(67 days)
Not Found
No
The summary describes image processing, registration, and visualization techniques, but does not mention AI, ML, or related terms. The performance studies focus on traditional image processing metrics like accuracy and error.
No
The device is a software application designed for processing, visualizing, and recording 3D digital ultrasound images of the prostate, primarily for diagnostic and mapping purposes in the context of prostate biopsies. It does not exert any physical, chemical, or biological action on the body for treatment.
No
The device processes, visualizes, and records 3D digital ultrasound images for guiding prostate biopsies and mapping results, but it does not independently provide a diagnosis or diagnostic interpretation. Its function is to aid in the procedure and visualization, not to determine the presence or absence of a disease.
No
The device description explicitly states that the application is designed to work in connection with commercially available 3D ultrasound scanners, 3D transrectal ultrasound probes, and needle guides. It also mentions being controlled by a footswitch and manual input devices. While the core functionality is software-based, it requires specific hardware components to operate and perform its intended use.
Based on the provided information, the UROSTATION - 3D PROSTATE SUITE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- UROSTATION's Function: The UROSTATION processes, visualizes, and records imaging data (ultrasound and MRI) of the prostate gland. It facilitates the fusion of these images and helps in mapping biopsy locations. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities... in order to map such prostate gland." This is an imaging and procedural guidance tool, not a diagnostic test performed on a sample.
Therefore, the UROSTATION falls under the category of medical imaging software and potentially surgical planning/guidance software, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate.
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multiplanar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D image registration and data reporting.
Product codes
LLZ
Device Description
UROSTATION - 3D PROSTATE SUITE is a computer-based software application designed to process, visualize and record 3D digital ultrasound images of the prostate, and to manage patient and clinical data in the context of transrectal prostate biopsy. Software options provide the fusion of 3DTRUS with MRI or with other 3DTRUS modalities.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, MRI
Anatomical Site
prostate gland
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians in the clinic or hospital
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
Elastic MR/3DTRUS image fusion:
Brolis et al, Internal Technical Review, 2012: From 17 contoured TRUS patient volumes, 850 simulated deformations were registered using Koelis clastic registration method. The overall time for registration was 3.9s. After clastic registration the mean distance between the reference and deformed prostates was 0.09mm. The RMS error stemming from deformations in the probe area is reduced from 4.1mm down to 1.9mm. Clinical validation has been performed on 49 patients in 5 clinical sites. A total of 112 landmark pairs were identified and approved by physicians. The registration quality is measured using the distance between contours and between landmarks. Surfaces were superimposed after elastic registration with 0.7±0.3mm mean accuracy. The mean distance between corresponding landmarks was 1.7±0.7 mm after elastic registration, and the RMS error was 1.9mm.
Elastic 3DTRUS/3DTRUS image fusion and organ tracking:
Baumann et al, Medical Image Analysis 16 (2012) 562-576: A volume-swept 3DTRUS based tracking system for fast and accurate estimation of prostate tissue motion is proposed. Prostate deformations are estimated with elastic registration to maximize accuracy. The system is robust with only 17 registration failures out of 786 (2%) biopsy volumes acquired from 47 patients during biopsy sessions. Accuracy was evaluated to 0.76mm±0.52mm using fiducials on 687 registered volumes stemming from 40 patients.
Targeting Accuracy of Urostation:
Ukimura et al, J. Urol. Vol. 187, 1080-1086, 2012: The accuracy of the Urostation 3DTRUS system for image-based mapping biopsies was evaluated in 6 prostate phantoms. 3 containing 3 hypoechoic lesions and 3 containing 3 isoechoic but MRI-visible lesions, to perform MR fusion guided biopsy. Three targeted biopsies were done per lesion. A total of 27 ultrasound guided biopsies were targeted into 9 hypocchoic lesions. All 27 biopsies (100%) successfully hit the target lesion with a procedural targeting error of 1.52±0.78mm and a system registration error of 0.83mm, resulting in an overall error of 2.35mm. Of the 27 MR fusion biopsies 24 (84%) hit the lesion. For isoechoic lesions mean procedural targeting error was 2.09±1.28mm, resulting in an overall error of 2.92mm.
Conclusion on performance and accuracy: The overall fusion RMS error of the UROSTATION - 3D PROSTATE SUITE. combines preoperative MRI/3DTRUS fusion (1.9mm error) and intraoperative 3DTRUS/3DTRUS fusion used for organ tracking (0.76mm error). The total RMS error of the visualization process is hence 2.05mm at any time during the procedure, giving the physician a probability greater than 95% to hit the lesion according to Karnick et al. Med. Phys. 37 (2). 802-813.
Key Metrics
Mean distance between contexts after elastic registration: 0.7±0.3mm,
Mean distance between corresponding landmarks after elastic registration: 1.7±0.7 mm,
RMS error for MR/3DTRUS image fusion: 1.9mm,
Accuracy for 3DTRUS/3DTRUS image fusion and organ tracking: 0.76mm±0.52mm,
Procedural targeting error for hypoechoic lesions: 1.52±0.78mm,
System registration error for hypoechoic lesions: 0.83mm,
Overall error for hypoechoic lesions: 2.35mm,
Hit rate for hypoechoic lesions: 100%,
Hit rate for isoechoic lesions: 84%,
Mean procedural targeting error for isoechoic lesions: 2.09±1.28mm,
Overall error for isoechoic lesions: 2.92mm,
Total RMS error of visualization process: 2.05mm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string is "K13/448". The characters are written in a cursive style with thick, dark lines.
510(k) Summary for UROSTATION – 3D Prostate Suite MRI/3DTRUS FUSION OPTION SECOND LOOK 3DTRUS FUSION OPTION
The 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Owner: | KOELIS
5, avenue du Grand Sablon 38700 La Tronche
FRANCE | |
|----------------|--------------------------------------------------------------------|--|
| | Phone: +33 476 637 588 Fax: +33 476 549.561 | |
| Contact Name: | Ms Laetitia GERVAIS
Quality Manager
Mail: gervais@koelis.com | |
| Date Prepared: | 04/30/2013 | |
Proposed Device:
| Trade Name: | UROSTATION - 3D PROSTATE SUITE |
|---|---|
| Common Name: | Medical Image Processing Software System |
| Classification Name: | System, Image processing, Radiological |
| Picture archiving and communication system, | |
| 21 CFR PART 892.2050 | |
| Device Class | II |
| Product Code | LLZ |
Cleared Device:
The Urostation system is substantially equivalent to:
| 510(k) Number | Device Name: |
|---|---|
| K100793 | UROSTATION-3D Prostate Suite |
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Image /page/1/Picture/0 description: The image shows the word "KOELIS" in a sans-serif font. To the left of the word is a black arrow pointing to the left. The letters are all capitalized and evenly spaced. The image is black and white.
Intended Use:
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate.
Indications for Use:
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multiplanar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D image registration and data reporting.
Device Description:
UROSTATION - 3D PROSTATE SUITE is a computer-based software application designed to process, visualize and record 3D digital ultrasound images of the prostate, and to manage patient and clinical data in the context of transrectal prostate biopsy. Software options provide the fusion of 3DTRUS with MRI or with other 3DTRUS modalities.
Hardware Platform and Operating System
The application runs on a standard Personal Computer under Microsoft Windows® operating system (version 7 or higher).
Peripheral and accessories
The application is controlled by a footswitch and manual input devices (mousc, kevboard),
It is designed to work in connection with commercially available 3D ultrasound scanners with Ethernet connection, 3D transrectal ultrasound probe and needle guide.
Software Features
UROSTATION - 3D PROSTATE SUITE implements image fusion and display algorithms to provide 3D representation of prostate biopsies.
A typical workflow enables the physician to intraoperatively visualize the 3D mapping of biopsies with respect to a 3DTRUS reference image of the patient's prostate.
For that purpose. 3D digital images may be transferred at any time from the 3D ultrasound scanner to the Urostation for registration and display, while the physician keeps track of the organ on the ultrasound scanner using the usual 2D live B mode.
Optionally, MRI/3DTRUS fusion allows the elastic registration of the 3DTRUS reference image with other imaging modalities (MRI here) in order to display the 3D biopsy mapping on multiple imaging modalities.
Optionally, Second Look 3DTRUS Fusion allows the elastic registration of the 3DTRUS reference image with a previously acquired 3DTRUS reference image of the same patient in order to superimpose two 3D biopsy mappings on a unique 3DTRUS reference image.
Alternatively, UROSTATION - 3D PROSTATE SUITE also provides a review mode that allows the mapping of histologic results on the said 3D reference image of the patient's prostate. Patient
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Image /page/2/Picture/0 description: The image shows the word "KOELIS" in a sans-serif font. To the left of the word is a black arrow pointing to the left. The letters are all capitalized and evenly spaced. The image is simple and clear, with a focus on the text and arrow.
information, images and 3D biopsy mapping may be stored or printed for future retrieval and examination.
Technological Characteristics compared with the cleared device:
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS Fusion option and Second Look 3DTRUS Fusion option utilizes the same technological characteristics as the cleared device:
- Both are PC-based software applications that provide 2D/3D medical image acquisition ﮯ and visualization for enhanced observation and analysis of the prostate gland.
- Both software architectures follow a workflow adapted to the physician's practice. -
- Both systems implement a dedicated algorithm to visualize biopsies with respect to a single 3DTRUS reference image of the prostate.
- Both systems have no measurement features. -
- Both systems provide in addition patient and clinical data management features. -
- Both systems deal with 3D ultrasound images received from commercially available imaging devices.
- Both systems provide 3D image registration and data reporting features -
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS Fusion option and Second Look 3DTRUS Fusion option provide also additional features are based on the same fundamental scientific technology and do not raise any safety or effectiveness concern in comparison with the cleared device:
- The MR/3DTRUS Fusion option implements the same principles of 3D model-based । iterative matching of prostate data as the cleared device. More specifically, the implemented algorithm to fuse multimodal images (Ultrasound. MRI) is based on userdelineated 3D prostate contours. The accuracy and repeatability are equivalent.
- -The Second Look 3DTRUS Fusion option implements the same principles and imagebased matching of prostate data as the cleared device. The accuracy and repeatability are equivalent.
- -The system provides patient data management. multimodal data communication, multiplanar reconstruction, surface and volume rendering, organ delineation, region of interest delineation. 3D image registration and data reporting
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| Company: | KOELIS | KOELIS | KOELIS |
|---|---|---|---|
| System: | 3D PROSTATE SUITE | ||
| 3DTRUS prostate | |||
| mapping | 3D PROSTATE SUITE | ||
| MRI/3DTRUS FUSION | |||
| OPTION | 3D PROSTATE SUITE | ||
| SECOND LOOK | |||
| 3DTRUS FUSION | |||
| OPTION | |||
| 510(k) number: | K100793 | ||
| Function | 2D/3D image: | ||
| acquisition viewing/reviewing processing registration storage Multi-Planar Reformatting (MPR) | |||
| Volume rendering | |||
| Patient and clinical data management | |||
| Patient and clinical data reporting | |||
| Printing | - Surface rendering |
- Organ delineation
- Region of interest
delineation | |
| Intended Use: | To process, visualize and record 3D digital ultrasound images of the
prostate | | |
| Data Source: | 3D TRUS scanners | | |
| | • 3D TRUS scanners | - 3D TRUS scanners - Dicom MR images | • 3D TRUS scanners |
| Physical Characterization: | Software package - operates on standard PC-based hardware
- Windows operating system | | |
Substantial Equivalence Comparison Chart
Conclusion:
The results of comparing the intended uses, functions and technological characteristics of the UROSTATION - 3D PROSTATE SUITE including MRI/3DTRUS Fusion option and Second Look 3DTRUS Fusion option with its cleared device shows that the system is as safe and as effective as its cleared device.
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and Second Look 3DTRUS fusion option is substantially equivalent to existing product currently on the market.
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Image /page/4/Picture/0 description: The image shows the word "KOELIS" in a sans-serif font. To the left of the word is a black arrow pointing to the left. The letters are spaced apart, and the font is simple and clean. The image is in black and white.
Performance summary
UROSTATION - 3D PROSTATE SUITE's 3D display and image fusion capabilities are based on a patented technology called Organ-Based Tracking. The ability of Urostation to register biopsy cores, and optionally MR lesions, on a reference 3DTRUS image of the prostate would consequently allow to assist the physician in targeting different regions of the prostate.
The performance and accuracy of KOELIS fusion technology has been validated on phantom and patient data, as shown in the following studies.
Elastic MR/3DTRUS image fusion:
[Brolis et al, Internal Technical Review, 2012]
From 17 contoured TRUS patient volumes, 850 simulated deformations were registered using Koelis clastic registration method. The overall time for registration was 3.9s. After clastic registration the mean distance between the reference and deformed prostates was 0.09mm The RMS error stemming from deformations in the probe area is reduced from 4.1mm down to 1.9mm. Clinical validation has been performed on 49 patients in 5 clinical sites. A total of 112 landmark pairs were identified and approved by physicians. The registration quality is measured using the distance between contours and between landmarks. Surfaces were superimposed after elastic registration with 0.7±0.3mm mean accuracy. The mean distance between corresponding landmarks was 1.7+0.7 mm after elastic registration, and the RMS error was 1.9mm.
Elastic 3DTRUS/3DTRUS image fusion and organ tracking:
[Baumann et al, Medical Image Analysis 16 (2012) 562-576]
A volume-swept 3DTRUS based tracking system for fast and accurate estimation of prostate tissue motion is proposed. Prostate deformations are estimated with elastic registration to maximize accuracy. The system is robust with only 17 registration failures out of 786 (2%) biopsy volumes acquired from 47 patients during biopsy sessions. Accuracy was evaluated to 0.76mm±0.52mm using fiducials on 687 registered volumes stemming from 40 patients.
Targeting Accuracy of Urostation
[Ukimura et al, J. Urol. Vol. 187, 1080-1086, 2012]
The accuracy of the Urostation 3DTRUS system for image-based mapping biopsies was evaluated in 6 prostate phantoms. 3 containing 3 hypoechoic lesions and 3 containing 3 isoechoic but MRJ-visible lesions, to perform MR fusion guided biopsy. Three targeted biopsies were done per lesion. A total of 27 ultrasound guided biopsies were targeted into 9 hypocchoic lesions. All 27 biopsies (100%) successfully hit the target lesion with a procedural targeting error of 1.52±0.78mm and a system registration error of 0.83mm, resulting in an overall error of 2.35mm. Of the 27 MR fusion biopsies 24 (84%) hit the lesion. For isoechoic lesions mean procedural targeting error was 2.09±1.28mm, resulting in an overall error of 2.92mm.
Conclusion on performance and accuracy:
The overall fusion RMS error of the UROSTATION - 3D PROSTATE SUTE. combines preoperative MRI/3DTRUS fusion (1.9mm error) and intraoperative 3DTRUS/3DTRUS fusion used for organ tracking (0.76mm error). The total RMS error of the visualization process is hence 2.05mm at any time during the procedure, giving the physician a probability greater than 95% to hit the lesion according to /Karnick et al. Med. Phys. 37 (2). 802-8131.
KOELIS therefore concluded that the accuracy provided by the UROSTATION fusion technology is clinically acceptable.
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Public Health Service
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble birds in flight or flowing lines. The logo is printed in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEPARTMENT OF HEALTH & HUMAN SERVICES
LAETITIA GERVAIS QUALITY MANAGER KOELIS 5, AVENUE DU GRAND SABLON LA TRONCHE 38700
Re: K131448
FRANCE
Trade/Device Name: Urostation - 3D Prostate Suite, MRI/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option Regulation Number: 21 CFR 892.2050
July 26, 2013
Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 20, 2013 Received: June 03, 2013
Dear Ms. Gervais:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Gervais
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Smh7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K131448
UROSTATION 3D Prostate Suite Device Name: MRV3DTRUS FUSION OPTION SECOND LOOK 3DTRUS FUSION OPTION
Indications for Use:
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multi-planar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D image registration and data reporting.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.7?)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K131448 510(k)
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