(62 days)
Not Found
No
The summary describes a passive coil for an MRI machine and does not mention any software or processing capabilities that would suggest AI/ML.
No.
The device is used to produce diagnostic images, which aids in diagnosis rather than providing therapy.
Yes
This device, a SPEEDER Shoulder coil, is used with an MRI scanner to produce "diagnostic images of the shoulder that can be interpreted by a trained physician," explicitly stating its role in generating images for diagnosis.
No
The device description explicitly states it is a "SPEEDER Shoulder coil," which is a hardware component used in MRI systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce diagnostic images of the shoulder" using a magnetic resonance scanner. This is a medical imaging device used in vivo (on a living patient), not in vitro (on samples outside the body).
- Device Description: The device is a "Shoulder coil" for use with MR systems. This further confirms its role in medical imaging of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to acquire images of an anatomical site within the body.
N/A
Intended Use / Indications for Use
For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The SPEEDER Shoulder coil is designed for use with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance
Anatomical Site
shoulder
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)
Not Found
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
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
K093667
510(k) . SUMMARY OF SAFETY AND EFFECTIVENESS
1. Applicant
Quality Electrodynamics (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone (440) 484-2228
2. Contact
JAN 2 8 2010
Christie Zydyk, MBA VP & GM, Regulatory Affairs, Quality Assurance, & Corporate Communications
-
Date prepared: 12 January 2010
-
Tradename
Shoulder 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 |
|---|---|---|
| SPEEDER | ||
| Shoulder coil | 420 GE-64 Phased Array Shoulder Coil | Medical Advances Inc. (MAI, now |
| INVIVO) | ||
| 1.5T Atlas SPEEDER Head-Neck Coil | Quality Electrodynamics |
8. Device Description
The SPEEDER Shoulder coil is designed for use with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.
1
age 2/2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
9. Intended Use
For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resonance scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
10. Comparison with Predicate Devices
| 510(k) # | Legally marketed predicate device | Manufacturer |
|---|---|---|
| K945778 | 420 GE-64 Phased Array Shoulder Coil | Medical Advances Inc. (now INVIVO) |
| K083160 | 1.5T Atlas SPEEDER Head-Neck Coil | Quality Electrodynamics |
The SPEEDER Shoulder coil and the predicate devices have intended uses as well as similar designs and are constructed of similar materials.
11. Conclusion
It is the opinion of Quality Electrodynamics that the SPEEDER Shoulder 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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three tail feathers, representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The seal is simple and monochromatic.
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
Quality Electrodynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 53313
JAN 2 8 2010
Re: K093667
Trade/Device Name: SPEEDER Shoulder Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 13, 2009 Received: January 14, 2009
Dear Mr. Job:
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 iddinons for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmontes, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or o 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, l'isting 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 21c, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish finther 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 af 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 vours.
Donald J. Trump
Donald J. St. Pierre 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): _ K093667
Device Name: SPEEDER Shoulder coil
Indications for Use:
For use with a Toshiba 1.5T EXCELART Vantage or 1.5T Vantage Titan magnetic resoluce scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Prescription Use
(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 Device Evaluation (ODE)
Dmes. Joff
(Division Sign Off) Division of Radiological Devices .
510(k) Number
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