NEURO II-SE, MODELS OR-MB-DR AND OR-DR

K061916 · Imris, Inc. · LNH · Aug 11, 2006 · Radiology

Device Facts

• Record ID: K061916
• Device Name: NEURO II-SE, MODELS OR-MB-DR AND OR-DR
• Applicant: Imris, Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body. The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. correspond to the distribution of protons exhibiting MR characteristics; 2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and 3. display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Neuro II-SE may also be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment. The Neuro II-SE may also be used in a multi-room suite.

Device Story

Neuro II-SE is a traditional MRI unit mounted on an overhead rail system for intra-operative use. System components include Siemens Espree MRI, Magnet Mover System, OR Table Assembly, and Intra-operative Coil Kit. Device inputs are proton density, flow velocity, T1, and T2 relaxation signals; transforms these into tomographic cross-sectional images. Used in OR or multi-room suites by physicians to visualize soft tissue structures. Intra-operative use requires MR-compatible anesthesia and monitoring equipment. Output images assist physicians in diagnosis and intra-operative decision-making. Benefits include enabling real-time or near-real-time diagnostic imaging during surgical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing verified equivalence to Siemens Magnetom Espree and confirmed safe/effective intra-operative operation, including assessment of image quality metrics (signal-to-noise, uniformity, geometric distortion, slice profile, thickness, gap, and high contrast spatial resolution).

Technological Characteristics

1.5T MRI system; overhead rail-mounted; includes Magnet Mover System, OR Table Assembly, and Intra-operative Coil Kit. Operates via NMR principles (proton density, T1/T2 relaxation). Connectivity includes diagnostic coils. Software and hardware are based on Siemens Magnetom Espree architecture.

Indications for Use

Indicated for diagnostic imaging of the head and whole body in patients requiring tomographic cross-sectional images based on proton density, flow velocity, T1, and T2 relaxation times. Used in clinical or intra-operative settings.

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-S
• Neuro II
• Siemens Magnetom Espree 1.5T MRI System

Submission Summary (Full Text)

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### AUG 1 1 2006 APPENDIX F 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS REQUIRED BY 21 CFR 807.92)

Attached is the IMRIS 510(k) Summary of Safety and Effectiveness for the IMRIS Neuro II-SE Intra-Operative Magnetic Resonance Imaging System.

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS REQUIRED BY 21 CFR 807.92)

#### 1. GENERAL INFORMATION

| Establishment: | IMRIS Inc. |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1370 Sony Place<br>Winnipeg, Manitoba<br>Canada<br>R3T 1N5 |
| Registration Number: | 3003807210 |
| Contact Person: | Mrs. B. Newis<br>Quality Assurance Representative<br>eMail: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date of Summary<br>Preparation: | May 15, 2006 |
| Device Name: | Neuro II-SE Intra-operative Imaging System |
| Trade Name: | Neuro II-SE |
| Common Name: | MRDD (Magnetic Resonance Diagnostic Device) |
| Proprietary name: | Neuro II-SE |
| Classification name: | System, Nuclear Magnetic Resonance Imaging |
| Classification: | 21 CFR 892.1000 |
| Class: | Class II |
| Product Code: | LNH (Magnetic Resonance Imaging System) |
| Performance Standards: | None established under Section 514 of the Food, Drug<br>and Cosmetic Act |

#### 2. INDICATIONS FOR USE

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

#### INTENDED USE OF THE DEVICE 3.

The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:

- 1. correspond to the distribution of protons exhibiting MR characteristics;
- depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time 2. (T1) and spin-spin relaxation time (T2); and
- 3. display the soft tissue structure of the head and whole body.

When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Neuro II-SE may be used during intra-operative procedures when performed in an intraoperative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.

The Neuro II-SE may also be used for imaging in a multi-room suite.

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#### DEVICE DESCRIPTION 4.

The Neuro II-SE 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 II-SE system are the Espree MRI System (including diagnostic coils), the Magnet Mover System, the OR Table Assembly and the Intra-operative Coil Kit.

#### SAFETY AND EFFECTIVENESS 5.

The Neuro II-SE has been designed to provide MRI imaging in an intra-operative setting in the same manner as the Neuro II -S and Neuro II predicate devices. The Neuro II-SE Intra-operative System features including the Magnet Mover System, OR Table Assembly and Intra-operative Coil Kit are substantially equivalent to the same intra-operative features of the Neuro II -S and Neuro II. The Neuro II-SE 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 II-SE MRI system's software and hardware, excepting the Intra-operative Coil Kit and OR Table Assembly, are substantially equivalent to the Siemens Magnetom Espree 1.5T MRI System. The Neuro II-SE 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.

The Neuro II-SE Intra-operative Coil Kit design is substantially equivalent to the Neuro II-S Intra-operative RF Coil. The use of the Intra-operative Coil Kit does not raise any new safety or effectiveness issues.

Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operation of the Neuro II-SE.

The Neuro II-SE Intra-operative Magnetic Resonance Imaging System is substantially equivalent to the Siemens Magnetom Espree, the IMRIS Neuro II-SE and the Neuro II imaging systems.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

### AUG 1 1 2006

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

Re: K061916

Trade/Device Name: Neuro II-SE 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: July 4, 2006 Received: July 6, 2006

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 (Premarket Approval), it may be subject to such 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.

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oting Public S

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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 (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.

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). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon
Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 火011916

## Indications for Use Statement

| Ver/ 3 - 4/24/96 | |
|------------------|---------------------------------------------------------------|
| Applicant: | IMRIS Inc. |
| Device Name: | Neuro II-SE Intra-operative Magnetic Resonance Imaging System |

Indications For Use:

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

The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:

1. correspond to the distribution of protons exhibiting MR characteristics;
2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and
3. display the soft tissue structure of the body.

When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Neuro II-SE may also be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.

The Neuro II-SE may also be used in a multi-room suite.

Prescription Use ✓


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

| 510(k) Number | K061916 |
|---------------|---------|
|---------------|---------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Optional Format 1-2-96)

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