(444 days)
No
The document describes image processing, registration, segmentation, and tracking, but does not mention AI, ML, or related terms like neural networks or deep learning. The focus is on traditional image processing and mechanical tracking for guidance.
No.
Artemis is an image-guided system for interventional and diagnostic procedures, primarily for visualization, planning, and guidance, not for directly delivering therapy. While it supports cryoablation planning and guidance, it does not perform the cryoablation itself which is delivered by a separate cryoablation system.
Yes
The device explicitly states it is used for "image-guided interventional and diagnostic procedures of the prostate gland" and "intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures." It also mentions "image fusion for diagnostic clinical examinations."
No
The device description explicitly states that Artemis is comprised of a "mechanical assembly that holds the ultrasound probe and tracks probe position" and that 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 Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Artemis's Function: Artemis is a system used for image-guided interventional and diagnostic procedures of the prostate gland. It provides visualization, image fusion, tracking of instruments, and planning capabilities during a procedure performed on the patient's body. It does not analyze specimens taken from the body.
Artemis is clearly an in vivo medical device, used directly on or within the patient's body for guidance and planning during procedures.
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 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 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 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.
Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure.
The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder and urethra.
Product codes (comma separated list FDA assigned to the subject device)
QTZ, GEH
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, probe, commercially available biopsy needle guide, needle gun combination, and cryoablation systems. 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 tasks including measurements (e.g., volume estimation), allowing physicians to examine for abnormalities. Patient information, notes, and images may be stored for future retrieval, and locations for biopsies may be selected by the physician. The system can recall, align, or register 3D models from previous procedures to the current 3D model of the prostate, which is particularly useful for patients under active surveillance.
The physician may attach a commercially available biopsy needle guide compatible to the ultrasound probe and use the probe and needle to perform tissue biopsy and or cryoablation. 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 procedure. As the ultrasound 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 the procedure 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. This NGA will be used for both biopsy and cryo needles. 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 needle guide 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 Ultrasound 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, bladder, urethra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, 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 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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Eigen % William Mandel Director of Operations, Regulatory Affairs, and Quality Assurance 13300 Grass Valley Avenue, Suite A GRASS VALLEY CA 95945
Re: K222222
October 12, 2023
Trade/Device Name: Artemis Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ, GEH Dated: September 28, 2023 Received: October 3, 2023
Dear William 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
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 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 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 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.
Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure.
The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder and urethra. □
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
leading innovation
in medical imaging
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510(k) Summary
K222222
| 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: | Feb 11, 2022 |
| Trade or Proprietary Name: | Artemis |
| Common or Usual Name: | Medical Image Processing Workstation |
| Classification Name: | Primary - Radiological Image Processing for Ablation Therapy |
| Planning and Evaluation, QTZ | |
| Secondary - Unit, Cryosurgical, Accessories, GEH | |
| Picture Archiving and Communications. 21CFR 892.2050 |
Predicate Devices:
| Device Name | 510(k) Number | Type |
|---|---|---|
| Artemis | K162474 | Primary |
| ICEfx Cryoablation System | K181153 | Reference |
The design, function, and specifications of Artemis are similar to the identified legally marketed predicate devices. Similar to the devices from Eigen, LLC (K162474), ICEfx Cryoablation System (K181153), 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. 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. Similar to predicate devices, the subject device can import data from other DICOM based imaging devices and also output selected image views, processed data and user-defined reports. Similar to ICEfx Cryoablation System (K181153) listed predicate device, Artemis provides Navigation of cryo-needles and visual growth of ice-balls.
The ICEfx Cryoablation System (K181153) utilizes its own cryo-needles while Artemis utilizes a
4
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Image /page/4/Picture/1 description: The image shows the word "eigen" in a light blue font against a teal background. The font appears to be sans-serif and slightly rounded. The letters are close together, creating a compact and unified visual element.
mechanical semi-robotic arm with encoders to navigate third party cryo-needles.
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 ICEfx Cryoablation System (K181153) devices does not impact device safety or effectiveness. Artemis and 3D-Imaging Workstation (K162474) utilize the identical navigation and tracking mechanism.
The current Artemis for this 510(k) and the previous Artemis (K162474) 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, probe, commercially available biopsy needle guide, needle gun combination, and cryoablation systems. 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 imaging
Image /page/5/Picture/2 description: This image contains text describing a medical procedure. The text mentions measurements including volume estimation, which can be examined for abnormalities by a physician. Patient information, notes, and images may be stored for future retrieval, and locations for biopsies may be selected by the physician. The text also mentions 3-D models that may be recalled, aligned, or registered to the current 3-D model of the prostate, which is especially useful for patients under active surveillance.
The physician may attach a commercially available biopsy needle guide compatible to the ultrasound probe and use the probe and needle to perform tissue biopsy and or cryoablation. 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 procedure. As the ultrasound 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 the procedure 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. This NGA will be used for both biopsy and cryo needles. 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 needle guide 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 Ultrasound probe based procedures,
6
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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.
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.
Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology
7
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provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure.
The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder, and urethra.
8
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Substantial Equivalence
Following is a comparison of technological characteristics between Artemis and predicate devices:
| Product | Submitted Device | Primary Predicate Device: Eigen, LLC
3-D Imaging Workstation K081093 | Reference Predicate Device: ICEfx
Cryoablation System (K181153) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Eigen
Artemis | | |
| 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 | 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 | The ICEfx Cryoablation System is
indicated for use as a cryosurgical
tool in the fields of
general surgery, dermatology,
neurology (including
cryoanalgesia), thoracic surgery
(with the
exception of cardiac tissue), ENT,
gynecology, oncology, proctology
and urology. This
System is designed to destroy
tissue (including prostate and
kidney tissue, liver metastases,
tumors, skin lesions) by the
application of extremely cold
temperatures.
The ICEfx Cryoablation System
has the following specific
indications:
• Urology Ablation of prostate
tissue in cases of prostate cancer
and Benign Prostate
Hyperplasia (BPH)
• Oncology Ablation of cancerous
or malignant tissue and benign
tumors, and palliative
intervention
• Dermatology Ablation or
freezing of skin cancers and other
cutaneous disorders;
Destruction of warts or lesions,
angiomas, sebaceous hyperplasia,
basal cell tumors of
the eyelid or canthus area,
ulcerated basal cell tumors,
dermatofibromas, small
hemangiomas, mucocele cysts,
multiple warts, plantar warts,
actinic and seborrheic
keratosis, cavernous
hemangiomas, peri-anal
condylomata, and palliation of
tumors of
the skin |
| | procedures. The device is intended to
be used in interventional and | procedures. The device is intended
to be used in interventional and | |
| | diagnostic procedures in a clinical | diagnostic procedures in a clinical | |
| | setting. Example procedures include, | setting. Example procedures include, | |
| | but are not limited to image fusion for
diagnostic clinical examinations and | but are not limited to image fusion
for diagnostic clinical examinations
and | |
| | procedures, soft tissue biopsies, soft | procedures, soft tissue biopsies, | |
| | tissue ablations and placement of | soft tissue ablations and placement
of | |
| | fiducial markers. Artemis is also | fiducial markers. Artemis is also | |
| | intended to be used for patients in | intended to be used for patients in | |
| | active surveillance to keep track of
previous procedures information and
outcomes.
Artemis Cryo Treatment Planning
module is an add on to the existing
Artemis software that allows
physicians to prepare for cryo
treatment planning based on positive
pathology cores obtained during
Artemis guided biopsies and
registration results with other
imaging modalities such as MRI, CT.
The module allows accurate
placement of cryo probes on targets,
3D tracking, real-time feedback on
extend of cryo ice formation. The
technology provided by Artemis
generates ice models based on the
specifications provided by the cryo
device manufacturers and displays
the models on the live ultrasound to
provide guidance to the users during
the procedure.
The module also allows outlining or
segmenting other organs that
surround the prostate. Organs include
bladder, and urethra. | active surveillance to keep track of
previous procedures information and
outcomes. | • Gynecology Ablation of
malignant neoplasia or benign
dysplasia of the female genitalia
• General surgery Palliation of
tumors of the rectum, anal
fissures, pilonidal cysts, and
recurrent cancerous lesions,
ablation of breast fibroadenomas
• ENT Palliation of tumors of the
oral cavity and ablation of
leukoplakia of the mouth
• Thoracic surgery (with the
exception of cardiac tissue)
• Proctology Ablation of benign or
malignant growths of the anus or
rectum |
| | | | |
| Product | Submitted Device
Eigen
Artemis | Primary Predicate Device: Eigen, LLC
3-D Imaging Workstation K081093 | Reference Predicate Device: ICEfx
Cryoablation System (K181153) |
| Product Code | QTZ, GEH | LLZ | GEH |
| Class | II | II | II |
| Target
Anatomy | Prostate | Prostate | Prostate |
| Anatomy
Access | Transrectal & Transperineal | Transrectal & Transperineal | Transperineal |
| Software | | | |
| Windows OS | Yes | Yes | Yes |
| Medical
Imaging
Software | Yes | Yes | Yes |
| Image Display | | | |
| Multi-
Modality
Support | | | |
| 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 | unknown |
| Rigid
Registration | Yes | Yes | unknown |
| Elastic
Registration | Yes | Yes | unknown |
| Multi-Planar
Reformation | Yes | Yes | unknown |
| Connectivity | | | |
| DICOM
Import/Export | Yes | Yes | unknown |
| Ultrasound
Video | Yes | Yes | unknown |
| Review Tools | | | |
| Stand Image
Viewing Tools | Yes | Yes | unknown |
| Measurement
Tools | Yes | Yes | unknown |
| Product | Submitted Device
Eigen
Artemis | Primary Predicate Device: Eigen, LLC
3-D Imaging Workstation K081093 | Reference Predicate Device: ICEfx
Cryoablation System (K181153) |
| Annotation
Tools | Yes | Yes | Yes |
| Segmentation
Tools | Yes | Yes | unknown |
| Reporting
Tools | Yes | Yes | Yes |
| Video Capture | Yes | Yes | unknown |
| Image
Overlays | Yes | Yes | Yes |
| Planning &
Navigation | | | |
| Import Prior
Plans | Yes | Yes | unknown |
| Import/Add
targets | Yes | Yes | unknown |
| Plan/Marks
Locations | Yes | Yes | Yes |
| Navigation
Type | Mechanical | Mechanical | CT |
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Image /page/9/Picture/0 description: The image contains the text "leading innovation in medical imaging". The text is stacked on top of each other, with "leading innovation" on the top line and "in medical imaging" on the bottom line. The text is in a sans-serif font and is a light gray color.
Image /page/9/Picture/1 description: The image contains the word "eigen" in a sans-serif font. The text is light blue and appears to be glowing. The background is a darker shade of blue, providing contrast to the text.
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leading innovation in medical imaging
Image /page/10/Picture/1 description: The image shows the word "eigen" in white font on a teal background. The word is written in lowercase letters. The font appears to be sans-serif. The background is a solid teal color.
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Image /page/11/Picture/0 description: The image contains the text "leading innovation in medical imaging". The text is in a sans-serif font and is light gray in color. The text is stacked on top of each other, with "leading innovation" on the top line and "in medical imaging" on the bottom line.
Image /page/11/Picture/1 description: The image shows the word "eigen" in a sans-serif font. The text is light blue and is set against a teal background. The word is written in lowercase letters.
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 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 IEC 60601-1-2:2014 - - Medical electrical equipment
Immunity:
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Image /page/12/Picture/0 description: The image shows the Eigen logo and tagline. The logo is in a teal color and the tagline is "Leading innovation in medical imaging" in a light gray color. The logo is simple and modern, and the tagline is clear and concise.
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 EC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601-1: 2012 IEC 60601-1-6:2010, AMD1:2013 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 the device is substantially equivalent to the predicate 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 the primary predicate device.