(27 days)
Not Found
No
The summary describes an MRI coil, a hardware component, and its performance metrics (SNR, uniformity). There is no mention of software, algorithms, or any AI/ML related terms.
No.
The device is intended to produce diagnostic images, not to treat a condition or disease.
Yes
The device is described as producing "diagnostic images of the head that can be interpreted by a trained physician," explicitly stating its role in diagnosis.
No
The device description explicitly states it is a "Head SPEEDER Coil," which is a physical hardware component used in MRI systems. The performance studies also focus on hardware characteristics like SNR and image uniformity.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Toshiba 3T 32CH Head SPEEDER Coil is an accessory for an MRI system. Its purpose is to improve the quality of the magnetic resonance images of the head. It does not analyze biological samples.
- Intended Use: The intended use is to "produce diagnostic images of the head that can be interpreted by a trained physician." This is a function of an imaging device, not an IVD.
- Input: The input is the patient's head within the MRI scanner, not a biological specimen.
Therefore, based on the provided information, the Toshiba 3T 32CH Head SPEEDER Coil is a component of a medical imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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 Head | ||
| SPEEDER 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.
2
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
3
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
4
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
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