The Toshiba 3T 32CH Head SPEEDER Coil is intended for use with the Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the head that can be interpreted by a trained physician.

Device Description

The Toshiba 3T 32CH Head SPEEDER Coil is designed for use with a Vantage Titan 3T System, manufactured by Toshiba Medical Systems Corporation.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Toshiba 3T 32CH Head SPEEDER Coil:

This 510(k) submission (K122638) is for a magnetic resonance imaging (MRI) coil, not an AI/algorithm-based device. Therefore, many of the typical acceptance criteria and study methodologies applicable to AI devices (e.g., human-in-the-loop, standalone performance, training set details, expert consensus for ground truth on clinical images) are not relevant here.

The device is a hardware component (an MRI coil) that works with an existing MRI system. Its performance is primarily assessed through technical specifications and physical safety, not diagnostic accuracy in the way an AI algorithm would be.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance/Method
Safety	Compliance with general medical electrical equipment standards	Tested to and found compliant with IEC 60601-1 (second and third editions) - "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance".
Image Quality	Signal-to-Noise Ratio (SNR)	SNR was measured according to NEMA MS 9-2008, "Characterization of Phased Array Coils for Diagnostic Resonance Images."
Image Quality	Image Uniformity	Assessed in accordance with NEMA MS-3 2008, "Determination of Image Uniformity in Diagnostic Magnetic Resonance Images."
Substantial Equivalence	Comparison to predicate device	The device was deemed substantially equivalent to the 1.5T Atlas SPEEDER Head-Neck Coil (K083160) because it's also a phased-array, receive-only coil with similar functionality, despite differences in channel count, anterior attachments, and compatible MR system field strength (3T vs. 1.5T).

Study Details (as applicable to an MRI Coil)

Sample size used for the test set and the data provenance:
- The document implies that the "test set" for the coil's performance was physical testing and measurements according to NEMA and IEC standards, rather than a clinical dataset of patient images.
- The sample size for these technical tests is not specified in terms of "cases" or "patients" but would refer to the number of measurements taken or the number of coils tested.
- Data provenance isn't applicable in the clinical sense (e.g., country of origin of patient data, retrospective/prospective) as these are engineering and performance tests on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. Ground truth in this context refers to established engineering standards (IEC, NEMA) and physical measurements, rather than expert interpretation of clinical images. The "experts" would be the engineers and technicians performing the tests according to the specified standards.
Adjudication method for the test set:
- Not applicable for the type of testing performed (physical and engineering standards compliance).
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:
- No. This is an MRI coil, not an AI algorithm. MRMC studies are designed for assessing the diagnostic performance of AI or new imaging techniques involving human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm; it is a hardware component.
The type of ground truth used:
- For safety: Compliance with the established safety standards (IEC 60601-1).
- For image quality (SNR, Uniformity): Measurements against specified limits and methodologies defined by NEMA standards (NEMA MS 9-2008, NEMA MS-3 2008). This is an objective technical measurement, not a clinical "ground truth" like pathology or outcomes.
The sample size for the training set:
- Not applicable. This device does not use an AI algorithm and therefore does not have a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this hardware device.

Summary for K122638:

This 510(k) submission is for an MRI receive coil. The "acceptance criteria" revolve around the safety and technical performance of the hardware device itself, as evaluated against established international and national engineering standards (IEC, NEMA), rather than clinical diagnostic accuracy or AI performance. The study is a non-clinical technical evaluation demonstrating compliance with these standards and substantial equivalence to a predicate device. The document does not involve AI, clinical image interpretation studies, or patient data in the context of performance testing.

Summary

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K122638

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant 1.

Quality Electrodynamics, LLC. (QED) . 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone (440) 484-2228

Contact 2.

Kathleen Aras Director, Regulatory and Quality Affairs

3. Date prepared:

August 27, 2012

4. Tradename

Toshiba 3T 32CH Head SPEEDER Coil

5. Common name

Coil, magnetic resonance, specialty

6. Classification

21 CFR 892.1000

7. Equivalent Device

Trade name	Legally marketed predicate device	Manufacturer
Toshiba 3T 32CH HeadSPEEDER Coil	1.5T Atlas SPEEDER Head-Neck Coil	Quality Electrodynamics

Device Description 8.

The Toshiba 3T 32CH Head SPEEDER Coil is designed for use with a Vantage Titan 3T System, manufactured by Toshiba Medical Systems Corporation.

9. Indications for Use

The Toshiba 3T 32CH Head SPEEDER Coil is intended for use with the Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the head that can be interpreted by a trained physician.

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K122638 page 2 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Comparison with Predicate Devices 10.

510(k) #	Legally marketed predicate device	Manufacturer
K083160	1.5T Atlas SPEEDER Head-Neck Coil	Quality Electrodynamics

The Toshiba 3T 32CH Head SPEEDER Coil in this submission and the 1.5T Atlas SPEEDER Head-Neck Coil described in K083160 are both phased-array, receive-only coils. The main differences are that the Toshiba 3T 32CH Head SPEEDER Coil has a higher channel count (32 vs. 15), fewer anterior attachments (2 vs. 4) and is designed for use with a 3T system as opposed to a 1.5T system compared to the predicate coil.

Non-Clinical Tests 11.

The Toshiba 3T 32CH Head SPEEDER Coil was tested to and found to be compliant with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, second and third editions.

The signal-to-noise ratio (SNR) was measured according to NEMA MS 9-2008, Characterization of Phased Array Coils for Diagnostic Resonance Images.

Image Uniformity was assessed in accordance with NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images.

Conclusion 12.

It is the opinion of Quality Electrodynamics that the Toshiba 3T 32CH Head SPEEDER Coil is substantially equivalent to the above-listed legally marketed predicate devices. Use of the Quality Electrodynamics coil does not result in any new potential hazards.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around 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

SEP 2 5 2012

Ms. Kathleen Aras Director, Regulatory and Quality Affairs Ouality Electrodynamics, LLC 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143

Re: K122638

Trade/Device Name: Toshiba 3T 32 CH Head SPEEDER Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 27, 2012 Received: August 29, 2012

Dear Ms. Aras:

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 (301) 796-5450. 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 (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

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): ____________________________________________________________________________________________________________________________________________________

Device Name:

Toshiba 3T 32CH Head SPEEDER Coil

Indications for Use:

The Toshiba 3T 32CH Head SPEEDER Coil is intended for use with the Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the head that can be interpreted by a trained physician.

Prescription Use
X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Arsh D. Ok

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K122638

Page 1 of 1

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.