OPART, MODEL MRT-600

K991740 · Toshiba America Mri, Inc. · MOS · Aug 2, 1999 · Radiology

Device Facts

• Record ID: K991740
• Device Name: OPART, MODEL MRT-600
• Applicant: Toshiba America Mri, Inc.
• Product Code: MOS · Radiology
• Decision Date: Aug 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Anatomical regions: Head, body, extremity, spine, neck, TMJ, breast, and heart Nuclei excited: Hydrogen Diagnostic use: Diagnostic imaging of the human body (including head, abdomen, breast, heart, pelvis, spine, blood vessels, limbs, extremities, and small parts which include: wrist, elbow, ankle, shoulder, hand, knee), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.

Device Story

Flexible Small Parts coil accessory for OPART™ MRI system; used for diagnostic imaging of human anatomy. Input: hydrogen nuclei signals from patient anatomy. Device consists of flexible copper winding encased in closed-cell foam; conforms to irregular body surfaces to maintain consistent spacing. Operation: solenoid-type coil; 50-ohm nominal impedance; dual active decoupling via PIN diodes. Used in clinical MRI settings by trained operators. Output: raw MR signal data processed by the host MRI system to produce diagnostic images. Benefits: improved signal acquisition for small or irregular anatomical regions; facilitates 2D/3D imaging, angiography, and fluoroscopy. Healthcare providers use images for clinical diagnosis and decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of the coil's performance within the OPART™ system. Sample phantom and clinical images were provided to demonstrate imaging performance.

Technological Characteristics

Solenoid-type RF coil; flexible copper winding; closed-cell foam housing. Impedance: 50 ohms nominal. Decoupling: dual active via PIN diodes. Static field strength: 0.35 Tesla. SAR: <0.4 W/kg. Acoustic noise: 98.4 dB(A). Connectivity: integrated with OPART™ MRI system. Materials are identical to those used in previously cleared OPART™ coil sets.

Indications for Use

Indicated for diagnostic MRI imaging of the human body, including head, abdomen, breast, heart, pelvis, spine, blood vessels, limbs, extremities, and small parts (wrist, elbow, ankle, shoulder, hand, knee) in patients requiring MRCP, MR urography, MR myelography, MR fluoroscopy, surface anatomy scans, dynamic scans, or cine imaging.

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

• Small Belt and Extremity coils (K962933)

Submission Summary (Full Text)

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K991740

## 510(k) Premarket Notification

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 1. DEVICE NAME | Magnetic Resonance Diagnostic Device Accessory |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Number | MRT-600 |
| Trade/Proprietary Name | OPART™ |
| 2. ESTABLISHMENT REGISTRATION | 2636923 |
| 3. U.S. AGENT NAME AND ADDRESS | Toshiba America MRI, Inc.<br>280 Utah Avenue<br>South San Francisco, CA 94080 |
| CONTACT PERSON | Ken Nehmer<br>[phone] ext. 6083 |
| 4. MANUFACTURING SITE | same as above |
| 5. DATE OF SUBMISSION | May 19, 1999 |
| 6. DEVICE DESCRIPTION | The Flexible Small Parts coil is comprised of a flexible coil winding, tune box, and clamp. The flexible coil winding is fabricated from a single strip of copper and encased in soft closed cell foam. The winding conforms to the irregular surface of anatomy and keeps the shape it is formed to while the foam provides consistent spacing between the windings and anatomy.<br><br>Decoupling is dual active and achieved with PIN diodes. The impedance of the coil is 50 ohms nominal and it is a solenoid type coil.<br><br>The Flexible Small Parts coil is constructed with the same materials that are currently in use for the released coil set for OPART™. |
| 7. SAFETY PARAMETERS | |
| | Maximum static field strength: 0.35 Tesla<br>Rate of change of magnetic field: 19T/second<br>Maximum radio frequency power deposition (SAR): <0.4 Watt/kg<br>Acoustic noise levels (maximum): 98.4 dB (A) |
| 8. IMAGING PERFORMANCE PARAMETERS | |
| | Specification volume: |
| | Head: 10cm dsv<br>Body: 20cm dsv |

Sample phantom images and clinical images are presented from the Extra Large Body coil (Appendix 6 & 7).

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| INTENDED USE | Anatomical regions: | Head, body, extremity, spine, neck,<br>TMJ, breast, and heart |
|--------------|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Nuclei excited: | Hydrogen |
| | Diagnostic use: | Diagnostic imaging of the human body<br>(including head, abdomen, breast,<br>heart, pelvis, spine, blood vessels,<br>limbs, extremities, and small parts<br>which include: wrist, elbow, ankle,<br>shoulder, hand, knee), fluid<br>visualization, 2D and 3D imaging, MR<br>angiography and MR fluoroscopy. |
| | EQUIVALENCY INFORMATION | |

9.

10.

Toshiba America MRI, Inc., believes that the Flexible Small Parts coil option for OPART™ system is substantially equivalent to the current Small Belt and Extremity coils which were cleared with the OPART™ diagnostic resonance system 510(k) number K962933.

This optional coil does not introduce any new indications for use from those cleared in the Premarket Notification for OPART™ diagnostic resonance system 510(k) number K962933.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -2 1999

Ken Nehmer Quality Engineer Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, California 94080 RE:

K991740

OPART™ Model MRT-600 Flexible Small Parts Coil. MRI Accessory Dated: May 19, 1999 Received: May 21, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Nehmer:

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 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). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 the Electronic Product 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 vitro 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 entitled, "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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

11991740

Device Name:

Flexible Small Parts Coil with OPART™ (MRT-600)

Indications for Use:

Imaging of:

- The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels, small parts which include: wrist, elbow, ankle, shoulder, hand, knee). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization ﮯ
- 2D/3D Imaging -
- MR Angiography/MR Vascular Imaging

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR§801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

Vind A. Slegman
(Division Sign. Off.

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

OR