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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the medical device "Artemis". This document focuses on demonstrating substantial equivalence to predicate devices and outlines nonclinical testing performed. However, it does not contain detailed acceptance criteria, specific reported device performance metrics (e.g., sensitivity, specificity, accuracy, dice score), or a study that directly proves the device meets specific performance acceptance criteria related to clinical efficacy or diagnostic accuracy.

The document states: "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." However, these detailed results and acceptance criteria are not elaborated within this specific K162474 summary. The provided text primarily focuses on regulatory compliance, safety, and a comparison of technological characteristics with predicate devices to establish substantial equivalence.

Based on the available text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
Safety & Effectiveness	Device labeling contains instructions for use and necessary cautions, warnings, and notes. Risk Management procedure identifies and controls potential hazards.	Passed all in-house testing criteria validating design, function, and specifications. Measurement validation using phantoms, clinical CT, and MRI images showed performance as well as or better than predicate devices, and demonstrated safety and effectiveness.
Regulatory Compliance	Complies with applicable standards (listed below for Emissions, Immunity, Risk, Usability).	Designed to comply with: - 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 (Emissions) - 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 61000-4-5:2005, 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 (Immunity) - EN/ISO 14971:2012, IEC 62366:2007, IEC 60601-1-6:2010 (Risk and Usability)

Note: The document explicitly states "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met," but the specific numerical acceptance criteria for performance (e.g., accuracy of measurement, registration error tolerance, segmentation precision) and the corresponding quantitative results are not included in this summary. The "Reported Device Performance" column above summarizes the claim of meeting criteria rather than the data itself.

Regarding the study proving the device meets acceptance criteria:

The document mentions "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." This indicates that nonclinical testing was performed.

However, the specific "study" details are limited in this summary. This document is a summary and refers to more detailed "Nonclinical and performance testing results...provided in the 510(k)." The information below is based only on what is explicitly stated in the provided text.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified in the provided summary.
Data Provenance: The document mentions "phantoms, clinical CT, and MRI images." It does not specify the country of origin of the clinical data. It is implied these were retrospective images used for validation, as it doesn't mention a prospective clinical trial for this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the summary.

4. Adjudication method for the test set

This information is not provided in the summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A MRMC comparative effectiveness study involving human readers with and without AI assistance is not mentioned in this summary. The device's primary function is image-guided interventional and diagnostic procedures (e.g., visualization, registration, navigation, segmentation, measurement for prostate biopsies/treatment), which are often tools for physicians rather than AI for interpretation of images. The comparison focuses on the device's technical performance against predicate devices, not on physician performance improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes Artemis as providing "2D and 3D visualization," "ability to fuse and register images," "display a simulated image of a tracked insertion tool," "virtual grid," "patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management." These functionalities are tools to assist a human physician. The text "Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis" further indicates a human-in-the-loop system. While several features (segmentation, registration, measurement) are algorithmic, the context suggests these are components of a larger system used by a physician, rather than a standalone diagnostic AI algorithm. Therefore, a standalone performance evaluation in the typical sense of a diagnostic AI is not specifically detailed or claimed in this summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The summary states "Measurement validation using, phantoms, clinical CT, and MRI images." For phantoms, the ground truth would be the known physical dimensions or properties of the phantom. For clinical CT and MRI images, the method for establishing ground truth (e.g., pathology, surgical findings, expert measurement, or other imaging modalities) is not specified.

8. The sample size for the training set

The document describes "nonclinical testing" and "measurement validation." It does not provide details on a "training set" for a machine learning algorithm, which suggests the device might not heavily rely on a machine learning model that requires a distinct training/test split in the way modern AI algorithms do for clinical inference. The discussion around "software source code for basic system functionality" points to more traditional image processing and navigation algorithms. Therefore, a "training set" in the context of deep learning is not applicable or mentioned in this summary.

9. How the ground truth for the training set was established

As a training set is not explicitly mentioned or clearly applicable based on the summary, how its ground truth was established is not provided.

Summary

{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 (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)

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)

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, LLZPicture 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

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.

{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 DeviceEigenArtemis	Predicate Device:Eigen, LLC 3-D ImagingWorkstation K081093	Predicate Device: InvivoUroNav (Version 2.0)K153073
Intended Use	Artemis along with the Needle GuideAttachment is used for image-guidedinterventional and diagnostic proceduresof the prostate gland. It provides 2D and3D visualization of Ultrasound (US) imagesand the ability to fuse and register theseimages with those from other imagingmodalities such as Ultrasound, MagneticResonance, Computed Tomography, etc. Italso provides the ability to display asimulated image of a tracked insertiontool such as a biopsy needle, guidewire orprobe on a computer monitor screen thatshows images of the target organ and thecurrent and the projected future path ofthe interventional instrument taking intoaccount patient movement. The softwarealso provides a virtual grid on the liveultrasound for performing systematicsampling of the target organ. Othersoftware features include patient datamanagement, multi-planar reconstruction,segmentation, image measurements,2D/3D image registration, reporting, andpathology management.Artemis is intended for treatmentplanning and guidance for clinical,interventional and/or diagnosticprocedures. The device is intended to beused in interventional and diagnosticprocedures in a clinical setting. Exampleprocedures include, but are not limited toimage fusion for diagnostic clinicalexaminations and procedures, soft tissuebiopsies, soft tissue ablations andplacement of fiducial markers. Artemis isalso intended to be used for patients inactive surveillance to keep track ofprevious procedures information andoutcomes.	The 3-D ImagingWorkstation isintended to be used byphysicians in the clinicor hospital for 2-D and3-D visualization ofultrasound images ofthe prostate gland.Additional softwarefeatures includepatient datamanagement, multi-planar reconstruction,segmentation, imagemeasurement and 3-Dimage registration.	UroNav is a stereotaxic accessoryfor image-guided interventionaland diagnostic procedures of theprostate gland. It provides 2D and3D visualization of Ultrasound(US) images and the ability to fuseand register these images withthose from other imagingmodalities such as MagneticResonance (MR), ComputedTomography, etc. It also providesthe ability to display a simulatedimage of a tracked insertion toolsuch as a biopsy needle,guidewire, gridplate or probe on acomputer monitor screen thatshows images of the target organand the current and the projectedfuture path of the interventionalinstrument taking into accountpatient movement. Othersoftware features include patientdata management, multi-planarreconstruction, segmentation,image measurements and 2D/3Dimage registration.UroNav is intended for treatmentplanning and guidance for clinical,interventional and/or diagnosticprocedures. The device isintended to be used ininterventional and diagnosticprocedures in a clinical setting.Example procedures include, butare not limited to image fusionfor diagnostic clinicalexaminations and procedures,soft tissue biopsies, soft tissueablations and placement offiducial markers.
Product	Submitted Device	Predicate Device:	Predicate Device: Invivo
	EigenArtemis	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 ImagingSoftware	Yes	Yes	Yes
Image Display
Multi-ModalitySupport	Yes	Yes	Yes
General Image2D/3D Review	Yes	Yes	Yes
3D Rendering View	Yes	Yes	Yes
Live 2DUltrasound	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-PlanarReformation	Yes	Yes	Yes
Connectivity
DICOMImport/Export	Yes	Yes	Yes
Ultrasound Video	Yes	Yes	Yes
Review Tools
Stand ImageViewing 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 DeviceEigenArtemis	Predicate Device:Eigen, LLC 3-D ImagingWorkstation K081093	Predicate Device: InvivoUroNav (Version 2.0)K153073
Plan/MarksLocations	Yes	Yes	Yes
Navigation Type	Mechanical	Mechanical	Electromagnetic

{8}------------------------------------------------

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.

{9}------------------------------------------------

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

{10}------------------------------------------------

Image /page/10/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 aligned to the left and is stacked on top of each other.

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.

Regulation Number and Section

§ 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).