True 3D Viewer Software

K170167 · Echopixel, Inc. · LLZ · Mar 3, 2017 · Radiology

Device Facts

• Record ID: K170167
• Device Name: True 3D Viewer Software
• Applicant: Echopixel, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 3, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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.

Device Story

Software application enabling health care professionals to visualize and interact with DICOM image data (CT, MRI, Ultrasound) in clinical or hospital settings. Loads DICOM data to present stereoscopic 3D rendered views; allows visualization of tissue and organs in open 3D space as physical objects. Displays 2D MPR images, 3D volumes, 3D surfaces, labels, and measurements. Operates on user-provided performance-tested hardware. Clinicians use output to assist in clinical decision-making and pre-operative analysis of surgical options. Final patient management decisions remain with the clinician.

Clinical Evidence

Bench testing only. Verification and validation testing performed per 21 CFR 820.30, including compliance with DICOM standards, ISO 14971, IEC/TR 80002-1, and IEC 62304. No clinical data presented.

Technological Characteristics

Software-only application; DICOM compliant; supports CT, MRI, and Ultrasound. Features include 3D rendering, stereoscopic display, 2D MPR, and interactive manipulation (tag, annotate, measure, segment). Operates on user-provided hardware meeting specified performance requirements. Software lifecycle processes follow IEC 62304.

Indications for Use

Indicated for health care professionals to process, review, analyze, and communicate digital images from CT, MRI, and Ultrasound sources for pre-operative surgical planning.

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

• True 3D Viewer (K142107)

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

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.

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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 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) | |
|-----------------------------------------------------------------------------------------------------|--|
| <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |

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#### 510(k) Summary

### Prepared March 1, 2017

| Sponsor: | EchoPixel Inc.<br>2490 Hospital Dr.<br>Suite 310<br>Mountain View CA 94040 |
|--------------------------------------|----------------------------------------------------------------------------|
| Contact Person: | Sergio Aguirre |
| Telephone: | [phone] |
| Fax: | [phone] |
| Submission Date: | December 20, 2016 |
| Device Name: | True 3D Viewer Software |
| Common Name: | Imaging Software |
| Classification:<br>Regulatory Class: | II |
| Review Category: | System, image processing, radiological<br>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.

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# 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<br>EchoPixel True 3D Viewer<br>K142107 | Subject Device<br>EchoPixel True 3D Viewer Software<br>Modification |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Intended as a medical diagnostic<br>imaging system that allows the<br>processing, review, analysis,<br>communication and media interchange<br>of multi-dimensional digital images<br>acquired from CT or MR imaging<br>devices. It is also intended as pre-<br>operative software for simulating /<br>evaluating surgical treatment options.<br>The True 3D Viewer is designed for<br>use by health care professionals and is<br>intended to assist the clinician who is<br>responsible for making all final patient<br>management decisions | The True 3D Viewer Software is<br>intended for processing, review,<br>analysis, communication and media<br>interchange of digital images acquired<br>from CT, MRI and Ultrasound sources.<br>It is also intended as software for pre-<br>operative analysis of surgical options.<br>The True 3D Viewer Software is<br>designed for use only with performance<br>tested hardware specified in the user<br>documentation. The device is intended to<br>be used by health care professionals,<br>who are responsible for making all final<br>patient management decisions. |
| Intended<br>Users | Intended Users<br>Health Care Professionals | Intended Users<br>Health Care Professionals |
| Class II | Class II | Class II |
| Regulation /<br>Code | 21CFR 892.2050;<br>LLZ | 21CFR 892.2050;<br>LLZ |
| Image<br>analysis<br>features: | Image analysis features: interactive<br>manipulation, tag, annotate,<br>measure, segment | Image analysis features: interactive<br>manipulation, tag, annotate, measure,<br>segment |
| Components | Hardware and software | Software only |
| Hardware | Included in system | Provided by user |
| Display | Stereoscopic display part of<br>system;23.6 inch (Diagonal);<br>Resolution - 1980x1080 full HD<br>Aspect Ratio - 16:9; Contrast Ratio -<br>50:1 for 2D and 3D; Color - 16.7<br>million; Frame Rate - 120 Hz | Stereoscopic display;<br>Performance tested hardware is provided<br>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<br>EchoPixel True 3D Viewer<br>K142107 | Subject Device<br>Echo Pixel Modified True<br>3D Viewer Software |
|--------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|
| Data Source | CT and MR DICOM Images | CT, MR and Ultrasound<br>DICOM Images |
| DICOM compliant | Yes | Yes |
| Display Images | Yes | Yes |
| 3D display mode | Yes | Yes |
| Select Images for closer<br>examination | Yes | Yes |
| Original 2D image<br>remains on the display<br>screen during other views | Yes | Yes |
| Human intervention for<br>interpretation of images | Yes | Yes |
| Multi-dimensional<br>visualization | Yes | Yes |

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| Interactively manipulate<br>images in real time to<br>visualize anatomy | Yes | Yes |
|---------------------------------------------------------------------------|-----|-----|
| Visual Tracking | Yes | Yes |
| Provides the viewer the<br>ability to view spatially<br>registered 2D MPR | Yes | Yes |
| Interact with mages using<br>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.