SIGNA PROFILE SMALL HEAD COIL

K982972 · GE Medical Systems · MOS · Nov 16, 1998 · Radiology

Device Facts

• Record ID: K982972
• Device Name: SIGNA PROFILE SMALL HEAD COIL
• Applicant: GE Medical Systems
• Product Code: MOS · Radiology
• Decision Date: Nov 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Indications for Use for the Signa Profile Small Head coil expands the imaging capability of the Signa Profile System. The small head coil is intended for imaging of the head anatomy and extremities.

Device Story

Signa Profile Small Head Coil is a receive-only magnetic resonance (MR) imaging coil; utilizes a helmholtz RF design; designed for use with vertical magnetic field MR imaging systems. Device functions as an accessory to the Signa Profile MR System to expand imaging capabilities for head and extremity anatomy. Operated by trained MR technologists or radiologists in clinical settings. Output consists of raw MR signal data processed by the host MR system to generate diagnostic images. Benefits include improved imaging performance for specific anatomical regions compared to standard coils.

Clinical Evidence

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

Technological Characteristics

Receive-only MR coil; helmholtz RF design; designed for vertical magnetic field MR systems. Evaluated per NEMA performance standards and IEC 601-1/IEC 601-2-33 safety standards.

Indications for Use

Indicated for imaging of head anatomy and extremities using the Signa Profile MR System.

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 Head Coil

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are decorative swirls or flourishes around the outer edge of the circle, adding a touch of elegance to the design. The logo is presented in black and white.

K982972

GE Medical Systems

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

## SUMMARY OF SAFETY AND EFFECTIVENESS

- o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- ் Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, August 21, 1998
- o Identification of the Product Signa Profile Small Head Coil

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

- া Marketed Devices The Signa Profile MR System with the Small Head Coil is substantially equivalent to the currently marketed Signa Profile Head Coil.
- ୍ ୦ Device Description The Signa Profile Small Head Coil is a receive only coil with a birdcage RF design. It is designed for use with a vertical magnetic field MR imaging system.
- o Indications for Use The Indications for Use for the Small Head Coil expands the imaging capability of the Signa Profile System. It can be used to image the head anatomy and extremities.
- o Comparison with Predicate

The Signa Profile Small Head Coil is similar Signa Profile Head Coil except that the Small Head Coil is smaller and uses a helmholtz RF design.

- 0 Summary of Studies
The Profile Small Head Coil was evaluated to the appropriate NEMA performance standards. The coil was evaluated to the International safety standards IEC 601-1 and IEC 601-2-33 and performed to stated specifications.

- o Conclusions
It is the opinion of GE that the Signa Profile System with the Small Head Coil is substantially equivalent to the presently marketed Signa Profile Head Coil. This coil does not result in any new potential hazards.

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

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1008

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

K982972

Re:

Signa Profile Small Head Coil Dated: August 21, 1998 Received: August 25, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Dr. Kroger:

We have reviewed your Section 510%) 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 requirements, as set forth in the Quality System Regulation (OS) 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/cdr/dsmardsmamain.html".

Sincerely yours,

William Yih, Ph.D.

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

Enclosure

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

## K982972

510(k) Number (if known):_

Device Name: Signa Profile Small Head Coil

Indications For Use:

The Indications for Use for the Signa Profile Small Head coil expands the imaging capability of the Signa Profile System

The small head coil is intended for imaging of the head anatomy and extremities .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eric K. Seymour
(Division Sign-Off)

of Reproductive, Abdominal, EN 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_