(43 days)
Not Found
No
The summary describes standard image processing and analysis techniques (BOLD fMRI, diffusion, fiber tracking, dynamic analysis, vessel analysis, 3D visualization) and mentions "Pre-set processing algorithms," but does not mention AI, ML, or related terms.
No
The device is described as image processing software for viewing, manipulating, and quantifying medical images, not for providing therapy.
Yes
Explanation: DC Neuro performs image viewing, manipulation, quantification, and analysis of medical imaging data (MRI), including fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis. These functions are used to quantify changes, visualize structures, and analyze patient data, which directly supports diagnosis.
Yes
The device is described as a "software package" that runs on "standard PC hardware" and "off-the-shelf computer components." It receives image data and performs processing and viewing functions. There is no indication that the device includes or requires any specialized or proprietary hardware components beyond a standard computer.
Based on the provided text, 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 of DC Neuro clearly states it processes image data from medical imaging devices (MRI) and image archives (PACS). It analyzes images of the human body, not biological samples taken from the body.
- The intended use and device description focus on image processing, analysis, and visualization. This is characteristic of medical imaging software, not IVDs.
- The examples of analysis (BOLD fMRI, diffusion, fiber tracking, dynamic analysis, vessel analysis) are all based on interpreting imaging data. They are not tests performed on biological specimens.
Therefore, DC Neuro falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing.
DC Neuro provides both analysis and viewing capabilities which integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.
Diffusion/Fiber tracking: The diffusion of water molecules through brain tissue can be measured with diffusion-weighted MRI scanning. Actual diffusion properties depend on the local tissue. With fiber tracking, the directional dependency can be used to visualize the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Analysis: Allows the visualization of vascular morphology from MR images.
3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
DC Neuro is a software package available for viewing, printing, storing, transferring, and quantifying DICOM magnetic resonance imaging (MRI) studies. The DC Neuro software is able to run on "off the shelf" standard PC components using the Microsoft Windows XP Professional Operating Software.
DC Neuro provides both analysis and viewing capabilities that integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
DC Neuro software provides automated processing of DICOM images. Imaging cxams are transferred to the DC Neuro system in DICOM format either directly from the MR system or from a picture archiving and communications system (PACS) or via supported digital media. The DC Neuro system reads the incoming image headers and automatically sorts the images into exams consisting of multiple data sets. Pre-set processing algorithms may be performed on the incoming data as defined by the user such as image co-registration, fMRI analysis, diffusion analysis, dynamic analysis, vessel analysis, and 3D displays.
DC Neuro is a software package that uses standard PC hardware, with a standard uscr/operator interface (keyboard and mouse), and a standard Operating System: Microsoft Windows XP Professional.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
K032096, K052078, K990329, K971965, K953095
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Invivo Corporation - DC Neuro Premarka Notification [510(k)] Submission
K081242
pg. 1 of 3
510(K) SUMMARY
This summary is being submitted in accordance with 21 CFR 807.92.
1. GENERERAL INFORMATION
1.1. Submitter Information
Manufacturer's Name: Address:
Invivo Corporation N27 W23676 Paul Road Pewaukee, WI 53072 2183683.
treiskertajnvivocorp.com
JUN 1 7 2008
Establishment Registration #
1.2. Contact Person Name and Information
| Contact: | Theodore J. Reisker |
|---|---|
| Title: | Director, Product Development |
| Company: | Invivo Corporation |
| Address: | N27 W23676 Paul Road |
| Pewaukee, WI 53072 | |
| Telephone # | (262) 524-1402 ext. 175 |
| Facsimile #: | (262) 524-1403 |
1.3. Trade name and common name of device
| Trade name: | DC Neuro |
|---|---|
| Common name: | Image Processing System |
1.4. Classification of the device
| Classification: | Image Processing System, 21 CFR 892.2050 |
|---|---|
| Class: | Class II |
| Procode: | LLZ |
1.5. Predicate Devices
E-mail:
Table 1 summarizes the correspondence between various features in DC Neuro and predicate devices, along with the pertinent 510(k) submission references.
| Feature | Predicate Device Name | Predicate
510(k)
Submission
Reference |
|---------------------------------------|-------------------------------------------------------------------------|------------------------------------------------|
| Diffusion / FiberTrak | Philips Achieva, Intera, & Panorama 1.0T | K052078 |
| BOLD / fMRI | Philips EasyVision Family Workstation
Option - BOLD Analysis Package | K990329 |
| Dynamic Analysis,
Vessels Analysis | Philips Quantitative Analysis Package | K971965 |
| 3D Rendering | Philips EasyVision Family Workstation
Option - 3D Volume Rendering | K953095 |
| Image processing
workstation | Philips View Forum | K032096 |
Summary of Predicate Devices and 510(k) references Table 1:
1
Invivo Corporation - DC Neuro Premarket Notification [510(k)] Submission
K081262
pg. 2 of 3
2. BASIS FOR SUBSTANTIAL EQUIVALENCE DETERMINATION 2.1. Device Description
2.1.1. Summary of device functions and the devices major components
DC Neuro is a software package available for viewing, printing, storing, transferring, and quantifying DICOM magnetic resonance imaging (MRI) studies. The DC Neuro software is able to run on "off the shelf" standard PC components using the Microsoft Windows XP Professional Operating Software.
DC Neuro provides both analysis and viewing capabilities that integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
DC Neuro software provides automated processing of DICOM images. Imaging cxams are transferred to the DC Neuro system in DICOM format either directly from the MR system or from a picture archiving and communications system (PACS) or via supported digital media. The DC Neuro system reads the incoming image headers and automatically sorts the images into exams consisting of multiple data sets. Pre-set processing algorithms may be performed on the incoming data as defined by the user such as image co-registration, fMRI analysis, diffusion analysis, dynamic analysis, vessel analysis, and 3D displays.
2.1.2. Description of device (major components)
DC Neuro is a software package that uses standard PC hardware, with a standard uscr/operator interface (keyboard and mouse), and a standard Operating System: Microsoft Windows XP Professional.
2.2. Intended use
DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing,
DC Neuro provides both analysis and viewing capabilities which integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
2
K081262
pg. 3 of 3
BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.
Diffusion/Fiber tracking: The diffusion of water molecules through brain tissue can be measured with diffusion-weighted MRI scanning. Actual diffusion properties depend on the local tissue. With fiber tracking, the directional dependency can be used to visualize the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studics, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Analysis: Allows the visualization of vascular morphology from contrast-enhanced MR images.
3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.
2.3. Safety Information
No new hazards are introduced by Invivo Corporation's DC Neuro, as compared to predicated devices and image processing functionality.
2.4. Conclusion
Invivo Corporation's DC Neuro is substantially equivalent to the Philips ViewForum 2003 workstation, and the Philips BOLD fMRI. Diffusion/Fiber Tracking, Dynamic and Vessel Analyses, and 3D visualization image processing functionality.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is simple and uses a monochrome color scheme.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2008
Invivo Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K081262
Trade/Device Name: DC Neuro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2008 Received: June 6, 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
Page 2
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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
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 | |
|---|---|
| own): | K081262 |
510(k) Number (if knov
Device Name:
DC Neuro
Indications For Use:
DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing.
DC Neuro provides both analysis and viewing capabilities which integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views.
BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task.
Diffusion/Fiber tracking: The diffusion of water molecules through brain tissue can be measured with diffusion-weighted MRI scanning. Actual diffusion properties depend on the local tissue. With fiber tracking, the directional dependency can be used to visualize the white matter structure in the brain.
Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Analysis: Allows the visualization of vascular morphology from MR images.
AND/OR
3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.
Prescription Use J (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arjun Mr. Whang
ductive Abdominal, and 510(k) Numbe
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