ALTAIRE INTERVENTIONAL MR PACKAGE

{0}------------------------------------------------ K053309 JAN 2 4 2006 #### 510(k) SUMMARY # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared. Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Phone: (330) 425-1313 Fax: (330) 425-1410 - Contact Person: Doug Thistlethwaitc Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Phone: (330) 425-1313 Fax: (330) 425-1410 Date Prepared:November 15, 2005 #### Name of Device Altaire MR Interventional Package ### Common or Usual Name MRI System #### Classification Name Magnetic Resonance Diagnostic Device #### Predicate Device Hitachi AIRIS II Magnetic Resonance Diagnostic Device Interventional MR Package (K984280) (2005 Hitachi Medical Systems America, Inc. Altaire Interventional MR Package · ---- {1}------------------------------------------------ ## Intended Use The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutie, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures mast be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user. ## Device Description The Hitachi Model Altaire Interventional MR Package is an optional enhancement designed for use with the Hitachi Model Altaire Magnetic Resonance Diagnostic Device (K050620). It's intended function and use is to aid to aid in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. (Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user). The package consists of an open head coil, an open body coil and an MR compatible in room color monitor. The head and body coils are used for obtaining diagnostic images of the head and body regions, while the display monitor is used for in room review of the images during the interventional procedure(s). The head and body coils are compatible with existing Altaire hardware and software. Therefore no hardware or software modifications are needed to use these coils. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 4 2006 Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371 Re: K053309 Trade/Device Name: Hitachi Model Altaire MR Interventional Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 23, 2005 Received: November 28, 2005 Dear Mr. Thistlewaite: 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. 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 oystams (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control organisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ 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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Nancy C. Brigdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): _ 野 大 053307 Device Name: Hitachi Model Altaire MR Interventional Package Indications for Use: The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user. 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 Device Evaluation (ODE) Daniel A. Sayum (Division Sign. Ora (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Page 1 of 1