The Octave SPEEDER Head is a receive-only phased Array Coil that can receive NMR signal from head, cervical region and upper chest. The coil consists two parts of a head base, a removable anterior coil. The head base includes 7 coil elements, which are divided into 3 sections. The removable anterior coil includes 4 coil elements, which are divided into 2 sections: 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).

AI/ML Overview

This document is a 510(k) summary for the Octave SPEEDER Head (MJAH-167A), an MRI receive-only phased array coil. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (Atlas SPEEDER Head/Cervical coil, K083014) rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a novel AI algorithm might.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not explicitly stated in the provided text. The submission relies on "testing utilizing phantoms and accepted imaging quality metrics" and demonstrating that the new device does not change the indications for use or intended use.

Here's an analysis based on the provided text, addressing the points where information is available and noting when it's not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics in a table. It instead relies on demonstrating "substantial equivalence" to a predicate device through conformity to recognized consensus standards and general statements about imaging quality.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to predicate device (Atlas SPEEDER Head/Cervical coil, K083014)	"The new Octave SPEEDER Head (MJAH-167A) does not change the indication for use or the intended use of the predicate device." "Sample phantom images and clinical images are presented in Appendix F & G." (Appendices not provided)
Conformity to recognized consensus standards (e.g., IEC60601-series)	"Testing was done in accordance with applicable recognized consensus standards as listed below."
Biocompatibility	"All patient contacting materials have a history of use or test data that demonstrates its biocompatibility, i.e., non-toxic, non-irritating."
Safety Parameters (Magnetic Field, dB/dt, SAR)	Conforms to 1st operation mode specified in IEC60601-2-33 (2002) for dB/dt and SAR, and 1.5 T static field strength.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document mentions "sample phantom images and clinical images" but does not give a number for either.
Data Provenance: Not specified. Based on the manufacturing site in Japan and the U.S. agent's location, the clinical images could be from either region, or a combination. The document mentions "clinical images," implying prospective or retrospective data from human subjects, but no specifics are given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this 510(k) summary. The evaluation focuses on physical device performance and equivalence, not diagnostic accuracy requiring expert interpretation for ground truth. The "testing was conducted utilizing phantoms and accepted imaging quality metrics," suggesting engineering and physics evaluations rather than clinical diagnostic assessments with expert reads.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation is not based on diagnostic performance that would require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an MRI coil, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device (MRI coil), not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation largely refers to physical measurements and imaging metrics against established standards for MRI coil performance. For example:

Phantoms: Phantoms are used as a controlled "ground truth" to measure parameters like signal-to-noise ratio (SNR), uniformity, and image artifact levels.
Accepted Imaging Quality Metrics: These would be objective measurements of image quality, not derived from expert consensus on pathology or outcomes.
Biocompatibility Testing: Demonstrates non-toxicity and non-irritation, which are established through standardized laboratory tests.
Safety Parameters: Ground truth established by international standards (e.g., IEC60601-2-33) for dB/dt, SAR, and static field strength.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning, so there is no training set in that context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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K121910

Appendix A

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Classification and Device Name

Classification Name

Magnetic Resonance Diagnostic Device

Model Number

MJAH-167A

Trade/Propriety Name

Octave SPEEDER Head

2. Establishment Registration

2020563

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

Contact Person

Charlemagne Chua, Manager, Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310 e-mail: cchua@tams.com

U.S. Agent/Official Correspondent

Paul Biggins, Director, Regulatory Affairs T: (714) 730-5000 F: (714) 730-1310e-mail: pbiggins@tams.com

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 7/24/2012)

6. Device Intended Use

Field Strength

1.5 T

AUG 1 7 2012

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Resonant Nucleus

Hydrogen

Anatomical Region of Interest

Head, cervical region and upper chest.

Diagnostic Use

Diagnostic imaging of the the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.

7. Device Description

8. Indication for Use

The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.

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

Design Change 9.

The SPEEDER technology has been previously cleared under K083014 as an Atlas SPEEDER Head/Cervical coil. The primary difference is the creation of an 8ch SPEEDER Head. The new Octave (8ch) SPEEDER Head will use the same SPEEDER technology as other cleared SPEEDER devices.

10. 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

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Biocompatibility

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

Summary of Testing

Testing was conducted utilizing phantoms and accepted imaging quality metrics.

.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Imaging Performance Parameter 12.

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

13. Software

The Octave SPEEDER Head coil does not contain software.

. . . . .

14. Equivalency Information

Toshiba Medical Systems Corporation believes that this Octave SPEEDER. Head is substantially equivalent to the current Atlas SPEEDER Head/Cervical [K083014]. 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)

Conclusion

The new Octave SPEEDER Head (MJAH-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 Head.

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Image /page/3/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.

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: K121910

Trade/Device Name: Octave SPEEDER Head; MJAH-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 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 pactice mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as be form in art quality device as described in your Section 510(k) premarket will anow you to oogin marketing your and equivalence of your device to a legally marketed nonlication. THE I D71 imating of Saction 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 11 you desire specific advise of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5456. Thise, process not 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 I ou inter of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 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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Indications for Use
---------------------

510(k) Number (if known):	K121910
Device Name:	Octave SPEEDER Head, MJAH-167A

Indications for Use:
----------------------

The Octave SPEEDER Head is intended for imaging of the brain, cervical spine, and soft tissue and vasculature of the head, neck and upper chest.

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

Prescription Use	X	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	K121910
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and the comments of the comments of

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Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.