SHOULDER COIL

K013541 · Usa Instruments, Inc. · MOS · Dec 14, 2001 · Radiology

Device Facts

• Record ID: K013541
• Device Name: SHOULDER COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Dec 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 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 Shoulder Coil is designed for use with the Rhapsody (1.0Tesla) MRI scanner manufactured by Siemens Medical Systems Inc.

Device Story

Shoulder Coil is a receive-only phased array RF coil; designed for shoulder and adjacent region imaging. Device consists of two volume RF coil elements in quadrature design; enclosed in flexible vinyl housing. Operates as accessory to Siemens Rhapsody (1.0T) MRI scanner. Coil receives MR signals; does not transmit RF power. Decoupling via switching diodes isolates elements during RF transmission; prevents RF burns. Non-conductive housing and cable design prevent resonant loop formation. Used in clinical MRI settings by trained technicians/physicians. Output provides diagnostic images of soft tissue structure; aids physician in diagnosis. Benefits include high-quality imaging of shoulder anatomy.

Clinical Evidence

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

Technological Characteristics

Receive-only phased array RF coil; two-channel quadrature design. Materials: vinyl-coated PVC foam, Delrin Acetyl, polyurethane plastic. Decoupling: switching diode. Connectivity: dedicated interface for Siemens Rhapsody MRI scanner. Non-conductive enclosure. SAR limited by scanner algorithm.

Indications for Use

Indicated for obtaining diagnostic MR images of the shoulder and surrounding regions in patients requiring standard MRI imaging. Contraindications are those standard for MRI procedures.

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 (K983143)
• Phased Array Shoulder Coil (K945778)

Submission Summary (Full Text)

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## Kol 35 41

## DEC 1 4 2001

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## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | 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 Shoulder is a receive-only phased array RF coil,<br>used for obtaining diagnostic images of the<br>shoulder and adjacent regions in Magnetic<br>Resonance Imaging systems. The indications for<br>use are the same as for standard MR Imaging. The<br>Shoulder Coil is designed for use with the Rhapsody<br>(1.0Tesla) MRI scanner manufactured by Siemens<br>Medical Systems Inc. |
| 8. Device Description : | The Shoulder Coil consists of two volume RF coil<br>elements in a quadrature design. The elements and<br>associated circuitry are enclosed in a flexible vinyl<br>enclosure housing. |

:

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## 9. Safety and Effectiveness

| Shoulder Coil Product Features | Comparison to Predicate Device or other 510(k)<br>Cleared Product |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>Shoulder imaging applications | -Similar to Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>- Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |
| Indications for Use<br>Identical to routine MRI imaging | -Similar to Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>- Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |
| Coil Enclosure Material<br>Vinyl coated PVC Foam<br>Delrin Acetyl<br>Polyurethane Plastic | -Similar to Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>-Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |
| Coil Design<br>Two channel receive-only phased array<br>coil | -Similar to Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>- Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |
| Decoupling<br>Switching diode decoupling | -Similar to Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>-Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |
| Prevention of RF Burns<br>Does not transmit RF power; decoupling<br>isolates the coil elements from RF fields<br>during RF transmission; coil elements<br>and circuitry are enclosed in a non-<br>conductive housing. | -Similar to Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>-Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |
| Radio Frequency Absorption<br>Coil is a receive only coil and does not<br>transmit RF power; power deposition<br>during imaging is limited<br>by SAR<br>algorithm | -Similar to Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>-Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |
| 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 Mark 5000 Phased Array Shoulder Coil<br>manufactured by USA Instruments, Inc. (K983143)<br>- Similar to Phased Array Shoulder Coil<br>manufactured by Medical Advances Inc. (K945778) |

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2001

Mr. Rony Thomas Vice President, Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K013541 Trade/Device Name: Shoulder Coil MRI Specialty Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 24, 2001 Received: October 24, 2001

Dear Mr. Thomas:

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 (OS) 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. Snogdin

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: Shoulder Coil

Indications for Use: The Shoulder Coil is a receive-only phased array RF coil, indications for OSC. The Shoulder and surrounding regions in used for obtaining diagnooils imaging systems. The Shoulder Coil is designed for use Magnetic Hesonanoe Imaging Syother manufactured by Siemens Medical Systems, Inc.

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

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

The Siemens Rhapsody system is indicated for use as an NMR device that rno Olonions 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)

(Division Sign-Off)
Division of Reproduction, Assistant,
and Radiological Devices
510(k) Number: KM3544