MARK 5000 PHASED ARRAY SHOULDER COIL

K983143 · Usa Instruments, Inc. · MOS · Nov 16, 1998 · Radiology

Device Facts

• Record ID: K983143
• Device Name: MARK 5000 PHASED ARRAY SHOULDER COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Nov 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Mark 5000 Phased Array Shoulder is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and adjacent regions in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Mark 5000 Phased Array Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.

Device Story

Mark 5000 Phased Array Shoulder Coil is a receive-only RF coil for MRI systems; utilizes two volume RF coil elements in quadrature design. Enclosed in flexible vinyl housing; positioned on patient shoulder via straps. Device does not transmit RF power; decoupling via switching diodes isolates elements during RF transmission to prevent RF burns and resonant loops. Used in clinical MRI settings; operated by MRI technicians/radiologists. Output consists of raw MR signals processed by the host MRI scanner (Picker Outlook) to generate diagnostic images. Clinical benefit includes high-quality soft tissue imaging of the shoulder region to assist physicians in diagnosis.

Clinical Evidence

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

Technological Characteristics

Receive-only phased array RF coil; two-channel quadrature design. Materials: vinyl fabric enclosure, ABS/PVC plastic alloy, polyurethane. Decoupling: switching diode. Connectivity: connects to Picker Outlook (0.23T) MRI scanner. Non-conductive housing. No internal software/firmware; passive hardware component.

Indications for Use

Indicated for diagnostic imaging of the shoulder and surrounding regions in patients undergoing MRI. Used with the Picker Outlook (0.23T) MRI scanner to produce images of proton distribution, T1, T2, and proton density for soft tissue structure visualization. For use by trained physicians.

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 Shoulder Coil Medical Advances Inc. (K945778)

Reference Devices

• Flexible Phased Array Spine Coil Picker International (K960497)
• Phased Array CTL Spine Coil USA Instruments, Inc. (K980157)
• Profile 7000 Volume Neck Coil USA Instruments, Inc. (K964531)
• Outlook system Picker International (K945827)

Submission Summary (Full Text)

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## NOV 1 6 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Mark 5000 Phased Array Shoulder Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,<br>Aurora, Ohio 44202, USA<br>Telephone: [phone]; Fax: [phone]. |
| 6. Performance Standard: | No applicable performance standards have been issued<br>under Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The Mark 5000 Phased Array Shoulder is a receive-only<br>phased array RF coil, used for obtaining diagnostic<br>images of the shoulder and adjacent regions in Magnetic<br>Resonance Imaging systems. The indications for use are<br>the same as for standard MR Imaging. The Mark 5000<br>Phased Array Coil is designed for use with the Outlook<br>(0.23Tesla) MRI scanner manufactured by Picker<br>International Inc. |
| 8. Device Description : | The Mark 5000 Phased Array Coil consists of two<br>volume RF coil elements in a quadrature design. The<br>elements and associated circuitry are enclosed in a<br>flexible vinyl enclosure housing. The coil is positioned on<br>the patient's shoulder, by means of straps, during<br>imaging. |

Please Turn Over

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## 9. Safety and Effectiveness

| Parameter | Mark 5000<br>Phased Array Shoulder Coil | Predicate |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Shoulder imaging applications | Phased Array Shoulder Coil<br>Medical Advances Inc.<br>(K945778) |
| Indications for Use | Identical to routine MRI imaging | Phased Array Shoulder Coil<br>Medical Advances Inc.<br>(K945778) |
| Coil Enclosure<br>Material | Vinyl Fabric | Flexible Phased Array Spine Coil<br>Picker International (K960497) |
| | ABS/PVC plastic alloy<br>Polyurethane Plastic | Phased Array CTL Spine Coil<br>USA Instruments, Inc. (K980157) |
| Coil Design | Two channel receive-only phased array coil | Flexible Phased Array Spine Coil<br>Picker International (K960497) |
| Decoupling | Switching diode decoupling | Flexible Phased Array Spine Coil<br>Picker International (K960497) |
| Prevention of RF<br>Burns | Does not transmit RF power; decoupling<br>isolates the coil elements from RF fields<br>during RF transmission; coil elements and<br>circuitry are enclosed in a non-conductive<br>housing. | Flexible Phased Array Spine Coil<br>Picker International (K960497)<br>Same as other Outlook Coils<br>Picker International (K945827) |
| Radio Frequency<br>Absorption | Coil is a receive only coil and does not<br>transmit RF power; power deposition<br>during imaging is limited by SAR<br>algorithm | Profile 7000 Volume Neck Coil<br>USA Instruments, Inc. (K964531)<br>Algorithm on Outlook system<br>(K945827) |
| Formation of<br>Resonant Loop | Decoupling isolates the coil elements from<br>RF fields during RF transmission; length of<br>cable and stiffness does not permit looping | Profile 7000 Volume Neck Coil<br>USA Instruments, Inc.<br>(K964531),<br>Flexible Phased Array Spine Coil<br>Picker International (K960497) |

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Image /page/2/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and human aspects. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 1998

Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive Aurora, Ohio 44202

Re:

K983143

Mark 5000 Phased Array Shoulder Coil Dated: October 20, 1998 Received: October 22, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Thomas:

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 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). 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 substantiation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 ritto 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 Compirance 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/cdrividsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductiv Abdominal, Ear, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K9 8 3 1 4 3

Device Name: Mark 5000 Phased Array Shoulder Coil

Indications for Use: The Mark 5000 Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Phased Array Shoulder Coil is designed for use with the Outlook (.23 Tesla) MRI scanner manufactured by Picker International.

> Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen

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

The Picker Outlook 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) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K983143 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |