(63 days)
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.
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.
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.
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.
The provided text describes a Magnetic Resonance Imaging Accessory called the Sharp 9000 Phased Array Brain Coil. This device is a receive-only RF coil used for obtaining diagnostic images of the brain, brain vasculature, and other intracranial structures, as well as small joints like knees and elbows, in Magnetic Resonance Imaging Systems.
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices rather than defining specific performance acceptance criteria for a new clinical outcome. The "performance" described is centered around demonstrating that the new device shares similar functional and safety characteristics with existing, legally marketed devices.
The table below summarizes the claimed features of the Sharp 9000 Phased Array Brain Coil and how they compare to predicate devices. The acceptance criteria implicitly seem to be "similar to predicate devices" for each feature.
| Acceptance Criteria (Implied) | Reported Device Performance (Claimed Similarity to Predicate) |
|---|---|
| Intended Use: Imaging of the brain, brain vasculature, and other intracranial structures, as well as a secondary application of imaging small joints. | Similarity: Similar to Quadrature Brain Coil Model 340GE-21C manufactured by Medical Advances, Inc. (K982918) |
| Indications for Use: Identical to routine MRI imaging. | Similarity: 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. | Similarity: Similar to Profile 7000 Quadrature Volume Neck Coil manufactured by USA Instruments, Inc. (K964531) |
| Coil Design: Four coil receive-only phased array design. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
| Decoupling: RF Chokes with Switching Diodes. | Similarity: 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 elements from RF fields; elements and circuitry enclosed in non-conductive housing. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
| Radio Frequency Absorption: Receive-only coil, does not transmit RF power; power deposition limited by SAR algorithm. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
| Formation of Resonant Loops: Decoupling isolates coil elements; cable length and stiffness prevent looping. | Similarity: Similar to Insight 7000 Phased Array Torso Coil manufactured by USA Instruments, Inc. (K972340) |
2. Sample Size Used for the Test Set and Data Provenance
The provided submission does not describe a specific clinical study or test set with a defined sample size for performance evaluation in the way one might expect for an AI algorithm or a novel diagnostic device. Instead, the submission relies on comparison to predicate devices to demonstrate substantial equivalence. Therefore, there is no explicit "test set" or information on data provenance relating to new clinical data generation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since there is no described clinical test set for independent performance evaluation, there is no information provided on experts used to establish ground truth for such a set. The regulatory review process itself involves expert review by the FDA.
4. Adjudication Method for the Test Set
As there is no described clinical test set, no adjudication method for a test set is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study was done or described. This device is an MRI accessory (a receive-only coil) and not an AI-powered diagnostic tool. The submission is focused on physical and functional equivalence to existing hardware.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm performance study was done or described. The device is a hardware component, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this submission is the established safety and effectiveness of the predicate devices. The Sharp 9000 Phased Array Brain Coil aims to demonstrate that its design and function are sufficiently similar to these predicate devices, implying similar safety and effectiveness. There are no mentions of expert consensus, pathology, or outcomes data being used to establish a new ground truth for this specific device.
8. The Sample Size for the Training Set
No training set is mentioned or applicable as this submission concerns a hardware medical device and not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this hardware device.
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K994042
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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, USATelephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have been issuedunder Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The Sharp 9000 Phased Array Brain Coil is a receive-onlyRF coil, used for obtaining diagnostic images of the brain,brain vasculature and other intracranial structures as wellas a secondary application of imaging small joints such asknees and elbows, in Magnetic Resonance ImagingSystems. The indications for use are the same as forstandard MR Imaging. The Sharp 9000 Phased ArrayBrain Coil is designed for use with the 1.5T SignaHorizon MRI scanner manufactured by GE MedicalSystems. |
| 8. Device Description: | The Sharp 9000 Phased Array Brain Coil is a four loopreceive-only coil. The coil consists of two sections: a leftand right section, which are positioned on the left andright side of the patient head respectively. The left andright coil sections, each containing two loop coils and theaccessory coil electronics, are enclosed in a vacuumformed housing made of polyurethane plastic, which isfire rated and has a high impact and tensile strength. |
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K994042
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- Safety and Effectiveness
: :
- Safety and Effectiveness
| Sharp 9000 Phased Array Brain CoilProduct Features | Comparison to predicate device or other510(k) Cleared Products |
|---|---|
| Intended Use: Imaging of the brain, brainvasculature and other intracranial structures, as wellas a secondary application of imaging small joints. | -Similar to Quadrature Brain Coil Model340GE-21C manufactured by MedicalAdvances, Inc. (K982918) |
| Indications for Use: Identical to routine MRIimaging | -Similar to Insight 7000 Phased Array TorsoCoil manufactured by USA Instruments Inc.(K972340) |
| Coil Enclosure Material: Polyurethane Plastic andRoyalite ™ R59 ABS/PVC alloy | -Similar to Profile 7000 Quadrature VolumeNeck Coil manufactured by USA Instruments,Inc. (K964531) |
| Coil Design: Four coil receive-only phased arraydesign | -Similar to Insight 7000 Phased Array TorsoCoil manufactured by USA Instruments, Inc.(K972340) |
| Decoupling: RF Chokes with Switching Diodes | -Similar to Insight 7000 Phased Array TorsoCoil manufactured by USA Instruments, Inc.(K972340) |
| Prevention of RF Burns: Does not transmit RFpower; decoupling isolates the coil elements fromRF fields during RF transmission; coil elements andcircuitry are enclosed in a non-conductive housing. | -Similar to Insight 7000 Phased Array TorsoCoil manufactured by USA Instruments, Inc.(K972340) |
| Radio Frequency Absorption: Coil is a receiveonly coil and does not transmit RF power; powerdeposition during imaging is limited by SARalgorithm | -Similar to Insight 7000 Phased Array TorsoCoil manufactured by USA Instruments, Inc.(K972340) |
| Formation of Resonant Loops: Decouplingisolates coil elements from RF fields during RFtransmission;length of cable and stiffness does not permit looping | -Similar to Insight 7000 Phased Array TorsoCoil manufactured by USA Instruments, Inc.(K972340) |
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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.
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
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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) | ✓ |
| OR | Over-The-Counter Use (Optional Format 1-2-96) |
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.