SPIRIT III TOTALSENSE CARDIAC COIL

K031172 · Usa Instruments, Inc. · MOS · May 29, 2003 · Radiology

Device Facts

• Record ID: K031172
• Device Name: SPIRIT III TOTALSENSE CARDIAC COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: May 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit III Total SENSE Cardiac Coil is designed for use with the Intera 3.0T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

Device Story

Receive-only phased array RF coil; six-element design; flexible top piece and rigid bottom piece. Used with Philips Intera 3.0T MRI system. Captures hydrogen NMR signals from cardiovascular system; transforms signals into diagnostic images for physician interpretation. Designed for patient comfort; minimizes claustrophobia. Decoupling via switching diodes isolates elements during RF transmission to prevent RF burns. Non-conductive housing ensures safety. Used in clinical MRI settings by trained professionals to aid diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by comparison of design, materials, and electrical characteristics to legally marketed predicate devices.

Technological Characteristics

Six-element receive-only phased array RF coil. Materials: flame-retardant polyurethane, vinyl-coated EVA foam, flame-retardant polycarbonate. Decoupling: switching diode. Energy: passive receive-only (no RF transmission). Form factor: flexible top, rigid bottom. Connectivity: dedicated to Philips Intera 3.0T MRI system.

Indications for Use

Indicated for obtaining diagnostic images of the cardiovascular system using 3.0T MRI systems. Applicable to patients requiring standard MR imaging of soft tissue structures; images correspond to proton distribution and NMR parameters (proton density, T1, T2).

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

• Spirit III TotalSENSE Cardiac Coil (K024187)

Reference Devices

• Insight Plus 9000 Phased Array Torso and Pelvis Coil (K023650)

Submission Summary (Full Text)

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Ko 3 1172

## MAY 2 9 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | Spirit III TotalSENSE Cardiac 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 Spirit III TotalSENSE Cardiac Coil is a receive-<br>only phased array RF coil, used for obtaining<br>diagnostic images of the cardiovascular system in<br>Magnetic Resonance Imaging Systems. The Spirit III<br>Total SENSE Cardiac Coil is designed for use with<br>the Intera 3.0T MRI system manufactured by Philips<br>Medical Systems, Inc. The indications for use are<br>the same as for standard MR Imaging. |
| 8. Device Description: | The Spirit III TotalSENSE Cardiac Coil is a six<br>element receive only phased array coil. The coil is<br>composed of a flexible top piece and a rigid bottom<br>piece. The flexible top piece allows for imaging of<br>patients of different sizes. The open, patient friendly<br>design minimizes claustrophobic effects and<br>maximizes patient comfort. The coil elements and<br>accessory electronics are enclosed in flexible and<br>rigid plastic housings, which are fire rated. All rigid<br>plastic housing parts have a high impact and tensile<br>strength. |

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| | | | | 9. Safety and Effectiveness |
|--|--|--|--|-----------------------------|
|--|--|--|--|-----------------------------|

| Spirit III TotalSENSE Cardiac Coil Product<br>Features | Comparison to predicate device or other 510(k)<br>cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Intended Use: imaging of the<br>cardiovascular system | -Similar to the Spirit III TotalSENSE Cardiac Coil<br>manufactured by USA Instruments, Inc. (K024187). |
| Indications for Use: Identical to routine<br>MRI imaging. | -Similar to the Spirit III TotalSENSE Cardiac Coil<br>manufactured by USA Instruments, Inc. (K024187). |
| Coil Enclosure Material:<br>Flame Retardant Polyurethane<br>Vinyl Coated EVA foam<br>Flame Retardant Polycarbonate | -Similar to the Spirit III TotalSENSE Cardiac Coil<br>manufactured by USA Instruments, Inc. (K024187). |
| Coil Design: Receive-only phased array<br>coil. | -Similar to the Spirit III TotalSENSE Cardiac Coil<br>manufactured by USA Instruments, Inc. (K024187). |
| Decoupling:<br>Switching diode decoupling. | -Similar to the Insight Plus 9000 Phased Array Torso<br>and Pelvis Coil manufactured by USA Instruments, Inc.<br>(K023650) |
| 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 Spirit III TotalSENSE Cardiac Coil<br>manufactured by USA Instruments, Inc. (K024187). |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit RF<br>power. | -Similar to the Spirit III TotalSENSE Cardiac Coil<br>manufactured by USA Instruments, Inc. (K024187). |
| 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 Spirit III TotalSENSE Cardiac Coil<br>manufactured by USA Instruments, Inc. (K024187). |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2003

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

Re: K031172

Trade/Device Name: Spirit III TotalSENSE Cardiac Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 11, 2003 Received: April 22, 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 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 vours.

Nancy 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):_____________________________________________________________________________________________________________________________________________________

Device Name: Spirit III TotalSENSE Cardiac Coil

Indications for Use: The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.

> Anatomic Regions: cardiovascular system 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) OR Over-The-Counter Use Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)