(63 days)
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.
Brain Coil, Model # 9900GE-64
This document is a 510(k) premarket notification from the FDA for a medical device. It does NOT contain the acceptance criteria, reported device performance, or study details requested.
The document is a letter from the FDA to Clinical MR Solutions, LLC, confirming the substantial equivalence of their "Brain Coil, Model # 9900GE-64" to legally marketed predicate devices. It states that the device is a Magnetic Resonance Diagnostic Device (21 CFR 892.1000, Regulatory Class II).
The "Indications for Use" section (Attachment 3) describes what the device is intended for:
- 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head.
- It is used in conjunction with a General Electric 1.5 Tesla MRI Scanner.
- For Spectroscopy, it requires the addition of the PROBE (Proton Brain Exam) software option.
Therefore, I cannot provide the requested information from this document. This document focuses on regulatory approval based on substantial equivalence, not on specific performance studies or acceptance criteria for a new AI/software device. It predates the widespread use of AI in medical devices by many years (2003).
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Image /page/0/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird in flight. The bird is stylized with three curved lines representing its body and wings. The text "U.S. Public Health Service" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
Mr. Ralph S. Hashoian Managing Member Clinical MR Solutions, LLC 3735 Shadybrook Place BROOKFIELD WI 53005
Re: K031536 Trade/Device Name: Brain Coil, Model
9900GE-64 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: May 13, 2003 Received: May 16, 2003
Dear Mr. Hashoian:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indication for Use 5.0 Attachment 3:
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Brain Coil, Model # 9900GE-64 Device Name:
Indications for Use:
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-off) |
|---|
| Division of Reproductive, Abdominal, ENT, |
| and Radiological Devices |
510(K) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use (Optional Format 1-2-96)
CMRS Brain Coil #9900GE-64
Attachment 3
Indication for Use
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number
Page 1 of 1
§ 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.