GYREX PRIMA 1TG 1.0T MRI SYSTEM

K970990 · Elscint Mr, Inc. · LNH · Aug 25, 1997 · Radiology

Device Facts

• Record ID: K970990
• Device Name: GYREX PRIMA 1TG 1.0T MRI SYSTEM
• Applicant: Elscint Mr, Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.

Device Story

Elscint Gyrex Prima 1TG is a 1.0T whole-body MRI system; utilizes superconducting actively shielded 900mm bore magnet; inputs include proton density, NMR relaxation times (T1, T2), and flow data; transforms inputs into cross-sectional images of head, body, or extremities in transverse, sagittal, coronal, or oblique planes; features Twin Gradient subsystem (switching gradient amplifier and dual gradient coil) with slew rates of 42-72 mT/m/msec; includes local phased array coils for shoulder/wrist imaging; incorporates Context Vision™ image filter; operated by trained professionals in clinical/hospital settings; output interpreted by physicians to assist in diagnosis, surgery, or therapy planning.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing of system components.

Technological Characteristics

1.0T superconducting actively shielded 900mm bore magnet; Twin Gradient subsystem (switching gradient amplifier and dual gradient coil); slew rates 42-72 mT/m/msec; local phased array coils for shoulder/wrist; Context Vision™ image filter; system electronics and RF coils optimized for 1.0T operation.

Indications for Use

Indicated for patients requiring cross-sectional imaging of head, body, or extremities for diagnosis, surgery planning, or therapy planning. Used in clinic or hospital settings 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

• Prestige 2.0T MRI System

Submission Summary (Full Text)

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K970990

# Summary of Safety and Effectiveness

The following information is made available pursuant to the requirements of the Safe Medical devices Act of 1990.

1. Submitter: Elscint MR, Inc.
AUG 25 1997
2555 Midpoint Drive
Fort Collins, CO 80521
Tel: [phone]
Fax: [phone]
Contact: Elizabeth F. Lowder, Director of Quality and Programs
Date: March 13, 1997

2. Product Identification: Elscint Gyrex Prima 1TG 1.0T MRI System

3. Predicate device: Prestige 2.0T MRI System

4. Device Description and Indications for Use:

The Elscint Prima 1TG 1.0T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

5. Comparison to Predicate Device

The major components changed or updated over that described in the predicate device submission are:

- A superconducting actively shielded 900mm bore 1.0T magnet
- A switching gradient amplifier and dual gradient coil combining to produce slew rates of 42 mT/m/msec and 72 mT/m/msec dependent on operational mode. This design is known as the Twin Gradient subsystem.
- Local phased array coils for imaging the shoulder and wrist
- Operator selectable application of the Context Vision™ image filter

In addition, changes to RF Coils, sequences and system electronics have been performed to allow operation at 1.0T.

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6. Conclusion:

It is the opinion of Elscint MR, Inc. that the Prima 1TG MR system is substantially equivalent to the Prestige MR system. The Prima 1TG does not include any new indications for use, nor does use of this device result in any new potential hazards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

AUG 25 1997

Elizabeth Lowder
Director, Quality and Programs
Elscint MR, Inc.
2555 Midpoint Drive
Fort Collins, CO 80525

Re: K970990
Gyrex Prima ITG 1.0T MRI System
Dated: June 25, 1997
Received: June 30, 1997
Regulatory class: II
21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Lowder:

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 use stated in the enclosure) to 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 requirement, 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 regulation may result 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 regulations.

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/dsmamain.html".

Sincerely yours,


Enclosure

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Elscint
Page 1 of 1

510(k) number

Device Name: Gyrex Prima 1TG 1.0T MRI System

Indications for Use:

The Gyrex Prima 1TG 1.0T MRI system is a general purpose whole-body MRI system that produces images of the internal structures of the head, body, or extremities. The indications for use are not dissimilar to established indications for use for other general purpose whole-body MRI systems. The established indications for use are that when interpreted by a trained physician, MRI can be useful in determination of a diagnosis, surgery planning, or therapy planning and is used in a clinic or hospital setting.

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970990

Prescription Use ☑
(Per CRF 801.109)

OR

Over-the Counter Use ☐
(Optional Format 1-2-96)