SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL

K982772 · Ge Medical Systems, Inc. · MOS · Oct 15, 1998 · Radiology

Device Facts

• Record ID: K982772
• Device Name: SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL
• Applicant: Ge Medical Systems, Inc.
• Product Code: MOS · Radiology
• Decision Date: Oct 15, 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 Quadrature Thoracic/Lumbar Spine Phased Array Coil expands the imaging performance of the Signa Profile System. The Quadrature Thoracic / Lumbar spine Phased Array coil can also be used to image the following regions of anatomy: Thoracic Spine, Lumbar Spine, Chest, Abdomen, Pelvis, Hips.

Device Story

The Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil is a receive-only MR coil designed for use with vertical magnetic field MR imaging systems. It captures quadrature signals from the thoracic/lumbar spine, chest, abdomen, pelvis, and hips. The device utilizes phased array technology to improve imaging performance compared to standard flexible coils. It is operated by trained medical personnel in a clinical MR environment. The coil output is processed by the MR system to generate diagnostic images, which are reviewed by radiologists to inform clinical decision-making and patient diagnosis.

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 phased array MR coil; quadrature signal reception; designed for vertical magnetic field MR systems; larger circumference than predicate; evaluated per NEMA standards and IEC 601-1/601-2-33.

Indications for Use

Indicated for imaging of the thoracic spine, lumbar spine, chest, abdomen, pelvis, and hips 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 Body Flexible Coil

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular border. There are small, teardrop-shaped elements positioned around the outer edge of the circle, adding a decorative touch to the design.

K982772

GE Medical Systems

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

# SUMMARY OF SAFETY AND EFFECTIVENESS

- ் This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, July 31, 1998
- o Identification of the Product Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil

| 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 Quadrature Thoracic/Lumbar Spine Phased Array Coil is substantially equivalent to the currently marketed Signa Profile Body Flexible Coil.

#### ் Device Description

The Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil is a receive only coil and can receive the quadrature signal . It is designed for use with a vertical magnetic field MR imaging system.

#### o Indications for Use

The Indications for Use for the Quadrature Thoracic/Lumbar Spine Phased Array Coil expands the capability of the Signa Profile System. It can be used to image the thoracic spine, lumbar spine, chest, abdomen, pelvis and hips.

- 0 Comparison with Predicate
The Quadrature Thoracic/Lumbar Spine Phased Array Coil is similar Signa Profile Body Flexible Coil except that the Thoracic/Lumbar Spine Phased Array Coil has a larger circumference and uses phased array technology.

## o Summary of Studies

The Quadrature Thoracic/Lumbar Spine Phased Array 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.

- ে Conclusions
It is the opinion of GE that the Signa Profile System with the Quadrature Thoracic/Lumbar Spine Phased Array Coil is substantially equivalent to the presently marketed Signa Profile Body Flexible Coil. This coil does not result in any new potential hazards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1998

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

K982772

Re:

Signa Profile Ouadrature Thoracic/Lumbar Spine Phased Array Coil Dated: July 31, 1998 Received: August 7, 1998 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 referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enolosure) 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 vitn 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/odrh/dsmaldsmamain.html".

Sincerely yours,

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

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510(k) Number (if known):_ K982772

Device Name: Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil Indications For Use:

The Indications for Use for the Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil expands the imaging performance of the Signa Profile System.

The Quadrature Thoracic / Lumbar spine Phased Array coil can also be used to image the following regions of anatomy:

- Thoracic Spine ●
- Lumbar Spine .
- Chest ●
- Abdomen ●
- Pelvis .
- Hips.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982772

Prescription Use *✓* OR Over-The-Counter Use__
(Per 21 CFR 801.109)