suite 140 DURHAM NC 27713

Re: K152949 Trade/Device Name: WebPAX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 27, 2016 Received: August 1, 2016

Dear Dr. Judd:

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.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152949

Device Name WebPAX

#### Indications for Use (Describe)

WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.

Due to special customer requirements based on the imaging modality and clinical focus, WebPAX can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use.

Not intended for diagnostic use on mobile devices.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> |
|----------------------------------------------|-------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> |

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# 510(k) Summary - K152949

## Identification of Submitter

| Address: | Heart Imaging Technologies, LLC<br>5003 Southpark Drive, Suite 140<br>Durham, NC 27701 |
|--------------------------|----------------------------------------------------------------------------------------|
| Registration Number: | 3005107869 |
| Contact Person: | Robert M. Judd, Ph.D.<br>President<br>Telephone: [phone]<br>FAX: [phone] |
| Date of Preparation: | July 29, 2016 |
| Identification of Device | |
| Trade Name: | WebPAX |
| Common Name: | Picture archiving and communications system |
| Regulation Number: | 892.2050 |
| Device Class: | II |

LLZ

#### Predicate Devices

Product Code:

### PREDICATE DEVICE 1:

| Manufacturer: | Siemens Medical Solutions, Inc. |
|--------------------|----------------------------------------------------|
| Trade Name: | LEONARDO syngo Cardiology Workstation |
| Common Name: | Picture archiving and communications system (PACS) |
| Regulation Number: | 892.2050 |
| Device Class: | II |
| Product Code: | LLZ |
| 510k Number: | K042203 |

#### PREDICATE DEVICE 2:

| Manufacturer: | Heart Imaging Technologies, LLC |
|--------------------|----------------------------------------------------|
| Trade Name: | WebPAX |
| Common Name: | Picture archiving and communications system (PACS) |
| Regulation Number: | 892.2050 |
| Device Class: | II |
| Product Code: | LLZ |
| 510k Number: | K051325 |

## Description of Device

WebPAX consists of a server, typically located in a hospital data center, and one or more client systems used by technicians and physicians. On the server side, WebPAX is a software-only solution that is installed on customer-supplied hardware, such as dedicated computer server or virtual machine. The server-side software communicates with other DICOM-compliant systems and with end-users via

(PACS)

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standard Intranet and/or Internet mechanisms. On the client side, technicians and physicians access the WebPAX server using standard Internet web browsers, such as Google Chrome and Internet explorer.

WebPAX provides users with the ability to manage, store, and interpret digital medical images, including the following application specific modules:

- . Echocardiography Workstation
- Cardiovascular MRI Workstation
- 3D Post Processing (Multi-Planar Reconstruction)

# Indications for Use

WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.

Due to special customer requirements based on the imaging modality and clinical focus, WebPAX can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use.

Not intended for diagnostic use on mobile devices.

# Performance Testing

The following test reports have been provided in support of substantial equivalence:

- 1. Software Verification Report
The purpose of this report is to demonstrate that the WebPAX software meets all of the requirements described in the Software Requirement Specification. Testing was conducted with clients running on the two supported web browsers: Google Chrome and Microsoft Internet Explorer 11. All tests passed.

- 2. Software Validation Report
The purpose of this report was to validate the performance of the following WebPAX image analysis functionalities: Basic measurements, Echocardiography measurements, and Cardiovascular MR measurements. Testing was conducted with clients running on the two supported web browsers: Google Chrome and Microsoft Internet Explorer 11. [Note: Some functionalities are only available with the Google Chrome browser, and thus were only tested with that browser].

For all Software Validation tests for which the Predicate Device offered the same functionality, the "WebPAX Measurement Accuracy" was assessed by direct comparison to measurements made using the Predicate Device on the exact same DICOM dataset, image,

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and location(s) within the image. In all cases WebPAX met the Acceptance Criteria that accuracy be greater than 98%.

- 3. Reader Study Report
The purpose of the Reader Study was to demonstrate that the 3D post processing capability of WebPAX 9.3 is equivalent to that of the predicate Siemens Leonardo Workstation (K042203). Three board-certified physicians who routinely read cardiovascular MRI studies were asked to evaluate six DICOM datasets that represent typical clinical scenarios. All scores for WebPAX were at least a 1 (Excellent) or a 2 (Very good). The performance of WebPAX was comparable to that of the predicate Siemens device.

# Substantial Equivalence Discussion

The following table compares WebPAX to the predicate device:

| FEATURE | WebPAX | Predicate<br>Device<br>(Siemens<br>Leonardo<br>K042203) | Comments |
|-------------------------------------|--------|---------------------------------------------------------|----------------------------------|
| Basic PACS Functions | | | |
| TCP/IP network connectivity | Yes | Yes | DICOM standard |
| DICOM storage class provider (SCP) | Yes | Yes | DICOM standard |
| DICOM storage class user (SCU) | Yes | Yes | DICOM standard |
| Digital image storage | Yes | Yes | DICOM standard |
| Image visualization | Yes | Yes | DICOM standard |
| Generic Tools | | | |
| Distance Measurements | Yes | Yes | DICOM standard |
| ROI Area Measurements | Yes | Yes | DICOM standard |
| ROI Grayscale Measurements | Yes | Yes | DICOM standard |
| Angle Measurements | Yes | Yes | Basic Geometry |
| Specialty Tools: Echocardiography | | | |
| Doppler Velocity | Yes | No | DICOM standard |
| Deceleration Time | Yes | No | DICOM standard |
| Velocity-Time Integral | Yes | No | DICOM standard |
| Stress Echo Display | Yes | No | DICOM standard |
| Specialty Tools: Cardiovascular MRI | | | |
| Volumes/Mass | Yes | Yes | ROI Area times Slice Thickness |
| Hyperintensity | Yes | Yes | ROI Area times Slice Thickness |
| Velocity Encoding | Yes | Yes | ROI Grayscale times Scale Factor |
| Time-Intensity Curves | Yes | Yes | ROI Grayscale versus time |
| T2 and T2* Decay | Yes | No | ROI Grayscale versus time |
| T1 Recovery | Yes | No | ROI Grayscale versus time |
| 3D Post Processing | | | |
| Multi-Planar Reconstruction | Yes | Yes | For WebPAX, based on WebGL |

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Both the WebPAX and Siemens Leonardo devices provide generic PACS functionalities with common measurement tools and basic image processing.

Both devices also provide specialty tools for Cardiovascular MRI that allow assessment of cardiac volumes, masses, blood flow velocities, and time-intensity curves. The performance of these functions for both devices were directly compared. WebPAX also provides users with the ability to fit a monoexponential curve to MRI T2(*) and/or T1 grayscale data based on well-established techniques. WebPAX additionally provides specialty tools for Echocardiography. Although the Siemens Leonardo does not provide Echocardiography functions, all of these are an integral part of the DICOM standard itself and testing demonstrated that performance met established acceptance criteria.

Both devices provide multi-planar reconstruction (MPR) techniques that allow the user to re-slice 3D data into directions other than the original imaging planes. The underlying technology used by WebPAX to achieve this, namely WebGL, is different than that used by the Siemens Leonardo, but a reader study demonstrated equivalent performance.

# Summary of Substantial Equivalence

No significant differences were detected when comparing measurements and post-processing results made using the candidate WebPAX system with those of the predicate devices. We conclude that the WebPAX system is substantially equivalent.