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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the IMRIS iMRI 3T V system, based on the provided text:

Acceptance Criteria and Device Performance

The FDA clearance document for the IMRIS iMRI 3T V system does not explicitly detail a table of specific numerical acceptance criteria and corresponding reported device performance values in the way one might see for an AI algorithm's sensitivity/specificity. Instead, the "acceptance criteria" are implied by the successful completion of design verification and validation tests against established standards and the confirmation of "sufficient quality for diagnostic use" by radiologists.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1 (general medical electrical equipment)	Passed
Compliance with IEC 60601-2 (particular standard for MRI)	Passed
Compliance with IEC 60601-2-33 (particular standard for MRI)	Passed
Image quality sufficient for diagnostic use	Board-certified Radiologist confirmation of sufficient quality for diagnostic use
No new safety issues related to static magnetic field effects	Verification and validation support substantial equivalence
No new safety issues related to changing magnetic field effects	Verification and validation support substantial equivalence
No new safety issues related to RF heating	Verification and validation support substantial equivalence
No new safety issues related to acoustic noise	Verification and validation support substantial equivalence
No new effectiveness issues related to specification volume	Verification and validation support substantial equivalence
No new effectiveness issues related to signal-to-noise	Verification and validation support substantial equivalence
No new effectiveness issues related to image uniformity	Verification and validation support substantial equivalence
No new effectiveness issues related to geometric distortion	Verification and validation support substantial equivalence
No new effectiveness issues related to slice profile, thickness, and gap	Verification and validation support substantial equivalence
No new effectiveness issues related to high contrast spatial resolution	Verification and validation support substantial equivalence

Study Details

Sample sizes used for the test set and data provenance:
- The document mentions "a number of V&V tests" and that images were produced and confirmed by radiologists, but it does not specify the sample size (number of images, cases, or patients) used for a distinct test set for image quality evaluation.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and their qualifications:
- The document states, "Board certified Radiologist confirmation that images produced by the device are of sufficient quality for diagnostic use."
- Number of Experts: Singular ("Radiologist") is used, implying at least one board-certified radiologist. The exact number is not provided.
- Qualifications: "Board certified Radiologist". (No specific years of experience are mentioned).
Adjudication method for the test set:
- Not specified. The document only mentions "Board certified Radiologist confirmation," but it does not detail a specific adjudication method like 2+1 or 3+1 if multiple radiologists were involved.
Multi Reader Multi Case (MRMC) comparative effectiveness study:
- No, a MRMC comparative effectiveness study was not explicitly mentioned or described. The study focuses on demonstrating the substantial equivalence of the device to its predicate through compliance with standards and expert confirmation of image quality, rather than quantifying human reader improvement with/without AI assistance. The device is an MRI system, not an AI-powered diagnostic tool for interpretation.
Standalone (algorithm only without human-in-the-loop performance) study:
- Yes, in the sense that the device's technical performance and image quality were evaluated independently. The "Board certified Radiologist confirmation" would be an assessment of the output (images) produced by the device itself, rather than an assessment of how well a human interprets those images with or without AI assistance. The device is a diagnostic imaging system, designed to produce images for human interpretation, not an AI algorithm for autonomous diagnosis.
Type of ground truth used:
- Expert Consensus/Opinion: The ground truth for image quality was established by a "Board certified Radiologist confirmation" that images were of "sufficient quality for diagnostic use." This relies on expert interpretation and judgment. There's no mention of pathology or outcomes data being used for this specific evaluation.
Sample size for the training set:
- Not applicable/Not specified. The IMRIS iMRI 3T V is a magnetic resonance diagnostic device (hardware system), not an AI algorithm that undergoes "training" on a dataset in the conventional machine learning sense for image interpretation. The "training" of the system would refer to its engineering, calibration, and adherence to established physical principles and specifications.
How the ground truth for the training set was established:
- Not applicable. As above, this is a hardware device, not an AI algorithm model that learns from a labeled training set.

Summary

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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

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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 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: LNHSecondary: LNI, MOS

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3. Predicate Devices:

Predicate Device Name	510(K)	DecisionDate	ProductCode	Manufacturer
iMRI 3T S	K133692	Feb 10, 2014	LNH	IMRIS

Reference Device Name	510(k)	DecisionDate	ProductCode	Manufacturer
MAGNETOM Vida(with syngo MR XA20A)	K192924	March 11,2020	LNH,LNI,MOS	Siemens HealthcareGmbH

Device Description: 4.

5. Indications for Use:

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.

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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 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.
1. Standards:

RecognitionNumber	Product Area	ReferenceNumber andDate	Title of Standard	StandardsDevelopmentOrganization
19-4	General II (ES/EMC)	ES606011:2005/(R)2012and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012	Medical electrical equipment- Part 1: generalrequirements for basic safetyand essential performance	ANSI /AAMI
19-8	General II (ES/EMC)	60601-1-2, Ed.4.0:2014-02	Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagneticdisturbances - Requirementsand tests	IEC
12-295	Radiology	60601-2-33, Ed.B:2015	Medical electrical equipment- Part 2-33: Particularrequirements for the basicsafety and essentialperformance of magneticresonance equipment formedical diagnosis	IEC
TIATKI'S IIVIRI 21 V
RecognitionNumber	Product Area	ReferenceNumber andDate	Title of Standard	StandardsDevelopmentOrganization
5-125	General I (QS/RM)	14971:2019	Medical devices -Application of riskmanagement to medicaldevices	ISO
5-129	General I (QS/RM)	62366-1:2015+AMD1:2020	Medical devices -Application of usabilityengineering to medicaldevices, includingAmendment 1	ANSIAAMIIEC
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 NoiseMeasurement Procedure forDiagnosingMagnetic ResonanceImagingDevices	NEMA
12-288	Radiology	MS 9:2008(R2014)	Standards PublicationCharacterization of PhasedArrayCoils for DiagnosticMagneticResonance Images	NEMA
12-195	Radiology	MS 6-2008 (R2014)	Determination of Signal-to-NoiseRatio and Image Uniformityfor Single-Channel Non-Volume Coils in DiagnosticMR Imaging	NEMA
2-220	Biocompatibility	10993- 1:2009/(R)2013	Biological evaluation ofmedical devices - Part 1:evaluation and testing withina risk management process	AAMIANSIISO

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

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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.

Regulation Number and Section

§ 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.