(85 days)
The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode. The device is intended to excite and receive signal from hydrogen protons for diagnostic quelity radiographic images when used with GE 1.5T Signa Advantage, Horizon and Horizon LX scanner(s) during MR imaging.
The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or training set information.
The document is a 510(k) clearance letter from the FDA for a medical device (MEDRAD 1.5T Extremity Array) and specifies its intended use and regulatory classification. It does not include the technical study details typically found in a clinical study report or a detailed submission document that would outline performance metrics and their validation.
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Public Health Service
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DEC 30
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Ann Greenawalt Senior Regulatory Affairs Associate MEDRAD, Inc. One Medrad Drive Indianola, PA 15051
Re: K973787
MEDRAD 1.5T Extremity Array (MRI accessory) Dated: October 3, 1997 Received: October 6, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Ms. Greenawalt:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 requirement, as set forth in the Qualion (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 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 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".
Sincerely yours.
H. William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the word "MEDRAD" in a stylized, bold, black font. The letters are slightly slanted to the right, giving the word a dynamic appearance. A small "R" in a circle, indicating a registered trademark, is positioned to the upper right of the letter "D". Above the word "MEDRAD" is the text "P.2".
MEDRAD 1.5T EXTREMITY ARRAY INTENDED USE
510(k) Number: K973787 Medrad 1.5T Extremity Array Device Name: Intended Use: The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode. The device is
intended to excite and receive signal from hydrogen protons for diagnostic quelity radiographic images when used with GE 1.5T Signa Advantage, Horizon and Horizon LX scanner(s) during MR imaging.
Environment of Use: Health Care Facilities Signa Advantage, Horizon and Horizon LX Magnetic Equipment of Use: Resonance Systems
Medrad, inc
One Medrad Drive Indianola, PA 15051-07B0 (412) 767-2400
hiliaufr
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.