← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K994042 # SHARP 9000 PHASED ARRAY BRAIN COIL (K994042) _Usa Instruments, Inc. · MOS · Jan 31, 2000 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K994042 ## Device Facts - **Applicant:** Usa Instruments, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jan 31, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The Sharp 9000 Phased Array Brain Coil is a receive-only RF coil, used for obtaining diagnostic images of the brain, brain vasculature and other intracranial structures as well as a secondary application of imaging small joints such as knees and elbows, in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Sharp 9000 Phased Array Brain Coil is designed for use with the 1.5T Signa Horizon MRI scanner manufactured by GE Medical Systems. ## Device Story Sharp 9000 Phased Array Brain Coil is a receive-only RF coil for MRI systems; captures hydrogen nuclei signals to produce diagnostic images of brain, brain vasculature, intracranial structures, and small joints. Device consists of two sections (left/right) with four loop coils and accessory electronics; housed in vacuum-formed polyurethane plastic. Used in clinical MRI settings; operated by trained MRI technicians/physicians. Coil does not transmit RF power; decoupling via RF chokes and switching diodes isolates elements during RF transmission to prevent RF burns. Output images are interpreted by physicians to assist in diagnosis. Benefits include high-quality diagnostic imaging of specified anatomical regions. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Four-loop receive-only phased array coil. Materials: Polyurethane plastic, Royalite R59 ABS/PVC alloy. Sensing: RF signal reception. Decoupling: RF chokes with switching diodes. Connectivity: Dedicated interface for GE Signa Horizon 1.5T MRI scanner. Power: Passive receive-only (no RF transmission). ## Regulatory Identification A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). ## Special Controls *Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. ## Predicate Devices - Quadrature Brain Coil Model 340GE-21C ([K982918](/device/K982918.md)) - Insight 7000 Phased Array Torso Coil ([K972340](/device/K972340.md)) - Profile 7000 Quadrature Volume Neck Coil ([K964531](/device/K964531.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K994042 Page 1 of 2 ## SUMMARY OF SAFETY AND EFFECTIVENESS | 1. Device Name : | Magnetic Resonance Imaging Accessory | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Proprietary Name : | Sharp 9000 Phased Array Brain Coil | | 3. Classification : | Class II | | 4. Establishment Registration #: | 1529041 | | 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive,
Aurora, Ohio 44202, USA
Telephone: 330-562-1000; Fax: 330-562-1422. | | 6. Performance Standard: | No applicable performance standards have been issued
under Section 514 of the Food, Drug and Cosmetic Act. | | 7. Intended Use: | The Sharp 9000 Phased Array Brain Coil is a receive-only
RF coil, used for obtaining diagnostic images of the brain,
brain vasculature and other intracranial structures as well
as a secondary application of imaging small joints such as
knees and elbows, in Magnetic Resonance Imaging
Systems. The indications for use are the same as for
standard MR Imaging. The Sharp 9000 Phased Array
Brain Coil is designed for use with the 1.5T Signa
Horizon MRI scanner manufactured by GE Medical
Systems. | | 8. Device Description: | The Sharp 9000 Phased Array Brain Coil is a four loop
receive-only coil. The coil consists of two sections: a left
and right section, which are positioned on the left and
right side of the patient head respectively. The left and
right coil sections, each containing two loop coils and the
accessory coil electronics, are enclosed in a vacuum
formed housing made of polyurethane plastic, which is
fire rated and has a high impact and tensile strength. | {1}------------------------------------------------ K994042 Page 2 of 2 - 9. Safety and Effectiveness : : | Sharp 9000 Phased Array Brain Coil
Product Features | Comparison to predicate device or other
510(k) Cleared Products | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Intended Use: Imaging of the brain, brain
vasculature and other intracranial structures, as well
as a secondary application of imaging small joints. | -Similar to Quadrature Brain Coil Model
340GE-21C manufactured by Medical
Advances, Inc. (K982918) | | Indications for Use: Identical to routine MRI
imaging | -Similar to Insight 7000 Phased Array Torso
Coil manufactured by USA Instruments Inc.
(K972340) | | Coil Enclosure Material: Polyurethane Plastic and
Royalite ™ R59 ABS/PVC alloy | -Similar to Profile 7000 Quadrature Volume
Neck Coil manufactured by USA Instruments,
Inc. (K964531) | | Coil Design: Four coil receive-only phased array
design | -Similar to Insight 7000 Phased Array Torso
Coil manufactured by USA Instruments, Inc.
(K972340) | | Decoupling: RF Chokes with Switching Diodes | -Similar to Insight 7000 Phased Array Torso
Coil manufactured by USA Instruments, Inc.
(K972340) | | Prevention of RF Burns: Does not transmit RF
power; decoupling isolates the coil elements from
RF fields during RF transmission; coil elements and
circuitry are enclosed in a non-conductive housing. | -Similar to Insight 7000 Phased Array Torso
Coil manufactured by USA Instruments, Inc.
(K972340) | | Radio Frequency Absorption: Coil is a receive
only coil and does not transmit RF power; power
deposition during imaging is limited by SAR
algorithm | -Similar to Insight 7000 Phased Array Torso
Coil manufactured by USA Instruments, Inc.
(K972340) | | Formation of Resonant Loops: Decoupling
isolates coil elements from RF fields during RF
transmission;
length of cable and stiffness does not permit looping | -Similar to Insight 7000 Phased Array Torso
Coil manufactured by USA Instruments, Inc.
(K972340) | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the top and "USA" at the bottom. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Jan 3 1 2000 Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive Aurora, Ohio 44202 Re: Sharp 9000 Phased Array Brain Coil Dated: November 22, 1999 Received: November 29, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS Dear Mr. Thomas: 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 redassified 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. K994042 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 obliadion 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 requiried. "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 {3}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Sharp 9000 Phased Array Brain Coil Indications for Use: The Sharp 9000 Phased Array Brain Coil is designed to provide Magnetic Resonance Images of the brain anatomy. The Sharp 9000 Phased Array Brain Coil is designed for use with the GE Signa Horizon 1.5T scanner. > Anatomic Regions: Brain and Head Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, 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) | | |--------------------------------------------------------------------|-----------------------------------------------| | (Division Sign-Off) | | | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | 510(k) Number | K994042 | | Prescription Use (Per 21 CFR 801.109) |
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