The iMRX system uses the Artis zee family of dedicated angiography systems for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the iMRX system include cardiac angiography, neuro-angiography, general angiography, rotational angiography, operating room angiography and whole body radiographic/fluoroscopic procedures. The iMRX system can also support the acquisition of position triggered imaging for spatial data synthesis.

The iMRX system uses the IMRIS family of Intra-operative MRI systems indicated for use as a magnetic resonance diagnostic device (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the head and whole body. Depending on the region of interest, contrast agents may be used. These images and i or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The iMRX 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 iMRX system may also be used for imaging in a multi-room suite.

Device Description

The iMRX system is an integrated configuration combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging. The iMRX system is the integration of a Siemens Artis zee family (biplane or floor mounted single plane) and the IMRISheuro System (Neuro III-SV or Neuro II-SE system). The iMRX system is a solution providing MRI scanning capabilities in the Angiography room while retaining all the functionality of Siemens Artis zee system. The iMRX system includes 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 imaging in multiple rooms. It provides imaging to support intra-operative and interventional capability in the operating room and angio room, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room.

AI/ML Overview

The provided 510(k) summary for the iMRX system is a premarket notification for a medical device and therefore does not contain a study with acceptance criteria and reported device performance in the typical sense of a clinical trial or performance study comparing the device against a defined metric.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of defining specific performance metrics (like accuracy, sensitivity, specificity) and then conducting a study to meet those, the manufacturer aims to show that the new device is as safe and effective as devices already on the market.

Therefore, many of the requested points about acceptance criteria, sample size, ground truth, and expert adjudication are not applicable to this type of regulatory submission. The "study" here is primarily a technical comparison and safety assessment against the predicate devices.

Here's an breakdown based on the provided document, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Demonstrated Equivalence to Predicates)	Reported Device Performance (Demonstrated Equivalence)
- Retains all safety features of Siemens Artis zee system (visual & audible warnings).	- "The iMRX system retains all Siemens Artis zee system safety features including visual and audible warnings." - "Testing has been completed to verify the equivalence of iMRX to the Siemens Artis zee system. This assures that the performance of this device can be considered safe and effective with respect to the currently available Siemens Artis zee system."
- Adherence to recognized and established industry practice for electrical, mechanical, and radiation hazards.	- "IMRIS adheres to recognized and established industry practice, and all equipment complies with standard performance testing."
- Intra-operative features (MRI system, Magnet Mover Assembly, OR Patient Table, Intra-operative Coils, Head Fixation Device) are substantially equivalent to predicate Neuro III-SV and Neuro II-SE.	- "The iMRX intra-operative features... are substantially equivalent to the same intra-operative features of the predicate Neuro III-SV and predicate Neuro II-SE."
- Does not raise new safety or effectiveness issues related to a moving MRI system in an intra-operative setting.	- "The iMRX does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting."
- MRI imaging system's software and hardware substantially equivalent to Neuro III-SV (based on Siemens MAGNETOM Verio 3T MRI) and Neuro II-SE (based on Siemens MAGNETOM Espree MRI).	- "The iMRX MRI imaging system's software and hardware are substantially equivalent to the Neuro III-SV... System and the Neuro II-SE... system."
- Does not raise new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating, or acoustic noise.	- "The iMRX does not raise any new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating or acoustic noise..."
- Does not raise new effectiveness issues related to specification volume, signal to noise, image uniformity, geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution as compared to IMRISneuro systems.	- "...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 of iMRX to the IMRISneuro (Neuro III-SV/Neuro II-SE) system. This assures that the performance of this device can be considered safe and effective with respect to the currently available IMRISneuro system."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission does not describe a test set with patient data for clinical performance evaluation. The "testing" mentioned refers to engineering and quality assurance tests to ensure the integrated system functions as intended and meets safety standards, similar to its predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As no clinical test set requiring ground truth labeling is described, no experts for this purpose were involved in the context of this submission. The "trained physician" mentioned in the Indications for Use refers to the end-users interpreting the images, not experts establishing ground truth for a study dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set requiring expert adjudication is described in this submission.

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 device is an imaging system (MR and X-ray Angiography), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

Not Applicable. This is an integrated imaging system, not an algorithm, so standalone performance in that context is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. Since no clinical performance study for a diagnostic claim is presented, no ground truth type is specified. The assessment is based on technical equivalence to established predicate devices.

8. The sample size for the training set

Not Applicable. This is an integrated imaging system, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary

{0}------------------------------------------------

510(k) Summary for iMRX system

510(k) SUMMARY FOR iMRX SYSTEM

1. GENERAL INFORMATION

IMRIS

Establishment:	IMRIS Inc.
Address:	100-1370 Sony PlaceWinnipeg, ManitobaCanada, R3T 1N5	SEP - 2 2009
Registration Number:	3003807210
Contact Person:	Mrs. B. NewisQuality Assurance Representativeemail: bnewis@imris.comPhone: 1-204-480-7070 ext.7043Fax: 1-204-480-7071
Date of Summary Preparation:	April 15, 2009
Device Name:	iMRX
Trade Name:	IMRISnv / IMRIScardio
Classification Name:	Angiography X-ray system, Magnetic ResonanceDiagnostic Device (MRDD)
Classification Panel:	Radiology
Classification (CFR section):	21 CFR 892.1600, 21 CFR 892.1000
Class:	Class II
Product Code:	IZI (Angiography x-ray system), LNH (Magnetic ResonanceImaging System)

2. INTENDED USE OF THE DEVICE

iMRX is an integrated imaging system combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging.

The iMRX 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 iMRX system may also be used for imaging in a multi-room suite.

{1}------------------------------------------------

3. INDICATIONS FOR USE

The iMRX system is indicated for use for the head and whole body.

4. DEVICE DESCRIPTION

5. SUBSTANTIALLY EQUIVALENT

The iMRX system is substantially equivalent to the following cleared medical devices.

Predicate Device name	510(k) Number	FDA Clearance date
Siemens Artis zee / zeego	K073290	Feb 11, 2008
IMRIS Neuro III-SV Intra-operative MRI System	K083137	Dec 16, 2008
IMRIS Neuro II-SE Intra-operative MRI System	K061916 K071099	Aug 11, 2006May 22, 2007

6. SAFETY & EFFECTIVENESS

The iMRX has been designed to provide MRI imaging in an intra-operative setting in the same manner as the predicate IMRISneuro (Neuro II-SE) Systems and to provide a complete range of angiography applications in the same manner as the predicate Siemens Arts zee system.

The iMRX system retains all Siemens Artis zee system safety features including visual and audible warnings. To minimize electrical, mechanical and radiation hazards, IMRIS adheres to recognized and established industry practice, and all equipment complies with standard performance testing. Testing has been combleted to verify the equivalence of iMRX to the Siemens Artis zee system. This assures that the performance of this device can be considered safe and effective with respect to the currently available Siemens Artis zee system.

The iMRX intra-operative features, including Siemens MRI system, Magnet Mover Assembly, OR Patient Table, Intra-operative Coils and Head Fixation Device are substantially equivalent to the same intra-operative features of the predicate Neuro III-SV and predicate Neuro II-SE. The iMRX does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting.

The iMRX MRI imaging system's software and hardware are substantially equivalent to the Neuro III-SV (based on the Siemens MAGNETOM Verio 3T MRI) System and the Neuro II-SE (based on the Siemens MAGNETOM Espree MRI) system. The iMRX does 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 of iMRX to the IMRISneuro (Neuro III-SV/Neuro II-SE) system. This assures that the performance of this device can be considered safe and effective with respect to the currently available IMRISneuro system.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle in flight, rendered in blue. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

NOV 22 2009

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

IMRIS, Inc. % Mr. Thomas M. Tsakeris President Devices & Diagnostic Consulting Group, Inc. 16809 Briardale Road ROCKVILLE MD 20855

Re: K091166

Trade/Device Name: iMRX Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and IZI Dated: August 6, 2009 Received: August 10, 2009

Dear Mr. Tsakeris:

This letter corrects our substantially equivalent letter of September 2, 2009.

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 (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.

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

{3}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ff CF CFR Part 801), please
the Center for Devices and Podic locked on infrices/CDRH/CDRHOffices/ucm11 15809.htm fo the Center for Devices and Radiological Health 's (CDRH) incessurem i 13809.htm for the note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pat 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/cdrisms.net/member for the MDR regil 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 the (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Lamme M. Morsul

Janine M. Morsul

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Device Name:

K091166
iMRX

Indications For Use:

iMRX is an integrated imaging system combining X-ray Angiography and Magnetic Resonance for interventional, diagnostic, and intra-operative imaging.

The iMRX system uses the Artis zee family of dedicated angiography systems for single and biplane diagnostic imaging that were were including, but not limited to, pediatric and obese patients. Procedures that can be performed with the MRX system include cardiac angiography, newnangiography, general angiography, rotational angiography, operating room angiography, neuro, body radiographic fluoroscopic procedures. The iMRX system can also support the acquisition of position triggered imaging for spatial data synthesis.

The iMRX system uses the IMRIS family of Intra-operative MRI systems indicated for use as a magnetic resonance diagnostic device (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and for spectra, and that display the internal structure and / or function of the head and whole body. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The iMRX 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 iMRX system may also be used for imaging in a multi-room suite.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic

510(k) Number K091166

AND/OR

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.