MAGNETIC RESONANCE DIAGNOSTIC SYSTEM

K972296 · Ge Medical Systems, Inc. · MOS · Sep 15, 1997 · Radiology

Device Facts

• Record ID: K972296
• Device Name: MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
• Applicant: Ge Medical Systems, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Indications for Use for the Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the knee and surrounding structures. The 9 inch Coil is intended for imaging of the cervical spine, shoulder, knee and surrounding structures.

Device Story

Signa Profile 9 Inch Coil and Kinematic Positioner are accessories for vertical magnetic field MR imaging systems. The 9 Inch Coil is a linear solenoid, split two-part design (base and removable top) for patient positioning. The Kinematic Positioner supports legs during MR scanning, allowing for fixed or moving leg imaging. Used in clinical settings by trained operators to facilitate diagnostic imaging of cervical spine, shoulder, and knee. The device improves imaging capability of the Signa Profile System; output is MR image data used by clinicians for diagnostic decision-making.

Clinical Evidence

Bench testing only. The device was evaluated to NEMA performance standards and international safety standards IEC 601-1 and IEC 601-2-33. No clinical data provided.

Technological Characteristics

Linear solenoid surface coil; split two-part design. Kinematic positioner for leg support. Designed for vertical magnetic field MR imaging systems. Evaluated to NEMA performance standards and IEC 601-1/IEC 601-2-33 safety standards.

Indications for Use

Indicated for patients requiring MRI imaging of the cervical spine, shoulder, knee, and surrounding structures. The Kinematic Positioner is indicated to accommodate and improve imaging of the knee and surrounding structures.

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

• Signa Profile System (software and electronics)
• Signa Profile Extremity Coil

Submission Summary (Full Text)

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K972296
GE Medical Systems

SEP 1 5 1097

P.O. Box 414. Milwaukee, WI 53 USA

## SUMMARY OF SAFETY AND EFFECTIVENESS

- This 510(k) summary of safety and effectiveness information is O submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- 0 Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, June 11, 1997
- o Identification of the Product Signa Profile 9 Inch Coil and Kinematic Positioner Options

Manufacturer Address:

GE Yokogawa Medical Systems, Ltd. 4-7-127, Asahigaoka, Hino-Shi Tokyo, 191 Japan

- O Marketed Devices
The Signa Profile MR System with the 9 Inch Coil and the Kinematic Positioner Options are substantially equivalent to the currently marketed Signa Profile System (software and electronics) and the Signa Profile Extremity Coil.

## o Device Description

Profile 9 Inch Coil consists of a linear solenoid coil. The lt is a split two part design that has a base and a removable top to facilitate patient positioning. It is designed for use with a vertical magnetic field MR imaging system.

The Kinematic Positioner provides support for the legs for MR scanning. It has two usages. One is for a scan when the scanned leg is fixed, and the other is while the scanned leg is moving down.

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age 2 of 2

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

# SUMMARY OF SAFETY AND EFFECTIVENESS

- o Indications_for_Use
The Indications for Use for the Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the knee and surrounding structures. The 9 inch Coil is intended for imaging of the cervical spine, shoulder, knee and surrounding structures.

### 0 Comparison with Predicate

The Profile 9 Inch Surface Coil is similar to the Profile Extremity Coil except that the Extremity coil is a quadrature receive only coil while the 9 inch coil is a linear receive only coil.

#### Summary of Studies o

The 9 Inch Surface Coil was evaluated to the appropriate NEMA performance standards. Both options were evaluated to the International safety standards IEC 601-1 and IEC 601-2-33. Both options performed to stated specifications.

#### O Conclusions

It is the opinion of GE that the Signa Profile System with the 9 Inch Surface Coil and Kinematic Positioner options are substantially equivalent to the presently marketed Signa Profile System and the Signa Profile Extremity Coil. These options do not result in any new potential hazards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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SEP 1 5 1997

Larry A. Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201

Re: K972296 Signa Profile 9-Inch Coil and Kinematic Positioner Dated: June 11, 1997 Received: June 19, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Dr. Kroger:

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 practice, labeling, 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 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 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. William Yui

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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

972296

Device Name: Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options Indications For Use:

The Indications for Use for the Signa Profile 9 Inch Diameter Coil and Kinematic Positioner Options expands the capability of the Signa Profile System. The Kinematic Positioner accommodates and improves imaging of the knee and surrounding structures. The 9 inch Coil is intended for imaging of the cervical spine, shoulder, knee and surrounding structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Beynon
(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