(60 days)
MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo. MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.
MR Enhancer
The provided document is a 510(k) premarket notification letter from the FDA to I.Z.I. Corporation for their device "MR Enhancer". This letter confirms substantial equivalence of the device to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment.
The document primarily focuses on FDA's regulatory decision regarding substantial equivalence. It describes the device's intended use as an MRI accessory to improve image homogeneity and reduce artifacts by reducing skin-air interfaces and stabilizing the patient.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the information provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB | 4 2000
I.Z.I. Corporation E.J. Smith C/O Smith Associates P.O. Box 4341 Crofton, MD 21114
Re:
K994117 MR Enchancer Dated: November 23, 1999 Received: December 6, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for vour 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Product Name: MR Enhancer
Indications for Use.
MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo.
MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.
Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.
Target Population: Adult
David h. Sezmore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.