QD KNEE/FOOT COIL, MODEL MJQJ-147A

K051763 · Toshiba America Medical Systems, In.C · MOS · Jul 14, 2005 · Radiology

Device Facts

• Record ID: K051763
• Device Name: QD KNEE/FOOT COIL, MODEL MJQJ-147A
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: MOS · Radiology
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Diagnostic imaging of the knee, ankle and foot regions. Fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy.

Device Story

QD Knee/Foot Coil is a quadrature (QD) volume radiofrequency (RF) coil accessory for the Vantage MRI system. It transmits RF pulses and receives nuclear magnetic resonance (NMR) signals from the knee, ankle, or foot. The device consists of a STIR-type coil element and a PC board with PIN diodes for switching between transmit and receive modes. It is used in clinical radiology settings by trained MRI technologists or radiologists. The coil enables high-resolution diagnostic imaging, including angiography and fluoroscopy, to assist clinicians in visualizing anatomical structures and fluid. The output is processed by the MRI system to generate diagnostic images, aiding in the assessment of musculoskeletal conditions.

Clinical Evidence

Bench testing only. Performance validated via sample phantom images and clinical images demonstrating diagnostic utility for the specified anatomical regions.

Technological Characteristics

Quadrature (QD) volume coil; STIR-type coil element; PC board with PIN diodes for transmit/receive switching. Compatible with 1.5 Tesla MRI systems. Maximum SAR < 4.8 watt/kg; acoustic noise 110 dB. 15 cm dsv specification volume. Materials identical to predicate QD Knee Coil.

Indications for Use

Indicated for diagnostic imaging of the knee, ankle, and foot regions in patients requiring MR examination, including fluid visualization, 2D/3D imaging, MR angiography, and MR fluoroscopy.

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

• QD Knee Coil (K032490)

Submission Summary (Full Text)

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JUL 1 4 2005

# 1051763

Appendix A

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

- DEVICE NAME 1. Magnetic Resonance Diagnostic Device Accessory Model Number MJQJ-147A Trade/Proprietary Name QD KNEE/FOOT COIL™
- 2. ESTABLISHMENT REGISTRATION 2020563
- 3. U.S. AGENT NAME AND ADDRESS Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle DriveTustin, CA 92780

### CONTACT PERSON

Michaela Mahl [phone]

#### MANUFACTURING SITE 4.

Toshiba Medical Systems Corporation (TMSC) 1385, Shimoishigami, Otawara-Shi, Tochigi 324-8550, Japan

#### 5. DATE OF SUBMISSION

June 16, 2005

#### 6. DEVICE DESCRIPTION

The QD KNEE/FOOT COIL is QD volume coil that can transmit RF and receive NMR signal from like the knee or other extremity regions.

The QD KNEE/FOOT COll. is comprised of coil element and PC board. The coil element shapes STIR type coil. The PC board switches transmit mode and receive mode with PIN diodes and combines the NMR signals.

The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.

#### 7. SAFETY PARAMETERS

Maximum static field strength Rate of change of magnetic field Maximum radio frequency power deposition (SAR) Acoustic noise levels (maximum)

1.5 Tesla 30 mT/second < 4.8 watt/kg 110 dB(A-weighted)

#### 8. IMAGING PERFORMANCE PARAMETERS

Specification volume

15 cm dsv

Sample phantom images and clinical images are presented in Appendix F & G.

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#### INTENDED USE 9.

Anatomical regions Nuclei excited Diagnostic use

Knee, ankle and foot regions Hydrogen Diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy

### 10. EQUIVALENCY INFORMATION

Toshiba Medical Systems Corporation believes that this QD Knee/Foot coil is substantially equivalent to the current QD Knee coil (K032490).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313

Re: K051763 Trade/Device Name: QD Knee/Foot Coil for Vantage MRI System (MRT-1503) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 28, 2005 Received: June 30, 2005

Dear Mr. Job:

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 (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 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.

JUL 1 4 2005

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his leter will anow you to ogen manises of your device of your device to a legally premaired notheation: "The PDF mailing of Survice and thus, permits 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 If you desire specific advice for your de following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain outer general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Page 1 _______________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | K051763 |
|---------------------------|-----------------------------------------------------|
| Device Name: | QD Knee/Foot Coil for Vantage MRI System (MRT-1503) |
| Indications for Use: | |

Imaging of:

- Diagnostic imaging of the knee, ankle and foot regions
- Fluid visualization
- 2D and 3D imaging

- 2D and 3D imaging .
- MR angiography .
- MR fluoroscopy .

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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)

Nancy C. Brogdon

(Dıvision Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 1051 165 510(k) Number _