(28 days)
The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage Titan MRI system to produce diagnostic images of the heart that can be interpreted by a trained physician.
The Toshiba 1.5T Cardiac Coil is designed for use with the Toshiba 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.
- Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly state numerical acceptance criteria for the Toshiba 1.5T Cardiac Coil. Instead, it describes performing tests and found the device "compliant with IEC 60601-1" and that SNR was "measured according to Toshiba Medical Systems Corporation's internal protocol" and Image Uniformity was "assessed in accordance with NEMA MS-3 2008".
| Test/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Basic Safety and Essential Performance | Compliance with IEC 60601-1 (second and third editions) | Found compliant |
| Signal-to-Noise Ratio (SNR) | N/A (Measured per internal protocol, no specific threshold stated in document) | Measured according to Toshiba Medical Systems Corporation's internal protocol. Specific values are not provided. |
| Image Uniformity | N/A (Assessed per NEMA MS-3 2008, no specific threshold stated in document) | Assessed in accordance with NEMA MS-3 2008. Specific results are not provided. |
-
Sample Size for Test Set and Data Provenance:
The document does not specify a separate "test set" in the context of clinical images or diagnostic performance. The testing described relates to the physical and electrical performance of the coil. Therefore, information on sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this summary. -
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
N/A - This information is not relevant as the study focuses on the technical performance of the MRI coil itself, not the diagnostic interpretation of images by experts. -
Adjudication Method for the Test Set:
N/A - Not applicable as the study evaluates the technical performance of the device, not diagnostic interpretations from a test set requiring adjudication. -
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document focuses on the technical performance specifications of the MRI coil and does not involve human readers' interaction with or interpretation of images, nor does it assess improvement with or without AI assistance. -
Standalone (Algorithm Only Without Human-in-the-Loop Performance):
N/A - This is not an AI/algorithm-driven device. It is an MRI coil, a hardware component for imaging. Therefore, a standalone algorithm performance evaluation would not be relevant. -
Type of Ground Truth Used:
For the tests conducted (IEC 60601-1, SNR, Image Uniformity), the "ground truth" refers to established technical standards and measurement protocols, rather than a clinical "ground truth" from pathology or outcomes data. The ground truth for these tests is the physical and electrical characteristics of the coil as measured against specifications. -
Sample Size for the Training Set:
N/A - This document does not describe the development of an AI algorithm or a "training set." The device is an MRI coil, a hardware component. -
How the Ground Truth for the Training Set Was Established:
N/A - There is no training set mentioned or implied as this is a hardware device.
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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
Christie Zydyk Chief Quality and Regulatory Affairs Officer
3. Date prepared:
January 30, 2012
4. Tradename
Toshiba 1.5T Cardiac Coil
5. Common name
Coil, magnetic resonance, specialty
6. Classification
21 CFR 892.1000
7. Equivalent Device
| Trade name | Legally marketedpredicate device | Manufacturer |
|---|---|---|
| Toshiba 1.5T Cardiac Coil | 1.5T SENSECardiovascular Array Coil | Invivo Corporation |
8. Device Description
The Toshiba 1.5T Cardiac Coil is designed for use with the Toshiba 1.5T MRI system manufactured by Toshiba Medical Systems Corporation.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
9. Indications for Use
The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage Titan MRI system to produce diagnostic images of the heart that can be interpreted by a trained physician.
10. Comparison with Predicate Devices
| 510(k) # | Legally marketed predicatedevice | Manufacturer |
|---|---|---|
| K061952 | 1.5T SENSE Cardiovascular ArrayCoil | Invivo Corporation |
The Toshiba 1.5T Cardiac coil and the predicate device have the same intended use, and are of a similar design. The Toshiba 1.5T Cardiac coil is constructed of the same materials as the devices in the following previously cleared submissions: K093667, K091114, and K112313.
11. Non-Clinical Tests
The Toshiba 1.5T Cardiac coil was tested to and found 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 Toshiba Medical Systems Corporation's internal protocol.
Image Uniformity was assessed in accordance with NEMA MS-3 2008, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
12.Conclusion
It is the opinion of Quality Electrodynamics that the Toshiba 1.5T Cardiac 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 or bird symbol with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -. WO66-G609 Silver Spring, MD 20993-0002
Ms. Christie Zydyk Chief Quality and Regulatory Affairs Officer Quality Electrodynamics 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143
FEB 2 8 2012
Re: K120290
Trade/Device Name: Toshiba 1.5T Cardiac Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 21, 2012 Received: February 22, 2012
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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Janine M. Mdrri 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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K120290 510(k) Number (if known):
Device Name: Toshiba 1.5T Cardiac Coil
Indications for Use:
The Toshiba 1.5T Cardiac coil is intended for use with the Toshiba 1.5T Vantage Titan MRI system to produce diagnostic images of the heart 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. Patel
Division Sign-Off Office of in Vitro Diagnostic Device Evaluation and Safety
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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.