(43 days)
Not Found
No
The document describes image processing and 3D rendering software, but there is no mention of AI, ML, or related concepts like training or test sets for algorithmic development.
No.
The device is described as software for processing, viewing, and analyzing digital images to assist in clinical decision-making and pre-operative analysis, not for directly treating or curing a medical condition.
No
The device is intended for processing, review, analysis, communication, and media interchange of digital images and for pre-operative analysis of surgical options. It assists in clinical decision-making by enabling visualization and interaction with DICOM image data but does not directly provide a diagnosis; healthcare professionals are responsible for final patient management decisions.
Yes
The device is explicitly described as a "software application" and "software only" in the intended use and device description sections. While it requires performance-tested hardware, the device itself is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Device Function: The True 3D Viewer Software processes and visualizes medical images (CT, MRI, Ultrasound) acquired from the human body. It does not analyze biological specimens.
- Intended Use: The intended use is for processing, review, analysis, communication, and media interchange of digital images, and for pre-operative analysis of surgical options. This aligns with medical imaging software, not IVD.
- Input: The input is image data from imaging modalities, not biological specimens.
The device is clearly a medical imaging software intended to assist healthcare professionals in interpreting and utilizing medical images for diagnosis and treatment planning. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The True 3D Viewer Software is a software application that enables a Health Care Professional (HCP) to visualize and interact with DICOM image data, from CT, MRI and Ultrasound imaging modalities, to assist in clinical decision making.
The application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The True 3D Viewer Software application enables HCPs to visualize and interact with image data and depictions of tissue and organs in an open 3D space as if they were real physical objects. The objects that the software will display are 2D MPR images, 3D volumes, 3D surfaces, labels, and measurements. The system is intended for use in the clinic or hospital settings. Information on performance tested hardware that is provided by the user is described in product labeling.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI and Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals, clinic or hospital settings
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Every specification of the True 3D Viewer Software device has been validated according to the company's documented development and test procedures. The verification and validation testing included testing to the following applicable standard:
- PS 3.1 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set PS 3.1
- ISO 14971 -Standard for the Application of Risk Management to Medical Devices
- IEC/TR 80002-1:2009 -Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
- IEC 62304- Medical Device Software-Software Lifecycle Processes
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing fulfilling the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design.
Results of performance testing demonstrated that the device met the design requirements and as well as the user needs.
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
§ 892.2050 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
EchoPixel Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K170167
Trade/Device Name: True 3D Viewer Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 22, 2017 Received: February 23, 2017
Dear Mr. Job:
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 D'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) K170167
Device Name
True 3D Viewer Software
Indications for Use (Describe)
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
| 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
Prepared March 1, 2017
| Sponsor: | EchoPixel Inc.
2490 Hospital Dr.
Suite 310
Mountain View CA 94040 |
|--------------------------------------|----------------------------------------------------------------------------|
| Contact Person: | Sergio Aguirre |
| Telephone: | (650) 404 7097 |
| Fax: | (844) 273 7766 |
| Submission Date: | December 20, 2016 |
| Device Name: | True 3D Viewer Software |
| Common Name: | Imaging Software |
| Classification:
Regulatory Class: | II |
| Review Category: | System, image processing, radiological
21CFR892.2050 (LLZ) |
| Classification Panel: | Radiology |
A. Legally Marketed Predicate Devices
The modified True 3D Viewer Software is substantially equivalent to the True 3D Viewer cleared pursuant to K142107.
B. Device Description:
The True 3D Viewer Software is a software application that enables a Health Care Professional (HCP) to visualize and interact with DICOM image data, from CT, MRI and Ultrasound imaging modalities, to assist in clinical decision making.
The application loads DICOM image data and presents a stereoscopic 3D rendered view of the DICOM image data. The True 3D Viewer Software application enables HCPs to visualize and interact with image data and depictions of tissue and organs in an open 3D space as if they were real physical objects. The objects that the software will display are 2D MPR images, 3D volumes, 3D surfaces, labels, and measurements. The system is intended for use in the clinic or hospital settings. Information on performance tested hardware that is provided by the user is described in product labeling.
4
C. Intended Use
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
| | Predicate Device
EchoPixel True 3D Viewer
K142107 | Subject Device
EchoPixel True 3D Viewer Software
Modification |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Intended as a medical diagnostic
imaging system that allows the
processing, review, analysis,
communication and media interchange
of multi-dimensional digital images
acquired from CT or MR imaging
devices. It is also intended as pre-
operative software for simulating /
evaluating surgical treatment options.
The True 3D Viewer is designed for
use by health care professionals and is
intended to assist the clinician who is
responsible for making all final patient
management decisions | The True 3D Viewer Software is
intended for processing, review,
analysis, communication and media
interchange of digital images acquired
from CT, MRI and Ultrasound sources.
It is also intended as software for pre-
operative analysis of surgical options.
The True 3D Viewer Software is
designed for use only with performance
tested hardware specified in the user
documentation. The device is intended to
be used by health care professionals,
who are responsible for making all final
patient management decisions. |
| Intended
Users | Intended Users
Health Care Professionals | Intended Users
Health Care Professionals |
| Class II | Class II | Class II |
| Regulation /
Code | 21CFR 892.2050;
LLZ | 21CFR 892.2050;
LLZ |
| Image
analysis
features: | Image analysis features: interactive
manipulation, tag, annotate,
measure, segment | Image analysis features: interactive
manipulation, tag, annotate, measure,
segment |
| Components | Hardware and software | Software only |
| Hardware | Included in system | Provided by user |
| Display | Stereoscopic display part of
system;23.6 inch (Diagonal);
Resolution - 1980x1080 full HD
Aspect Ratio - 16:9; Contrast Ratio -
50:1 for 2D and 3D; Color - 16.7
million; Frame Rate - 120 Hz | Stereoscopic display;
Performance tested hardware is provided
by user |
| Stylus | Stylus part of system; Buttons - Three programmable buttons; Tracking: 6 degrees of freedom (DOF) sensor; Vibrate Function – Small DC vibrating motor:Infrared LED – 2 IR LED's, one at each edge | Stylus; Performance tested hardware is provided by user |
| 3D Glasses | 3D glasses are part of system; Circular Polarized passive eyewear with trackable markers | 3D glasses; Performance tested hardware is provided by user |
| Personal computer (PC) | PC part of system; Windows 7 or 10 (64bit) ; Four core 2.5 GHz or equivalent Zeon processor ; 8 GB of system memory (RAM); NVidia Quadro Graphics Processing Unit (GPU) with 4GB of video memory; Open-GL 1.4 support (or later) stereo compatible graphics with DVI-d and/or Display Port 500GB drive | PC Performance tested hardware is provided by user |
D. Substantial Equivalence
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Based on the above comparison there is both reduced capability stated in the indications for use as well as some additional capability and software enhancements. Based on the performance data provided in the submission these differences do not introduce new issues related to safety and efficacy.
Comparison Table 2 – Technological Characteristics
| Feature | Predicate Device
EchoPixel True 3D Viewer
K142107 | Subject Device
Echo Pixel Modified True
3D Viewer Software |
|--------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|
| Data Source | CT and MR DICOM Images | CT, MR and Ultrasound
DICOM Images |
| DICOM compliant | Yes | Yes |
| Display Images | Yes | Yes |
| 3D display mode | Yes | Yes |
| Select Images for closer
examination | Yes | Yes |
| Original 2D image
remains on the display
screen during other views | Yes | Yes |
| Human intervention for
interpretation of images | Yes | Yes |
| Multi-dimensional
visualization | Yes | Yes |
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| Interactively manipulate
images in real time to
| visualize anatomy | Yes | Yes |
|---|---|---|
| Visual Tracking | Yes | Yes |
| Provides the viewer the | ||
| ability to view spatially | ||
| registered 2D MPR | Yes | Yes |
| Interact with mages using | ||
| stylus control | Yes | Yes |
In summary based on the comparison of technology technological characteristics of the subject device compare to the predicate are substantially equivalent. Based on the performance data provided in the submission these differences do not introduce new issues related to safety and efficacy.
E. Performance Data
Every specification of the True 3D Viewer Software device has been validated according to the company's documented development and test procedures. The verification and validation testing included testing to the following applicable standard:
- · PS 3.1 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set PS 3.1
- · ISO 14971 -Standard for the Application of Risk Management to Medical Devices
- · IEC/TR 80002-1:2009 -Medical device software -- Part 1: Guidance on the application of ISO 14971 to medical device software
- · IEC 62304- Medical Device Software-Software Lifecycle Processes
Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing fulfilling the requirements of FDA "Guidance on Software Contained in Medical Devices". Potential risks were analyzed and satisfactorily mitigated in the device design.
F. Conclusion
The True 3D Viewer Software is substantially equivalent to the predicate device with regards to intended use and technological characteristics. Results of performance testing demonstrated that the device met the design requirements and as well as the user needs.