(48 days)
Not Found
Not Found
No
The description focuses on parametric mapping and modeling based on MR data, which are traditional image processing and analysis techniques, not explicitly AI/ML. There is no mention of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML devices.
No
The device is described as a "post-processing software medical device intended for use in visualization of the brain" that "analyzes input data from MR imaging systems" to generate "parametric maps" and "image contrasts," which provides "information useful in determining diagnosis." It does not describe any direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that "SyMRI images can provide information useful in determining diagnosis." Its function to generate parametric maps and quantify brain tissue volumes also implies a diagnostic purpose.
Yes
The device is explicitly described as a "post-processing software medical device" and its function is to analyze data from existing MR imaging systems, generate parametric maps, and perform visualization and quantification. There is no mention of any hardware component 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.
- SyMRI's function: SyMRI is a software that processes data from MR imaging systems. This is an in vivo imaging modality, meaning it acquires data from within the living body without taking a sample.
- Intended Use: The intended use clearly states it's for "visualization of the brain" and "analyzes input data from MR imaging systems." It also mentions "head imaging." These are all related to imaging the body directly, not analyzing samples taken from the body.
Therefore, SyMRI falls under the category of a medical device used for imaging and image processing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast SyMRI is indicated for head imaging.
SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME.
When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR),
Product codes
LNH
Device Description
SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast SyMRI is indicated for head imaging.
SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging systems (multi-delay, multi-echo acquisition (MDME))
Anatomical Site
brain, head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.
June 12th, 2018
SyntheticMR AB % Raymond Kelly Consultant Licensale Inc 68 Southwoods Terrace SOUTHBURY, CT 06488
Re: K181093
Trade/Device Name: SyMRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: April 24, 2018 Received: April 25, 2018
Dear Raymond Kelly:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jeff Radigan
for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SyMRI
Indications for Use (Describe)
SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-delay, multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast SyMRI is indicated for head imaging.
SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME.
When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR),
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."