ALPHA 7000 QUADRATURE WRIST COIL

K972205 · Usa Instruments, Inc. · MOS · Sep 5, 1997 · Radiology

Device Facts

• Record ID: K972205
• Device Name: ALPHA 7000 QUADRATURE WRIST COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Alpha 7000 Quadrature Wrist Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the wrist and hand anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Wrist Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.

Device Story

Receive-only quadrature RF coil; captures hydrogen nuclei signals for wrist and hand MRI. Quadrature design; utilizes two volume RF coil elements; housed in flame-retardant polyurethane. Operates as accessory to GE Signa (1.5 Tesla) MRI scanner. Used in clinical imaging environments by trained MRI technicians/radiologists. Decoupling achieved via RF chokes and switching diodes to isolate elements during RF transmission; prevents RF burns and resonant loop formation. Output consists of diagnostic images interpreted by physicians to assess soft tissue structure and aid diagnosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, design, and intended use to legally marketed predicate devices.

Technological Characteristics

Receive-only quadrature RF coil. Materials: flame-retardant polyurethane housing. Design: two-element volume coil. Decoupling: RF chokes with switching diodes. Energy: passive receive-only (no RF transmission). Connectivity: dedicated interface for GE Signa (1.5 Tesla) MRI scanner. No software or active algorithm components.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the wrist and hand anatomy. Compatible with GE Signa (1.5 Tesla) MRI scanners. No specific age or gender contraindications stated beyond standard MRI safety protocols.

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

• Quadrature Wrist and Hand Coil, MRI Devices Corp. (K931008)
• Profile 7000 Quadrature Volume Neck Coil, USA Instruments, Inc. (K964531)

Reference Devices

• Lower Extremity Coil, Head Coil, and Vascular Head and Neck Coil, OUTLOOK MRI System, Picker International, Inc. (K945827)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Alpha 7000 Quadrature Wrist Coil SEP - 5 1997 |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 675-B Alpha Drive,<br>Highland Heights, Ohio 44143, 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 Alpha 7000 Quadrature Wrist Coil is a receive-only<br>quadrature RF coil, used for obtaining diagnostic images<br>of the wrist and hand anatomy in Magnetic Resonance<br>Imaging systems. The indications for use are the same as<br>for standard MR Imaging. The Quadrature Wrist Coil is<br>designed for use with GE Signa (1.5 Tesla) MRI scanner<br>manufactured by GE Medical Systems. |
| 8. Device Description: | The Alpha 7000 Quadrature Wrist Coil consists of two<br>volume RF coil elements in a quadrature design. The<br>elements and the associated circuitry are enclosed in a<br>durable housing made of polyurethane material, which<br>is fire rated and has high impact and tensile strength. |

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## 9. Safety and Effectiveness

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| Parameter | Features of Alpha7000<br>Quadrature Wrist Coil | Same as Predicate Device |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Wrist and Hand Imaging<br>Applications | Quadrature Wrist and Hand Coil<br>MRI Devices Corp.<br>(K931008) |
| Indications for Use | Identical to routine MRI<br>imaging | Quadrature Wrist and Hand Coil<br>MRI Devices Corp.<br>(K931008)<br>Profile 7000 Quadrature Volume Neck Coil<br>USA Instruments, Inc.<br>(K964531) |
| Coil Body Material | Flame retardant<br>Polyurethane | Lower Extremity Coil, Head Coil, and Vascular<br>Head and Neck Coil, OUTLOOK MRI System<br>Picker International, Inc.<br>(K945827) |
| Coil Design | Quadrature design | Profile 7000 Quadrature Volume Neck Coil<br>USA Instruments, Inc.<br>(K964531) |
| Decoupling | RF Chokes with Switching<br>Diodes | Profile 7000 Quadrature Volume Neck Coil<br>USA Instruments, Inc.<br>(K964531) |
| Prevention of RF<br>Burns | Does not transmit RF Power<br>Decoupling isolates the coil<br>elements from RF fields<br>during RF transmission<br>Coil elements and circuitry<br>are enclosed in a non-conductive housing. | Profile 7000 Quadrature Volume Neck Coil<br>USA Instruments, Inc.<br>(K964531) |
| Radio Frequency<br>Absorption | Coil is a receive only coil<br>and does not transmit RF<br>power | Profile 7000 Quadrature Volume Neck Coil<br>USA Instruments, Inc.<br>(K964531) |
| Formation of<br>Resonant Loops | Decoupling isolates coil<br>elements from RF fields<br>during RF transmission.<br>Length of cable and stiffness<br>do not permit looping. | Profile 7000 Quadrature Volume Neck Coil<br>USA Instruments, Inc.<br>(K964531) |

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Image /page/2/Picture/17 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three curved lines representing the wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1997

Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 675-B Alpha Drive Highland Heights, Ohio 44143 Re:

K972205 Maximum 7000 Ouadrature Extremity Coil Dated: May 6, 1997 Received: June 12, 1997 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, 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 requirement, 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 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 yitzo 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 of the regulation of "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/dsmamain.html".

Sincerely yours,

h7liau Yi

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: Alpha 7000 Quadrature Wrist Coil

Indications for Use: The Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.

> Anatomic Regions: Wrist and hand anatomy Nuclei Excited: Hydrogen

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

The GE Signa 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.

(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, ENT,
and Radiological Devices
510(k) Number K972205

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