MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE

{0}------------------------------------------------ 1183342 DEC 2 1 1998 # SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) #### 1. General Information | Classification: | Class II<br>Magnetic Resonance Imaging (MRI) System | | | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Common/Usual Name: | Magnetic Resonance Imaging (MRI) Option | | | | Proprietary Name: | MR Guided Procedures (MRGP) Basic Package | | | | Establishment Registration: | Manufacturer:<br>Picker Nordstar, Inc.<br>Ayritie 4, Vantaa<br>FIN-01510 Vantaa Finland<br>FDA Facility Registration: #9680194<br>United States Representative:<br>Picker International, Inc.<br>World Headquarters<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 | | | | Performance Standards: | No applicable performance standards have been<br>issued under section 514 of the Food, Drug and<br>Cosmetic Act. | | | #### 2. Intended Uses The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages. 】- 1 {1}------------------------------------------------ #### 3. Device Description The MRGP Basic Package is an optional hardware package for the Outlook and Outlook Proview systems. The package includes a foot pedal for starting scans from inside the scan room, kneeling pads for the physician, an MR compatible procedure light, a multipurpose coil with disposable protective coil coverings, and either an in-room LCD display or an in-room Large (36") Screen display. The package uses the standard software and sequences available with the Outlook and Outlook Proview systems. #### Safety and Effectiveness 4. The Picker MRGP Basic Package is substantially equivalent to the Siemens Magnetom Open MR Guided Procedures Package and the Picker Outlook System Enhancement Package. The following chart has been compiled to demonstrate this equivalence. ### PICKER INTERNATIONAL, INC. (MRGP) {2}------------------------------------------------ # Substantial Equivalence Chart | Parameter | MR Guided Procedures<br>(MRGP) Basic Package | Outlook System Enhancement<br>Package (Proview) - K974844 | Siemens MR Guided Procedure<br>Package - K955389 | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | System Compatibility | 0.23T Outlook,<br>0.23T Outlook Proview | Not Applicable. | 0.2T Magnetom Open | | Magnet Homogeneity | Same. | Same. | $\pm$ 5 ppm @ 40 cm DSV (FWHM) | | Magnet ramp time | Same as K974844. | 6 minutes | Approx. 30 minutes | | Gradient Design | Same as K974844. | Water-cooled gradient coils Peak strength - 16 mT/m Slew rate - 25 mT/m/ms | Water-cooled gradient coils Peak strength - 15 mT/m Slew rate - <17 mT/m/ms | | Patient accessibility | Same as K974844. | Gap (couch-pole) - 44 cm Access from three sides | Gap (couch-pole) - 40 cm Access from three sides | | Patient couch | Same. | Same. | Detachable mobile couch. | | Patient positioning | Same. | Same. | Laser localizer for positioning | | Sequence type | Same as K974844. | 2D/3D Gradient echo, FSE, Single-shot FSE. | Rapid gradient echo imaging, FIS | | Sequence capabilities | Same as K974844. | Dynamic imaging with auto start and<br>keyhole imaging capabilities.<br>Typical reconstruction of 200 ms<br>per image. | Continuous imaging with automatic<br>display. Typical reconstruction of<br>less than 600 ms per image. | | Sequence resolution | Same as K974844. | FOV- 4 to 40 cm Slice thickness - 2D: 1-100mm (0.1mm steps) 3D: 0.4-100mm (0.1mm steps) Matrix- up to 512 | FOV - 4 to 40 cm (2D), 12 to 40 cm (3D) Slice thickness - 2D: 2-60mm (1 mm steps) 3D: ?? Matrix- 128, 256, 512 (2D) | | Parameter | MR Guided Procedures<br>(MRGP) Basic Package | Outlook System Enhancement<br>Package (Proview) - K974844 | Siemens MR Guided Procedure<br>Package - K955389 | | In-room display and scan<br>control | Two types of in-room displays<br>available- 1) LCD same as<br>K974844, 2) Large (36")<br>Screen display with 1024x768<br>resolution. Foot pedal also<br>provided to start scans. | In-room LCD display with<br>1024x768 resolution. | In-room LCD display with<br>1024x1280 resolution. Foot pedal<br>also provided to start scans. | | RF coils | Same coils as K974844.<br>Non-sterile protective<br>coverings provided to prevent<br>degradation of performance<br>due to fluid ingress. | Belt shaped Multipurpose coils with<br>circumferences ranging from 40 to<br>136 cm. | Belt shaped Multipurpose coil with<br>a circumference 109 cm. | | Sterile drapes | User instructed to cover<br>magnet poles with standard<br>sterile drapes. Drapes not<br>provided with package. | None. | Reusable cover provided for magnet<br>poles. Can be steam sterilized. | | Physician Ergonomics | Set of kneeling cushions | None. | Chair | | Procedure Lighting | Adjustable MR compatible<br>light on movable stand. | None. | Flexible fiber-optic lamp, attached<br>on a flexible arm at the magnet<br>cover for sterile handling | | Indications for Use | The MRGP Basic Package is<br>designed to support and guide<br>diagnostic interventional<br>procedures, such as needle<br>biopsies and drainages. | Standard MR imaging indications<br>for use. No interventional<br>indications. | The MR-guided procedure package<br>is designed to support diagnostic<br>interventional needle biopsies and<br>drainages. | PICKER INTERNATIONAL, INC. r . ・ I - 3 : {3}------------------------------------------------ PICKER INTERNATIONAL, INC. ۱ ・ く {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is black and the background is white. The text is centered in the image. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Image /page/4/Picture/3 description: The image shows a partial view of a logo or emblem, likely from a government or organizational context. The visible portion includes a stylized graphic of three wavy lines stacked on top of each other, possibly representing movement or flow. To the left of the graphic, there is a fragment of text, with only the letters 'DEPARTMEN' visible, suggesting that the full text is 'DEPARTMENT' followed by the name of the department or organization. DEC 2 1 1998 Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re: K983342 MR Guided Procedures (MRGP) Basic Package Dated: September 21, 1998 Received: September 23, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LHN Dear Dr. Keeler: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Capt. Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): k 4 8 3 3 42 Magnetic Resonance Guided Procedures (MRGP) Basic Package Device Name: ## Indications for Use: The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ghind h. Hyam (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 449742 510(k) Number . Prescription Use 4 (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)