(28 days)
The Toshiba 1.5T QD Head Coil (MJQH-147A) is intended for use with a 1.5T Vantage Titan MRI system to produce diagnostic images of the head anatomy that can be interpreted by a trained physician.
The Toshiba 1.5T QD Head Coil is designed for use with the Toshiba Vantage Titan 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.
The provided text describes the 510(k) premarket notification for the Toshiba 1.5T QD Head Coil. This document focuses on demonstrating substantial equivalence to a predicate device for a medical imaging accessory (a head coil for an MRI machine), rather than evaluating the performance of an AI/ML-driven device or diagnostic algorithm.
Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) is not applicable or cannot be extracted from this type of regulatory submission for a medical device accessory like an MRI coil.
However, I can extract the acceptance criteria and reported device performance from the provided text as it relates to the technical specifications of the head coil.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to industry standards and the predicate device. The reported device performance is that it was found compliant with these standards and demonstrated substantial equivalence.
| Acceptance Criteria Category/Standard Used | Reported Device Performance |
|---|---|
| Safety and Essential Performance (General) | Complied with IEC 60601-1 (2nd and 3rd Edition), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. |
| Magnetic Resonance Equipment Safety (Specific) | Coil SAR (Specific Absorption Rate) complied with the requirements of IEC 60601-2-33, Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (3rd Edition). |
| Image Quality (Signal-to-Noise Ratio) | Measured according to NEMA MS-1 2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. (The specific SNR value is not provided, only that it was measured according to the standard). |
| Image Quality (Image Uniformity) | Measured according to NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Resonance Imaging. (The specific uniformity value is not provided, only that it was measured according to the standard). |
| Overall Equivalence for Intended Use, Design, and Materials to predicate (Siemens 1.5T/3T CP Head Coil) | The device has the same intended use, is of the same design, and is constructed of the same materials as the predicate device. Stated to be "substantially equivalent." |
Note: The document states that the SNR and image uniformity were measured according to NEMA standards, but it does not explicitly provide the numerical acceptance thresholds or the measured performance values for these parameters. The "reported device performance" in this context is the statement of compliance with the measurement methodology and the overall conclusion of substantial equivalence.
The following questions are not applicable to this type of device and submission (an MRI head coil accessory) and thus cannot be answered from the provided text:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This 510(k) submission is for hardware (a medical device accessory), not a diagnostic algorithm or AI software, which typically involves performance metrics against "ground truth" established by experts or pathology for diagnostic accuracy. The "study" referenced here consists of engineering tests and measurements against established electrical, safety, and imaging quality standards, and a direct comparison of its technical specifications and intended use against a legally marketed predicate device.
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SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
1. Applicant
Quality Electrodynamics (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone (440) 484-2228
2. Contact
Christie Zydyk, MBA Chief Quality and Regulatory Affairs Officer
3. Date prepared:
February 29th, 2012
4. Tradename
Toshiba 1.5T QD Head 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 1.5T QD Head Coil | Siemens 1.5T/3T CP Head Coil | Quality Electrodynamics |
8. Device Description
The Toshiba 1.5T QD Head Coil is designed for use with the Toshiba Vantage Titan 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.
MAR 2 9 2012
KI20627
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SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
9. Indications for Use
The Toshiba 1.5T QD Head Coil (MJQH-147A) is intended for use with a 1.5T Vantage Titan MRI system to produce diagnostic images of the head anatomy that can be interpreted by a trained physician.
10. Comparison with Predicate Devices
| 510(k) # | Legally marketed predicatedevice | Manufacturer |
|---|---|---|
| K091114 | Siemens 1.5T/3T CP Head Coil | Quality Electrodynamics |
The Toshiba 1.5T QD Head Coil and the predicate device have the same intended use, are of the same design, and are constructed of the same materials.
11.Non-Clinical Tests
The Toshiba 1.5T QD Head Coil was tested to and found complaint with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (200 Edition) and IEC 60601-1, Medical electrical equipment -Part 1: General requirements for basic safety and essential performance (300 Edition). The coil SAR complies with the requirements of IEC 60601-2-33, Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (36 Edition).
The signal-to-noise ratio (SNR) was measured according to NEMA MS-1 2008, Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging. The image uniformity was measured according to NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Resonance Imaging.
12. Conclusion
It is the opinion of Quality Electrodynamics that the Toshiba 1.5T QD Head Coil is substantially equivalent to the above-listed legally marketed predicate device. Use of the Quality Electrodynamics coil does not result in any new potential hazards. T
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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 features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
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
Ms. Christie Zydyk Chief Quality and Regulatory Affairs Officer Quality Electrodynamics 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143
MAR 2 9 2012
Re: K120627
Trade/Device Name: Toshiba 1.5T QD Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 23, 2012 Received: March 26, 2012
Dear Ms. Zydyk:
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
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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K120627
Indications for Use
510(k) Number (if known):
Device Name: Toshiba 1.5T QD Head Coil
Indications for Use:
The Toshiba 1.5T QD Head Coil (MJQH-147A) is intended for use with a 1.5T Vantage Titan MRI system to produce diagnostic images of the head anatomy 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)
gagurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitto Diagnostic Device Evaluation and Safety
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§ 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.