VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

K123091 · Imris, Inc. · MOS · Dec 27, 2012 · Radiology

Device Facts

• Record ID: K123091
• Device Name: VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
• Applicant: Imris, Inc.
• Product Code: MOS · Radiology
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended 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.

Device Story

VISIUS Wireless Coils are receive-only, three-channel flexible phased array coils for 1.5T and 3T MRI systems. Unlike predicate coils that use physical cables, these coils utilize inductive coupling to transmit signals, eliminating RF cable interfaces. Used in hospital diagnostic rooms or operating rooms during intra-operative or interventional procedures, they acquire MR images of the head and upper C-spine. The coils consist of a flexible upper coil (two elements) and a lower coil (one element). The upper coil is single-use and ETO sterilized, while the lower coil is reusable. Physicians interpret the resulting MR images to assist in diagnosis and therapy planning. Safety features include passive decoupling RF fuses. The device benefits patients by providing high-quality imaging during surgical procedures without the constraints of wired connections.

Clinical Evidence

Bench testing only. No clinical data. Testing included IEC 60601-1 and IEC 60601-2-33 compliance, MR image artifact and heating tests, and SNR/image non-uniformity measurements per NEMA MS 9-2008 and NEMA MS 6-2008. Sterilization validation performed per ANSI/AAMI/ISO 11135-1:2007. Clinical effectiveness demonstrated via clinical image comparison.

Technological Characteristics

Receive-only three-channel flexible phased array coil. Materials: Polyethylene EVA with CFMS health care fabric. Connectivity: Inductive coupling (wireless). Safety: Passive decoupling RF fuse. Standards: IEC 60601-1, IEC 60601-2-33, UL 94, NEMA MS 9-2008, NEMA MS 6-2008, ANSI/AAMI/ISO 11135-1:2007. Sterilization: ETO for flexible top coil.

Indications for Use

Indicated for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI systems to produce images of the head and upper C-spine internal structures for diagnostic and therapeutic decision-making by trained physicians.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• IMRIS HCI50 (1.5T Head Coil) and HC300 (3T Head Coil) (K103506)

Submission Summary (Full Text)

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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 Place<br>Winnipeg, Manitoba<br>Canada, R3T 1N5 |
| Registration Number: | 3003807210 |
| Contact Person: | Primary Contact:<br>Mr. Sanjay Shah<br>QA and Regulatory Engineer<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone]<br>Secondary Contact:<br>Mr. Daniel Biank<br>Director, Regulatory Affairs<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date of Summary Preparation: | November 23, 2012 |
| Device Name/ Trade Name | VISIUS Wireless Coils, 1.5T<br>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<br>CLEARANCE | MANUFACTURER |
|----------------------------------------------------------|---------------|----------------------|--------------|
| IMRIS HCI50 (1.5T Head Coil) and<br>HC300 (3T Head Coil) | K103506 | Feb 2, 2011 | IMRIS Inc. |

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# 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<br>Coils |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA 510(k) # | K102155 | Current Submission |
| Manufactured<br>by | IMRIS Inc. | IMRIS Inc. |
| Intended use<br>/Indications for<br>use | IMRIS Flex coils HC150 (1.5T Head<br>coil) and HC300 (3T Head coil) are<br>used in conjunction with respective MR<br>Systems IMRIS 1.5T MAGNETOM and<br>IMRIS 3T MAGNETOM as an imaging<br>device for clinical procedures.<br>IMRIS Flex coils produce images of the<br>human head and upper C-spine<br>internal structures.<br>When interpreted by a trained<br>physician, these images provide<br>information that can be useful in<br>determining a diagnosis and therapy<br>options. | VISIUS Wireless Coils 1.5T and 3T<br>are intended for use with IMRIS<br>(Siemens MAGNETOM) 1.5T and 3T<br>MRI Systems as an imaging device<br>for clinical procedures.<br>IMRIS VISIUS Wireless Coils<br>produce images of the head and<br>upper C-spine internal structures.<br>When interpreted by a trained<br>physician, these images provide<br>information that can be useful in<br>determining a diagnosis and therapy<br>options. |
| Where used | Hospital Diagnostic room / Operating<br>room | Hospital Diagnostic room / Operating<br>room |

# 5. COMPARISION TO PREDICATE DEVICES

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| Anatomical<br>sites | Head and upper C-spine | Head and upper C-spine |
|---------------------|------------------------|------------------------|
|---------------------|------------------------|------------------------|

.

・

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IMRIS

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

| Coils Characterists |
|---------------------|
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| VISIUS Wireless |
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| 1.5T/ 3T |
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| 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.

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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 [phone] or [phone] 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