TEM 3002G- HN DUAL TUNE HEAD COIL

{0}------------------------------------------------ Koro820 Image /page/0/Picture/1 description: The image shows the logo for MR Instruments INC. The logo consists of the letters "mrii" in a stylized font. The "m" and the two "i"s are solid black, while the "r" is a textured gray. Below the letters is the text "MR INSTRUMENTS INC" in a smaller, sans-serif font. #### TEM 3002G-HN Dual Tune Headcoil ### Section 2 - 510(k) Summary and Certification [As required by 21 CFR 807.92(c)] APR - 2 2008 ### 1. Contact Person | Mark Watson | Tel: (952) 229-8813 | |-----------------|---------------------| | VP, Engineering | Fax: (952) 746-1437 | MR instruments, Inc. 5610 Rowland Road, Suite 145 Minnetonka, MN 55343 ### 2. General Information | Name: | TEM 3002G-HN Dual Tune headcoil | |----------------------|--------------------------------------------------------------------------------------| | Trade Name: | TEM 3002G-HN Dual Tune headcoil | | Common Name: | Headcoil | | Classification Name: | Magnetic Resonance Diagnostic Device | | Classification: | This device is classified by the Radiology<br>Panel into Class II, (21 CFR 892.1000) | ### 3. Device Description The TEM 3002G-HN Dual Tune headcoil is a quadrature transmit/receive RF coil tuned to proton ('H) and sodium (22Na) frequencies 3T. The TEM resonant elements and associated matching and quadrature splitting circuitry are enclosed in a rigid plastic housing to prevent any exposure to patient or environment. The predicate devices are also quadrature transmit/receive RF headcoils. All have similar construction, size and shape. All are tuned to proton ('H) resonant frequency at 3T and two are dual resonant, one at phosphorus (31P) and one at carbon (18C). #### 4. Intended Use The MR Instruments TEM 3002G-HN Dual Tune headcoil is to be used in conjunction with a 3T Magnetic Resonance Imaging system to produce proton ('H) images and spectra of the internal structures of the head. In addition, sodium (20 a) images and spectra may be obtained during the same exam without changing the coil. These images and/or spectral information of the head, when interpreted by a trained physician, may yield information that may assist in diagnosis. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for MR Instruments Inc. The logo consists of the letters "mrii" in a stylized font, with the letters stacked on top of each other. The letters are black, and the background is white. Below the letters, the words "MR INSTRUMENTS INC" are written in a smaller font. ### TEM 3002G-HN Dual Tune Headcoil ## 5. Substantial Equivalence Comparison The TEM 3002G-HN Dual Tune headcoil is substantially equivalent to the following devices with respect to safety, intended use and design: | Coil Name | Premarket<br>Notification | Clearance Date | |--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-------------------| | GE Healthcare<br>Split Head Coil Assembly for G3, for use<br>with a Signa 3T MR system for producing<br>proton (1H) MR images and spectra | K040444 | April 14, 2004 | | Siemens Medical Solutions<br>31P/1H headcoil for MAGNETOM Allegra MR<br>system for producing phosphorus (31P) and<br>proton (1H) MR images and spectra | K042617 | November 5, 2004 | | Siemens Medical Solutions<br>13C/1H headcoil for MAGNETOM Allegra MR<br>system for producing carbon (13C) and proton<br>(1H) MR images and spectra | K042718 | November 12, 2004 | Similarities between the devices are devices in that they are all transmit and receive RF coils designed to work in conjunction with 3T MR System for acquiring proton ('H) diagnostic images and spectra of the internal structures of the head. The double resonance coils are similar in frequency as noted below. In addition, all coils are similar in size, shape and construction. Note: The resonance frequency of 13C = 32.4 MHz, 22 Na = 33.8 MHz, and 31P = 51.6 MHz at 3T. The primary differences between the devices are that the TEM 3002G-HN coil adds sodium (22) imaging capability instead of phosphorus (31P) or carbon (130). The GE Healthcare Split Top Coil is not a double resonant coil and requires switching coils to obtain images or spectra at other frequencies. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo for MR Instruments INC. The logo is black and white and features a stylized "m" followed by what appears to be a textured circle and two vertical lines. Below the symbol is the text "MR INSTRUMENTS INC" in a simple sans-serif font. # 6. Summary of Studies Verification and validation testing was performed to ensure that the coil design requirements specification and customer requirements specification were met. Testing activities included electrical bench measurements, electrical/mechanical safety tests, MR system safety and performance tests with phantoms and volunteer scans. MR system tests were conducted using the GE Healthcare Signa 3T MR system running standard clinical applications. ### 7. Conclusion (statement of equivalence) The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the TEM 3002G-HN Dual Tune headcoil. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 # APR - 2 2008 MR Instruments, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313 Re: K080820 Trade/Device Name: TEM 3002G-HN Dual Tune headcoil Regulation Number: 21 CFR 872.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 22, 2008 Received: March 24, 2008 Dear Mr. Job: 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/3/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating the years 1906-2006. The logo features the letters "FDA" prominently in the center, with the word "Centennial" written below. The logo is surrounded by a circular border with stars and other decorative elements. Protecting and Promoting Public Health {4}------------------------------------------------ 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Page 2 Enclosure {5}------------------------------------------------ #### TEM 3002G-HN Dual Tune Headcoil Image /page/5/Picture/1 description: The image shows a logo for MR Instruments Inc. The logo consists of a stylized "m" followed by "r" and two "i"s. Below the logo, the words "MR INSTRUMENTS INC" are printed in a simple sans-serif font. ### Indications for Use Statement Page 1 of 1 The MR Instruments TEM 3002G-HN Dual Tune headcoil is to be used in conjunction with a 3T Magnetic Resonance Imaging system to produce proton ('H) images and spectra of the internal structures of the head. In addition, sodium (20Na) images and spectra may be obtained during the same exam without changing the coil. These images and/or spectral information of the head, when interpreted by a trained physician, may yield information that may assist in diagnosis. This device is for prescription use. (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, and Radiological Devices ices 208082 MR Instruments, Inc. March 6, 2008 510(k) Number