OUTLOOK LARGE PHASED ARRAY NECK COIL

{0}------------------------------------------------ JUL 3 / 1998 K981959 # SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) #### General Information 1. | Classification: | Class II<br>Magnetic Resonance Imaging (MRI) Accessory | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil | | Proprietary Name: | Outlook Large Phased Array Neck Coil | | 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. | Not Applicable | #### Intended Uses 2. The Picker Outlook 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. The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region. | Anatomic Regions: | Neck | |-------------------|----------| | Nuclei Excited: | Hydrogen | #### 3. Device Description The Large Phased Array Neck Coil is a receive-only coil for the 0.23T Outlook system, and is optimized to image the cervical spine. The sensitive region of the coil covers the base of the cerebellum to the third thoracic vertebra for greater than 98% of patients. | PICKER INTERNATIONAL, INC. | (LNECK) | 5/22/98 | I - | |----------------------------|---------|---------|-----| |----------------------------|---------|---------|-----| {1}------------------------------------------------ #### Safety and Effectiveness 4. ୍କ ଦି The Picker Large Phased Array Neck Coil is substantially equivalent in safety and effectiveness to the USA Instruments (USAI) Quadrature Volume Neck Coil and the Picker Phased Array Neck Coil. The following chart has been compiled to demonstrate the substantial equivalence of these devices. | Parameter | Large Phased Array<br>Neck Coil | Predicate Device<br>Picker - Outlook Neck Coil (K964678)<br>USAI - Profile 7000 Neck Coil (K964531) | |--------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Compatibility | Picker 0.23T Outlook system | Hitachi 1.5T MRH-1500 system<br>(See K964531) | | Enclosure Material | Same. | Royalite R59 ABS/PVC alloy<br>(See K964531) | | Coil Design | Two-channel receive-only<br>phased array coil. | Two-channel receive-only quadrature coil<br>(See K964531). | | Decoupling | Same. | Switching Diode decoupling.<br>(See K964531) | | Formation of Resonant<br>Loops | Same. | Length of cable and stiffness does not<br>permit looping (See K964531 or K964678) | | Potential for RF burns | Same. | Limited by the following:<br>1) Does not transmit RF power<br>2) Coil elements and circuitry encased in<br>non-conductive material.<br>3) Decoupling isolates the coil elements<br>from transmitted RF.<br>(See K964531 or K964678) | | Radio Frequency<br>Absorption | Same. | Coil is receive-only and does not transmit<br>RF power. Power deposition during<br>imaging is limited by the system SAR<br>algorithm. (See K964531 or K964678) | | Tuning Scheme | Same. | Automatically tuned for each patient.<br>(See K964678) | (LNECK) 5/22/98 I - 2 {2}------------------------------------------------ | Parameter | Large Phased Array<br>Neck Coil | Predicate Device<br>Picker - Outlook Neck Coil (K964678)<br>USAI - Profile 7000 Neck Coil (K964531) | |---------------------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Same. | The Phased Array Neck Coil is indicated for<br>use in providing coverage of the neck, from<br>the cerebellum to the upper thoracic spine<br>region.<br><br>Anatomic Regions: Neck<br>Nuclei Excited: Hydrogen<br>(See K964678) | | Intended Use | Same. | The Picker Outlook system is intended for<br>use as a NMR device that produces images<br>that: (1) correspond to the distribution of<br>protons exhibiting NMR, (2) depend upon<br>the NMR parameters (proton density, flow<br>velocity, spin-lattice relaxation time (T1),<br>and spin-spin relaxation time (T2)) and 3)<br>display the soft tissue structure of the head<br>and whole body. When interpreted by a<br>trained physician, these images yield<br>information that can be useful in the<br>determination of a diagnosis.<br>(See K964678) | PICKER INTERNATIONAL, INC. ﻤﺴﺘﺸﻔﻪ (LNECK) : 11:40 PM IST 5/22/98 I - 3 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 31 1000 Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Cleveland, OH 44143 Re: K981959 Outlook Large Phased Array Neck Coil Dated: June 2, 1998 Received: June 4, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS 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 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 (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 (OS) 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 vito 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/dsmaldsmamain.html". Sincerely yours, William Yn 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 {4}------------------------------------------------ 510(k) Number (if known): K981959 Large Phased Array Neck Coil Device Name: ## Indications for Use: The Picker Outlook 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. The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region. Anatomic Regions: Neck Nuclei Excited: Hydrogen (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) William (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K981959 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)