(309 days)
Not Found
No
The description focuses on atlas-based segmentation and statistical modeling, without mentioning AI or ML techniques.
No
The device is described as an image processing software for automatic labeling, visualization, and volumetric quantification of brain structures from MR images, intended to support clinicians in assessing structural MRIs. It does not mention any direct application of therapy or treatment to a patient.
No
The device is intended to automate the process of identifying, labeling, and quantifying the volume of brain structures from MR images, acting as a "support tool for clinicians in assessing structural MRIs." It provides volumetric reports and estimates normal volumes but does not explicitly state it is used to diagnose diseases or medical conditions.
Yes
The device description explicitly states "Neuroreader is a medical image processing software" and the entire summary focuses on software functionalities and performance metrics related to image processing and segmentation. There is no mention of any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NeuroReader Medical Image Processing Software processes medical images (MR images) of the brain. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to automate the process of identifying, labeling, and quantifying brain structures from MR images, providing a support tool for clinicians in assessing structural MRIs. This is a form of medical image analysis, not in vitro testing.
Therefore, while it is a medical device used in a clinical setting, it falls under the category of medical image processing software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroReader Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
Product codes
LLZ, LNH
Device Description
Neuroreader is a medical image processing software intended for automatic labeling, visualization and volumetric quantification of identifiable brain structures from magnetic resonance images. The segmentation system relies on a number of atlases which each consist of a T1-weighted MR image, a binary mask covering the brain and a label map dividing the MR image into different anatomical segments.
Neuroreader provides an estimation of the normal volume for a person with similar demographic data. This is done based on a statistical model and a database of healthy material. Neuroreader is intended to automate the current manual process of identifying, labeling and quantifying the volume of brain structures identified on MR images. Neuroreader is aimed to be a support tool for clinicians in assessing structural MRIs. Neuroreader describes the analysis results in a self-explicative volumetric report within an analysis-time of 10 minutes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images (T1-weighted)
Anatomical Site
Brain structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians
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
In order to validate the segmentation quality of Neuroreader 11 fully automated brain segmentation, 100 images of the manually segmented AEAD-ADNI Hippocampal segmentation protocol dataset was used as the ground truth.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Validation of segmentation quality
Sample Size: 100 images
Key Results: Neuroreader 11 can segment the hippocampus with a Dice similarity index of 0.87 for both the right and left hippocampus. The Dice similarity reaches a maximum of 0.91. The validation indicates that Neuroreader is safe to use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dice similarity index
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2015
Brainreader ApS C/O Mette Munch QA Consultant Skagenvej 21 Egaa, 8250 DENMARK
Re: K140828 Trade/Device Name: NeuroReader Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, LNH Dated: January 15, 2015 Received: January 28, 2015
Dear Mette Munch:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140828
Device Name
NeuroReader Medical Image Processing Software
Indications for Use (Describe)
The NeuroReader Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) summary - Neuroreader Medical Image Processing Software
Administrative information:
| Name: | Brainreader Aps |
|---|---|
| Address: | Emil Møllers Gade 41a |
| DK-8700 Horsens | |
| Denmark | |
| Contact person: | Mette Munch, QA Consultant |
| Cell phone: | +45 29872000 |
| E-mail: | mm@addaction.dk |
Date of summary: 15-Jan-2015
Name of device:
Trade name: Neuroreader medical Image Processing Software Common name: Neuroreader Classification name: Picture archiving and communication system (LLZ)
Predicate device:
| 510(k) reg. no | Manufacturer | Device | Product code |
|---|---|---|---|
| K061855 | CorTechs Labs, Inc. | NeuroQuantTM | LLZ |
| Medical Image | |||
| Processing Software |
Device description:
Neuroreader is a medical image processing software intended for automatic labeling, visualization and volumetric quantification of identifiable brain structures from magnetic resonance images. The segmentation system relies on a number of atlases which each consist of a T1-weighted MR image, a binary mask covering the brain and a label map dividing the MR image into different anatomical segments.
Neuroreader provides an estimation of the normal volume for a person with similar demographic data. This is done based on a statistical model and a database of healthy material. Neuroreader is intended to automate the current manual process of identifying, labeling and quantifying the volume of brain structures identified on MR images. Neuroreader is aimed to be a support tool for clinicians
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in assessing structural MRIs. Neuroreader describes the analysis results in a self-explicative volumetric report within an analysis-time of 10 minutes.
Intended use:
The Neuroreader Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
Comparison to Predicate Device:
Table 1: Comparison between Neuroreader Medical Image Processing Software and K061855: NeuroQuant™ medical Image Processing Software.
| | Neuroreader Medical Image
Processing Software | NeuroQuant™ medical
Image Processing Software –
K061855 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Neuroreader Medical
Image Processing Software is
intended for automatic
labeling, visualization and
volumetric quantification of
segmentable brain structures
from a set of MR images. This
software is intended to
automate the current manual
process of identifying, labeling
and quantifying the volume of
segmentable brain structures
identified on MR images. | NeuroQuant™ is intended for
automatic labeling,
visualization and volumetric
quantification of segmentable
brain structures from a set of
MR images. This software is
intended to automate the
current manual process of
identifying, labeling and
quantifying the volume of
segmentable brain structures
identified on MR images. |
Summary of technical characteristics of device compared to predicate device:
The device and predicate device (K061855) have identical:
- Regulation name: "Picture archiving and communication system", ●
- Regulation number: 21 CFR 892.2050
- Regulatory Class: II
- Product code: LLZ
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Device and predicate device are software for measuring brain MRI volume, automatic labeling and visualization. The output volumes are then compared to a normative dataset computed based on MRI data from normal control subjects.
Neuroreader™ and Neuroquant achieve their intended use based on a similar principle, as the segmentation system relies on a number of atlases which each consist of a T1-weighted MR image, a binary mask covering the brain and a label map dividing the MR image into different anatomical segments. Analysis requires a T1 weighted MRI that includes nose, ears, and vertex without wraparound. All atlases must agree on which label values belong to which segments. For this purpose the standards implemented in the Freesurfer project are used. Image transformation use discrete cosine nonlinear registration to a probabilistic atlas.
Device and predicate device upload MR image to the analysis server, do automatic brain segmentation and determine the volume of brain structures. The MR image goes through filtering, a gradient non-linearities- and field inhomogeneities artifact correction as well as a skull stripping step.
Device and predicate device use the intra-cranial volume as a reference in the statistical calculations. The output compares an individual patient's regional brain volumes with those of a normative database, correcting for sex, head size, and age. Both devices generate a report with similar output parameters.
Summary of substantial equivalence based on clinical data: In order to validate the segmentation quality of Neuroreader 11 fully automated brain segmentation, 100 images of the manually segmented AEAD-ADNI Hippocampal segmentation protocol dataset was used as the ground truth. Neuroreader 11 can segment the hippocampus with a Dice similarity index of 0.87 for both the right and left hippocampus. The Dice similarity reaches a maximum of 0.91. The validation indicates that Neuroreader is safe to use.
Conclusion on substantial equivalence based on technical comparison and clinical data:
By virtue of the physical characteristics and intended use, Neuroreader™ is substantially equivalent to a device legally cleared to be marketed in the United States.
The conclusion drawn from the non-clinical and clinical performance data, shows that the device is as safe, as effective, and performs as well as the predicate device and the state of the art manual segmentation process.