EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL

K022582 · Usa Instruments, Inc. · MOS · Oct 22, 2002 · Radiology

Device Facts

• Record ID: K022582
• Device Name: EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Oct 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck in Magnetic Resonance Imaging Systems. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the ExcelArt 1.5T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

Device Story

Excalibur 9000 TotalSENSE Quad Array Head Coil is a receive-only, multi-element quadrature phased array RF coil; used for diagnostic imaging of brain, upper cervical spine, and head/neck soft tissues/vasculature. Device comprises main coil base, sliding head section, and removable chin section; rigid, high-impact, fire-rated plastic housing. Operates within Toshiba 1.5T MRI systems; used in clinical settings by trained MRI technicians/radiologists. Coil elements utilize switching diode decoupling to isolate from RF fields during transmission, preventing RF burns and resonant loop formation. Output is raw MR signal data processed by the host MRI system into diagnostic images; interpreted by physicians to aid clinical diagnosis. Benefits include patient comfort via open design and high-quality diagnostic imaging.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Receive-only quadrature phased array RF coil. Materials: Acetal, Polycarbonate, Polyurethane. Decoupling: Switching diode. Form factor: Multi-element, three-section (base, sliding head, removable chin). Connectivity: Dedicated interface for Toshiba 1.5T MRI system. Non-conductive, high-impact, fire-rated plastic housing.

Indications for Use

Indicated for patients requiring MRI of the brain, upper cervical spine, and soft tissues/vasculature of the head and neck. Used with Toshiba 1.5T MRI systems. Contraindications: standard MRI contraindications apply.

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 (K001870)

Reference Devices

• Profile 7000 Quadrature Volume Neck Coil (K964531)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

K022582

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Excalibur 9000 TotalSENSE™ Quad Array Head<br>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 Excalibur 9000 TotalSENSE™ Quad Array<br>Head Coil is a receive-only phased array RF coil,<br>used for obtaining diagnostic images of the brain,<br>upper cervical spine, and the soft tissues and<br>vasculature of the head and neck in Magnetic<br>Resonance Imaging Systems. The Excalibur 9000<br>TotalSENSE™ Quad Array Head Coil is designed for<br>use with the ExcelArt 1.5T MRI system<br>manufactured by Toshiba Medical Systems, Inc. The<br>indications for use are the same as for standard MR<br>Imaging. |
| 8. Device Description: | The Excalibur 9000 TotalSENSE™ Quad Array<br>Head Coil is a multi-element quadrature phased<br>array, receive-only coil. The coil consists of three<br>sections: a main coil base, a sliding head section,<br>and a removable chin coil section. The open, patient<br>friendly design minimizes claustrophobic effects 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

| Excalibur 9000 TotalSENSE™ Quad<br>Array Head Coil | Comparison to predicate device or other 510(k)<br>cleared products | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Intended Use: Imaging of the brain,<br>upper cervical spine and the soft<br>tissues and vasculature of the head and<br>neck. | -Similar to the Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870) | | |
| Indications for Use: Identical to routine<br>MRI imaging. | -Similar to the Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870) | | |
| Coil Enclosure Material:<br>Acetal<br>Polycarbonate<br>Polyurethane | - Similar to the Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870)<br>-Similar to the Profile 7000 Quadrature Volume<br>Neck Coil manufactured by USA Instruments. Inc.<br>(K964531) | | |
| Coil Design: Receive-only quadrature<br>phased array coil. | - Similar to the Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870) | | |
| Decoupling: Switching diode<br>decoupling. | -Similar to the Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870) | | |
| 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 Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870) | | |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit<br>RF power. | -Similar to the Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870) | | |
| Formation of Resonant Loop:<br>Decoupling isolates the coil elements<br>from RF fields during RF transmission;<br>length of cable and stiffness does not<br>permit looping. | -Similar to the Millennium 9000 Phased Array<br>Neurovascular Coil manufactured by USA<br>Instruments, Inc. (K001870) | | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the edge. In the center of the logo is a stylized image of a person with their arms outstretched. The logo is black and white.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2002

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

Re: K022582

Trade/Device Name: Excalibur 9000 TotalSENSE Quad Head Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 MOS Dated: August 2, 2002 Received: August 5, 2002

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 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 this 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" (21 CFR Part 807.97). 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. Snogdon

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): K024582

Device Name: Excalibur 9000 TotalSENSE™ Quad Array Head Coil

Indications for Use: The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSE™ Quad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems.

> Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. Nuclei Excited: Hydrogen

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

The 1.5T 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)

Nancy Chrogdon

**(Division Sign-Off)**
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022582