(120 days)
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.
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.
This device is a Toshiba 1.5T Extra Large Knee Coil, intended for use with specific Toshiba 1.5T MRI scanners to produce diagnostic images of the knee. The provided document is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new AI/software device.
Therefore, many of the requested categories related to AI/algorithm performance and clinical validation studies are not applicable to this submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Device Performance |
|---|---|
| Safety: Device compliance with IEC 60601-1 (general medical electrical equipment safety). | Found compliant with IEC 60601-1 (1988 plus Amendments 1 & 2). |
| Safety: SAR compliance with IEC 60601-2-33 (MRI specific safety). | SAR complies with IEC 60601-2-33 (2002 plus Amendment 1). |
| Performance (Imaging Quality): Signal-to-noise ratio (SNR) measured according to internal protocol. | SNR was measured according to Toshiba Medical Systems Corporation's internal protocol. (Specific numerical values or comparison to predicate SNR are not provided in this summary.) |
| Substantial Equivalence: Same intended use, similar design, and constructed of similar materials as the predicate device. | The device has the same intended use (diagnostic images of the knee) and similar designs and materials to the predicate 1.5T QD Knee/Foot Coil (K051763). Enclosure materials cleared under K072935 and K093667. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a medical device for imaging, not an AI or software device that processes data for diagnosis and therefore does not have a "test set" in the context of an algorithm. The testing described focuses on engineering and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth establishment by experts for image interpretation is not mentioned or relevant for this type of device submission, which is about the imaging coil itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable.
5. 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
This is not applicable. This is a hardware component (MRI coil), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable. The "ground truth" for this device relates to its physical performance (safety, SNR) rather than diagnostic accuracy against a clinical reference.
8. The sample size for the training set
This is not applicable. The device is a hardware component; it doesn't utilize a training set in the AI sense.
9. How the ground truth for the training set was established
This is not applicable.
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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 LargeKnee 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.
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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
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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,
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
Page 1 of 1
§ 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.