OCTAVE SPEEDER SPINE

K121911 · Toshiba Medical Systems Corporation, Japan · MOS · Aug 17, 2012 · Radiology

Device Facts

• Record ID: K121911
• Device Name: OCTAVE SPEEDER SPINE
• Applicant: Toshiba Medical Systems Corporation, Japan
• Product Code: MOS · Radiology
• Decision Date: Aug 17, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine. The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

Device Story

Octave SPEEDER Spine is a receive-only phased array coil for MRI systems; designed for imaging thoracolumbar spine. Device consists of 12 rectangular loop surface coils; 3 loops in one section aligned perpendicular to body axis; 4 sections aligned to body axis. Operates by receiving NMR signals from spine; utilizes PIN diodes to switch between transmit and receive modes; detuned during transmission by QD whole body coil. Used in clinical settings by trained MRI technicians/radiologists. Output is raw NMR signal processed by host Toshiba 1.5T MR system to generate diagnostic images. Benefits include improved signal reception for spine imaging. No software component.

Clinical Evidence

Bench testing only. Performance verified using phantoms and imaging quality metrics. No clinical data presented.

Technological Characteristics

Receive-only phased array coil; 12 rectangular loop surface coils; 1.5T field strength; PIN diode switching for transmit/receive detuning; biocompatible patient-contacting materials; no software; standalone hardware component for Toshiba 1.5T MR systems.

Indications for Use

Indicated for imaging the thoracolumbar spine using a Toshiba 1.5T MR System.

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 Spine coil (K063361)

Submission Summary (Full Text)

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K121911

## Appendix A

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. Classification and Device Name

## Classification Name

Magnetic Resonance Diagnostic Device

## Model Number

MJAS-167A

## Trade/Propriety Name

Octave SPEEDER Spine

#### 2. Establishment Registration

2020563

#### 3. Contact Person, U.S. Agent Name and Address

## Contact Person

Charlemagne Chua, Manager, Regulatory Affairs T: [phone] F: [phone] e-mail: [e-mail]

## U.S. Agent Name

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

## Address:

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

#### 4. Manufacturing Site

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

#### 5. · Date of Submission

June 28, 2012 (revised August 3, 2012)

#### Device Intended Use 6.

## Field Strength

1.5 T

AUG 1 7 2012

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## Resonant Nucleus

Hydrogen

## Anatomical Region of Interest

Spine

## Diagnostic Use

Diagnostic imaging of the thoracolumbar spine.

#### 7. Device Description

The Octave SPEEDER Spine is a receive-only phased Array Coil that can receive NMR signal from spine. The coil consists of a 12 rectangular loop surface coil. 3 loops (1 section) are aligned perpendicular to a body axis and 4 sections are aligned to a body axis. Users select the sections according to region of interest via a system user interface. The PC board switches transmit mode and receive mode with PIN diode. This coil is detuned during transmission by our QD whole body coil by means of activating the PIN diodes (transmit mode) and tuned during no transmission by means of not activating the PIN diodes (receive mode).

#### 8. Indication for use

The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.

The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

#### 9. Design Change

The SPEEDER technology has been previously cleared under K063361 as an Atlas SPEEDER Spine coil. The primary difference is the creation of an 8ch SPEEDER Spine. The new Octave (8ch) SPEEDER Spine will use the same SPEEDER technology as other cleared SPEEDER devices.

#### 10. Safety Parameter

## Maximum static field strength

1.5 T

## Maximum dB/dt

1 st 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

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## Biocompatibility

All patient contacting materials have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating.

#### 11. Summary of Testing

Testing was conducted utilizing phantoms and accepted imaging quality metrics.

#### 12. Imaging Performance Parameter

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

#### 13. Software ·

The Octave SPEEDER Spine coil does not contain software.

#### 14. Equivalency Information

Toshiba Medical Systems Corporation believes that this Octave SPEEDER Spine is substantially equivalent to the current Atlas SPEEDER Spine [K063361]. Testing was done in accordance with applicable recognized consensus standards as listed below.

IEC60601-1 (1998), Amd1 (1991), Amd2 (1995) IEC 60601-2 (2001), Amd1 (2004) IEC60601-1-6 (2006) IEC62366 (2007) IEC60601-2-33 (2002), Amd1 (2005), Amd2 (2007)

#### 15. Conclusion

The new Octave SPEEDER Spine (MJAS-167A) does not change the indication for use or the intended use of the predicate device. The safety and effectiveness has been verified via risk management and application of design controls to the new Octave SPEEDER Spine.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

# 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

## AUG 1 7 2012

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

Re: K121911

Trade/Device Name: Octave SPEEDER Spine, MJAS-167A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 24, 2012 Received: July 26, 2012

Dear Mr. Biggins:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security of the device is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivalent in i referenced above and nave determined the arredicate devices marketed in interstate for use stated in the enclosue) to tegally management date of the Medical Device Amendments, or to commerce prior to May 28, 1970, the enactified in accordance with Federal Food. Drug, devices that have been reclassified in accordance will as proval application (PMA).
and Cosmetic Act (Act) that do not require approval on treasissers provisions of the Act. and Cosmetic Act (Act) that do not require approvate approvisions of the Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, sucject success for amual registration, listing of
general controls provisions of the Act include requirements for among miskranding an general controls provisions of the receiners and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such If your device is classified (see alove) alles ones affecting your device can be found in Title 21, additional controls. Existing major Tegulations areoning John in The may publish further
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish Code of Pederal Regaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substitute with other requirements of the Act
that FDA has made a determination that your device with other requires. You must that FDA has made a determination und your diver Federal agencies. You must
or any Federal statutes and regulations administered by other Federal and listin or any Federal statures and regulations and including, but not limited to: registration and listing (21
comply with all the Act's requirements, including, but not ice reporti comply with all the Act s requirements, incruaing, our are cal 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 800). This letter requirents as set forum in the quality by stires (<described in your Section 510(k) premated whil allow you to ocgill marketing your active quivalence of your device to a legally marketed notification. THCTDA image of succiantial value and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Parts 801 and If you desire specific anytee for your do rise as a mostic Device Evaluation and Safety at (301) 796-007), prease other 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 under the MDA regulation (21 ℃) K F art 805), prodo goblem/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 Tou may obtain 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,

Janine M. Morris

Acting 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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# K12)911

. .

・

.

| Indications for Use | |
|---------------------------|---------------------------------|
| 510(k) Number (if known): | K121911 |
| Device Name: | Octave SPEEDER Spine, MJAS-167A |
| Indications for Use: | |

The Octave SPEEDER Spine is intended for imaging the thoracolumbar spine.

The MJAS-167A is intended to be used on a Toshiba 1.5T MR System

| Prescription Use | <b>X</b> | AND/OR | Over-The-Counter Use |
|-----------------------------|----------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (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)

(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

| 510(k) Number | K121911 |
|---------------|---------|
|---------------|---------|

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