(56 days)
No
The document describes automated post-processing software that calculates parametric images based on image intensity variations over time. There is no mention of AI, ML, or related concepts like training or test sets, which are typically associated with AI/ML development and validation. The description focuses on deterministic calculations from the image data.
No
The device is described as post-processing software that generates parametric images from MR data to assist in diagnosis, not directly treat or prevent a disease.
Yes.
The "Intended Use / Indications for Use" section explicitly states, "BrainStat provides information that when interpreted by a trained physician, can be useful in determining a diagnosis." This indicates its role in the diagnostic process.
Yes
The device is described as a "software option" and a "software application" that processes existing MR images. It is an improvement to a previous software application and does not mention any hardware components being part of the device itself.
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. They are used to examine these samples outside of the body.
- BrainStat's Function: BrainStat processes in vivo (within the living body) MR images acquired directly from the patient's brain. It analyzes the image data itself, not a sample taken from the body.
- Input Data: The input is MR images, not biological samples.
- Processing Method: It's a post-processing software for medical images.
Therefore, BrainStat falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BrainStat is an automated post-processing software option that is designed to process a time-series of MR images acquired in the brain. BrainStat is indicated for use on dynamic magnetic resonance imaging data sets to depict parametric images that are calculated from the image intensity variations over time. These parametric images include the integrated-area of the signal intensity change, the time from the beginning of the change of intensity to the intensity change, and the ratio of the integrated area to the time.
BrainStat provides information that when interpreted by a trained physician, can be useful in determining a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The BrainStat Software Option is a software application to be used on GE Signa MR scanners. It is an evolutionary improvement to the post-processing application known as FuncTool on the HDx 1.5T and 3.0T MRI scanners (K052293).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images (dynamic magnetic resonance imaging data sets)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / 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.
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
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
4 2008
510(k) Summary of Safety and Effectiveness
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
| Submitter: | |
|---|---|
| Name: | GE Medical Systems, LLC |
| 3200 N. Grandview Blvd., W-827 | |
| Waukesha, WI 53188 | |
| Contact: | Mark M. Stauffer |
| Safety and Regulatory Engineer, MR modality | |
| Tel: 262-521-6891 | |
| Fax: 262-521-6439 | |
| Date Prepared: | September 27, 2007 |
| Product Identification: | |
| Proprietary Device Name: | BrainStat Software Option for GE Signa MR Scanner |
| Common Name: | Software Option for Magnetic Resonance Imaging |
| System | |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
| (21 CFR 892.1000, Product Code LNH) |
Predicate Device(s):
Esaote S.p.A. Dynamic MRI Software Option for C-scan XQ and E-scan Opera - K061429
Device Description:
The BrainStat Software Option is a software application to be used on GE Signa MR scanners. It is an evolutionary improvement to the post-processing application known as FuncTool on the HDx 1.5T and 3.0T MRI scanners (K052293).
1
Intended Use:
BrainStat is an automated post-processing software option that is designed to process a timeseries of MR images acquired in the brain. BrainStat is indicated for use on dynamic magnetic resonance imaging data sets to depict parametric images that are calculated from the image intensity variations over time. These parametric images include the integrated-area of the signal intensity change, the time from the beginning of the change of intensity to the intensity change, and the ratio of the integrated area to the time.
BrainStat provides information that when interpreted by a trained physician, can be useful in determining a diagnosis.
Comparison with Predicate:
The BrainStat Software Option is substantially equivalent to an analogous feature contained in a product currently marketed by Esaote S.p.A. as Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera - K061429.
Conclusion:
When used in conjunction with a GE Signa MR System, the BrainStat Software Option represents an evolutionary change to the image data post-processing capabilities called FuncTool, currently found on the GE HDx MRI system (K052293). This premarket notification submission demonstrates that the BrainStat software option is substantially equivalent to an analogous feature in Esaote's Dynamic MRI Software Option for C-scan, E-scan XQ and E-scan Opera because it has the same intended use and functionality.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling a symbol or abstract representation.
Public Health Service
2008 JAN 4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems, LLC % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K073167
Trade/Device Name: BrainStat Software Option for GE Signa MR Scanners Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 19, 2007 Received: December 20, 2007
Dear Mr. Borsai:
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. Ilsting 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.
3
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" (21CFR 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/cdrh/industry/support/index.html.
Sincerely yours.
Nancy Brogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
BrainStat Software Option for GE Signa MR Scanner
Indications for Use:
BrainStat is an automated post-processing software option that is designed to process a time-series of MR images acquired in the brain. BrainStat is indicated for use on dynamic maqnetic resonance imaqing data sets to depict parametric images that are calculated from the image intensity variations over time. These parametric images include the intearated-area of the signal intensity change, the time from the beginning of the change of intensity to the end of the intensity change, and the ratio of the integrated area to the time.
BrainStat provides information that when interpreted by a trained physician, can be useful in determining a diagnosis.
※ AND/OR Prescription Use (21 CFR 801 Subpart D)
Over-the-Counter Use_ (21 CFR 807 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devic 510(k) Number