Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and performance of the MRI coils for image acquisition, with no mention of AI/ML for image processing, analysis, or interpretation.

Therapeutic

No.
The device is described as an "imaging device" used to "produce images" and provide "information that can be useful in determining a diagnosis and therapy options," but it does not directly administer therapy itself.

Diagnostic

Yes

This device is for imaging, and the "Intended Use / Indications for Use" section states that the images "provide information that can be useful in determining a diagnosis and therapy options." Additionally, the "Device Description" states that the coils "can also be used as standard diagnostic head coils for diagnostic examinations."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "receive-only three channel flexible phased array coil" and mentions physical components like "elements." The performance studies also detail testing related to electrical, mechanical, and flammability hazards, as well as physical properties like surface heating and MR image artifacts, which are characteristic of hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the device is an "imaging device for clinical procedures" and produces "images of the head and upper C-spine internal structures." These images are then "interpreted by a trained physician" to provide information for diagnosis and therapy options. This describes an in vivo imaging device, not an in vitro diagnostic device.
Device Description: The description details the physical components of the coils used for acquiring MRI images. This aligns with an imaging device.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on samples outside of the body, which are hallmarks of IVD devices.

Therefore, the VISIUS Wireless Coils are an in vivo imaging device used in conjunction with an MRI system, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MOS

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MR images

Anatomical Site

head and upper C-spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician, Hospital Diagnostic room / Operating room

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K103506

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 Place
Winnipeg, Manitoba
Canada, R3T 1N5
Registration Number:	3003807210
Contact Person:	Primary Contact:
Mr. Sanjay Shah
QA and Regulatory Engineer
Email: sshah@imris.com
Phone: 1-204-480-7070
Fax: 1-204-480-7071
Secondary Contact:
Mr. Daniel Biank
Director, Regulatory Affairs
Email: dbiank@imris.com
Phone: 1-952-358-7046
Fax: 1-204-480-7071
Date of Summary Preparation:	November 23, 2012
Device Name/ Trade Name	VISIUS Wireless Coils, 1.5T
VISIUS 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 OF
CLEARANCE | MANUFACTURER |
|----------------------------------------------------------|---------------|----------------------|--------------|
| IMRIS HCI50 (1.5T Head Coil) and
HC300 (3T Head Coil) | K103506 | Feb 2, 2011 | IMRIS Inc. |

1

IMRIS

------ A.1

3. 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.

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 Wireless
Coils |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA 510(k) # | K102155 | Current Submission |
| Manufactured
by | IMRIS Inc. | IMRIS Inc. |
| Intended use
/Indications for
use | IMRIS Flex coils HC150 (1.5T Head
coil) and HC300 (3T Head coil) are
used in conjunction with respective MR
Systems IMRIS 1.5T MAGNETOM and
IMRIS 3T MAGNETOM as an imaging
device for clinical procedures.
IMRIS Flex coils produce images of the
human 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. | 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.
IMRIS 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. |
| Where used | Hospital Diagnostic room / Operating
room | Hospital Diagnostic room / Operating
room |

5. COMPARISION TO PREDICATE DEVICES

2

Image /page/2/Picture/0 description: The image contains the word "IMRIS" in bold, black font. The letters are large and clearly visible against a white background. There is some space after the word, and then a small black dot.

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

| Anatomical

sites	Head and upper C-spine	Head and upper C-spine
---------------------	------------------------	------------------------

.

・

3

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

Page 4 of 5

4

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

5

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.

6

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

7

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