MR ENHANCER

K994117 · I.Z.I. Corp. · LNH · Feb 4, 2000 · Radiology

Device Facts

• Record ID: K994117
• Device Name: MR ENHANCER
• Applicant: I.Z.I. Corp.
• Product Code: LNH · Radiology
• Decision Date: Feb 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended 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.

Device Story

MR Enhancer functions as an MRI accessory; designed to improve image homogeneity by reducing skin-air interfaces; stabilizes tissue to minimize vascular and tissue pulsation artifacts; improves image quality for pulsing parameters including chemical shift fat saturation and gradient echo; used in clinical MRI settings; operated by trained medical personnel; assists clinicians in obtaining clearer diagnostic images; benefits patients by potentially reducing need for repeat scans due to artifacts.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

MRI accessory; physical stabilization device; non-electronic; non-implantable; dimensions and materials not specified in provided text.

Indications for Use

Indicated for adult patients undergoing MRI procedures to improve image homogeneity and reduce pulsation artifacts.

Regulatory Classification

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).

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use _________________________________________________________________________________________________________________________________________________________