(120 days)
Not Found
No
The 510(k) summary describes a passive medical device (a knee coil for an MRI scanner) and does not mention any software, image processing, or AI/ML capabilities. The performance studies focus on safety and basic coil performance metrics like SNR, not algorithmic performance.
No
The device is used to produce diagnostic images, not to treat a condition.
No
The device is a knee coil, which is an accessory for a magnetic resonance scanner, not a diagnostic device itself. It helps produce diagnostic images, but the interpretation and diagnosis are performed by a physician using the images produced by the overall MR system.
No
The device description explicitly states it is a "Knee Coil," which is a hardware component used in magnetic resonance imaging. The performance studies also focus on hardware-related metrics like SAR and SNR.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Knee Coil" for use with an MRI scanner. Its purpose is to produce diagnostic images of the knee. This is an in vivo diagnostic process (performed within the living body), not an in vitro process (performed outside the living body).
- Intended Use: The intended use is to produce images that can be interpreted by a physician, not to analyze biological samples.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
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 knee that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The Toshiba 1.5T Extra Large Knee Coil is designed for use with the 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
knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 1.5T Extra Large Knee Coil was tested to and found complaint with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1988 plus Amendments 1 (1991) and 2 (1995).
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, 2002 plus Amendment 1 (2005).
The signal-to-noise ratio (SNR) was measured according to Toshiba Medical Systems Corporation's internal protocol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
KID3
SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
FEB 25 2011
1. Applicant
Quality Electrodynamics (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone (440) 484-2228
2. Contact
Christie Zydyk, MBA Chief Regulatory Affairs and Quality Assurance Officer
3. Date prepared:
February 25, 2011
4. Tradename
Toshiba 1.5T Extra Large Knee 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 Extra Large | ||
| Knee Coil | 1.5T QD Knee Coil | Toshiba Medical Systems Corp. |
8. Device Description
The Toshiba 1.5T Extra Large Knee Coil is designed for use with the with the 1.5T EXCELART Vantage and the 1.5T Vantage Titan MR Systems manufactured by Toshiba Medical Systems Corporation.
1
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 knee that can be interpreted by a trained physician.
10. Comparison with Predicate Devices
| 510(k) # | Legally marketed predicate device | Manufacturer |
|---|---|---|
| K051763 | 1.5T QD Knee/Foot Coil | Toshiba Medical Systems Corp. |
The Toshiba 1.5T Extra Large Knee Coil and the predicate device have the same intended use as well as similar designs and are constructed of similar materials. Specifically, the enclosure materials used in Toshiba 1.5T Extra Large Knee Coil have been previously cleared under K072935 and K093667.
11. Non-Clinical Tests
The Toshiba 1.5T Extra Large Knee Coil was tested to and found complaint with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1988 plus Amendments 1 (1991) and 2 (1995).
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, 2002 plus Amendment 1 (2005).
The signal-to-noise ratio (SNR) was measured according to Toshiba Medical Systems Corporation's internal protocol.
12. Conclusion
It is the opinion of Quality Electrodynamics that the Toshiba 1.5T Extra Large Knee 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 eagle with three stripes forming its body and wings. The eagle is facing right. 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
Quality Electrodynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
FEB 2 5 2011
Re: K103185
Trade/Device Name: Toshiba 1.5T Extra Large Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 12, 2011 Received: January 13, 2011
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 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,
Mary S. Postel
Mary Pastel. ScD. 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 1.5T Extra Large Knee Coil
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 knee 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) O ITVD
Mary S. Pastel
Office of Ir
510k
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