(160 days)
MRI surface coil for peripheral anatomical imaging Anatomical region: Temporo-mandibular joint (TMJ), wrist and other anatomies that are no deeper than 1.5 inches fro the skin.
High Temperature Superconducting (HTS) coil
This 510(k) letter is for a device called "HTS Coil" (High Temperature Superconducting coil). However, the letter only states that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information would typically be found in the 510(k) submission itself, which is not provided in this document.
Therefore, I cannot provide the requested information. The provided document is a regulatory approval letter, not a technical report detailing the device's performance studies.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human profile in triplicate. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 4 2003
Professor Edward S. Yang Jockey Club MRI Engineering Building Room 204 Chow Yei Ching Building Pokfulam Road University of Hong Kong Hong Kong CHINA
Re: K022863
Trade/Device Name: HTS Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic coil Regulatory Class: II Product Code: 90 MOS Dated: November 12, 2002 Received: November 12, 2002
Dear Professor Yang:
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
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
to proceed to the market.
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (il known):_x022863---------
Oevice Nanc: High Temperature Superconducting (HTS) coil
Indications For Use:
:
MRI surface coil for peripheral anatomical imaging Anatomical region: Temporo-mandibular joint (TMJ), wrist and other anatomies that are no deeper than 1.5 inches fro the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHE NEEDED)
Concurrence of CORH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K022863 |
| Prescription Use (Per 21 CFR 801 109) | OR | Over-The-Counter |
|---|---|---|
| ---------------------------------------------------------------------------- | ---- | ------------------ |
§ 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.