3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL

K032618 · Usa Instruments, Inc. · MOS · Sep 12, 2003 · Radiology

Device Facts

• Record ID: K032618
• Device Name: 3.0T 8 CHANNEL NEUROVASCULAR (NV) 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 Neurovascular (NV) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest in Magnetic Resonance Imaging Systems. The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.

Device Story

The 3.0T 8 Channel Neurovascular (NV) Array Coil is a receive-only phased array RF coil designed for use with GE 3.0T MRI systems. It captures magnetic resonance signals from the brain, cervical spine, and head/neck/upper chest vasculature. The device features a rigid, patient-friendly enclosure made of flame-retardant materials. It utilizes switching diode decoupling to isolate coil elements during RF transmission, preventing RF burns and the formation of resonant loops. The coil does not transmit RF power. It is operated by MRI technicians in a clinical imaging environment. The resulting images are displayed for physician interpretation to assist in clinical diagnosis. The device benefits patients by providing high-quality diagnostic images of neurovascular structures.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and design comparison to the predicate device.

Technological Characteristics

Receive-only phased array RF coil; 8-channel configuration. Materials: Flame-retardant polyurethane, flame-retardant polycarbonate, and Delrin Acetal. Decoupling: Switching diode. Form factor: Rigid enclosure. Connectivity: Dedicated interface for GE 3.0T MRI systems. Energy: Passive receive-only (no RF transmission).

Indications for Use

Indicated for patients requiring MRI imaging of the brain, cervical spine, soft tissues, and vasculature of the head, neck, and upper chest. Used with GE 3.0T MRI systems to produce images based on proton density, T1, and T2 parameters for diagnostic interpretation by a 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

• Millennium 9000 Phased Array Neurovascular coil (K001807)

Reference Devices

• Champion 5000 Peripheral Vascular coil (K023247)

Submission Summary (Full Text)

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Ko32618

# SEP 1 2 2003

### SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | 3.0T 8 Channel Neurovascular (NV) 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 Neurovascular (NV) Array Coil<br>is a receive-only phased array RF coil, used for<br>obtaining diagnostic images of the brain, cervical<br>spine, soft tissues and vasculature of the head, neck<br>and upper chest in Magnetic Resonance Imaging<br>Systems. The 3.0T 8 Channel Neurovascular (NV)<br>Array Coil is designed for use with the 3.0T MRI<br>systems manufactured by GE Medical Systems. |
| 8. Device Description: | The 3.0T 8 Channel Neurovascular (NV) Array Coil<br>is a multi-element phased array receive only coil.<br>The coil has a rigid enclosure. The open, patient<br>friendly design eases patient handling and<br>positioning and maximizes patient comfort. The coil<br>elements and accessory electronics are enclosed in<br>a rigid plastic housing, which is fire rated and has a<br>high impact and tensile strength. |

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### 9. Safety and Effectiveness

| 3.0T 8 Channel Neurovascular (NV) Array<br>Coil product features | Comparison to predicate device or other 510(k)<br>cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the brain, cervical<br>spine, soft tissues and vasculature of the<br>head, neck, and upper chest | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA instruments,<br>Inc. (K001807) |
| Indications for Use: Identical to routine<br>MRI imaging | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Coil Enclosure Material:<br>Flame Retardant Polyurethane<br>Flame Retardant Polycarbonate<br>Delrin Acetal | -Similar to the Champion 5000 Peripheral Vascular coil<br>manufactured by USA Instruments, Inc. (K023247) |
| Coil Design: Receive-only phased array<br>coil | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Decoupling: Switching diode decoupling | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Prevention of RF Burns: Does not transmit<br>RF power; decoupling isolates the coil<br>elements from RF fields during RF<br>transmission; coil elements and circuitry are<br>enclosed in a non-conductive housing. | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit RF<br>power | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |
| Formation of Resonant Loop: Decoupling<br>isolates the coil elements from RF fields<br>during RF transmission; length of cable and<br>stiffness does not permit looping | -Similar to the Millennium 9000 Phased Array<br>Neurovascular coil manufactured by USA Instruments,<br>Inc. (K001807) |

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird in flight, composed of three parallel, curved lines that suggest movement and wings. Encircling the bird is text arranged in a circular pattern, likely the name of an organization or institution. The text is oriented to follow the curve of the circle, with the top portion of the text appearing larger and more prominent.

Food and Drug Administration 200 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: K032618

Trade/Device Name: 3.0T 8-Channel Neurovascular (NV) Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: August 21, 2003 Received: August 26, 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

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):__ Ko 3 乙んし

Device Name: 3.0T 8 Channel Neurovascular (NV) Array Coil

Indications for Use: The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

> Anatomic Regions: brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest 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) | |
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| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:middle;">✓</div> |
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| Over-The-Counter Use<br>(Optional Format 1-2-96) | |
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| (Division Sign-Off) | |
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| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K032618 |