VIRGO MRI SYSTEM

K990153 · Millennium Technology Services · LNH · Oct 8, 1999 · Radiology

Device Facts

• Record ID: K990153
• Device Name: VIRGO MRI SYSTEM
• Applicant: Millennium Technology Services
• Product Code: LNH · Radiology
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.

Device Story

Virgo MRI System is an open-configuration magnetic resonance imaging device utilizing a 0.35 Tesla C-shaped permanent magnet. It acquires hydrogen-1 proton imaging and spectroscopy data. The system includes a host computer, gradient subsystem, and various RF coils (head, body/spine, solenoid). It is operated by trained personnel in a clinical setting. The device transforms raw magnetic resonance signals into 2D/3D diagnostic images, including sagittal, transverse, coronal, and cross-sectional views. It supports advanced sequences like Fast Spin Echo, Inversion Recovery, and MR Angiography. Output is displayed on a console for physician review to assist in clinical diagnosis. The open design provides patient comfort and accessibility. The system features digital RF electronics, a low-noise preamplifier, and optional post-processing/image enhancement packages. It is DICOM compliant for integration into hospital imaging workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

0.35 Tesla C-shaped permanent magnet; homogeneity +/- 10 ppm with 30 cm DSV. Gradient strength 10mT/m, 0.6ms rise time. Air-cooled. RF subsystem includes quadrature head/body coils and solenoid coils. Digital RF electronics with 5kW max transmitter power. Host computer: Dual Pentium CPU, 128MB RAM, 2.1GB HDD. Connectivity: DICOM compliant, laser camera interface. Standards: ASTM, ISO 9000 series, QSR/CGMP.

Indications for Use

Indicated for non-invasive, non-ionizing diagnostic 2D and 3D imaging of the head, spine, torso, abdomen, and extremities in patients requiring MRI examination.

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

• AIRIS II M.R.I System (K961876, K974212, K980691)

Submission Summary (Full Text)

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K990153

STILL
POINT

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

### 1. Device Name:

Virga™ MRI SYSTEM Trade Name:

Common Name(s): MRI System

Classification Name(s): magnetic resonance diagnostic device

### 2. Establishment Name & Registration Number:

Name: MILLENNIUM TECHNOLOGY, INC. Number: Pending

### 3. Classification:

## & 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.

[53 FR 5078, Feb. 1, 1989]

Device Class: Class II Classification Panel: Radiology Devices Panel Product Code(s): 90LNH

### 4. Section 514 Compliance

MILLENNIUM TECHNOLOGY, INC. intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

### 5. Performance Standards

Food and Drug Administration mandated Performance standards MRI systems are not in effect. MILLENNIUM TECHNOLOGY, INC. will comply with all voluntary Performance Standards applicable to MRI systems. At the present time, various performance standards such as ASTM, ISO, QSR/CGMP and in-house SOP standards are used.

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### 6. Special Controls:

MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect, including:

(a) The provisions of § 1005.1 through 1005.24 are applicable to electronic products, which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.

(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.

Scope. The standards listed in this subchapter are prescribed pursuant to section ട്ട 1010.1 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [40 FR 32257, July 31, 1975]

### 4. Equivalent Predicate Device:

MILLENNIUM TECHNOLOGY, INC. believes that the Vog™ MRI SYSTEM is substantially equivalent to the following MRI system:

- AIRIS II M.R.I System, K961876, K974212, K980691 by Hitachi Medical Systems 1. America.
The comparison device represents an MRI system that is functionally and technologically equivalent. Equivalency can be drawn with respect to the design, intended use, clinical utility and "open design" configuration. To facilitate comparison of the Virge™ MRI SYSTEM to the comparison system identified above, a comparison table is provided below.

### 5. Device Description:

The Vaya MRI SYSTEM is functionally similar to most existing MRI systems. General specifications are as follows:

# Magnet Subsystem

0.35 Telsa C-Shaped Compact Permanent Magnet Optimized Pole Design Homogeneity +/- 10 ppm with30 cm DSV Dimension 110cm x 160cm x 180cm Detachable Patient Table 2nd Detachable Patient Table Gradient Subsystem Strenath: 10mT/m Rise Time: 0.6ms Air Cooled RF Subsystem Quadrature Head Coil Quadrature Body/Spine Coil 3 Solenoid Coils for Extremities, Shoulder and C Spine Low Noise Preamplifier (0.5 dB Noise Figure) Digital RF Electronics Maximum Transmitter Power 5kW

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### Computer System

Host Computer: Dual Pentium CPU True Multi-tasking NT Environment All JAVA Language Programming RAM: 128MB Hard Disk: 2.1GB Image Capacity: 9000 256x256 1.7 GB WORM Archiving Remote System Maintenance Console Patient Registration Scanning Post-Processing & Image Enhancement (option) Display & Analysis Package Archiving User Defined Protocols User Specific Menus View Console (option) DICOM Compliant Laser Camera Interface Via 3M Protocol Laser Camera (option) CD Rewritable Drive (option) Protocols As Described on the Intended Use Page Site Requirements 5 Gauss Line 15" x 15" Maximum 3 Phase AC Power20kVA No Water Requirement

### Applicant Name & Address: ર્ભ.

MILLENNIUM TECHNOLOGY, INC. 855 W. 12th Avenue Vancouver, B.C., Canada V5Z1M9 604.872.6039 - 604.872.0288 fax

#### 7. Company Contact:

Regulatory Affairs MILLENNIUM TECHNOLOGY, INC. 855 W. 12th Avenue Vancouver, B.C., Canada V5Z1M9 604.872.6039 - 604.872.0288 fax

#### 8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

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### 9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM. Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

MILLENNIUM TECHNOLOGY. INC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act,

### Special Controls: 10.

MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect, including:

(a) The provisions of § 1005.1 through 1005.24 are applicable to electronic products, which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.

(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.

ട്ട 1010.1 Scope. The standards listed in this subchapter are prescribed pursuant to section 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [40 FR 32257, July 31, 1975]

| FEATURE | VIRGO MRI SYSTEM | Hitachi | SE? |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----|
| Indications for Use: | Non-invasive, non-ionizing diagnostic 2D & 3D imaging<br>system for use on the head, spine, torso, abdomen and<br>extremities. | Same | YES |
| Design: | Open MRI | Open MRI | YES |
| Magnetic Field: | .35T | .30T | YES |
| Magnet Type: | Perm. | Perm. | YES |
| Origin: | Canada | Japan | YES |
| Manufacturer: | MTI | Hitachi | YES |
| Product Code: | 90LNH | 90LNH | YES |
| K - Number: | PENDING | K961876, K974212, K980691 | YES |

### 11. Summary Comparison Table:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999

Millenium Technology, Inc. C/O Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 Attn: David W. Schlerf

Re:

K990153 Virgo MRI System Dated: July 5, 1999 Received: July 23, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for ase 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in . regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 - of

K 99 0153 510(k) Number :_

Virga™ MRI SYSTEM Device Name(s):

# Intended Use(s) of the Device:

Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.

# Diagnostic Image capabilities include:

- Sagittal section images
- Cross section & curved cross section images ●
- Transverse section images .
- Coronal section images ●
- 2D Fast Spin Echo ●
- 2D Inversion Recovery .
- 2D Fast Inversion Recovery ●
- 2D Dual Slice Acquisition ●
- 2D/3D Spin Echo ●
- 2D/3D Gradient Echo .
- 2D/3D Gradient Echo w/ Rephasing .
- 2D/3D Steady State Acquisition w/ rewind Gradient Echo (SARGE) ●
- MR Angiography Image Processing ●
- MR Angiography Half Echo/High Resolution High Definition ●
- 2D/T1/T2 Weighted Imaging ●
- T1/T2 Proton Density Measurements ●

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Yamil A. Seppern
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional format 1-2-96)