The iMRI 1.5T A and 3T S are 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.

The iMRI 1.5T A and 3T S systems 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 iMRI 1.5T A and 3T S MRI systems may also be used for imaging in a multi-room suite.

Device Description

The IMRIS Intraoperative MRI systems (iMRI 1.5T A and iMRI 3T S) are 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 until imaging is requested. For Diagnostic room purposes, the system retains the standard diagnostic features of an MRI system. The diagnostic room is separated from the intra-operative suite by sliding doors that are part of the facility structure.

The iMRI system (1.5T A/3T S) is a tool for radiologists and surgeons, used to acquire images for diagnostic, intra-operative or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperative and after wound closure. The iMRI 1.5T A is based on the IMRIS Neuro II-SE predicate cleared under 510(k) K071099 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The iMRI 3T S is based on the IMRIS Neuro III-SV cleared under 510(k) K083137 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The major components of the iMRI systems are: the Siemens MAGNETOM MRI system with minor modifications; IMRIS Magnet Mover System, OR Table, RF coils and 3-pin head fixation device.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the IMRIS iMRI 1.5T A and 3T S systems, which are Magnetic Resonance Diagnostic Devices (MRDD). This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards. It does not describe a study involving specific acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) using a clinical dataset and expert review, as would be typical for an AI-powered diagnostic device.

Instead, the "study" described is a verification and validation process primarily focused on demonstrating safety, effectiveness, and substantial equivalence to existing MRI systems.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from standards and equivalence claims)	Reported Device Performance (as stated in the document)
Compliance with IEC 60601-1 (General Safety)	Passed IEC 60601-1 compliance tests.
Compliance with IEC 60601-1-2 (EMC)	Passed IEC 60601-1-2 compliance tests.
Compliance with IEC 60601-2-33 (MR Equipment Safety)	Passed IEC 60601-2-33 compliance tests.
Compliance with IEC 62304 (Medical Device Software Life Cycle)	Mentioned as a standard followed.
Substantial Equivalence to Predicate iMRI Systems	The iMRI 1.5T A and 3T S are "substantially equivalent" to their respective predicate devices (IMRIS Neuro II-SE and Neuro III-SV) in intra-operative features.
Substantial Equivalence to Siemens Reference Devices (Software/Hardware)	The iMRI imaging system's software and hardware are "substantially equivalent" to the Siemens MAGNETOM Skyra and Aera. No changes to Siemens' syngo® MR software.
No new safety issues (static magnetic field, changing magnetic field, RF heating, acoustic noise)	The iMRI systems "do not raise any new safety issues" related to these factors.
No new effectiveness issues (specification volume, signal to noise, image uniformity, geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution)	The iMRI systems "do not raise any new effectiveness issues" related to these factors when compared to reference systems.
Verification and Validation of Intra-operative Operation	Testing completed to "verify the safe and effective intra-operative operation" of the iMRI systems.
Meeting Product Specifications	Passed all listed tests and "meets product specifications."

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical image data for diagnostic performance evaluation, nor does it mention data provenance (country of origin, retrospective/prospective). The "Sample clinical images" mentioned under "Design Verification and Validation Test (Bench Testing)" are likely for qualitative visual assessment and system validation, not for quantitative diagnostic performance metrics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The filing does not detail a study involving expert-established ground truth for a test set of patient cases. The evaluation is focused on engineering and system performance standards, and comparison to predicate devices, rather than the diagnostic interpretive accuracy of the images by human readers.

4. Adjudication Method for the Test Set

Not applicable, as there is no specific test set requiring expert adjudication for establishing ground truth on diagnostic findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This 510(k) pertains to an MRI system itself, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a diagnostic imaging system, not an algorithm.

7. The Type of Ground Truth Used

For the safety and performance evaluations, the "ground truth" used is adherence to established engineering and medical device standards (IEC 60601 series, IEC 62304), and comparison against the technical specifications and performance characteristics of predicate and reference MRI devices for substantial equivalence. "Sample clinical images" were part of the V&V, implying visual assessment against expected image quality, but not a formally established clinical ground truth from pathology or outcomes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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IMRIS O

iMRI 1.5T A and 3T S

510(k) Premarket Notification

、

510(k) Summary

FEB 1 0 2014

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.

Submitter:	IMRIS, Inc.
	5101 Shady Oak Rd
	Minnetonka, MN 55343
	USA
	Establishment Registration Number: Not assigned yet
Contact Person:	Sanjay Shah, P.Eng.
	Manager, Regulatory Affairs
Telephone:	763.203.6380
Fax:	204.480.7071
Email:	sshah@imris.com
Alternate Contact Person:	Daniel Biank, JD, MEng, PE, RAC
	Vice President, Regulatory Affairs
Telephone:	763.203.6310
Fax:	204.480.7071
Email:	dbiank@imris.com
Date Prepared:	January 9, 2014
Device Name
Trade Name:	iMRI 1.5T A and iMRI 3T S
Common Name:	MRDD (Magnetic Resonance Diagnostic Device)
Classification Name:	System, Nuclear Magnetic Resonance Imaging (21 CFR §892.1000)
Product Code:	LNH

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Predicate Devices:

iMRI 1.5T A system is substantially equivalent to the IMRIS Neuro II-SE MRI system. Siemens AGNETOM Aera is a reference device.

510(k)	Decision Date	Device Name	Manufacturer
K071099	May 22, 2007	Neuro II-SE Intra-operative MagneticResonance Imaging System	IMRIS Inc.
K101347	Oct 1, 2010	MAGNETOM Aera (Reference Device)	Siemens Medical Solutions USA, Inc.

iMRI 3T System is substantially equivalent to the IMRIS Neuro III-SV MRI system. Siemens MAGNETOM Skyra is a reference device.

510(k)	Decision Date	Device Name	Manufacturer
K083137	Dec 16, 2008	Neuro III-SV Intra-operative MagneticResonance Imaging System	IMRIS Inc.
K101347	Oct 1, 2010	MAGNETOM Skyra (Reference Device)	Siemens Medical Solutions USA, Inc.

Device Description:

Intended 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

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IMRIS O

parameters derived from the images and/or spectra when interpreted by trained physician yield information that may assist in diagnosis.

The iMRI 1.5T A and 3T S MRI systems may also be used for imaging in a multi-room suite.

Comparison with Predicate Devices:

The iMRI 1.5T A is based on the IMRIS Neuro II-SE predicate cleared under 510(k) K071099 and the iMRI 3T S is based on the IMRIS Neuro III-SV cleared under 510(k) K083137. The reference devices Siemens MAGNETOM Aera/Skyra MRI system are cleared under 510(k) K101347. There are no changes made to the Siemens' syngo® MR software in the iMRI systems. The iMRI 1.5T A/JT S MRI imaging system's software is the same as the Siemens MAGNETOM Aera/Skyra MRI System cleared under 510(k) K101347 and K121434. The iMRI 1.5T A/3T S intra-operative features, including the Magnet Mover Assembly, Intraoperative Coil and Head Fixation Device are substantially equivalent to the same intra-operative features of the predicate Neuro III-SV. The iMRI system does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting.

Recognition#	Identifier	Title
5-4	IEC 60601-1:1988+A1:1991+A2:1995	Medical Electrical Equipment - Part 1: GeneralRequirements for Safety, 1988; Amendment 1, 1991-11,Amendment 2, 1995
5-77	AAMI / ANSI ES60601-1:2005/C1:2009/A2:2010	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD).
5-53	IEC 60601-1-2:2007	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: Electromagneticcompatibility - Requirements and Tests (Edition 3)
12-207	IEC 60601-2-33 : 2010	MEDICAL ELECTRICAL EQUIPMENTPart 2: Particular requirements for the safety ofmagnetic resonance equipment for medical diagnosis
13-8	IEC 62304:2006	Medical device software - Software life cycle processes

Standards:

Summary of Studies:

The iMRI systems (1.5T A and 3T S) have been designed to provide MRI imaging in an intra-operative setting in the same manner as the predicate Neuro systems (Neuro II-SV and Neuro II-SE System). The iMRI 3T S/1.5T A intra-operative features, including the Magnet Mover Assembly, OR Patient Table, Intraoperative Coil and Head Fixation Device are substantially equivalent to the same intra-operative features

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Image /page/3/Picture/0 description: The image shows the word "IMRIS" followed by a circle. The circle has two horizontal lines inside of it. The text and the circle are in black and white.

Image /page/3/Picture/1 description: The image shows the text "iMRI 1.5T A and 3T S" on the bottom left. On the top right, there is a handwritten "K133692" and "Page 4 of 4". The text appears to be part of a document or report related to iMRI scans.

510(k) Premarket Notification

of the predicate Neuro III-SV/ Neuro II-SE. The iMRI systems (1.5T A and3T S) do not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting,

The iMRI systems (1.5T A and 3T S) MRI imaging system's software and hardware are substantially equivalent to the Siemens MAGNETOM Skyra and Aera. The iMRI systems (1.5T A and 3T S) do not raise any new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating or acoustic noise or effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution.

Testing has been completed to verify the equivalence to the Siemens MAGNETOM Skyra and Aera System and to verify the safe and effective intra-operative operation of the iMRI systems (1.5T A and 3T S),

iMRI systems (1.5T A and 3T S) verification and validation supports a determination of substantial equivalence.

Summary of non-clinical data

Design Verification and Validation Test (Bench Testing)

The IMRIS iMRI systems passed the following tests and meets product specifications. IMRIS has performed a number of V&V tests as described in part 6 of this submission. The tests include

IEC 60601-1 compliance
. IEC 60601-2 compliance
. IEC 60601-2-33 compliance
Sample clinical images

Conclusion:

The iMRI 1.5T A is substantially equivalent to the predicate the IMRIS Neuro II-SE system (K071099) and the iMRI 3T S is substantially equivalent to the IMRIS Neuro III-5V system (K083137), based on the included studies and analysis.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002

February 10, 2014

IMRIS, INC. C/O MARK JOB 1394 25TH STREET, NW BUFFALO MN 55313

Re: K133692

Trade/Device Name: iMRI 1.5TA and iMRI 3.0TS Regulation Number: 21 CFR 892.1000 Regulation Name: magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: January 10, 2014 Received: January 14, 2014

Dear Mr. Job:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll

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Page 2-Mr. Job

free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.hun.

Sincerely yours,

Archant D. O'Hara

For

Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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iMRI 1.5T A and 3T S

510(k) Premarket Notification

Indications for Use

K133692 510(k) Number (if known):

Device Name: iMRI 1.5T A and 3T S

Indications for Use:

The iMRI 1.5T A and 3T S MRI systems may also be used for imaging in a multi-room suite.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use _

(21 CFR 801 Subpart C) ·

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) and Radiological Health (OIR)

AND/OR

Michael D. O'Hara

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

133692 510(k)

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Confidential

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.