(15 days)
No
The document describes image registration and motion correction techniques, which are standard image processing methods and do not explicitly mention or imply the use of AI or ML algorithms. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is described as software that corrects for motion artifacts in MRI images to assist radiologists in interpretation, not to treat a disease or condition.
No
Explanation: The device is described as an "adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies" by correcting motion artifacts. It explicitly states that "Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images," which indicates it processes images rather than making a diagnosis.
Yes
The device is explicitly described as "MRI Soft Tissue Motion Correction Software" and functions as a "plug-in module" for existing clinical workstations. It processes existing MRI image data and does not include or require any new hardware components for its operation.
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 described device is software that processes medical images (MRI). It does not analyze biological samples.
- Intended Use: The intended use is to assist radiologists in interpreting MRI studies by correcting for patient motion. This is an image processing function, not a diagnostic test performed on a biological sample.
Therefore, the MRI Soft Tissue Motion Correction Software falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions.
The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration process enables the correction of motion occuring both within-plane and across planes (3D). By aligning corresponding voxels, the software reduces the impact of patient motion in post-processing techniques including difference (subtraction) images, parametric displays, subtraction volume MIPs and mean-curve analysis.
Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNH
Device Description
MRI Soft Tissue Motion Correction Software VA10A provides the functionality to correct soft tissue motion of the MRI image volume between scan times. It supports the correction (registration) of one or more volumes relative to an initially supplied reference volume. The product reduces image deformation and displacement in soft tissues shape and location that may occur due to patient motion in between acquisitions of serial MRJ images. Correction of within imaging plane and across- plane motion is supported. The software corrects for inter-volume rigid displacement and non-rigid deformation between acquired MRI images. This reduces motion-related artifacts in post-processing techniques that use the corrected images as input, for example subtraction images, subtraction volume MIPs, parametric maps and mean-curve analysis. MRI Soft Tissue Motion Correction is a plug-in module for Numaris VA21A clinical workstation (K020991) or equivalent, Leonardo 2004 (K040970) or equivalent and MammoReport Plus (K042868) or equivalent. The visualization application invokes the motion correction device, receives and stores the corrected volumes, and displays the results to the user. MRI Soft Tissue Motion Correction provides both a high quality and a high-speed operational mode. The high-speed mode is optimized for speed, while the high-quality mode is recommended for cases having moderate to large amounts of patient motion between acquisitions and takes longer to complete.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI) studies
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
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
Performance testing on clinical data sets (Validation)
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
SEP - 8 2005
510(k) Summary
Ko523os
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h) and as described in 21 CFR 807.92.
| Submitter
(510k Owner) | Siemens Medical Solutions USA, Inc.
Computer Aided Diagnosis & Therapy Group
51 Valley Stream Parkway
Malvern, PA 19355
Tel: (610) 448-4530
Fax: (610) 219-1419 | | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----------------------------------------------------------------------|
| Contact | Barry V. Ashar
Makromed, Inc.
45 Stiles Road
Salem, NH 03079
Tel: (603) 890-3311
Fax: (603) 890-3322
bashar@makromed.com | | |
| Date of Preparation | July 7, 2005 | | |
| Device Trade Name | MRI Soft Tissue Motion Correction Software | | |
| Device Common Name | MRI Image Processing Software | | |
| Classification Name | Class II: Picture Archiving and Communications System
(21 CFR 892.2050)
Product Code LLZ: Image Processing System | | |
| Substantial Equivalence | CADstream v.4.0 | K043216 | Confirma, Inc. |
| | Fusion 7D | K020546 | Mirada Solutions Ltd.
(Now Siemens
Medical Solutions,
Inc.) |
| | Leonardo | K040970 | Siemens Medical
Solutions USA, Inc. |
Device Description
MRI Soft Tissue Motion Correction Software VA10A provides the functionality to correct soft tissue motion of the MRI image volume between scan times. It supports the correction (registration) of one or more volumes relative to an initially supplied reference volume.
1
The product reduces image deformation and displacement in soft tissues shape and location that may occur due to patient motion in between acquisitions of serial MRJ images. Correction of within imaging plane and across- plane motion is supported.
The software corrects for inter-volume rigid displacement and non-rigid deformation between acquired MRI images. This reduces motion-related artifacts in post-processing techniques that use the corrected images as input, for example subtraction images, subtraction volume MIPs, parametric maps and mean-curve analysis.
MRI Soft Tissue Motion Correction is a plug-in module for Numaris VA21A clinical workstation (K020991) or equivalent, Leonardo 2004 (K040970) or equivalent and MammoReport Plus (K042868) or equivalent. The visualization application invokes the motion correction device, receives and stores the corrected volumes, and displays the results to the user.
MRI Soft Tissue Motion Correction provides both a high quality and a high-speed operational mode. The high-speed mode is optimized for speed, while the high-quality mode is recommended for cases having moderate to large amounts of patient motion between acquisitions and takes longer to complete.
Intended Use
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions.
The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration process enables the correction of motion occuring both within-plane and across planes (3D). By aligning corresponding voxels, the software reduces the impact of patient motion in post-processing techniques including difference (subtraction) images, parametric displays, subtraction volume MIPs and mean-curve analysis.
Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images.
Comparison with Predicate Devices
Automatic flexible non-rigid 3D registration of serial patient MRI acquisitions to minimize the impact of patient motion, the primary feature of VA10A software, has been given 510(k) clearance in CADstream v. 4.0 (K043216, Confirma, Inc.). Similar to CADstream, MRI Soft Tissue Motion Correction VA10A software is designed to analyze MRI studies and uses flexible non-rigid registration in 3D.
2
Automatic flexible non-rigid as well as rigid registration of pairs of anatomical volumetric (MRI-MRI) images to help the clinician obtain better image visualization has been given 510(k) clearance in Fusion7D (K020546, Mirada Solutions, now Siemens Medical Solutions -- CTI Mirada). MRI Soft Tissue Motion Correction also performs non-rigid deformation on MRI image pairs.
Leonardo 2004 (K040970, Siemens Medical) has already been given 510(k) clearance for providing a host of MRI image processing features. The MRI Soft Tissue Motion Correction VA10A software is a plug-in module to it and adds one specific functionality to it - motion correction for soft tissue images. All other features remain unchanged.
Test Summary
The following quality assurance measures were applied to the development of the MRI Soft Tissue Motion Correction Software VA10A in accordance with internal procedures:
Risk Analysis Requirements Reviews Design Reviews Integration testing (System verification) Final acceptance testing (Validation) Performance testing on clinical data sets (Validation)
Conclusion
ુર્
The MRI Soft Tissue Motion Correction Software VA10A is as safe, as effective, and performs as well as the predicate devices.
3
Image /page/3/Picture/1 description: The image shows a logo with a stylized bird figure inside a circle. The bird is drawn with thick, black lines and appears to be in flight. The circle is formed by text that curves around the bird. The text is small and difficult to read, but it seems to be a company or organization name. The overall design is simple and modern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2005
Siemens Medical Solutions USA, Inc. % Ms. Laura Danielson Program Manager, Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K052305
Trade/Device Name: MRI Soft Tissue Motion Correction Software VA10A Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Product Code: LLZ Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Product Code: LNH Regulatory Class: II Dated: August 19, 2005 Received: August 24, 2005
Dear Ms. Danielson:
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 (Premarket Approval), 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.
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.
4
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 premated noticate 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 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 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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): צוב במבחמ
Device Name:
MRI Soft Tissue Motion Correction Software VA10A
Indications for Use:
The MRI Soft Tissue Motion Correction Software is an adjunctive tool to assist radiologists in interpreting magnetic resonance imaging (MRI) studies. The software is intended to be used in dynamic MRI examinations that consist of multiple image volumes where patient motion may have occurred between serial acquisitions.
The MRI Soft Tissue Motion Correction Software performs automatic 2D and/or 3D flexible registration of soft tissue. The registration process enables the correction of motion occuring both within-plane and across planes (3D). By aligning corresponding voxels, the software reduces the impact of patient motion in post-processing techniques including difference (subtraction) images, parametric displays, subtraction volume MIPs and mean-curve analysis.
Patient management decisions should not be made solely on the basis of motion corrected images and should always include review of uncorrected images.
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)
Nancy Schroeder
Division Slan-Off Division of Reprodu and Radiological Devices
510(k) हा प्रतिदिन प्रति Siemens Medical Solutions)
p. A-1