4CH FLEX SPEEDER

K111251 · Toshiba Medical Systems Coporation, Japan · MOS · May 27, 2011 · Radiology

Device Facts

• Record ID: K111251
• Device Name: 4CH FLEX SPEEDER
• Applicant: Toshiba Medical Systems Coporation, Japan
• Product Code: MOS · Radiology
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)

Device Story

4ch Flex SPEEDER is a flexible, phased-array MRI receive-only coil; consists of four single-loop coil elements arranged in a row. Device wraps around patient extremities, joints, or trunk to receive NMR signals during MRI procedures. Operates at 1.5 T field strength. Decoupled during transmission from the QD whole-body coil via PIN diodes. Used in clinical MRI settings by trained technologists/radiologists. Output is raw NMR signal processed by the host MRI system into diagnostic images (2D/3D, angiography, fluoroscopy, MRS). Benefits include improved signal reception for various anatomical regions due to flexible form factor.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including sample phantom images and clinical images provided in the submission to demonstrate imaging performance.

Technological Characteristics

Phased-array receive-only coil; 4 coil elements; flexible form factor; PIN diode decoupling; 1.5 T field strength; biocompatible materials; no software component.

Indications for Use

Indicated for diagnostic imaging of the extremities (foot, hand), joints (knee, shoulder, ankle, wrist, elbow), and body (chest, abdomen, pelvis) using magnetic resonance imaging. No specific age or gender restrictions noted.

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

• Atlas SPEEDER Body (K063361)
• ¢ 200 flex coil (K060003)

Submission Summary (Full Text)

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K11125|

# Appendix A

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. Classification and Device Name

Classification Name

Magnetic Resonance Diagnostic Device

# Model Number

MJAJ-197A

# Trade/Propriety Name

4ch Flex SPEEDER

#### 2. Establishment Registration

2020563

#### 3. U.S. Agent Name and Address

# Agent Name

Toshiba America Medical Systems, Inc. (TAMS) 2441 Michelle Drive Tustin, CA 92780

# Contact Person

Paul Biggins, Director Regulatory Affairs T: [phone] F: [phone] [e-mail]

#### 4. Manufacturing Site

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

#### Date of Submission 5.

May 3, 2011

- 6. Device Intended Use
# Field Strength

1.5 T

# Resonant Nucleus

Hydrogen

# Anatomical Region of Interest

The extremities, joints, and trunk of the body.

Company Confidential MAY 2011

MAY 2 7 2011

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# Diagnostic Use

Diagnostic imaging of the human body, fluid visualization, 2D and 3D imaging, MR angiography, MR fluoroscopy and MRS

#### 7. Device Description

The 4ch Flex SPEEDER is a phased array coil that can receive NMR signal from the extremities, joints, and trunk of the body. The 4ch Flex SPEEDER is mechanically flexible, and can wrap around various regions as mentioned above.

The 4ch Flex SPEEDER consists of four coil elements and PC board. The coil elements shape single loop and the four single loop coil elements are arranged to the row. The coil is decoupled during transmission from QD whole body by means of activating the PIN diodes.

#### 8. Safety Parameter

# Maximum static field strength

1.5 T

# Maximum dB/dt

1st operation mode specified in IEC60601-2-33 (2002)

# Maximum SAR

1st operation mode specified in IEC60601-2-33 (2002)

# Peak and A-weighted Acoustic Noise Level

Not applicable

# Biocompatibility

All materials used in contact with the patient have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating.

#### 9. Imaging Performance Parameter

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

# 10. Equivalency Information

Toshiba Medical Systems Corporation believes that this 4ch Flex SPEEDER is substantially equivalent to the current Atlas SPEEDER Body [K063361] and ¢ 200 flex coil [K060003].

# 11. Software

There is no software required for this coil.

A-2

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation, Japan % Mr. Paul Biggins Director Regulatory Affairs/US Agent Toshiba America Medical Systems, Inc. 2441 Michelle Dr TUSTIN CA 92780

MAY 2 7 2011

Re: K111251

Trade/Device Name: 4ch Flex SPEEDER, MJAJ-197A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 29, 2011 Received: May 4, 2011

# Dear Mr. Biggins:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) 4ch Flex SPEEDER, MJAJ-197A

PHONE MARK CONSULTION COLLECTION CONSULTERS CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONTRACTOR COLLECTION CONTRACTORS CONTACTORS CONTACTORS CONSTITUTION CONSTI

# Indications for Use

510(k) Number (if known): K11251

Device Name:

4 ch Flex SPEEDER, MJAJ-197A

# Indications for Use:

- 1. Imaging of the extremities (Foot and Hand), joints (knee, shoulder, ankle, wrist and elbow), and body (chest, abdomen and pelvis)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Postel
(Division Sign Off)

vision Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number | K111251 |

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