(50 days)
The intended use of the Noras OR Head Coil 3T 7230-PH is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).
Used in the 3T Philips Achieva Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Moras MRI Products GmbH for their Noras OR Head Coil 3T. This document is a regulatory approval letter and does not contain the results of a study or detailed acceptance criteria for a device.
Therefore, I cannot extract the information required by your request about acceptance criteria and the study proving the device meets them, because this information is not present in the provided text.
The document states that the FDA reviewed the 510(k) premarket notification and determined the device to be "substantially equivalent" to legally marketed predicate devices. This regulatory pathway typically relies on demonstrating equivalence to an already approved device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a Premarket Approval (PMA) application might.
The indications for use are provided, but these are not the acceptance criteria or device performance data.
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Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines above it, representing care and support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - W066-G609 Silver Spring, MD 20993-0002
JAN 1 9 2010
Mr. Zahed Sedighiani Regulatory Affairs Manager Moras MRI Products GmbH Leibnizstr. 4, Hoechberg, 97204 GERMANY
Re: K093693
Trade/Device Name: Noras OR Head Coil 3T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 20, 2009 Received: November 30, 2009
Dear Mr. Sedighiani:
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 (DMA). 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 2 one Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish firther 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 in 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,
Donald J. Trump
Donald J. St Pierre 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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Indications for Use
510(k) Number (if known): _ K09 3693
Device Name: Noras OR Head Coil 3T
Indications for Use:
The intended use of the Noras OR Head Coil 3T 7230-PH is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging).
Used in the 3T Philips Achieva Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Radiological Devices
510(k) Number K093693
Special 510(k) Noras MRI products GmbH OR Head Coil 3T 7230-PH November 20, 2009
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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.