ALPHA 5000 WRIST COIL

K031143 · Usa Instruments, Inc. · MOS · May 29, 2003 · Radiology

Device Facts

• Record ID: K031143
• Device Name: ALPHA 5000 WRIST 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 Alpha 5000 Wrist Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the wrist and hand in Magnetic Resonance Imaging Systems. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

Device Story

Alpha 5000 Wrist Coil is a two-element quadrature receive-only RF coil; designed for wrist and hand MRI. Device inputs are magnetic resonance signals; transforms these into diagnostic images via integration with Toshiba OPART 0.35T MRI system. Rigid, fire-rated plastic housing with open windows for patient comfort and positioning. Operated by MRI technicians/radiologists in clinical imaging settings. Coil does not transmit RF power; uses switching diode decoupling to isolate elements from RF fields during transmission, preventing RF burns and resonant loop formation. Output is diagnostic image data for physician interpretation; aids in clinical diagnosis of soft tissue structures.

Clinical Evidence

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

Technological Characteristics

Two-element quadrature receive-only RF coil. Materials: Flame retardant polyurethane, flame retardant polycarbonate, Kydex acrylic/PVC, Delrin. Decoupling: Switching diode. Form factor: Rigid enclosure with open windows. Energy: Passive receive-only (no RF transmission). Connectivity: Dedicated to Toshiba OPART 0.35T MRI system.

Indications for Use

Indicated for patients requiring diagnostic MRI of the hand and wrist. Used with Toshiba OPART 0.35T MR scanner to produce images of proton density, T1, and T2 relaxation times for soft tissue structure visualization. Prescription use only.

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

• Alpha 7000 Wrist Coil (K972205)

Reference Devices

• Hi-Res 9000 Phased Array Carotid Coil (K001210)

Submission Summary (Full Text)

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## Ko31143

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name: | Alpha 5000 Wrist 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 Alpha 5000 Wrist Coil is a receive-only<br>quadrature RF coil, used for obtaining diagnostic<br>images of the wrist and hand in Magnetic<br>Resonance Imaging Systems. The Alpha 5000 Wrist<br>Coil is designed for use with the Toshiba OPART<br>0.35T MRI system manufactured by Toshiba<br>Medical Systems, Inc. The indications for use are<br>the same as for standard MR Imaging. |
| 8. Device Description: | The Alpha 5000 Wrist Coil is a two element<br>quadrature receive-only coil. The coil has a rigid<br>enclosure with windows on top to facilitate patient<br>handling. The open, patient friendly design eases<br>patient handling and positioning and maximizes<br>patient comfort. The coil elements and accessory<br>electronics are enclosed in a rigid plastic housing,<br>which is fire rated and has a high impact and tensile<br>strength. |

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## 9. Safety and Effectiveness

| Alpha 5000 Wrist Coil Product<br>Features | Comparison to predicate device or other 510(k)<br>cleared products |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the wrist and<br>hand. | -Similar to the Alpha 7000 Wrist Coil manufactured<br>by USA Instruments, Inc. (K972205) |
| Indications for Use: Identical to routine<br>MRI imaging. | -Similar to the Alpha 7000 Wrist Coil manufactured<br>by USA Instruments, Inc. (K972205) |
| Coil Enclosure Material:<br>Flame Retardant Polyurethane<br>Flame Retardant Polycarbonate<br>Kydex Acyrlic/PVC<br>Delrin | -Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments, Inc.<br>(K001210) |
| Coil Design: 2 element saddle receive-<br>only quadrature coil. | -Similar to the Alpha 7000 Wrist Coil manufactured<br>by USA Instruments, Inc. (K972205) |
| Decoupling: Switching diode<br>decoupling. | -Similar to the Alpha 7000 Wrist Coil manufactured<br>by USA Instruments, Inc. (K972205) |
| Prevention of RF Burns: Does not<br>transmit RF power; decoupling isolates<br>the coil elements from RF fields during<br>RF transmission; coil elements and<br>circuitry are enclosed in a non-<br>conductive housing. | -Similar to the Alpha 7000 Wrist Coil manufactured<br>by USA Instruments, Inc. (K972205) |
| Radio Frequency Absorption: Coil is a<br>receive only coil and does not transmit<br>RF power. | -Similar to the Alpha 7000 Wrist Coil manufactured<br>by USA Instruments, Inc. (K972205) |
| 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 Alpha 7000 Wrist Coil manufactured<br>by USA Instruments, Inc. (K972205) |

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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 symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.

Public Health Service

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: K031143

Trade/Device Name: Alpha 5000 Wrist Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 2, 2003 Received: April 18, 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 yours,

Nancy C 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): K031143

Device Name: Alpha 5000 Wrist Coil

Indications for Use: The Alpha 5000 Wrist Coil is designed to provide Magnetic Resonance Images of the hand and wrist. The Alpha 5000 Wrist Coil is designed for use with the Toshiba OPART 0.35T MR scanner manufactured by Toshiba Medical Systesm, Inc.

> Anatomic Regions: Wrist and hand Nuclei Excited: Hydrogen

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

The 0.35T 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)

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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
2031143