(29 days)
The Toshiba 3T Extra Large Knee Coil is intended for use with a Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the knee that can be interpreted by a trained physician.
The Toshiba 3T Extra Large Knee Coil is designed for use with the Toshiba Vantage Titan 3T MRI system manufactured by Toshiba Medical Systems Corporation.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, 1988 plus Amendments 1 (1991) and 2 (1995)) compliance | The Toshiba 3T Extra Large Knee Coil was tested to and found compliant with IEC 60601-1. |
| 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)) compliance for SAR | The coil SAR complies with the requirements of IEC 60601-2-33. |
| Signal-to-noise ratio (SNR) measurement according to Toshiba Medical Systems Corporation's internal protocol | SNR was measured according to Toshiba Medical Systems Corporation's internal protocol. Specific values are not provided in this document, but the device is considered substantially equivalent, implying satisfactory performance based on internal protocols. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a clinical study involving a test set of patient data. The non-clinical tests reported are for device safety and performance standards rather than diagnostic efficacy with patient data.
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)
Not applicable, as no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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
Not applicable. This submission is for an MRI coil, not an AI-powered diagnostic device, and thus no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an MRI coil, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical study requiring ground truth is described. The "ground truth" for the non-clinical tests were the established international and corporate standards for safety and performance.
8. The sample size for the training set
Not applicable, as no machine learning algorithm is involved.
9. How the ground truth for the training set was established
Not applicable, as no machine learning algorithm is involved.
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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
SEP - 9 2011
KI12 313
P/2
2. Contact
Christie Zydyk, MBA Chief Quality and Regulatory Affairs Officer
3. Date prepared:
August 8, 2011
4. Tradename
Toshiba 3T Extra Large Knee Coil
5. Common name
Coil, magnetic resonance, specialty
6. Classification
21 CFR 892.1000
7. Equivalent Device
| Trade name | Legally marketedpredicate device | Manufacturer |
|---|---|---|
| Toshiba 3T Extra Large KneeCoil | Toshiba 1.5T Extra LargeKnee Coil | Quality Electrodynamics |
8. Device Description
The Toshiba 3T Extra Large Knee Coil is designed for use with the Toshiba Vantage Titan 3T MRI system manufactured by Toshiba Medical Systems Corporation.
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SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
9. Indications for Use
The Toshiba 3T Extra Large Knee Coil is intended for use with the Toshiba Vantage Titan 3T MRI system to produce diagnostic images of the knee that can be interpreted by a trained physician.
10. Comparison with Predicate Devices
| 510(k) # | Legally marketed predicatedevice | Manufacturer |
|---|---|---|
| K103185 | 1.5T Extra Large Knee Coil | Toshiba Medical Systems Corp. |
The Toshiba 3T Extra Large Knee 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 3T 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 3T Extra Large Knee 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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christie Zvdyk Chief Quality and Regulatory Affairs Officer Qulaity Electrodynamics 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143
SEP - 9 -
Re: K112313
Trade/Device Name: Toshiba 37 Extra Large Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 9, 2011 Received: August 11, 2011
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/cdrl/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. 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): K12313
Device Name: Toshiba 3T Extra Large Knee Coil
Indications for Use:
The Toshiba 3T Extra Large Knee Coil is intended for use with a Toshiba Vantage Titan 3T MRI system 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 In Vitro Diagnostic Devices (OIVD)
Mary S. Potter
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K 112313
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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.