CRYSTAL 5000 PHASES ARRAY TMJ COIL

K013528 · Usa Instruments, Inc. · MOS · Dec 13, 2001 · Radiology

Device Facts

• Record ID: K013528
• Device Name: CRYSTAL 5000 PHASES ARRAY TMJ COIL
• Applicant: Usa Instruments, Inc.
• Product Code: MOS · Radiology
• Decision Date: Dec 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Crystal 5000 Phased Array TMJ Coil is a receive-only phased array RF coil used for obtaining diagnostic images of the temporo-mandibular joint, condyle, and mandible in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Crystal 5000 Phased Array TMJ Coil is designed for use with the Proview™ (0.23Tesla) MRI scanner manufactured by Marconi Medical Systems Finland.

Device Story

Crystal 5000 Phased Array TMJ Coil is a receive-only RF coil for MRI systems; specifically designed for Marconi Proview 0.23T scanners. Device captures hydrogen NMR signals from temporo-mandibular joint, condyle, and mandible. Coil elements and circuitry are enclosed in high-impact, fire-rated plastic housing. Device utilizes switching diode decoupling to isolate elements from RF fields during transmission, preventing RF burns. Operated by MRI technicians/radiologists in clinical imaging settings. Output consists of raw signal data processed by the MRI scanner into diagnostic images. Clinicians interpret these images to assess soft tissue structures and aid in diagnosis. Benefit includes high-quality localized imaging of the TMJ region.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Receive-only phased array RF coil. Materials: PVC plastic alloy and polyurethane. Decoupling: Switching diode. Energy: Passive receive-only (no RF transmission). Connectivity: Dedicated interface for Marconi Proview 0.23T MRI scanner. Form factor: TMJ-specific coil housing.

Indications for Use

Indicated for patients requiring MRI of the temporo-mandibular joint, condyle, and mandible. Used with Marconi Proview 0.23T scanner to display soft tissue structures of the head and body based on proton density, T1, and T2 relaxation times for diagnostic purposes.

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

• 405GE-64 Phased Array TMJ Coil (K944773)
• Hi-Res 9000 Phased Array Carotid Coil (K001210)

Submission Summary (Full Text)

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KO i 3528

## DEC 1 3 2001

## SUMMARY OF SAFETY AND EFFECTIVENESS DEC : 2 2001

| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | Crystal 5000 Phased Array TMJ 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 Crystal 5000 Phased Array TMJ Coil is a<br>receive-only phased array RF coil used for obtaining<br>diagnostic images of the temporo-mandibular joint,<br>condyle, and mandible in Magnetic Resonance<br>Imaging systems. The indications for use are the<br>same as for standard MR Imaging. The Crystal 5000<br>Phased Array TMJ Coil is designed for use with the<br>Proview™ (0.23Tesla) MRI scanner manufactured by<br>Marconi Medical Systems Finland. |
| 8. Device Description : | The Crystal 5000 Phased Array TMJ Coil is a<br>phased array receive only coil. The elements and<br>associated circuitry are enclosed in housing made of<br>plastic materials, which are fire rated and have high<br>impact and tensile strength. |

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## 9. Safety and Effectiveness

| Crystal 5000 Phased Array TMJ Coil<br>Product Features | Comparison to predicate or other 510(k) cleared<br>products |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use:<br>Imaging of the temporo-mandibular<br>joint, condyle, and mandible. | - Similar to 405GE-64 Phased Array TMJ Coil<br>manufactured by IGC Medical Advances (K944773)<br>-Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |
| Indications for Use:<br>Identical to routine MRI imaging | -Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |
| Coil Enclosure Material:<br>PVC Plastic Alloy<br>Polyurethane | -Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |
| Coil Design:<br>Receive-only phased array coil | -Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |
| Decoupling:<br>Switching Diode decoupling | -Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |
| 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 Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |
| Radio Frequency Absorption:<br>Coil is a receive only coil and does not<br>transmit RF power. | -Similar to the Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |
| 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 Hi-Res 9000 Phased Array Carotid<br>Coil manufactured by USA Instruments (K001210) |

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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 3 2001

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

Re: K013528 Trade/Device Name: Crystal 5000 Phased Array TMJ Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 19, 2001 Received: October 23, 2001

Dear Mr. Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated 776, 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 general controls profice, 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 r rouse of active made a determination that your device complies with other requirements of the Act the r Drileral 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 noutication. The I Dri incing of succian 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 IT you desire spooline active 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 Additionally, for questions on any persons. Also, please note the regulation entitled, "Misbranding Other of Ochipmanted and (2007) Cation" (21 CFR Part 807.97). Other general information on by relected to promation the Act may be obtained from the Division of Small Manufacturers, your responsionnes and Consumer at its toll-free number [phone] or [phone] nternet.onal and Ocess http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

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: Crystal 5000 Phased Array TMJ Coil

Indications for Use: The Crystal 5000 Phased Array TMJ Coil is designed to provide Magnetic Resonance Images of the temporo-mandibular joint. The provide Magnetic Freemay TMJ Coil is designed for use with the Marconi Medical Systems' Proview 0.23Tesla scanner.

> Anatomic Regions: Temporo-mandibular Joint Nuclei Excited: Hydrogen

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

The Marconi Medical Systems Proview 0.23Tesla system is indicated for use as I no Maroni Modical eye that: (1) correspond to the distribution of arr NMR exhibiting NMR signal, (2) depend upon NMR parameters (proton provide online relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted display the bon 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) | <div style="display:inline-block; vertical-align:middle;">✓</div> OR Over-The-Counter Use (Optional Format 1-2-96) |
| (Division Sign-Off) | Nancy Brogdon |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K08528 |