(352 days)
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a 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 adjustment. 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).
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a 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 adjustment. 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.
The provided FDA 510(k) clearance letter and Indications for Use document do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the technical documentation submitted with the 510(k) application, such as validation studies, performance testing reports, and clinical trial summaries, which are not included in the provided text.
Specifically, the document focuses on the regulatory clearance process rather than the technical details of the device's performance validation. Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This would be in a performance study report.
- Sample size used for the test set and the data provenance: This would be detailed in the methodology section of a validation study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is specific to how a test set's ground truth was determined in a clinical or validation study.
- Adjudication method for the test set: Similarly, this relates to expert review processes in a study.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This would be a specific study design and its results.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This pertains to the type of performance evaluation conducted.
- The type of ground truth used: This would be explicitly stated in the study's methods.
- The sample size for the training set: This refers to the development phase of the algorithm, not typically found in the regulatory clearance document.
- How the ground truth for the training set was established: This is also part of the algorithm development documentation.
The provided text only states that SyMRI "analyzes input data from MR imaging systems" to "generate parametric maps of R1, R2 relaxation rates, and proton density (PD)" and "can generate multiple image contrasts from the parametric maps." It also mentions its use for "automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images." It emphasizes that "SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR)" and that "SyMRI images can provide information useful in determining diagnosis" when "interpreted by a trained physician."
These are descriptions of the device's functions and intended use, not performance metrics, acceptance criteria, or study details.
To answer your request, I would need access to the actual validation studies or performance testing reports submitted by SyntheticMR AB for their SyMRI device, which are not present in the provided FDA communication.
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November 3, 2021
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SyntheticMR AB % Raymond Kelly Consultant Licensale Inc 3422 Leonardo Lane NEW SMYRNA LANE FL 32168
Re: K203372
Trade/Device Name: SyMRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: October 1, 2021 Received: October 4, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
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combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use 001
Indications for Use
510(k) Number (if known) K203372
Device Name
SyMRI
Indications for Use (Describe)
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a 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 adjustment. 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) |
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§ 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.