(316 days)
Not Found
No
The summary describes standard medical image viewing, storage, and post-processing functionalities like MPR. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is intended to aid in diagnosis or treatment planning, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section states that WebPAX is intended 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" and can be configured with applications "which are intended to assist the physician in diagnosis or treatment planning."
Yes
The device description explicitly states that the server-side component of WebPAX is a "software-only solution that is installed on customer-supplied hardware." While it interacts with client systems (web browsers), the core medical device functionality resides in the server software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that WebPAX is for the communication, storage, viewing, optimization, and post-processing of medical images as an aid to physicians in the evaluation of digital imaging examinations. This focuses on the analysis of images generated from the body, not on testing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a software solution for managing and interpreting digital medical images, including specific modules for echocardiography and cardiovascular MRI. This aligns with image analysis, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. WebPAX's function is centered around the interpretation and manipulation of medical images, which falls under the category of medical imaging software or picture archiving and communication systems (PACS).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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 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)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technicians and physicians / hospital data center
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
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, and location(s) within the image. In all cases WebPAX met the Acceptance Criteria that accuracy be greater than 98%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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, and location(s) within the image. In all cases WebPAX met the Acceptance Criteria that accuracy be greater than 98%.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"WebPAX Measurement Accuracy" was greater than 98%.
Reader Study scores for WebPAX were at least a 1 (Excellent) or a 2 (Very good).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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.
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.
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
2
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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K152949
Identification of Submitter
| Address: | Heart Imaging Technologies, LLC
5003 Southpark Drive, Suite 140
Durham, NC 27701 |
|--------------------------|----------------------------------------------------------------------------------------|
| Registration Number: | 3005107869 |
| Contact Person: | Robert M. Judd, Ph.D.
President
Telephone: 919-384-5044
FAX: 866-457-3694 |
| 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)
4
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:
-
- 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.
- Software Verification Report
-
- 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].
- Software Validation Report
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,
5
and location(s) within the image. In all cases WebPAX met the Acceptance Criteria that accuracy be greater than 98%.
-
- 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.
- Reader Study Report
Substantial Equivalence Discussion
The following table compares WebPAX to the predicate device:
| FEATURE | WebPAX | Predicate
Device
(Siemens
Leonardo
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.