(24 days)
No
The summary describes a traditional MRI system with a unique mechanical design for intra-operative use. There is no mention of AI/ML in the intended use, device description, or performance studies. The focus is on the hardware and its mobility.
No
The device is described as a magnetic resonance diagnostic device (MRDD) used to produce images and spectra to assist in diagnosis, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)". Additionally, it mentions that the images and/or spectra, when interpreted by a trained physician, "may assist in diagnosis." The "Device Description" also highlights that "The system retains all standard diagnostic features of an MRI system."
No
The device description explicitly states it is a "traditional MRI unit" with major components including a magnet, magnet mover system, RF coils, and other hardware, indicating it is a physical medical device, not software-only.
Based on the provided text, the IMRIS iMRI 3T V is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- IMRIS iMRI 3T V Function: The description clearly states that the IMRIS iMRI 3T V is a magnetic resonance diagnostic device (MRDD) that produces images and spectra of the internal structure and/or function of the head, body or extremities. It works by imaging the body directly, not by analyzing samples taken from the body.
- Intended Use: The intended use is for diagnostic imaging, intra-operative imaging, and interventional procedures, all of which involve imaging the patient directly.
Therefore, the IMRIS iMRI 3T V falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the inages and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.
Product codes
LNH, LNI, MOS
Device Description
The IMRIS iMRI 3T V is a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate intra-operative and multi-room use. The magnet is normally situated in a Diagnostic Room (DR) until imaging is requested. The system retains all standard diagnostic features of an MRI system in the DR. The DR is separated from the intra-operative Operating Room (OR) by sliding doors that are part of the facility structure.
The IMRIS iMRI 3T V is a tool for radiologists and surgeons, used to acquire images for diagnostic, intraoperative, or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperatively, and after wound closure. The IMRIS iMRI 3T V is based on the IMRIS iMRI 3T S cleared under 510(k) K133692 and the Siemens MAGNETOM Vida MRI system cleared under 510(k) K192924. The major components of the IMRIS iMRI 3T V system are: the Siemens MAGNETOM Vida MRI system with minor modifications, IMRIS Magnet Mover System, RF coils, Application platform, OR Table Assembly, Head fixation device, IMRISeye, and Horseshoe headrest.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Head, body or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / intra-operative and interventional procedures / multi-room suite
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
Bench Testing: The IMRIS iMRI 3T V system passed the following tests and meets product specifications: IEC 60601-1 compliance, IEC 60601-2 compliance, IEC 60601-2-33 compliance, and Board certified Radiologist confirmation that images produced by the device are of sufficient quality for diagnostic use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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August 23, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font.
Deerfield Imaging, Inc. dba IMRIS % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K212367
Trade/Device Name: IMRIS iMRI 3T V Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: July 29, 2021 Received: July 30, 2021
Dear Prithul Bom:
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
1
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-reportingcombination-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
510(k) Number (if known)
Device Name IMRIS iMRI 3T V System
Indications for Use (Describe)
The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the inages and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for IMRIS. The word "IMRIS" is in bold, black, sans-serif font. To the right of the word is a blue circle with two horizontal lines inside of it. The circle is slightly offset from the word.
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.
1. Submitter's name and address
| Submitter: | Deerfield Imaging, Inc. dba IMRIS |
|---|---|
| 5101 Shady Oak Rd | |
| Minnetonka, MN 55343 | |
| USA | |
| Establishment Registration Number: 3010326005 | |
| Date Prepared: | May 3, 2021 |
| Contact Person: | Tracy Brinkmeyer |
| VP Quality and Regulatory | |
| Telephone: | (612) 412-6330 |
| Fax: | (866) 992-3224 Email: tbrinkmeyer@imris.com |
| Alternate Contact Person: | Sanjay Shah, P. Eng. |
| Regulatory Affairs Consultant | |
| Telephone: | (612) 812-6462 |
| Email: | sshah@imris.com |
| 2. Device Name and Classification | |
|---|---|
| Trade Name: | IMRIS iMRI 3T V |
| Common Name: | MRDD (Magnetic Resonance Diagnostic Device) |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging (21 CFR §892.1000) |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
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3. Predicate Devices:
| Predicate Device Name | 510(K) | Decision
Date | Product
Code | Manufacturer |
|-----------------------|---------|------------------|-----------------|--------------|
| iMRI 3T S | K133692 | Feb 10, 2014 | LNH | IMRIS |
| Reference Device Name | 510(k) | Decision
Date | Product
Code | Manufacturer |
|----------------------------------------|---------|-------------------|-----------------|----------------------------|
| MAGNETOM Vida
(with syngo MR XA20A) | K192924 | March 11,
2020 | LNH,
LNI,MOS | Siemens Healthcare
GmbH |
Device Description: 4.
The IMRIS iMRI 3T V is a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate intra-operative and multi-room use. The magnet is normally situated in a Diagnostic Room (DR) until imaging is requested. The system retains all standard diagnostic features of an MRI system in the DR. The DR is separated from the intra-operative Operating Room (OR) by sliding doors that are part of the facility structure.
The IMRIS iMRI 3T V is a tool for radiologists and surgeons, used to acquire images for diagnostic, intraoperative, or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperatively, and after wound closure. The IMRIS iMRI 3T V is based on the IMRIS iMRI 3T S cleared under 510(k) K133692 and the Siemens MAGNETOM Vida MRI system cleared under 510(k) K192924. The major components of the IMRIS iMRI 3T V system are: the Siemens MAGNETOM Vida MRI system with minor modifications, IMRIS Magnet Mover System, RF coils, Application platform, OR Table Assembly, Head fixation device, IMRISeye, and Horseshoe headrest.
5. Indications for Use:
The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
5
Image /page/5/Picture/0 description: The image shows the logo for IMRIS. The text "IMRIS" is in bold, black font. To the right of the text is a blue circle with two horizontal white lines inside.
IMRIS iMRI 3T V
The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.
The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.
-
Comparison with Predicate Devices: 6.
The IMRIS iMRI 3T V is based on the IMRIS iMRI 3T S cleared under 510(k) K133692 and the Siemens MAGNETOM Vida MRI system cleared under 510(k) K 192924. There are no changes made to the Siemens syngo® MR software in the IMRIS iMRI 3T V system. The IMRIS iMRI 3T V intra-operative features, including the Magnet Mover Assembly, OR Patient Table, Intra-operative Coils, Application platform, IMRISeye, and Head Fixation Device are substantially equivalent to the same intra-operative features of the predicate iMRI 3T S system. The IMRIS iMRI 3T V does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting. -
- Standards:
| Recognition
Number | Product Area | Reference
Number and
Date | Title of Standard | Standards
Development
Organization |
|-----------------------|--------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 19-4 | General II (ES/
EMC) | ES606011:2005/(R)2012
and A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012 | Medical electrical equipment
- Part 1: general
requirements for basic safety
and essential performance | ANSI /AAMI |
| 19-8 | General II (ES/
EMC) | 60601-1-2, Ed.
4.0:2014-02 | Medical electrical equipment - Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic
disturbances - Requirements
and tests | IEC |
| 12-295 | Radiology | 60601-2-33, Ed.
B:2015 | Medical electrical equipment - Part 2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for
medical diagnosis | IEC |
| TIATKI'S IIVIRI 21 V | | | | |
| Recognition
Number | Product Area | Reference
Number and
Date | Title of Standard | Standards
Development
Organization |
| 5-125 | General I (QS/
RM) | 14971:2019 | Medical devices -
Application of risk
management to medical
devices | ISO |
| 5-129 | General I (QS/
RM) | 62366-1:2015+
AMD1:2020 | Medical devices -
Application of usability
engineering to medical
devices, including
Amendment 1 | ANSI
AAMI
IEC |
| 13-79 | Software/
Informatics | 62304: Edition 1.1 2015-
06 | Medical device software -
Software life cycle processes | IEC |
| 12-232 | Radiology | MS 4:2010 | Acoustic Noise
Measurement Procedure for
Diagnosing
Magnetic Resonance
Imaging
Devices | NEMA |
| 12-288 | Radiology | MS 9:2008
(R2014) | Standards Publication
Characterization of Phased
Array
Coils for Diagnostic
Magnetic
Resonance Images | NEMA |
| 12-195 | Radiology | MS 6-2008 (R2014) | Determination of Signal-to-
Noise
Ratio and Image Uniformity
for Single-Channel Non-
Volume Coils in Diagnostic
MR Imaging | NEMA |
| 2-220 | Biocompatibility | 10993- 1:2009
/(R)2013 | Biological evaluation of
medical devices - Part 1:
evaluation and testing within
a risk management process | AAMI
ANSI
ISO |
The IMRIS iMRI 3T V conforms to the following FDA recognized consensus standards:
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Image /page/6/Picture/0 description: The image shows the logo for IMRIS. The text "IMRIS" is in bold, black, sans-serif font. To the right of the text is a blue circle with two horizontal lines through it. The circle is slightly offset to the right of the text.
510(k) Premarket Notification IMBIS IMBI
8. Summary of Studies:
The IMRIS iMRI 3T V has been designed to provide MRI imaging in an intra-operative setting in the same manner as the predicate iMRI 3T S System. The IMRIS iMRI 3T V intra-operative features, including the Magnet Mover Assembly, RF Coils, Application platform, OR Patient Table, Head fixation device, IMRISeye, and Horseshoe headrest are substantially equivalent to the same intra-operative features of the
7
predicate iMRI 3T S. The IMRIS iMRI 3T V does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting.
The IMRIS iMRI 3T V does not raise any new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating, acoustic noise, effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness, and gap, or high contrast spatial resolution.
The IMRIS iMRI 3T V verification and validation support a determination of substantial equivalence.
9. Summary of non-clinical data
Design Verification and Validation Test (Bench Testing)
The IMRIS iMRI 3T V system passed the following tests and meets product specifications. IMRIS has performed a number of V&V tests as that includes the following:
- IEC 60601-1 compliance .
- IEC 60601-2 compliance
- . IEC 60601-2-33 compliance
- . Board certified Radiologist confirmation that images produced by the device are of sufficient quality for diagnostic use.
10. Conclusion:
The IMRIS iMRI 3T V has the same intended use and same basic technological characteristics as the predicate device, iMRI 3T S.. While there are some differences in technological characteristics/features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device.
The IMRIS iMRI 3T V is substantially equivalent to the predicate device iMRI 3T S (K133692) based on the included studies and analysis.