NEURO III-SV

K083137 · Imris, Inc. · LNH · Dec 16, 2008 · Radiology

Device Facts

• Record ID: K083137
• Device Name: NEURO III-SV
• Applicant: Imris, Inc.
• Product Code: LNH · Radiology
• Decision Date: Dec 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Neuro III-SV Intra-operative MRI system is 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 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 Neuro III-SV 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 Neuro III-SV may also be used for imaging in a multi-room suite.

Device Story

Neuro III-SV is a traditional MRI system mounted on an overhead rail for intra-operative use; includes MRI assembly, magnet mover, OR table, head fixation device, and intra-operative coil. System captures magnetic resonance signals to produce cross-sectional images and spectra of head and whole body. Operated by trained physicians in OR or multi-room suites. Provides diagnostic information to assist clinical decision-making during surgery. Intra-operative mobility allows real-time imaging without moving patient from sterile field. Substantially equivalent to predicate IMRIS and Siemens systems regarding safety, effectiveness, and imaging performance.

Clinical Evidence

Bench testing only. Verification testing performed to confirm equivalence to Siemens MAGNETOM Verio system and to validate safe/effective intra-operative operation of the Neuro III-SV system components.

Technological Characteristics

Traditional MRI system with overhead rail integration. Includes diagnostic RF coils, magnet mover assembly, OR table, head fixation device, and intra-operative coil. Connectivity supports multi-room suite imaging. Software equivalent to Siemens MAGNETOM Verio. Operates as MRDD under 21 CFR 892.1000.

Indications for Use

Indicated for head and whole-body diagnostic imaging in patients requiring MRDD assessment, including intra-operative and interventional procedures using MR-safe or MR-conditional devices.

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

• Neuro II-SE System
• Neuro II-S
• Siemens MAGNETOM Verio 3T MRI System

Submission Summary (Full Text)

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K0t3137

#### 510(k) SUMMARY APPENDIX F

# F.1 GENERAL INFORMATION

| Establishment: | IMRIS Inc. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 100-1370 Sony Place<br>Winnipeg, Manitoba<br>Canada<br>R3T 1N5 |
| Registration<br>Number: | 3003807210 |
| Contact Person: | Mrs. B. Newis<br>Quality Assurance Representative<br>email: [e-mail]<br>Phone: [phone] ext.7043<br>Fax: [phone] |
| Date of Summary<br>Preparation: | September 30, 2008 |
| Device Name: | Neuro III-SV Intra-operative Magnetic Resonance Imaging<br>System |
| Trade Name: | Neuro III-SV |
| Common Name: | MRDD (Magnetic Resonance Diagnostic Device) |
| Proprietary name: | Neuro III-SV |
| Classification<br>name: | System, Nuclear Magnetic Resonance Imaging |
| Classification: | 21 CFR 892.1000 |
| Class: | Class II |
| Product Code: | LNH (Magnetic Resonance Imaging System) |
| Performance<br>Standards: | None established under Section 514 of the Food, Drug and<br>Cosmetic Act |

# F.2 INDICATIONS FOR USE

The IMRIS Neuro III-SV MRI system is indicated for use for the head and whole body.

# F.3 INTENDED USE OF THE DEVICE

The Neuro III-SV Intra-operative MRI system is 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 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 Neuro III-SV 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 Neuro III-SV may also be used for imaging in a multi-room suite.

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# F.4 DEVICE DESCRIPTION

The Neuro III-SV system is a traditional MRI unit that has been suspended on an overhead rail system to facilitate intra-operative use. The main components of the Neuro III-SV system are the MRI system assembly (including diagnostic RF coils), the magnet mover system, the OR Table assembly, Head Fixation Device and the Intra-operative Coil.

# F.5 SAFETY AND EFFECTIVENESS

The Neuro III-SV has been designed to provide MRI imaging in an intra-operative setting in the same manner as the predicate Neuro II-SE System and predicate Neuro II-S devices. The Neuro III-SV intra-operative features, including the Magnet Mover Assembly, OR Patient Table, Intra-operative Coil and Head Fixation Device are substantially equivalent to the same intraoperative features of the predicate Neuro II-SE and predicate Neuro III-SV does not raise any new safety or effectiveness issues related to the use of a moving MRI system in an intra-operative setting.

The Neuro III-SV MRI imaging system's software are substantially equivalent to the Siemens MAGNETOM Verio 3T MRI System. The Neuro III-SV 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 to the Siemens MAGNETOM Verio System and to verify the safe and effective intra-operative operation of the Neuro III-SV.

The Neuro III-SV Intra-operative Magnetic Resonance Imaging System is substantially equivalent to the Siemens MAGNETOM Verio: the IMRIS predicate Neuro II-SE and the predicate Neuro II-S imaging systems.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes representing the feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 6 2008

IMRIS, Inc.

% Mr. Thomas M. Tsakeris

President

Devices & Diagnostics Consulting Group, Inc.

16809 Briardale Road

ROCKVILLE MD 20855

Re: K083137

Trade/Device Name: Neuro III-SV Intra-operative Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 10, 2008 Received: October 23, 2008

#### Dear Mr. Tsakeris:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devicecan 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.

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#### Page 2

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

hoque Mr. Whang

Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

K083137

Neuro III-SV Intra-operative Magnetic Resonance Imaging System

Indications For Use:

The Neuro III-SV Intra-operative MRI system is 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 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 Neuro III-SV 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 Neuro III-SV may also be used for imaging in a multi-room suite.

Prescription Use (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 Device Evaluation (ODE)

Concurre

(Division Sign-Off) (Per 21 CFR 801.109) Division of Reproductive, Abdominal a Radiological De 510(k) Number

(Optional Format 1-2-96)