(14 days)
Not Found
No
The description focuses on traditional image processing techniques like reconstruction, segmentation, and registration, without mentioning AI or ML algorithms.
No
The device is described as an imaging workstation that aids in visualization, measurement, and planning. It does not exert any direct therapeutic action on the patient.
Yes
The device is described as allowing the physician to "examine abnormalities" and providing "additional 3-D information for assessing prostate abnormalities," which are key functions of a diagnostic device. It aids in the visualization and assessment of health conditions.
No
The device description explicitly states that the system is comprised of a "mechanical assembly that holds the ultrasound probe and tracks probe position" and is connected to a "PC-based workstation containing a video digitizing card". These are hardware components, making it more than just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this device is used for "2-D and 3-D visualization of ultrasound images of the prostate gland" and for "reconstructing a 3-D ultrasound image" from live 2-D video. This is imaging of the body itself, not analysis of a biological sample taken from the body.
- The device processes and displays imaging data. While it performs image processing, this is applied to ultrasound images acquired directly from the patient, not to in vitro samples.
- The intended use is for visualization, measurement, and planning related to in-vivo imaging and procedures. The description focuses on using the 3-D images for assessing abnormalities, planning biopsies, and guiding procedures, all of which are performed on the patient.
Therefore, the 3-D Imaging Workstation falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 3-D Imaging Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.
Product codes
LLZ
Device Description
The 3-D Imaging Workstation 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, end fire TRUS probe, commercially available needle guide and needle gun combination. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration.
The 3-D Imaging Workstation is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. 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 the 3-D Imaging Workstation. 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.
Finally, the physician may attach a commercially available biopsy needle guide 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 3-D Imaging Workstation during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. The 3-D Imaging Workstation is able to add, display and edit plans for biopsy sites as well as an estimate of the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.
The 3-D Imaging Workstation 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were developed and used to verify system performance through verification, validation (Appendix D) and benchmarking (Appendix F).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Device Name 510(k) Number 3-Dnet Suite K063107 XELERIS 2 Processing and K051673
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).
0
081093
510(k) Summary
| Submitter's Name: | Eigen LLC | ||||||
|---|---|---|---|---|---|---|---|
| Submitter's Address: | 13366 Grass Valley Avenue, Grass Valley, CA 95945 | ||||||
| Submitter's Telephone: | 530-274-1240 | ||||||
| Contact Name: | Mark A. Hoffman | ||||||
| Date Summary was Prepared: | March 25, 2007 | ||||||
| Trade or Proprietary Name: | 3-D Imaging Workstation | ||||||
| Common or Usual Name: | Medical Image Processing Workstation | ||||||
| Classification Name: | System, Image Processing, Radiological, LLZ | ||||||
| Picture Archiving and Communications, 21CFR 892.2050 | |||||||
| Predicate Devices: | Device Name 510(k) Number 3-Dnet Suite K063107 XELERIS 2 Processing and K051673 |
Description of the Device and Summary of the Technological Characteristics The 3-D Imaging Workstation 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, end fire TRUS probe, commercially available needle guide and needle gun combination. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration.
Review Workstation
The 3-D Imaging Workstation is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. 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 the 3-D Imaging Workstation. 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.
1
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.
Finally, the physician may attach a commercially available biopsy needle guide 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 3-D Imaging Workstation during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. The 3-D Imaging Workstation is able to add, display and edit plans for biopsy sites as well as an estimate of the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.
The 3-D Imaging Workstation 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.
Substantial Equivalence
5
The product's technical features are substantially equivalent to the 3-Dnet Suite (K063107) and the XELERIS 2 Processing and Review Workstation (K051673). The 3-D Imaging Workstation is primarily a software product that runs on a PC-based workstation. Image data is input to the devices and used to generate 3-D views and perform image processing. Like the two predicate devices, the software has image measurement, multi-planar reformatting, segmentation and image registration abilities, image storage and retrieval, as well as patient information management functions.
The 3-D Net Suite and XELERIS 2 are software products that accept multiple image data types including magnetic resonance, computed tomography and ultrasound. The 3-D Imaging Workstation has been designed for ultrasound imaging, using standard analog NTSC video input from commercially available transrectal ultrasound systems. The 3-D Imaging Workstation incorporates a mechanical device to track the position of an end fire ultrasound probe. Ultrasound system operation and transrectal probe movement all remain under manual control of the physician.
2
Testing and Performance Data
All product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were developed and used to verify system performance through verification, validation (Appendix D) and benchmarking (Appendix F).
Conclusion
5
The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of the 3-D Imaging Workstation with those of the two predicate devices demonstrate that the 3-D Imaging Workstation is substantially equivalent to existing products in the market today.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eigen LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
MAY - 1 2008
Re: K081093
Trade/Device Name: 3-D Imaging Workstation Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: LLZ Dated: April 16, 2008 Received: April 17, 2008
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odri/industry/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): pending
Device Name: 3-D Imaging Workstation
Indications for Use:
4
Use
The 3-D Imaging Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional પ્રતિ software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.
Arry Thithy
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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