Artemis

K162474 · Eigen · LLZ · Oct 21, 2016 · Radiology

Device Facts

• Record ID: K162474
• Device Name: Artemis
• Applicant: Eigen
• Product Code: LLZ · Radiology
• Decision Date: Oct 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management. Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.

Device Story

Artemis is a medical image processing workstation for prostate procedures. It inputs live 2D ultrasound video from standard ultrasound machines and imports DICOM data from other modalities (MRI, CT). A mechanical semi-robotic arm with encoders tracks the ultrasound probe position and orientation. The system reconstructs 3D ultrasound models, performs multi-planar reconstruction, and registers 3D images with imported modalities. It displays a virtual grid and a simulated trajectory of tracked interventional tools (biopsy needles, probes) on a monitor, accounting for patient movement. Used by physicians in clinical settings for treatment planning and guidance. Output includes 3D visualizations, navigation guidance, and automated reports. Benefits include improved accuracy for prostate biopsies and longitudinal tracking for active surveillance patients.

Clinical Evidence

Bench testing only. Verification and validation testing evaluated all input/output functions and operational modes. Measurement validation was performed using phantoms, clinical CT, and MRI images to demonstrate performance equivalent to or better than predicate devices. Compliance with electrical safety and electromagnetic compatibility standards (IEC/EN 60601-1-2, etc.) was confirmed.

Technological Characteristics

PC-based workstation with video digitizing card. Mechanical assembly with encoders for probe tracking. Supports transrectal and transperineal access. Connectivity via DICOM import/export. Software features include 3D reconstruction, rigid/elastic registration, segmentation, and multi-planar reformation. Complies with IEC/EN 60601-1-2 (EMC), IEC 62366 (Usability), and ISO 14971 (Risk Management).

Indications for Use

Indicated for image-guided interventional and diagnostic procedures of the prostate gland, including soft tissue biopsies, ablations, and fiducial marker placement. Used for patients in active surveillance to track procedure history and outcomes. Intended for clinical settings.

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

• 3-D Imaging Workstation (K081093)
• UroNav (Version 2.0) (K153073)

Reference Devices

• 3D-Imaging Workstation (K121498)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

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

October 21, 2016

Eigen % Mr. William Mandel Director Of Operations, Regulatory Affairs and Quality Assurance 13366 Grass Valley Avenue GRASS VALLEY CA 95945

Re: K162474 Trade/Device Name: Artemis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 11, 2016 Received: September 6, 2016

Dear Mr. Mandel:

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 [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 Oclo

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) K162474

Device Name Artemis

## Indications for Use (Describe)

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management.

Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diaical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers. Artemis is also intents in active surveillance to keep track of previous procedures information and outcomes.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 5px;">☑</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-left: 20px; padding-right: 5px;">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the text "leading innovation in medical imaging". The text is written in a sans-serif font and is gray. The text is stacked on top of each other.

Image /page/3/Picture/1 description: The image shows the word "eigen" in a sans-serif font. The word is white and is set against a teal background. The letters are lowercase and evenly spaced.

# 510(k) Summary

| Submitter's Name: | Eigen |
|----------------------------|-----------------------------------------------------------------------------------------------------|
| Submitter's Address: | 13366 Grass Valley Avenue, Grass Valley, CA 95945 |
| Submitter's Telephone: | 530-274-1240 |
| Submitter's Fax: | 530-274-3536 |
| Contact Name: | William Mandel |
| Date Summary was Prepared: | Aug 11, 2016 |
| Trade or Proprietary Name: | Artemis |
| Common or Usual Name: | Medical Image Processing Workstation |
| Classification Name: | System, Image Processing, Radiological, LLZ<br>Picture Archiving and Communications, 21CFR 892.2050 |

Predicate Devices:

| Device Name | 510(k) Number |
|-------------------------|---------------|
| 3-D Imaging Workstation | K081093 |
| UroNav (Version 2.0) | K153073 |

The design, function, and specifications of Artemis are similar to the identified legally marketed predicate devices. Similar to the devices from Eigen, LLC (K081093), Invivo UroNav (K153073), Artemis provides image-guided interventional planning and navigation for prostate procedures, the ability to view and capture live 2D ultrasound data to create reconstructed 3D ultrasound images/models and the ability to fuse and register these images with those acquired and imported from other modalities like Magnetic Resonance Imaging, X-ray Computed Tomography, and Ultrasound. Similar to all of the above listed predicate devices, Artemis also performs other viewing and image-processing functions such as image registration, multi-planar reformats and includes tools to segment, measure and annotate images. Each of the devices can import data from other DICOM based imaging devices and also output selected image views, processed data and user-defined reports.

The main difference between Artemis and the UroNav (K153073) device is the method used for procedure navigation and tracking.

The UroNav system utilizes an Electromagnetic Measurement System (EMMS) for procedure navigation and tracking while Artemis utilizes a mechanical semi-robotic arm with encoders to

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the phrase "leading innovation in medical imaging". The text is written in a simple, sans-serif font and is evenly spaced. The color of the text is a light gray, which gives it a subtle and understated appearance.

Image /page/4/Picture/1 description: The image shows the word "eigen" in a sans-serif font. The word is light blue and is set against a teal background. The letters are evenly spaced and the word is horizontally oriented.

determine the location of the ultrasound probe.

This difference in navigation and tracking technique does not significantly affect the use of the device, nor does it raise new or additional safety risks. This difference between Artemis and UroNav devices does not impact device safety or effectiveness.

Artemis and 3D-Imaging Workstation (K121498) utilize the identical navigation and tracking mechanism.

Artemis and 3D-Imaging Workstation (K121498) also share common software source code for basic system functionality such as multi-modality image viewing, segmentation, registration, navigation, annotation, reporting and DICOM functionality.

## Description of the Device and Summary of the Technological Characteristics

Artemis is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, TRUS probe, commercially available needle guide, and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement, reporting and 3-D image registration.

Artemis is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate.

The reconstructed 3-D image can be further processed to perform various

{5}------------------------------------------------

leading innovation in medical imaqing

Image /page/5/Picture/1 description: The image shows the word "eigen" in a sans-serif font. The text is light blue and is set against a darker blue background. The word is written in lowercase letters.

measurements including volume estimation, and can be examined for abnormalities by the physician. Patient information, notes, and images may be stored for future retrieval. Locations for biopsies may be selected by the physician, displayed on the 3-D image and 3-D rendered surface model, and stored. Previously stored 3-D models may be recalled and a stored 3-D model may be aligned or registered to the current 3-D model of the prostate. This is especially useful for patients under active surveillance.

The physician may attach a commercially available biopsy needle guide compatible to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of Artemis during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe with respect to the organ is tracked. Artemis is able to add, display and edit loaded plans for biopsy as well as provide the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.

In addition to standard transrectal needle guidance procedures, Artemis also supports transperineal needle guidance by mounting a Needle Guide Attachment (NGA). A commercially available needle guide compatible with the NGA is used. The NGA provides additional data to track the needle direction angle. When using transperineal mode, the procedure planning, segmentation, registration and navigation are performed in the same way as the standard transrectal procedure. The only difference lies in how the needs to be moved to target the different planned locations. For the transrectal procedure, the needle guide is always attached to the probe. Therefore moving the probe moves the needle guide. In transperineal needle guidance procedures the needle is not attached to the probe. Therefore the NGA needs to be moved to move the needle guide. Artemis highlights the closed target to the current needle guide position.

Artemis offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains the text "leading innovation in medical imaging". The text is arranged in two lines, with "leading innovation" on the first line and "in medical imaging" on the second line. The text is in a sans-serif font and is gray in color. The background is white.

Image /page/6/Picture/1 description: The image shows the word "eigen" in a sans-serif font. The word is white and is set against a teal background. The letters are lowercase and the dot on the "i" is a circle.

the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure. The device also provides automated reports with information and pictures from the procedure.

# Intended Use

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management.

Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue biopsies, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the text "leading innovation in medical imaging". The text is written in a simple, sans-serif font and is arranged in two lines. The color of the text is a light gray, which gives it a subtle and understated appearance.

Image /page/7/Picture/1 description: The image shows the word "eigen" in a sans-serif font. The letters are a light blue color, and the background is a darker teal color. The word is written in lowercase letters.

# Substantial Equivalence

Following is a comparison of technological characteristics between Artemis and predicate devices:

| Product | Submitted Device<br>Eigen<br>Artemis | Predicate Device:<br>Eigen, LLC 3-D Imaging<br>Workstation K081093 | Predicate Device: Invivo<br>UroNav (Version 2.0)<br>K153073 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Artemis along with the Needle Guide<br>Attachment is used for image-guided<br>interventional and diagnostic procedures<br>of the prostate gland. It provides 2D and<br>3D visualization of Ultrasound (US) images<br>and the ability to fuse and register these<br>images with those from other imaging<br>modalities such as Ultrasound, Magnetic<br>Resonance, Computed Tomography, etc. It<br>also provides the ability to display a<br>simulated image of a tracked insertion<br>tool such as a biopsy needle, guidewire or<br>probe on a computer monitor screen that<br>shows images of the target organ and the<br>current and the projected future path of<br>the interventional instrument taking into<br>account patient movement. The software<br>also provides a virtual grid on the live<br>ultrasound for performing systematic<br>sampling of the target organ. Other<br>software features include patient data<br>management, multi-planar reconstruction,<br>segmentation, image measurements,<br>2D/3D image registration, reporting, and<br>pathology management.<br>Artemis is intended for treatment<br>planning and guidance for clinical,<br>interventional and/or diagnostic<br>procedures. The device is intended to be<br>used in interventional and diagnostic<br>procedures in a clinical setting. Example<br>procedures include, but are not limited to<br>image fusion for diagnostic clinical<br>examinations and procedures, soft tissue<br>biopsies, soft tissue ablations and<br>placement of fiducial markers. Artemis is<br>also intended to be used for patients in<br>active surveillance to keep track of<br>previous procedures information and<br>outcomes. | The 3-D Imaging<br>Workstation is<br>intended to be used by<br>physicians in the clinic<br>or hospital for 2-D and<br>3-D visualization of<br>ultrasound images of<br>the prostate gland.<br>Additional software<br>features include<br>patient data<br>management, multi-<br>planar reconstruction,<br>segmentation, image<br>measurement and 3-D<br>image registration. | UroNav is a stereotaxic accessory<br>for image-guided interventional<br>and diagnostic procedures of the<br>prostate gland. It provides 2D and<br>3D visualization of Ultrasound<br>(US) images and the ability to fuse<br>and register these images with<br>those from other imaging<br>modalities such as Magnetic<br>Resonance (MR), Computed<br>Tomography, etc. It also provides<br>the ability to display a simulated<br>image of a tracked insertion tool<br>such as a biopsy needle,<br>guidewire, gridplate or probe on a<br>computer monitor screen that<br>shows images of the target organ<br>and the current and the projected<br>future path of the interventional<br>instrument taking into account<br>patient movement. Other<br>software features include patient<br>data management, multi-planar<br>reconstruction, segmentation,<br>image measurements and 2D/3D<br>image registration.<br>UroNav is intended for treatment<br>planning and guidance for clinical,<br>interventional and/or diagnostic<br>procedures. The device is<br>intended to be used in<br>interventional and diagnostic<br>procedures in a clinical setting.<br>Example procedures include, but<br>are not limited to image fusion<br>for diagnostic clinical<br>examinations and procedures,<br>soft tissue biopsies, soft tissue<br>ablations and placement of<br>fiducial markers. |
| Product | Submitted Device | Predicate Device: | Predicate Device: Invivo |
| | Eigen<br>Artemis | Eigen, LLC 3-D Imaging | UroNav (Version 2.0) |
| | | Workstation K081093 | K153073 |
| Product Code | LLZ | LLZ | LLZ |
| Class | II | II | II |
| Target Anatomy | Prostate | Prostate | Prostate |
| Anatomy Access | Transrectal & Transperineal | Transrectal | Transrectal & Transperineal |
| Software | | | |
| Windows OS | Yes | Yes | Yes |
| Medical Imaging<br>Software | Yes | Yes | Yes |
| Image Display | | | |
| Multi-Modality<br>Support | Yes | Yes | Yes |
| General Image<br>2D/3D Review | Yes | Yes | Yes |
| 3D Rendering View | Yes | Yes | Yes |
| Live 2D<br>Ultrasound | Yes | Yes | Yes |
| Image Processing |…