PHASED ARRAY FLEXIBLE CARDIAC COIL

K984588 · Philips Medical Systems (Cleveland), Inc. · MOS · Feb 8, 1999 · Radiology

Device Facts

• Record ID: K984588
• Device Name: PHASED ARRAY FLEXIBLE CARDIAC COIL
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: MOS · Radiology
• Decision Date: Feb 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system. The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, 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.

Device Story

Receive-only MRI coil; flexible, water-resistant fabric housing; secured to patient with Velcro straps. Input: hydrogen proton signals from thoracic region. Operation: phased array antenna configuration (two anterior, two posterior loops) for signal reception; active PIN diode decoupling; fixed tuning/impedance matching. Output: raw signal data processed by compatible Picker 1.5T MRI system into diagnostic images. Used in clinical MRI settings; operated by trained technicians/physicians. Benefits: improved signal-to-noise ratio, image resolution, and acquisition time compared to standard body coils. Physician interprets images to assist in diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technical parameters.

Technological Characteristics

Receive-only phased array coil; two anterior and two posterior loops; flame-rated foam and fabric enclosure; active PIN diode decoupling; fixed factory-set tuning/impedance matching; compatible with Picker 1.5T MRI systems.

Indications for Use

Indicated for imaging of the heart and associated structures in the thoracic region using hydrogen nuclei.

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

• Phased Array Flexible Body Coil (K962117)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

K98 4588

### General Information 1.

| Classification: | Class II<br>Magnetic Resonance Imaging (MRI) Accessory |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil |
| Proprietary Name: | Phased Array Flexible Cardiac Coil |
| Establishment Registration: | Picker International, Inc.<br>World Headquarters<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 |
| Performance Standards: | Not Applicable. |

#### 2. Intended Uses

The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T Edge Eclipse system.

The 1.5T Edge Eclipse system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, 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.

The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Heart and associated structures in the thoracic region. Anatomic Regions:

Nuclei Excited: Hydrogen.

【 - 【 12/23/98 PICKER INTERNATIONAL, INC. (CARDIAC)

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# Device Description 3.

The Picker Phased Array Flexible Cardiac Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil.

## Safety and Effectiveness 4.

The Picker Phased Array Cardiac Coil is substantially equivalent to the Picker Phased Array Flexible Body Coil (K962117) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.

| Parameter | Phased Array Flexible<br>Cardiac Coil | Predicate Device: Phased Array<br>Flexible Body Coil (K962117) |
|-------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible MRI<br>Systems | Same. | Picker International 1.5T Systems |
| Mode of Operation | Same. | Receive-Only |
| Antenna Configuration | Two anterior loops and<br>two posterior loops. | Co-rotating saddle coils and loops |
| Tuning/Impedance<br>Matching | Same. | Fixed tuning and matching. Factory<br>set. |
| Method of Decoupling | Same. | Active PIN diode decoupling |
| Coil Enclosure | Same. | Flame rated foam and fabric |
| Number of Receive<br>Channels | Same. | Four |
| Intended Use | Same. | The 1.5T EDGE system is intended<br>for use as a NMR device that<br>produces images that: (1) correspond<br>to the distribution of protons<br>exhibiting NMR, (2) depend upon<br>NMR parameters (proton density,<br>flow velocity, spin-lattice relaxation<br>time T1, spin-spin relaxation time T2)<br>and (3) display the soft tissue<br>structure of the head and whole body.<br>When interpreted by a trained<br>physician, these images yield<br>information that can be useful in the<br>determination of a diagnosis. |

PICKER INTERNATIONAL, INC.

(CARDIAC)

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| Parameter | Phased Array Flexible<br>Cardiac Coil | Predicate Device: Phased Array<br>Flexible Body Coil (K962117) |
|---------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei: | The Flexible Body Coil is indicated for use in the following anatomic regions and with the designated nuclei: |
| | Anatomic Regions: Heart and associated structures in the thoracic region. | Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures. |
| | Nuclei Excited: Hydrogen | Nuclei Excited: Hydrogen. |

・

.

(CARDIAC)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 FEB

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re:

K984588 Phased Array Flexible Cardiac Coil Dated: December 23, 1998 Received: December 24, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Dr. Keeler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

R. I. R. U.S.I. M.P.

Capt. Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Phased Array Flexible Cardiac Coil Device Name:

Indications for Use:

Intended Use

The Phased Array Flexible Cardiac Coil does not change the intended use of the Picker 1.5T EDGE ECLIPSE system.

The 1.5T EDGE ECLIPSE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, 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.

Indications for Use

The Phased Array Flexible Cardiac Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: Heart and associated structures in the thoracic region.

Nuclei Excited: Hydrogen.

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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)