3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL

K032538 · Usa Instruments, Inc. · MOS · Sep 12, 2003 · Radiology

Device Facts

• Record ID: K032538
• Device Name: 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 3.0T 8-Channel CTL Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine (cervical, thoracic and lumbar regions) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The 3.0T 8-Channel CTL Array Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.

Device Story

The 3.0T 8-Channel CTL Array Coil is a multi-element, receive-only phased array RF coil designed to conform to the contours of the human spine. It functions as an accessory to GE 3.0T MRI scanners to capture hydrogen nuclei signals for diagnostic imaging. The device consists of coil elements and circuitry housed in flame-retardant, high-impact plastic. It does not transmit RF power; it utilizes RF chokes and switching diodes for decoupling to isolate elements from RF fields during transmission, preventing RF burns and resonant loop formation. The coil is operated by MRI technicians or radiologists in a clinical imaging environment. By providing high-quality signal reception for the spine, it assists physicians in visualizing soft tissue structures to aid in clinical diagnosis.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Receive-only phased array RF coil. Materials: Flame-retardant Kydex, PVC, Polyurethane, and Polycarbonate. Connectivity: Dedicated interface for GE 3.0T MRI scanners. Decoupling: RF chokes with switching diodes. Form factor: Contoured housing for spine imaging. Non-conductive housing.

Indications for Use

Indicated for obtaining diagnostic MRI images of the cervical, thoracic, and lumbar spine regions in patients undergoing standard MRI procedures. Designed for use with GE 3.0T MRI scanners.

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

• Premier III Phased Array CTL Spine Coil (K013595)
• Premier 9000 8 Channel Phased Array CTL Spine Coil (K031366)
• Premier III Phased Array CTL Spine Coil (K030042)

Submission Summary (Full Text)

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K032538

## SEP 1 2 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | 3.0T 8-Channel CTL 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<br>issued under Section 514 of the Food, Drug and<br>Cosmetic Act. |
| 7. Intended Use: | The 3.0T 8-Channel CTL Array Coil is a receive-only<br>phased array RF coil, used for obtaining diagnostic<br>images of the spine (cervical, thoracic and lumbar<br>regions) in Magnetic Resonance Imaging Systems.<br>The indications for use are the same as for standard<br>MR Imaging. The 3.0T 8-Channel CTL Array Coil is<br>designed for use with the GE Medical Systems<br>3.0Tesla MRI scanner. |
| 8. Device Description: | The 3.0T 8-Channel CTL Array Coil is a multi-<br>element phased array receive-only coil. The coil is<br>shaped to conform to the contours of the spine and<br>has been designed to maximize comfort and ease of<br>use. The elements and associated circuitry are<br>enclosed in a housing made of plastic materials,<br>which are fire rated and have high impact and tensile<br>strength. |

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## 9. Safety and Effectiveness

| 3.0T 8 Channel CTL Array Coil Product<br>Features | Comparison to predicate device or other 510(k)<br>cleared product |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the spine. | -Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K013595) |
| Indications for Use: Identical to routine<br>MRI imaging | -Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K013595) |
| Coil Material:<br>Flame Retardant Kydex<br>Flame Retardant PVC<br>Flame Retardant Polyurethane<br>Flame Retardant Polycarbonate | -Similar to the Premier 9000 8 Channel Phased<br>Array CTL Spine Coil manufactured by USA<br>Instruments, Inc. (K031366)<br>-Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K030042) |
| Coil Design: Receive-only phased array<br>design | -Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K013595) |
| Decoupling: RF Chokes with Switching<br>Diodes | -Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K013595) |
| Prevention of RF Burns: Does not<br>transmit RF Power, Decoupling isolates<br>the coil elements from RF fields during<br>RF transmission, Coil elements and<br>circuitry are enclosed in a non-<br>conductive housing. | -Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K013595) |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit<br>RF power | -Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K013595) |
| Formation of Resonant Loops:<br>Decoupling isolates coil elements from<br>RF fields during RF transmission. Length<br>of cable and stiffness<br>does not permit looping | -Similar to the Premier III Phased Array CTL Spine<br>Coil manufactured by USA Instruments, Inc.<br>(K013595) |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 2 2003

Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K032538

Trade/Device Name: 3.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: August 15, 2003 Received: August 19, 2003

Dear Ms. Shumaker:

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 (PMA), it may be subject to 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) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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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510(k) Number (if known): K032538

Device Name: 3.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array Coil

Indications for Use: The 3.0T 8-Channel CTL Array Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 8-Channel CTL Array Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

> Anatomic Regions: cervical, thoracic, and lumbar regions of the spine Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

David A. Legum

510(k) Numb