ASSET APOLLO

{0}------------------------------------------------ # K971884 AUG 2 0 ## SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) | 1. | General Information<br>Classification: | Class II - Magnetic Resonance Imaging System | |----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Common/Usual Name: | Magnetic Resonance Imaging System | | | Proprietary Name: | ASSET APOLLO | | | Establishment Registration: | 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 issued<br>under section 514 of the Food, Drug and Cosmetic Act. | #### 2. Intended Uses The ASSET APOLLO does not change the existing intended use for the ASSET system as defined below. The Picker International ASSET system is intended 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. #### 3. Device Description The ASSET APOLLO MR system includes the following enhancements: a water cooled gradient system, increased gradient performance, increased scan/reconstruction rates, and a user selectable bandwidth option. #### 4. Safety and Effectiveness The ASSET APOLLO is similar in technological characteristics and intended use to the standard ASSET system and the EDGE/VISTA system enhancement package. The following chart has been created to demonstrate their substantial equivalence. | PICKER INTERNATIONAL, INC. | (APOLLO) | 5/8/97 | I - 1 | |----------------------------|----------|--------|-------| |----------------------------|----------|--------|-------| . {1}------------------------------------------------ ## SUBSTANTIAL EQUIVALENCE CHART ﺴﻌﻪ ﺍ | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | |----------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Computer Subsystem | Same as K964626. | Display/Database computer and<br>scan reconstruction hardware<br>connected together by a dedicated<br>Ethernet communications system.<br>Allows for simultaneous scanning<br>and image<br>reconstruction/manipulation.<br>Single monitor for system<br>operation and image review.<br>Second Ethernet interface allows<br>for communication with systems<br>on the external network. | Display/database computer,<br>monitor and Ethernet<br>communications systems.<br>Ethernet communications link<br>complies with DICOM v3.0 to<br>allow image transfer to other MR,<br>CT, Nuclear, workstation systems<br>and cameras. Optional packages<br>available for increased image<br>reconstruction rates. | | Image Storage<br>Short Term:<br>Archival: | Same.<br>Same. | Magnetic Disk<br>Optical Disk | Magnetic Disk<br>Optical Disk | | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | | Gradient Subsystem<br>Gradient Coils: | Water-cooled self-shielded<br>gradient system. Phosphorous-<br>bronze RF screen. | Self-shield gradient coil designed<br>for Magnex 0.5T actively<br>shielded magnet. Copper RF<br>screen. | Water-cooled self-shielded<br>gradient system for all<br>performance levels. Stainless steel<br>RF screen. | | Max. Gradient Strength | 16 mT/m | 10 mT/m | 16, 20 or 27 mT/m | | Max. Slew Rate | 25 mT/m/msec | 18 mT/m/msec | 25, 40, 72 mT/m/msec | | Gradient Amps: | 150 A RMS, 300 A peak, 400 V | Single high current drive<br>amplifier per axis. | 150 A RMS, 300 A peak, 400 V<br>or<br>270 A RMS, 440 A peak, 600 V | | RF Subsystem | | | | | DTR Spectrometer: | Same. | Single channel with fast sampling<br>ADC and additional digital<br>filtering. Three additional<br>receive channels are available as<br>an option. | Single Channel with fast sampling<br>ADC and additional digital<br>filtering. Three additional receive<br>channels are available as an<br>option. | | RF Amplifiers: | Single frequency 5.0 kW RF<br>amplifier. | Single frequency 2.5 kW RF<br>amplifier. | Single frequency RF amplifiers. | | Body Coil | Same as K933835. | 57 cm quadrature multi-<br>conductor transmit/receive. | 61 cm quadrature multi-conductor<br>transmit/receive coil. | | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | | Head Coil | Same. | Quadrature multi-conductor<br>receive only. | Quadrature multi-conductor<br>receive only. | | Receive Only Coil Connection | Same. | All receive only coils plug into<br>single couch RF connector. | All receive only coils plug into<br>single couch RF connector. | | Transmit/Receive Box | Same. | Four receive channels in system.<br>(1 standard, 4 optional) | Four receive channels in system.<br>(1 standard, 4 optional) | | Magnet Subsystem | Same as K933835. | Actively shielded magnet offered<br>at 0.5 T. | Active Shield Magnets offered at<br>1.5 T and 1.0 T. | | Patient Handling | Same as K933835. | Horizontal motion only,<br>computer controlled patient<br>transport system. | Computer controlled patient<br>transport system with vertical and<br>horizontal motion. | | Magnet Facade | Same. | Cylindrical fiberglass enclosure. | Cylindrical fiberglass enclosure. | | Power Distribution Subsystem | Same. | Isolation transformer, transient<br>suppression circuitry, and power<br>distribution center all contained<br>in a single cabinet. | Isolation transformer, transient<br>suppression circuitry, and power<br>distribution center all contained in<br>a single cabinet. | | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | | Operating Software | Same as K964626. | UNIX - X Windows based<br>operating software. Graphical<br>User Interface - windows and<br>Multi-tasking capability<br>provided. | UNIX - X Windows based<br>operating software. Graphical<br>User Interface - windows and<br>multi-tasking capability provided<br> | | | | SCAN, VIEW, FILM, and<br>UTILITIES operations all<br>accessed from single console. | SCAN, VIEW, FILM and<br>UTILITIES operations all<br>accessed from single console.<br> | | | | Able to switch between on-going<br>tasks. | Able to switch between on-going<br>tasks. | | Operational Features | Same. | SCAN capabilities include: Pilot<br>positioning on three different<br>reference images. Preloaded<br>anatomical protocol categories. | SCAN capabilities include: Pilot<br>positioning on three different<br>reference images. Preloaded<br>anatomical protocol categories. | | | | VIEW capabilities include:<br>Multiplanar reconstruction and<br>curvilinear reformatting. | VIEW capabilities include: Multi<br>planar reconstruction and<br>curvilinear reformatting.<br> | | | | FILM capabilities include: ability<br>to set film formats and load print<br>queue directly from<br>Display/Database computer. | FILM capabilities include: ability<br>to set film formats and load print<br>queue directly from<br>Display/Database computer. | | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | | Standard Imaging Sequences | Same standard imaging<br>sequences with the addition of the<br>AcuScan package. | 2DFT: Field Echo, Spin Echo,<br>Multiple Echo, Inversion<br>Recovery and FAST.<br>3DFT: FAST | 2DFT: Field Echo, Spin Echo,<br>Multiple Echo, Inversion<br>Recovery and FAST.<br>3DFT: FAST | | Acquisition and Reconstruction<br>Techniques | Same as K964626. | Main features include:<br>Presaturation, phase conjugate<br>symmetry, TrueRes, TrueSlice,<br>and Geometric Distortion<br>Correction. | Main features include:<br>Presaturation, phase conjugate<br>symmetry, TrueRes and TrueSlice. | PICKER INTERNATIONAL, INC. I. 5/8/97 I - 2 'معرب ا {2}------------------------------------------------ ﻣﺴﺴﺴﺴﺔ PICKER INTERNATIONAL, INC. .. (APOLLO) 5/8/97 I - 3 نسببها {3}------------------------------------------------ ' · مسلا PICKER INTERNATIONAL, INC. ) 5/8/97 ﻟﺴﻴﺮ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- {4}------------------------------------------------ ﺳﺴﻪ PICKER INTERNATIONAL, INC. امارات سنڌ ا 5/21/97 I - 5 ب {5}------------------------------------------------ ﻤﺴﻴﺴﻪ ﺍ PICKER INTERNATIONAL, INC. - I - 6 {6}------------------------------------------------ | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | |------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Optional Receive Only Coils<br>and Accessories | Same as K933835. | Large Joint Coil<br>Small Joint Coil<br>Volume Neck Coil<br>Quad Spine Coil and Positioner<br>Bilateral TMJ Coil (Linear and<br>Phased Array versions)<br>Bilateral Breast Coil<br>General Purpose Flex Coil<br>C/T/L Phased Array<br>Pelvic Phased Array<br>Flexible Body Coil - Quadrature<br>Quadrature Wrist Coil<br>Quadrature Lower Extremity Coil<br>Coil Combiner | Large Joint Coil<br>Small Joint Coil<br>Volume Neck Coil<br>Quad Spine Coil and Positioner<br>Bilateral TMJ Coil (Linear and<br>Phased Array versions)<br>Bilateral Breast Coil<br>General Purpose Flex Coil<br>C/T/L Phased Array<br>Pelvic Phased Array<br>Flexible Body Coil (Quadrature<br>and Phased Array versions)<br>Quadrature Wrist Coil<br>Quadrature Lower Extremity Co<br>Coil Combiner<br>Head-Neck Vascular Phased A<br>Shoulder Phased Array | | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | | Software Options | Angiography | Angiography | Angiography | | | Cardiac Imaging | Cardiac Imaging | Cardiac Imaging | | | Variable Fast Spin Echo<br>Sequences (2, 4, 8, 16, 32, 48 and<br>64 echo sequences) | Variable Fast Spin Echo<br>Sequences. | Variable Fast Spin Echo (2, 4, 8,<br>16, 32, 48 and 64 echo sequences) | | | Gradient-Recalled and Spin-Echo<br>(GRaSE) Technique | Gradient-Recalled and Spin-Echo<br>(GRaSE) Technique | Gradient-Recalled and Spin-Echo<br>(GRaSE) Technique | | | Echo Planar Imaging | Echo Planar Imaging | Echo Planar Imaging | | Time Varying Magnetic Field | Same as K964626. | Not to exceed 20 T/s. | Normal Operating Mode:<br>dB/dt ≤ 40 T/s | | | | | First Controlled Operating Mode:<br>40 T/s < dB/dt ≤ 60 T/s | | Radiofrequency Absorption | Same as K964626. | Normal Operating Mode: Limited<br>to a maximum level of 1.2 W/kg. | Normal Operating Mode:<br>Limited to a maximum level of<br>1.2 W/kg. | | | | First Level Controlled Operating<br>Mode: Limited to a maximum<br>value of 2.4 W/kg. | First Level Controlled Operating<br>Mode: Limited to a maximum<br>value of 3.2 W/kg. | | ITEM | ASSET APOLLO | Predicate Device<br>ASSET (K933835) | Predicate Device<br>EDGE/VISTA with System<br>Enhancement Package<br>(K964626) | | Acoustic Noise | | | | | Typical | 71.7 dBA (average)<br>82.9 dB (peak) | 83.8 dBA (average)<br>96.8 dB (peak) | 80.6 dBA (average)<br>93.3 dB (peak) | | Worst Case | 88.8 dBA (average)<br>96.3 dB (peak) | 98.2 dBA (average)<br>108.2 dB (peak) | 115.1 dBA (average)<br>123.8 dB (peak) | | Intended Use | Same. | The Picker International ASSET<br>system is intended for use as a<br>NMR device that produces<br>images that: (1) correspond to the<br>distribution of protons exhibiting<br>NMR, (2) depend upon the NMR<br>parameters (proton density, flow<br>velocity, spin-lattice relaxation<br>time (T1), and spin-spin<br>relaxation time (T2)) and (3)<br>display the soft tissue structure of<br>the head and whole body. When<br>interpreted by a trained physician,<br>these images yield information<br>that can be useful in the<br>determination of a diagnosis. | The Picker International EDGE /<br>VISTA systems are intended for<br>use as a NMR devices that<br>produce images that: (1)<br>correspond to the distribution of<br>protons exhibiting NMR, (2)<br>depend upon the NMR parameters<br>(proton density, flow velocity,<br>spin-lattice relaxation time (T1),<br>and spin-spin relaxation time (T2))<br>and (3) display the soft tissue<br>structure of the head and whole<br>body. When interpreted by a<br>trained physician, these images<br>yield information that can be<br>useful in the determination of a<br>diagnosis. | ﻤﺴﺴﺴﺴ PICKER INTERNATIONAL, INC. ﺮ ﺍﻟﺴﻨﺔ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﺎﺭﻳﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴﺘﺸﻔﻴﺔ ﺍﻟﻤﺴ (APOLLO) 5/8/97 I - 7 {7}------------------------------------------------ مسس PICKER INTERNATIONAL, INC. ﺳﺴﺴﺔ ﻧ 5/8/97 I - 8 سسيدا {8}------------------------------------------------ PICKER INTERNATIONAL, INC. 5/8/97 (APOLLO) I.- I - 9 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three stripes representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 5500 Avion Park Drive Highland Heights, Ohio 44143 Re: K971884 ASSET APOLLO (MRI System) Dated: May 12, 1997 Received: May 22, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH AUG 20 1997 Dear Dr. Keeler: We have reviewed your Section SI0(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 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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 צוות diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/edri/dsmamain.html" Sincerely yours. William Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ 510(k) Number (if known): __Ka7 1884 Device Name: ASSET APOLLO ### - Indications for Use: The ASSET APOLLO does not change the existing intended use and indications for the ASSET system as defined below. The Picker International ASSET system is intended 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David L. Shapiro (Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number Prescription Use (Per 21 CFR 801.109) ✓ OR Over-The-Counter Use _ (Optional Format 1-2-96)