VISIUS Wireless Coils 1.5T and 3T are intended for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI Systems as an imaging device for clinical procedures.

VISIUS Wireless Coils produce images of the head and upper C-spine internal structures.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.

Device Description

The IMRIS VISIUS Wireless Coil 1.5T is a receive-only three channel flexible phased array coil. The 1.5T upper coil has two elements and the lower coil has one element. The 1.5T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 1.5T MRI system.

The IMRIS VISIUS Wireless Coils, 3T is a receive-only three channel flexible phased array coil. The 3T upper coil is has two elements and the lower coil has one element. The 3T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 3T MRI system.

The IMRIS 1.5T/3T VISIUS Wireless Coils balance surgical requirements with the MRI requirements to provide MR imaging in intra-operative and interventional procedures. The coils are used to acquire MR images of the head and upper C-spine during intra-operative finterventional procedures. The IMRIS 1.5T/3T Disposable Coils can also be used as standard diagnostic head coils for diagnostic examinations.

AI/ML Overview

This document is a 510(k) summary for MRI coils, not an AI/ML device submission. Therefore, it does not contain the information requested about acceptance criteria and study designs typically associated with AI/ML device performance evaluation, such as:

A table of acceptance criteria and reported device performance for an algorithm. Instead, it lists various engineering and safety tests for the hardware.
Sample sizes for AI algorithm test sets.
Number and qualifications of experts for ground truth establishment.
Adjudication methods.
MRMC studies for human reader improvement with AI assistance.
Standalone algorithm performance.
Ground truth types for AI models.
Training set sample sizes or how their ground truth was established.

The document describes the VISIUS Wireless Coils, 1.5T/3T, which are hardware components (receive-only phased array coils) for MRI systems. The 510(k) submission establishes their substantial equivalence to predicate devices (IMRIS HC150/HC300 coils) based on their intended use, technological characteristics, and safety and performance testing.

Here's an analysis of the provided text, focusing on what is present in terms of acceptance criteria and the study (testing) conducted for this hardware device:

Acceptance Criteria and Device Performance (Bench Testing/Verification & Validation)

The document lists several tests performed to demonstrate the safety and effectiveness of the device. These tests serve as the "acceptance criteria" for a hardware component, ensuring it meets specified engineering and safety standards.

1. Table of "Acceptance Criteria" (Tests) and "Reported Device Performance" (Outcome):

Acceptance Criteria (Test Performed)	Reported Device Performance (Outcome)
IEC 60601-1 compliance	Passed / Complies
IEC 60601-2-33 compliance	Passed / Complies
Clinical image comparison	Provided clinical images which demonstrate clinical effectiveness
MRI compatibility test (MR image artifacts test)	Tested with acceptable results / Meets product specifications (implicitly, no significant artifacts)
MRI compatibility test (MR heating test)	Tested with acceptable results (implicitly, no unsafe heating)
Surface heating (normal and single fault conditions)	Tested with acceptable results / Meets product specifications (implicitly, no unsafe heating)
Single fault condition unplugged (passive detuning test)	Tested with acceptable results
Workflow	Tested with acceptable results (implicitly, seamless integration into workflow)
Image Non-Uniformity and SNR (measured per NEMA MS 9-2008)	Measured and reported in accordance with NEMA MS 9-2008 and NEMA MS 6-2008. Tested with acceptable results.
Sterilization method validation (ANSI/AAMI/ISO 11135-1:2007)	Validated for a sterility assurance level of 10^-6
Electrical, mechanical, and flammability hazards	Complies with voluntary standards (IEC 60601-1, IEC 60601-2-33, and UL 94)

Study Information (for a Medical Device Hardware Component):

This document describes a series of non-clinical data (bench testing) and some clinical image comparison as the "study" proving the device meets its criteria for safety and effectiveness.

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

Test Set Sample Size: Not explicitly stated for each test. For "Clinical image comparison," the number of images or patients is not provided. For NEMA testing, specific phantom data would be used, but the quantity is not detailed.
Data Provenance: Not explicitly stated. Given IMRIS is a Canadian company and the device is intended for use with Siemens MAGNETOM MRI systems, it's likely testing was conducted in a controlled lab or clinical environment associated with the manufacturer or partner. It's retrospective in the sense that these are pre-market tests, but not "retrospective data" in the AI/ML context of analyzing a pre-existing dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable in the AI/ML sense. Ground truth for this hardware device involves engineering specifications, safety standards, and image quality metrics (like SNR, non-uniformity) which are objectively measured. For the "Clinical image comparison," performance would be assessed by trained physicians, as stated in the indications for use. Their number and specific qualifications are not detailed, but they would be radiologists or other physicians interpreting MRI images.

4. Adjudication Method for the Test Set:

Not Applicable for hardware testing. This concept applies to human interpretation of data, typically in AI/ML performance evaluation. The "clinical image comparison" would rely on a physician's ability to interpret the images effectively, but no formal adjudication process for a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No evidence of an MRMC study. This type of study assesses how AI assistance affects human reader performance. As this is a hardware device (MRI coil) and not an AI algorithm, such a study would not be relevant or described in the 510(k) for this product aspect. The focus is on the coil's ability to produce diagnostically usable images.

6. Standalone Performance:

Standalone (algorithm only) performance is not applicable. This device is a passive hardware component (a receive-only coil). Its "performance" is inherently tied to being used with an MRI system. The NEMA standard measurements (SNR, non-uniformity) are a form of standalone technical performance for the coil's imaging capabilities, but not an "algorithm-only" performance as in AI.

7. Type of Ground Truth Used:

Engineering Specifications / Objective Measurements: For the majority of tests (IEC standards, heating, electrical, flammability, NEMA image quality metrics), the "ground truth" is defined by compliance to established engineering standards, physical measurements, and performance benchmarks.
Clinical Efficacy (Implicit): For "clinical image comparison," the ground truth is implicitly the ability of the images produced by the new coils to be diagnostically equivalent or superior to those from the predicate coils, as assessed by trained physicians. This is not "pathology" or "outcomes data" in the typical sense for a diagnostic device, but rather the diagnostic quality of the images themselves.

8. Sample Size for the Training Set:

Not Applicable. This is a hardware device. It does not involve a training set as an AI/ML model would. The design and manufacturing processes are refined through engineering, prototyping, and testing (V&V), not "training."

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no AI/ML training set, this question is irrelevant to the described device.

Summary

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510(K) Summary for VISIUS Wireless Coils, 1.5T/3T

123091

510(k) SUMMARY FOR VISIUS WIRELESS COILS 1.5T/3T

(As required by 21 CFR 807.92)

DEC 2 7 2012

1. GENERAL INFORMATION

Establishment:	IMRIS Inc.
Address:	100-1370 Sony PlaceWinnipeg, ManitobaCanada, R3T 1N5
Registration Number:	3003807210
Contact Person:	Primary Contact:Mr. Sanjay ShahQA and Regulatory EngineerEmail: sshah@imris.comPhone: 1-204-480-7070Fax: 1-204-480-7071Secondary Contact:Mr. Daniel BiankDirector, Regulatory AffairsEmail: dbiank@imris.comPhone: 1-952-358-7046Fax: 1-204-480-7071
Date of Summary Preparation:	November 23, 2012
Device Name/ Trade Name	VISIUS Wireless Coils, 1.5TVISIUS Wireless Coils, 3T
Classification Name:	Magnetic resonance diagnostic device.
Classification Panel:	Radiology
Classification (CFR section):	21 CFR 892.1000
Class:	Class II
Product Code:	MOS

2. PREDICATE DEVICES

IMRIS 1.5T/3T VISIUS Wireless Coils are substantially equivalent to the IMRIS HC150/HC300 coils.

NAME OF THE DEVICE	510(K) NUMBER	DATE OFCLEARANCE	MANUFACTURER
IMRIS HCI50 (1.5T Head Coil) andHC300 (3T Head Coil)	K103506	Feb 2, 2011	IMRIS Inc.

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IMRIS

------ A.1

3. DEVICE DESCRIPTION

4. INDICATIONS FOR USE

VISIUS Wireless Coils 1.5T and 3T are intended for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI Systems as an imaging device for clinical procedures.

VISIUS Wireless Coils produce images of the head and upper C-spine internal structures. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.

Characteristic	IMRIS HC 150 / HC 300 Coils	IMRIS 1.5T/3T VISIUS WirelessCoils
FDA 510(k) #	K102155	Current Submission
Manufacturedby	IMRIS Inc.	IMRIS Inc.
Intended use/Indications foruse	IMRIS Flex coils HC150 (1.5T Headcoil) and HC300 (3T Head coil) areused in conjunction with respective MRSystems IMRIS 1.5T MAGNETOM andIMRIS 3T MAGNETOM as an imagingdevice for clinical procedures.IMRIS Flex coils produce images of thehuman head and upper C-spineinternal structures.When interpreted by a trainedphysician, these images provideinformation that can be useful indetermining a diagnosis and therapyoptions.	VISIUS Wireless Coils 1.5T and 3Tare intended for use with IMRIS(Siemens MAGNETOM) 1.5T and 3TMRI Systems as an imaging devicefor clinical procedures.IMRIS VISIUS Wireless Coilsproduce images of the head andupper C-spine internal structures.When interpreted by a trainedphysician, these images provideinformation that can be useful indetermining a diagnosis and therapyoptions.
Where used	Hospital Diagnostic room / Operatingroom	Hospital Diagnostic room / Operatingroom

5. COMPARISION TO PREDICATE DEVICES

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. . . . . . . . . . . .

Anatomicalsites	Head and upper C-spine	Head and upper C-spine
---------------------	------------------------	------------------------

・

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IMRIS

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE: (807.92
(A) (6))

Coils Characterists








VISIUS Wireless



1.5T/ 3T

CHARACTERISTIC	HC150	HC300	VISIUS WIRELESS COILS 1.5T THIS SUBMISSION	VISIUS WIRELESS COILS 3T THIS SUBMISSION	COMPARISION
FDA 510(k) #	K103506	K103506
MRI system Compatibility	IMRIS 1.5T MRI system (Siemens MAGNETOM 1.5T MRI scanner)	IMRIS 3T MRI system (Siemens MAGNETOM 3T MRI scanner)	IMRIS 1.5T MRI system (Siemens MAGNETOM 1.5T MRI scanner)	IMRIS 3T MRI system (Siemens MAGNETOM 3T MRI scanner)	Same
Coil Type	Receive-only eight channel phased array coil	Receive-only eight channel phased array coil	Receive-only three channel phased array coil	Receive-only three channel phased array coil	Same Phase array coil
System connection	The coil plugs into the MRI System	The coil plugs into the MRI System	Inductive Coupling	Inductive Coupling	Different
RF Cable Interface	Interface Cable with Insulated Cable Traps	Interface Cable with Insulated Cable Traps	No Cable	No Cable	Different
Tune and Match	No tune, no match	No tune, no match	No tune, no match	No tune, no match	Same
Safety features	Active and Passive Decoupling RF Fuse	Active and Passive Decoupling RF Fuse	Passive Decoupling RF Fuse	Passive Decoupling RF Fuse	Same
Coil Enclosure Material and design	Polyurethane Plastic, Vinyl coated closed cell foam	Polyurethane Plastic, Vinyl coated closed cell foam	Polyethylene EVA with CFMS health care fabric	Polyethylene EVA with CFMS health care fabric	Different
Cleaning and Sterilization Reusable	Cleaning Yes	Cleaning Yes	Flexible Top Coil: ETO Sterilized Bottom coil: Cleaned	Flexible Top Coil: ETO Sterilized Bottom coil: Cleaned Top Coil: No, single use. Bottom Coil: Yes	Same Different Different

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7. SUMMARY OF NON-CLINICAL DATA

Design Verification and Validation Test (Bench Testing)

The IMRIS 1.5T/3T VISIUS Wireless Coils passed the following tests and meets product specifications.

IMRIS has performed a number of V&V tests. The main tests include

IEC 60601-1 compliance .
IEC 60601-2-33 compliance ●
Clinical image comparison ●
MRI compatibility test (MR image artifacts test. MR heating test). .
Surface heating (normal and single fault conditions) .
Single fault condition unplugged (passive detuning test) .
Workflow .
The 1.5T/3T VISIUS Wireless Coils Image Non-Uniformity and SNR was measured and is ◆ reported in accordance with NEMA MS 9-2008 Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images. The NEMA MS 9-2008 references the ALTERNATE MEASUREMENT PROCEDURE as described in NEMA MS 6-2008
The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO . 11135-1:2007, Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. A sterility assurance level of 10° has been validated for this product

The IMRIS 1.5T/3T VISIUS Wireless Coils are tested for electrical, mechanical, and flammability hazards. The IMRIS 1.5T/3T VISIUS Wireless Coils complies with voluntary standards (IEC 60601-1, IEC 60601-2-33, and UL 94). The 1.5T/3T VISIUS Wireless Coils provided clinical images which demonstrate the clinical effectiveness of the 1.5T/3T Disposable Craniotomy Coils. The 1.5T/3T VISIUS Wireless Coils are tested for MR image artifacts and surface heating test. The 1.5T/3T VISIUS Wireless Coils SNR and Image non-uniformity are tested according to NEMA standards. The tests outlined above have been executed with acceptable results. Performance data demonstrate safety and effectiveness of the IMRIS 1.5T/3T Disposable Craniotomy Coils.

8. CONCLUSION

The IMRIS 1.5T/3T VISIUS Wireless Coils have the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the IMRIS 1.5T/3T VISIUS Wireless Coils with the new characteristics.

The IMRIS 1.5T/3T V/SIUS Wireless Coils verification/validation results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate device, HC150/HC300 coils.

Page 5 of 5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 27, 2012

Sanjay Shah IMRIS. Inc 100-1370 Sony Place Winnipeg, Manitoba CANADA, R3T 1N5

Re: K123091

Trade/Device Name: VISIUS Wireless Coils, 1.5T, VISIUS Wireless Coils, 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: December 7, 2012 Received: December 11, 2012

Dear Mr. Shah:

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.

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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/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. 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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IMRIS

Indications for Use

510(k) Number (if known): K123091

Device Name: VISIUS Wireless Coils 1.5T / VISIUS Wireless Coils 3T

Indications For Use:

VISIUS Wireless Coils 1.5T and 3T are intended for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI Systems as an imaging device for clinical procedures.

VISIUS Wireless Coils produce images of the head and upper C-spine internal structures.

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael (Division Sign Off)ara

Davision of Hadlologica

Office of in Vitto Diagriostics and Ra

Page 1 of _

510(k) K123091

IMRIS VISIUS Wireless Coils 1.5T and 3T

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.