(75 days)
To be used in conjunction with a 1.5T GE HD or DV series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, head, neck and spine that can be interpreted by a trained physician.
Not Found
The provided text is a set of FDA letters regarding a 510(k) premarket notification for a medical device called "MetaFlexCoil," and an "Indications for Use" statement.
This document describes the regulatory approval of a medical device, specifically a "Magnetic resonance diagnostic device" (Product Code MOS) called "MetaFlexCoil." It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. The letter only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a study report or a summary of performance data.
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Image /page/0/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design that resembles an eagle or other bird-like figure. The design is composed of three curved lines that converge at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
.. "
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NeoCoil, LLC % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA 2307 E Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K101632
AUG 2 4 2010
Trade/Device Name: MetaFlexCoil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 8, 2010 Received: June 10, 2010
Dear Mr. Lehtonen:
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. Iisting 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 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 requirents as set forth in the quality systems (QS) regulation (21 CFR Part 200). This letter will allow you to begin marketing your device as described in your Section 5 00%). This recei 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 (011) 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 vents 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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K101632
Indications for Use
510(k) Number (if known):
Device Name: MetaFlexCoil
Indications for Use:
To be used in conjunction with a 1.5T GE HD or DV series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, head, neck and spine that can be interpreted by a trained physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Dr Franchise (ODE
(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K.
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.