ESTEEM 1.5T MRI SYSTEM

K972826 · Elscint Mr, Inc. · LNH · Oct 15, 1997 · Radiology

Device Facts

• Record ID: K972826
• Device Name: ESTEEM 1.5T MRI SYSTEM
• Applicant: Elscint Mr, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System 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 times (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.

Device Story

1.5T MRI system; produces cross-sectional images of internal structures (head, body, extremities) based on proton density, NMR relaxation times (T1, T2), and flow. System upgrades include high-performance water-cooled gradient amplifier (29mT/M peak, 60mT/M/msec slew rate), ECG monitoring for cardiac-gated pulse sequences to reduce motion artifacts, and phased array spine RF coil for increased FOV. Operated by trained personnel in clinical/hospital settings. Physician interprets images to support diagnosis, surgery, or therapy planning. Software version 5.0 provides user interface flexibility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

1.5 Tesla MRI system; water-cooled gradient amplifier (29mT/M peak, 60mT/M/msec slew rate); phased array spine RF coil; ECG monitoring unit for cardiac gating; software version 5.0 with updated user interface.

Indications for Use

Indicated for general purpose whole-body MRI imaging of head, body, or extremities to assist trained physicians in diagnosis, surgery planning, or therapy planning. Used in clinic or hospital 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

• Elscint Gyrex Esteem 1.5T MRI System (K962677)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

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

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

July 3, 1996 Date:

- Elscint Gyrex Eteem 1.5T MRI System, Product Indentification: 2. Software Version 5.0 Upgrade Esteem 1.5T MRI System 3. Predicate Device:
- Device Description and Indications for Use: 4.

The Elscint MR, Inc. Esteem Whole Body MR Imaging System is a 1.5 Tesla Magnetic Resonance Imaging System 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 times (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.

- Comparison to Predicate Device ട.
The major components changed or updated over that described in the predicate device submission are:

- > A higher performance gradient amplifier and a water-cooled gradient that when utilized together provide a peak strength of 29mT/M and a slew rate of 60mT/M/msec,
- > An ECG monitoring unit to allow pulse sequences gated to the cardiac cvcle to provide cardiac and pulmonary images with reduced artifact from heart motion,
- > The addition of a phased array spine RF coil for increased FOV coverage in the z-direction,
- > Additional flexibility added to existing user interface software

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re:

K972826 Software Version 5.0 Upgrade for Elscint Gyrex Esteem 1.5T MRI System Dated: Undated Received: July 29, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

OCT 1 5 1997

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, 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 OS inspections the Food and Drue 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 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

H.J.Liau Yin

Lillian Yin, Ph.D. Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Elscint MR, Inc.

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## Elscint

510(k) number K962677

Device Name: Gyrex Esteem 1.5T MRI System

Indications for Use:

The Gyrex Esteem 1.5T 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.

The SW Version 5.0 upgrade does not change or contain any additional indications for use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per CRF 801.109)

OR

(Division Sign-Off)

Over the Counter Use

(Optional Format 1-2-96) ==

Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number