PREMIER III PHASED ARRAY CTL SPINE COIL

K030042 · Usa Instruments, Inc. · MOS · Feb 24, 2003 · Radiology

Device Facts

• Record ID: K030042
• Device Name: PREMIER III PHASED ARRAY CTL SPINE COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Feb 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Premier III Phased Array CTL Spine Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier III Phased Array CTL Spine Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.

Device Story

Premier III Phased Array CTL Spine Coil is a 12-element receive-only RF coil; designed for cervical, thoracic, and lumbar spine imaging. Device conforms to patient anatomy; housed in rigid, fire-rated, high-impact plastic. Operates as accessory to Siemens Magnetom Trio 3.0T MRI system; does not transmit RF power. Decoupling via switching diodes and RF fuses prevents RF burns and resonant loops. Used in clinical MRI settings by trained technicians/physicians. Output consists of raw RF signals processed by the host MRI system into diagnostic images; assists physicians in soft tissue structure assessment and clinical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

12-element receive-only phased array coil. Materials: Rovalite ABS, polycarbonate, flame-retardant polyurethane. Decoupling: switching diode with additional RF fuses. Form factor: rigid, contoured housing. Energy: passive receive-only (no RF transmission). Connectivity: dedicated interface for Siemens Magnetom Trio 3.0T MRI system.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the cervical, thoracic, and lumbar spine regions. Used with Siemens Magnetom Trio 3.0T MRI systems to produce images based on proton density, T1, and T2 parameters for soft tissue structure visualization and physician diagnosis.

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 7000 Phased Array C/T/L Spine Coil (K980157)

Submission Summary (Full Text)

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# KO300 42

# FEB 2 4 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | Premier III Phased Array CTL Spine 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 Premier III Phased Array CTL Spine Coil is a<br>receive- only phased array RF coil, used for<br>obtaining diagnostic images of the cervical, thoracic,<br>and lumbar regions of the spine in Magnetic<br>Resonance Imaging Systems. The Premier III<br>Phased Array CTL Spine Coil is designed for use<br>with the Magnetom Trio 3.0T MRI system<br>manufactured by Siemens Medical Solutions, Inc.<br>The indications for use are the same as for standard<br>MR Imaging. |
| 8. Device Description: | The Premier III Phased Array CTL Spine Coil is a<br>twelve element receive only phased array coil. The<br>coil is shaped to conform to the contours of the<br>spine and has been designed to maximize comfort<br>and ease of use. The coil elements and accessory<br>electronics are enclosed in a rigid plastic housing,<br>which is fire rated and has a high impact and tensile<br>strength. |

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#### USA Instruments, Inc.

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### 9. Safety and Effectiveness

| Premier III Phased Array CTL Spine<br>Coil Product Features | Comparison to predicate device or other<br>510(k) cleared product |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use:<br>Imaging of the spine. | -Similar to the Premier 7000 Phased Array<br>C/T/L Spine Coil manufactured by USA<br>Instruments, Inc. (K980157) |
| Indications for Use:<br>Identical to routine MRI imaging | -Similar to the Premier 7000 Phased Array<br>C/T/L Spine Coil manufactured by USA<br>Instruments, Inc. (K980157) |
| Coil Material:<br>Rovalite ABS Plastic<br>Polycarbonate Plastic<br>Flame Retardant Polyurethane | -Similar to the Premier 7000 Phased Array CTL<br>Spine Coil manufactured by USA Instruments,<br>Inc. (K980157) |
| Coil Design:<br>Receive-only phased array design | -Similar to the Premier 7000 Phased Array<br>C/T/L Spine Coil manufactured by USA<br>Instruments, Inc. (K980157) |
| Decoupling:<br>Switching diode decoupling.<br>Additional RF fuses incorporated. | -Similar to the Premier 7000 Phased Array<br>C/T/L Spine Coil manufactured by USA<br>Instruments, Inc. (K980157) |
| Prevention of RF Burns:<br>Does not transmit RF Power.<br>Decoupling isolates the coil elements<br>from RF fields during RF transmission,<br>Coil elements and circuitry are enclosed<br>in a non-conductive housing. | -Similar to the Premier 7000 Phased Arrav<br>C/T/L Spine Coil manufactured by USA<br>Instruments, Inc. (K980157) |
| Radio Frequency Absorption:<br>Coil is a receive only coil and does not<br>transmit RF power | -Similar to the Premier 7000 Phased Array<br>C/T/L Spine Coil manufactured by USA<br>Instruments, Inc. (K980157) |
| Formation of Resonant Loops:<br>Decoupling isolates coil elements from<br>RF fields during RF transmission.<br>Length of cable and stiffness<br>does not permit looping | -Similar to the Premier 7000 Phased Array<br>C/T/L Spine Coil manufactured by USA<br>Instruments, Inc. (K980157) |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head with three profiles overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 4 2003

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

Re: K030042 Trade/Device Name: Premier III Phased Array CTL Spine Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: January 3, 2003 Received: January 6, 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 yours,

Nancy C. Brogdon

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): K030042

Device Name: Premier III Phased Array CTL Spine Coil

Indications for Use: The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Siemens 3.0T Magnetom Trio MR scanner manufactured by Siemens Medical Solutions, Inc.

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

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)

(Division Sign-Off 4
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030042

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)