1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL

K052621 · Usa Instruments, Inc. · MOS · Oct 7, 2005 · Radiology

Device Facts

• Record ID: K052621
• Device Name: 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen. The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI systems manufactured by GE Medical Systems.

Device Story

1.5T Brain/Spine Array Coil is a receive-only RF coil for GE 1.5T MRI systems; used to obtain diagnostic images of brain, cervical spine, soft tissues, and vasculature of head, neck, upper chest, thoracic, and lumbar spine. Device features open, rigid plastic housing with four parts: main head base, split-top head housing, chest housing, and T-L spine housing. Contains 21 coil elements in brain unit (loop elements) and 8 elements in spine unit (loop and saddle coils). Operated by MRI technician/radiologist in clinical setting. Provides patient comfort via open design. Output is raw RF signal processed by existing GE MRI system software to generate diagnostic images. No software changes required for operation.

Clinical Evidence

Bench testing only. Testing performed to demonstrate that design modifications meet predetermined acceptance criteria.

Technological Characteristics

Receive-only RF coil; 16-channel array; 21 elements in brain unit (loop), 8 elements in spine unit (loop and saddle). Rigid plastic housing. Compatible with GE 1.5T MRI systems. No software changes required. Hydrogen nucleus excitation.

Indications for Use

Indicated for diagnostic imaging of the brain, cervical spine, soft tissues, and vasculature of the head, neck, upper chest, thoracic, and lumbar spine in patients undergoing MRI using GE Healthcare 1.5T systems. Nucleus excited is hydrogen.

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

• USA Instruments Millennium 9000 Phased Array Neurovascular coil (K001870)

Submission Summary (Full Text)

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KD52621

## OCT 7 - 2005

## 510(k) Summary

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | 1.5T 16 Channel Brain-Spine () Array Coil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.<br>1515 Danner Drive<br>Aurora, Ohio 44202, USA<br>Telephone: [phone]; Fax: [phone]. |
| 6. Performance Standard: | No applicable performance standards have been issued under<br>Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The 1.5T Brain / Spine Array Coil is designed for use with the<br>1.5T MRI system manufactured by GE Healthcare. The coil is for<br>imaging of the brain, cervical spine, soft tissues and vasculature<br>of the head, neck, upper chest, thoracic and lumbar spine. The<br>nucleus excited is hydrogen. The 1.5T Brain / Spine Array Coil is<br>designed for use with the 1.5T MRI systems manufactured by GE<br>Medical Systems. |
| 8. Device Description: | The 1.5T Brain / Spine Array Coil is a receive-only RF coil, used<br>for obtaining diagnostic images of the brain, cervical spine, soft<br>tissues and vasculature of the head, neck, upper chest, thoracic<br>and lumbar spine in GE 1.5T MR Imaging systems.<br><br>The open design of the 1.5T Brain / Spine Array Coil reduces<br>claustrophobic effects and allows for increased patient comfort.<br>The coil elements are enclosed in a rigid plastic housing. The<br>housing is designed to conform to the patient anatomy. The<br>design of the coil allows for easy positioning of the patient and<br>provides patient comfort.<br><br>The mechanical housing of 1.5T Brain / Spine Array Coil consists<br>of four main parts: (1) a main head coil base, (2) a split-top head<br>coil housing (3) a chest coil housing and (4) a T-L Spine housing.<br>The chest coil housing is free floating and it rests on the patient's<br>chest.<br><br>The 1.5T Brain / Spine Array Coil has an array of 21 coil elements<br>in the Brain Unit and 8 coil elements in the Spine Unit; The 21 coil<br>elements in the brain unit are Loop elements. Twelve loop coils<br>(L1 to L12) cover the head region. Another four loop coils (L13 to |
| | L16) cover the Lower neck and torso regions. Five Loop coils<br>(L17 to L21) cover the upper neck and the chest region. The<br>Spine Unit has an array of four loop coils and four saddle coils<br>which cover the thoracic and lumbar spine regions. |
| | For operation, the 1.5T Brain / Spine Array Coil does not require<br>any change to the software used on the GE Medical Systems Inc.<br>1.5T MRI system. |
| 9. Marketed Device: | 1.5T Brain / Spine Array |
| 10. Comparison with Predicate: | The 1.5T Brain / Spine Array is a modification of the existing<br>cleared USA Instruments Millennium 9000 Phased Array<br>Neurovascular coil (K001870) with the main difference being the<br>physically integration of the antenna and shape of the Premier<br>CTL coil with the antenna and shape of the Millennium 9000<br>Phase Array Neurovascular coil. The integration increases the<br>number of receive channels to 16 to make it compatible with the<br>GE Healthcare Signa Excite 1.5T Magnetic Resonance<br>Scanners. Both coils included spine imaging in their indications,<br>but this modification improves user workflow by allowing more<br>comprehensive patient coverage with a single coil. |
| 11. Summary of Studies: | Testing was performed to demonstrate that the design<br>modifications to the 1.5T Brain / Spine Array meet predetermined<br>acceptance criteria. |

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#### Conclusion:

It is the opinion of USA Instruments that the 1.5T Brain / Spine Array is substantially equivalent to the USA Instruments Millennium 9000 Phase Array Neurovascular coil (K001870) Usage of the USA Instruments 1.5T Brain / Spine Array does not result in any new potential hazards.

.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

OCT 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert B. Smith Quality Assurance/Regulatory Affairs Manager USA Instruments, Inc. 1515 Danner Road AURORA OH 44202

Re: K052621

Trade/Device Name: 1.5T Brain/Spine Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 19, 2005 Received: September 23, 2005

Dear Mr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yourse of substantial equivalence of your device to a legally premaired predication: "The PDF missification 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), please If you desire specific at nee of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, process note the regulation emation on your responsibilities under the Act from the 807.77). I od may obtain sturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INTENDED USE

510(K) Number (if known): _K052621

1.5T Brain / Spine Array Coil Device Name:

### Indications For Use

The 1.5T Brain / Spine Array Coil is designed for use with the Excite 1.5T incl system The 1.51 Brail / Spine Array Ool is Goligi is for imaging of the brain, cervical spine, soft manufactured by GE Healthoale. The soll is for maging these on himbar spine. The nucleus excited is hydrogen.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ × (Per 21 CFR 801-109) OR

Over-The-Counter Use_

Daniel A. Swanson

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