MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL

K031056 · Usa Instruments, Inc. · MOS · May 8, 2003 · Radiology

Device Facts

• Record ID: K031056
• Device Name: MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: May 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Premier III Linear CTL Spine Coil is a receive only 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 Linear CTL Spine Coil is designed for use with the Signa 3.0T MRI system manufactured by GE Medical Systems. The indications for use are the same as for standard MR Imaging.

Device Story

Premier III Linear Phased Array CTL Spine Coil is a multi-element, receive-only RF coil for MRI systems. Device captures hydrogen nuclei signals from cervical, thoracic, and lumbar spine regions. Rigid, patient-friendly plastic housing contains coil elements and accessory electronics. Operates as a passive receive-only component; does not transmit RF power. Decoupling achieved via RF chokes and switching diodes; active diodes and fast-blowing fuses prevent resonant loop formation. Used in clinical MRI settings by trained technicians/radiologists. Output consists of raw RF signals processed by the host MRI system into diagnostic images. Benefits include high-quality spinal imaging and patient comfort through ergonomic design. Non-conductive housing and decoupling mechanisms mitigate RF burn risks.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of technical specifications, materials, and design features to legally marketed predicate devices.

Technological Characteristics

Multi-element phased array receive-only RF coil. Materials: Flame retardant ABS plastic, polycarbonate, and Kydex. Decoupling: RF chokes with switching diodes. Safety: Active diodes and fast-blowing fuses for resonant loop prevention; non-conductive housing. Form factor: Rigid enclosure. Connectivity: Dedicated interface for GE Signa 3.0T MRI system.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the cervical, thoracic, and lumbar spine regions. Used with GE Signa 3.0T MRI systems to produce images based on proton density, T1, and T2 parameters for soft tissue structure visualization. Requires interpretation by a trained physician.

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 CTL Spine Coil (K013595)
• Premier 7000 Phased Array C/T/L Spine Coil (K980157)

Reference Devices

• Hi-Res 9000 Phased Array Carotid Coil (K001210)

Submission Summary (Full Text)

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## MAY - 8 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

Ka3/056

| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | Premier III Linear 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 Linear CTL Spine Coil is a receive<br>only RF coil, used for obtaining diagnostic images of<br>the cervical, thoracic, and lumbar regions of the<br>spine in Magnetic Resonance Imaging Systems. The<br>Premier III Linear CTL Spine Coil is designed for use<br>with the Signa 3.0T MRI system manufactured by<br>GE Medical Systems. The indications for use are the<br>same as for standard MR Imaging. |
| 8. Device Description: | The Premier III Linear CTL Spine Coil is a multi-<br>element phased array receive only coil. The coil has<br>a rigid enclosure. The open, patient friendly design<br>eases patient handling and positioning and<br>maximizes patient comfort. The coil elements and<br>accessory electronics are enclosed in a rigid plastic<br>housing, which is fire rated and has a high impact<br>and tensile strength. |

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## 9. Safety and Effectiveness

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| Premier III Phased Array CTL Spine<br>Coil Product Features | Comparison to predicate device or other 510(k)<br>cleared products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the cervical,<br>thoracic, and lumbar regions of the<br>spine. | -Similar to the Premier III CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K013595) |
| Indications for Use: Identical to routine<br>MRI imaging. | -Similar to the Premier III CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K013595) |
| Coil Enclosure Material:<br>Flame Retardant ABS Plastic<br>Flame Retardant Polycarbonate<br>Flame Retardant Kydex | -Similar to the Premier III CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K013595)<br>- Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments, Inc.<br>(K001210) |
| Coil Design: receive only linear coil. | -Similar to the Premier 7000 Phased Array C/T/L<br>Spine Coil manufactured by USA Instruments, Inc.<br>(K980157) |
| Decoupling: RF chokes with Switching<br>Diodes | -Similar to the Premier III CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K013595) |
| Prevention of RF Burns: Does not<br>transmit RF Power, Decoupling isolates<br>the coil elements from RF fields during<br>RF transmission, and Coil elements and<br>circuitry are enclosed in a non-<br>conductive housing. | -Similar to the Premier III CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K013595) |
| Radio Frequency Absorption: Coil is<br>a receive only coil and does not<br>transmit RF power | -Similar to the Premier III CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K013595) |
| Formation of Resonant Loop: Active<br>diodes and fast RF blowing fuses<br>isolate the coil elements from RF fields;<br>length of cable and stiffness does not<br>permit looping | -Similar to the Premier III CTL Spine Coil<br>manufactured by USA Instruments, Inc. (K013595) |

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY - 8 2003

Re: K031056 Trade/Device Name: Premier III Linear Phased Array CTL Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 2, 2003 Received: April 3, 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. Iisting 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.

Sincerelv vours.

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): کی ص ر 3 / کی ک

Device Name: Premier III Linear Phased Array CTL Coil

Indications for Use: The Premier III Linear Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier III Linear Phased Array CTL Coil is designed for use with the GE Signa 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 defermination 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. Lepson

Orvision of Reproductive. and Radiological Device 510(k) Numbe