NEURO II-S

K050132 · Innovative Magnetic Resonance Imaging Systems, Inc. · LNH · Feb 15, 2005 · Radiology

Device Facts

• Record ID: K050132
• Device Name: NEURO II-S
• Applicant: Innovative Magnetic Resonance Imaging Systems, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The IMRIS Neuro II-S MRI system is indicated for use for the whole body. The Neuro II-S 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-S 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.

Device Story

Neuro II-S is a 1.5T MRI system suspended from an overhead gantry for intra-operative use. System components include MRI assembly, diagnostic RF coils, magnet mover assembly, and OR patient table. Device captures proton density, flow velocity, T1, and T2 relaxation signals to generate tomographic cross-sectional images of soft tissue. Operated by clinicians in an intra-operative MRI suite; requires MR-compatible anesthesia and monitoring equipment. Images are interpreted by physicians to assist in diagnosis and intra-operative decision-making. Benefits include real-time imaging capability during surgical procedures.

Clinical Evidence

Bench testing only. Laboratory testing verified equivalence to the Siemens Magnetom Symphony system and confirmed safe/effective intra-operative operation.

Technological Characteristics

1.5T MRI system; overhead gantry suspension; includes diagnostic RF coils, magnet mover assembly, and OR patient table. Connectivity: standard MRI imaging chain. Software: equivalent to Siemens Magnetom Symphony. Sterilization: N/A (non-invasive diagnostic imaging).

Indications for Use

Indicated for whole-body diagnostic imaging in patients requiring tomographic cross-sectional soft tissue visualization, including 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™ 1.5T MRI system (K002964)
• Magnetom Symphony System (K020991)
• Edge Eclipse 1.5T™ Magnet, NMR Electronics & VIA 2.0 Software (K964626)

Submission Summary (Full Text)

{0}------------------------------------------------

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

#### General Information 1.

| Establishment: | Innovative Magnetic Resonance Imaging Systems,<br>Inc. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Address: | 78 Innovation Drive<br>Winnipeg, Manitoba<br>Canada<br>R3T 6C2 |
| Registration Number: | 3003807210 |
| Contact Person: | Mrs. Barbara Newis<br>Quality Assurance Representative<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date of Summary<br>Preparation | January 11, 2005 |
| Device name: | Neuro II-S Intra-operative Imaging System |
| Trade name: | Neuro II-S |
| Common name: | MRDD (Magnetic Resonance Diagnostic Device) |
| Proprietary name: | Neuro II-S |
| Classification 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,<br>Drug, and Cosmetic Act |

#### 2. Indications for use

The IMRIS Neuro II-S MRI system is indicated for use for the whole body.

#### Intended use of the device 3.

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

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

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

{1}------------------------------------------------

### Device Description 4.

The IMRIS Neuro II-S Intra-operative MRI system is a traditional 1.5T MRI system that has been suspended from an overhead gantry to facilitate intra-operative use. The main components of the Neuro II-S system are the MRI system assembly ( including diagnostic RF coils), the magnet mover assembly, the OR patient table assembly and the intra-operative RF coil.

#### Safety and Effectiveness 5.

The Neuro II-S has been designed to provide MRI imaging in an intra-operative setting in the same manner as the Neuro II predicate device. The Neuro II-S intra-operative features including the Magnet Mover Assembly, OR Patient Table and Intra-operative RF Coil are substantially equivalent to the same intra-operative features of the Neuro II. The Neuro II-S 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-S MRI system's software and hardware, excepting the Intra-operative RF Coil and Patient Table, are substantially equivalent to the Siemens Magnetom Symphony 1.5T MRI system. The Neuro II-S 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, geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution.

The Neuro II-S Intra-operative RF Coil design is substantially equivalent to the Picker Large Joint Coil but it has been modified to facilitate its use with the Symphony system in the OR Theatre. The use of the intra-operative RF coil does not raise any new safety or effectiveness issues.

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

It is the opinion of IMRIS that the Neuro II-S Intra-operative Magnetic Resonance Imaging System is substantially equivalent with the following legally marketed devices to which IMRIS is claiming equivalence.

| Device | Manufactured by | FDA Classification # | 510(k) # |
|------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------|----------|
| Neuro II™ 1.5T MRI<br>system | Innovative Magnetic<br>Resonance Imaging Systems,<br>Inc. (IMRIS) | 892.1000 | K002964 |
| Magnetom Symphony<br>System | Siemens Medical Solutions<br>USA, Inc. | 892.1000 | K020991 |
| Edge Eclipse 1.5T™<br>Magnet, NMR<br>Electronics & VIA 2.0<br>Software | Picker International Inc.<br>(Marconi Medical Systems) | 892.1000 | K964626 |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract image of an eagle, with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2005

Innovative Magnetic Resonance Imaging Systems, Inc. % Mr. Thomas M. Tsakeris President Devices & Diagnostics Consulting Group, Inc. 16809 Briardale Road ROCKVILLE MD 20855

Re: K050132

Trade/Device Name: Neuro II-S Intra-operative Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 20, 2005 Received: January 21, 2005

Dear Mr. Tsakeris:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your betwent beach is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cherosate) to regary mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the classified in 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 do not require approval or a previsions of the Act. The general controls provisions of the Act at nee, subjoct to the general 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 11 your av, it may be subject to such additional controls. Existing major regulations affecting your Apploval), it 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 I Rase be actives that i 27 r i on that your device complies with other requirements of the Act or any I DA has made a deceminations administered by other Federal agencies. You must comply with all the I cacral statues and regulations unnot limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moraing, out noing practice requirements as set forth in the quality systems (QS) (2) CFR Part 80 77 governot if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to ough hass of substantial equivalence of your device to a legally prematice notification: "The PDF 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 If you desire specific acrise for your be restled wing numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain other generational and Consumer Assistance at its toll-free number (800) Division or offen Manufacturers internet address http://www.fda.gov/cdrb/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon
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

{4}------------------------------------------------

K050132

# Indications for Use Statement

| Ver/ 3 - 4/24/96 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Innovative Magnetic Resonance Imaging Systems Incorporated (IMRIS) |
| Device Name: | Neuro II-S Intra-operative Magnetic Resonance Imaging System |
| Indications For Use: | |
| | The IMRIS Neuro II-S MRI system is indicated for use for the whole body. |
| | The Neuro II-S 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-S 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. |
| | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| | <i>Prescription Use</i><br>(Per 21 CFR 801.109)<br>(Optional Format 1-2-96) |
| (Division Sign-Off) | <div style="text-align:left"><img alt="Signature" src="signature.jpg" width="200"/></div> Nancy C. Brogdon |

Division of Reproductive and Radiological Dev 510(k) Number 050132