MARK 5000 QUADRATURE SHOULDER COIL

K013854 · Usa Instruments, Inc. · MOS · Feb 6, 2002 · Radiology

Device Facts

• Record ID: K013854
• Device Name: MARK 5000 QUADRATURE SHOULDER COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Feb 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Mark 5000 Quadrature Shoulder Coil is a receive-only specialty 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 Quadrature Coil is designed for use with the Opart 0.35 Tesla MRI scanner manufactured by Toshiba Medical Systems Inc.

Device Story

Mark 5000 Quadrature Shoulder Coil is a receive-only RF coil for MRI systems; specifically designed for Toshiba Opart 0.35 Tesla scanners. Device consists of two RF coil elements in quadrature configuration; enclosed in rigid housing and vinyl-coated PVC/EVA foam. Positioned on patient shoulder during imaging. Coil does not transmit RF power; decoupling via switching diodes isolates elements during RF transmission to prevent RF burns. Output is raw MR signal data processed by the host MRI system to generate diagnostic images. Used in clinical settings by trained MRI technicians/radiologists. Benefits include high-quality diagnostic imaging of shoulder anatomy; safety ensured by non-conductive housing and decoupling circuitry preventing resonant loops.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Receive-only quadrature RF coil. Materials: Vinyl-coated EVA foam, polyurethane plastic, PVC foam. Decoupling: Switching diode. Energy: Passive receive-only (no RF transmission). Connectivity: Dedicated interface for Toshiba Opart 0.35T MRI. Form factor: Rigid housing with foam padding for patient positioning.

Indications for Use

Indicated for diagnostic imaging of the shoulder and surrounding regions using MRI. Intended for use with the Toshiba Opart 0.35 Tesla MRI system to produce images based on proton density, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2) of hydrogen nuclei. Images are interpreted by a trained physician to determine diagnosis of soft tissue structures of the head and whole body.

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

• Mark 5000 Phased Array Shoulder Coil (K893143)
• Quadrature Shoulder Coil (Hitachi Medical Systems America) (K992650)

Submission Summary (Full Text)

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FEB 0 6 2002

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## SUMMARY OF SAFETY AND EFFECTIVENESS

KO13854

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Mark 5000 Quadrature 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<br>issued under Section 514 of the Food, Drug and<br>Cosmetic Act. |
| 7. Intended Use: | The Mark 5000 Quadrature Shoulder Coil is a<br>receive-only specialty RF coil, used for obtaining<br>diagnostic images of the shoulder and adjacent<br>regions in Magnetic Resonance Imaging systems.<br>The indications for use are the same as for standard<br>MR Imaging. The Mark 5000 Quadrature Coil is<br>designed for use with the Opart 0.35 Tesla MRI<br>scanner manufactured by Toshiba Medical Systems<br>Inc. |
| 8. Device Description : | The Mark 5000 Quadrature Shoulder Coil consists<br>of two RF coil elements in a quadrature design. The<br>coil elements and associated circuitry are enclosed<br>to prevent any exposure to the patient or<br>environment. The coil electronics are enclosed in<br>both the rigid housing and the vinyl coated PVC<br>foam. The coil is positioned on the patient's shoulder<br>during imaging. |

Mark 5000

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## 9. Safety and Effectiveness:

| Mark 5000 Quadrature Shoulder Coil<br>Product Features | Comparison to Predicate or other 510(k) cleared<br>products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Shoulder imaging applications | -Similar to the Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments Inc. (K893143)<br>-Similar to the Quadrature Shoulder Coil manufactured<br>by Hitachi Medical Systems America (K992650) |
| Indications for Use<br>Identical to routine MRI imaging | -Similar to the Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments Inc. (K893143) |
| Coil Enclosure Material<br>Vinyl coated EVA foam<br>Polyurethane Plastic | -Similar to the Quadrature Shoulder Coil manufactured<br>by Hitachi Medical Systems America (K992650)<br>-Similar to the Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments Inc. (K893143) |
| Coil Design<br>Receive-only Quadrature design | -Similar to the Quadrature Shoulder Coil manufactured<br>by Hitachi Medical Systems America (K992650) |
| Decoupling<br>Switching diode decoupling | -Similar to the Mark 5000 Shoulder Coil manufactured<br>by USA Instruments Inc. (K893143) |
| Prevention of RF Burns<br>Does not transmit RF power;<br>decoupling isolates the coil elements<br>from RF fields during RF transmission;<br>coil elements and circuitry are<br>enclosed in a non-conductive housing. | -Similar to the Mark 5000 Shoulder Coil manufactured<br>by USA Instruments Inc. (K893143) |
| Radio Frequency Absorption<br>Coil is a receive only coil and does not<br>transmit RF power; power deposition<br>during imaging is limited by SAR<br>algorithm | -Similar to the Mark 5000 Shoulder Coil manufactured<br>by USA Instruments Inc. (K893143) |
| 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 Mark 5000 Shoulder Coil manufactured<br>by USA Instruments Inc. (K893143) |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Ms. Tori Masiella Regulatory Specialist USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K013854

Trade/Device Name: Mark 5000 Quadrature Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 21, 2001 Received: November 20, 2001

Dear Ms. Masiella:

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. Brogdon

Nancv 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/ 38 5 4

Device Name: Mark 5000 Quadrature Shoulder Coil

Indications for Use: The Mark 5000 Quadrature Shoulder Coil is a receive-only Indications for USe. The Mant 0000 Quanostic images of the shoulder and quadrature HF Coli, used for obtaining alsgring systems. The Mark 5000
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> Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen

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

The Toshiba Opart MRI system is indicated for use as an NMR device that The Toshiba Opart Milli System is indication of protons exhibiting produces images that. (1) office prometers (proton density, spin lattice NWH Sighali, (2) depend upon Nim Pparamon time T2) display the soft tissue relaxation time 11, Spir-Spiritoliation interpreted by a trained physician,
structure of the head and whole body. When interpreted by a trained of se structure of the nead and whole bouty.
these images yield information that can be useful in the determination of a diagnosis.

(Please do not WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013854 |

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