(45 days)
Not Found
No
The summary describes image processing, registration, and 3D reconstruction based on tracked probe position, but does not mention AI or ML.
No
The device is used for image-guided interventional and diagnostic procedures, not for direct therapeutic treatment. It assists in treatment planning and guidance, but does not deliver therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "image-guided interventional and diagnostic procedures of the prostate gland" and "is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures."
No
The device description explicitly states that Artemis is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position, and this mechanical tracker is connected to a PC-based workstation. This indicates the presence of hardware components beyond just software.
Based on the provided information, Artemis is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Artemis's Function: Artemis is an image-guided system used for interventional and diagnostic procedures of the prostate gland. It works by processing and displaying medical images (Ultrasound, MRI, CT) and assisting physicians with procedures like biopsies and treatment planning. It does not analyze biological specimens.
Artemis falls under the category of medical imaging and surgical guidance devices, not IVDs.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (US), Magnetic Resonance, Computed Tomography
Anatomical Site
prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians in the clinic or hospital; interventional and diagnostic procedures in a clinical setting.
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)
Nonclinical and performance testing has been performed by designated individuals as required by Eigen's quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by Artemis in each operational mode. Artemis has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Measurement validation using, phantoms, clinical CT, and MRI images were used to show that Artemis preforms as well as or better than the other predicate devices and furthermore shows that Artemis was safe and effective. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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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 (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.
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) |
|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| 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
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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
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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
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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.
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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
Eigen
Artemis | Predicate Device:
Eigen, LLC 3-D Imaging
Workstation K081093 | Predicate Device: Invivo
UroNav (Version 2.0)
K153073 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The 3-D Imaging
Workstation is
intended to be used by
physicians in the clinic
or hospital for 2-D and
3-D visualization of
ultrasound images of
the prostate gland.
Additional software
features include
patient data
management, multi-
planar reconstruction,
segmentation, image
measurement and 3-D
image registration. | UroNav is a stereotaxic accessory
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 Magnetic
Resonance (MR), Computed
Tomography, etc. It also provides
the ability to display a simulated
image of a tracked insertion tool
such as a biopsy needle,
guidewire, gridplate 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. Other
software features include patient
data management, multi-planar
reconstruction, segmentation,
image measurements and 2D/3D
image registration.
UroNav 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. |
| Product | Submitted Device | Predicate Device: | Predicate Device: Invivo |
| | Eigen
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
Software | Yes | Yes | Yes |
| Image Display | | | |
| Multi-Modality
Support | Yes | Yes | Yes |
| General Image
2D/3D Review | Yes | Yes | Yes |
| 3D Rendering View | Yes | Yes | Yes |
| Live 2D
Ultrasound | Yes | Yes | Yes |
| Image Processing | | | |
| Gland Segmentation | Yes | Yes | Yes |
| Image Registration | Yes | Yes | Yes |
| Rigid Registration | Yes | Yes | Yes |
| Elastic Registration | Yes | Yes | Yes |
| Multi-Planar
Reformation | Yes | Yes | Yes |
| Connectivity | | | |
| DICOM
Import/Export | Yes | Yes | Yes |
| Ultrasound Video | Yes | Yes | Yes |
| Review Tools | | | |
| Stand Image
Viewing Tools | Yes | Yes | Yes |
| Measurement Tools | Yes | Yes | Yes |
| Annotation Tools | Yes | Yes | Yes |
| Segmentation Tools | Yes | Yes | Yes |
| Reporting Tools | Yes | Yes | Yes |
| Video Capture | Yes | Yes | Yes |
| Image Overlays | Yes | Yes | Yes |
| Planning &
Navigation | | | |
| Import Prior Plans | Yes | Yes | Yes |
| Import/Add targets | Yes | Yes | Yes |
| Product | Submitted Device
Eigen
Artemis | Predicate Device:
Eigen, LLC 3-D Imaging
Workstation K081093 | Predicate Device: Invivo
UroNav (Version 2.0)
K153073 |
| Plan/Marks
Locations | Yes | Yes | Yes |
| Navigation Type | Mechanical | Mechanical | Electromagnetic |
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Image /page/8/Picture/0 description: The image contains the text "leading innovation in medical imaging". The text is in a sans-serif font and is gray in color. The text is arranged in two lines, with "leading innovation" on the first line and "in medical imaging" on the second line.
Image /page/8/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 dot over the "i" is also light blue.
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Image /page/9/Picture/0 description: The image contains the text "ading innovation in medical imaging" in gray font on the left side of the image. To the right of the text is the word "eigen" in a light blue font on a teal background. The text is a company logo or slogan.
leading innova
The new device and predicate devices are substantially equivalent in the areas of technological characteristics such as basic design, features, energy source, method of operation, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
Safety and Effectiveness
Artemis labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via Artemis Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via the product (software and hardware) development process, verification and validation testing.
Nonclinical Testing and Performance Information
Nonclinical and performance testing has been performed by designated individuals as required by Eigen's quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by Artemis in each operational mode. Artemis has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Measurement validation using, phantoms, clinical CT, and MRI images were used to show that Artemis preforms as well as or better than the other predicate devices and furthermore shows that Artemis was safe and effective. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met. The Artemis has been designed to comply with the applicable standards:
Emissions:
IEC/EN 60601-1-2:2007/AC:2010, EN 55011:2009+A1:2010, CISPR 11:2009+A1:2010, IEC 61000-3-2:2005+A1:2009 +A2:2009, EN 61000-3-2:2006+A1:2009 +A2: 2009, IEC 61000-3-3:2008, EN 61000-3-3:2008
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Image /page/10/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 centered in the image.
Immunity:
IEC/EN 60601-1-2:2007/AC:2010, IEC 61000-4-2:2008, EN 61000-4-2:2009, IEC 61000-4-3:2006+A1:2008 +A2:2010, EN 61000-4-3:2006+A1:2008 +A2:2010, IEC 61000-4-4: 2004+A1:2010, EN 61000-4-4:2004+A1:2010, IEC 61000-45:2005, EN61000-4-5:2006, IEC61000-4-6:2004/A2:2006, EN61000-46:2009, IEC 61000-4-8:2009,EN61000-4-8:2010,IEC61000-4-11:2004,, EN61000-4-11:2004
Risk and Usability
- EN/ISO 14971:2012
- IEC 62366:2007
- IEC 60601-1-6:2010
Conclusion
The 510(k) Pre-Market Notification for Artemis contains adequate information, data, and nonclinical test results to enable FDA – CDRH to determine substantial equivalence to the predicate devices. Eigen has determined that its device, Artemis, is substantially equivalent to the identified predicate devices listed above. A comparison with the legally marketed predicate devices indicates that it is substantially equivalent to this device, and that it does not raise any new safety or efficacy concerns. The results of comparing the intended use, function, technological characteristics, mode of operation, and specifications of Artemis with those of the two predicate devices demonstrate that Artemis is substantially equivalent to existing products in the market today.