(72 days)
The Premier 9000 8 Channel Phased Array CTL Spine Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier 9000 8 Channel Phased Array CTL Spine Coil is designed for use with the Excite 1.5T MRI system manufactured by GE Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T scanner manufactured by GE Medical Systems, Inc.
Anatomic Regions: cervical, thoracic and lumbar regions of the spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T MRI 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 Premier 9000 8 Channel Phased Array CTL Spine Coil is a twelve element receive only phased array coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
This document is a 510(k) premarket notification for a Medical Resonance Imaging Accessory, specifically the Premier 9000 8 Channel Phased Array CTL Spine Coil. The objective of a 510(k) submission is to demonstrate that the device is substantially equivalent to a predicate device already legally marketed in the US. The "study" described herein is essentially a comparison to predicate devices, rather than a traditional clinical study with detailed performance metrics against specific acceptance criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) rely on demonstrating substantial equivalence to predicate devices, particularly the Premier 7000 Phased Array CTL Spine Coil (K980157). The "device performance" in this context refers to the features and safety aspects of the new device being comparable to or the same as the predicate.
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (Premier 9000) |
|---|---|
| Intended Use: Imaging of the spine. (Similar to Premier 7000 Phased Array CTL Spine Coil, K980157) | Intended Use: Imaging of the spine (cervical, thoracic, lumbar regions). "Similar to the Premier 7000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K980157)" |
| Indications for Use: Identical to routine MRI imaging. (Similar to Premier 7000 Phased Array CTL Spine Coil, K980157) | Indications for Use: Identical to routine MRI imaging. "Similar to the Premier 7000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K980157)" |
| Coil Material: Flame Retardant Kydex, Flame Retardant PVC, Flame Retardant Polyurethane. (Similar to Hi-Res 9000 Carotid Coil, K001210) | Coil Material: Flame Retardant Kydex, Flame Retardant PVC, Flame Retardant Polyurethane. "Similar to the Hi-Res 9000 Carotid Coil, manufactured by USA Instruments, Inc. (K001210)." |
| Coil Design: Receive-only phased array design. (Similar to Premier 7000 Phased Array CTL Spine Coil, K980157) | Coil Design: Receive-only phased array design. "Similar to the Premier 7000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K980157)" |
| Decoupling: Switching diode decoupling. (Similar to Premier 7000 Phased Array CTL Spine Coil, K980157) | Decoupling: Switching diode decoupling. "Similar to the Premier 7000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K980157)" |
| Prevention of RF Burns: Does not transmit RF Power, Decoupling isolates coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing. (Similar to Premier 7000 P.A. CTL Spine Coil, K980157) | 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 the Premier 7000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K980157)" |
| Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. (Similar to Premier 7000 Phased Array CTL Spine Coil, K980157) | Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. "Similar to the Premier 7000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K980157)" |
| 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 Premier 7000 P.A. CTL Spine Coil, K980157) | 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 the Premier 7000 Phased Array CTL Spine Coil manufactured by USA Instruments, Inc. (K980157)" |
| Compatibility: Designed for use with the Excite 1.5T MRI system manufactured by GE Medical Systems, Inc. | Compatibility: The Premier 9000 8 Channel Phased Array CTL Spine Coil is designed for use with the Excite 1.5T MRI system manufactured by GE Medical Systems, Inc. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional test set involving patient data or images for performance evaluation of the new coil against specific efficacy metrics.
Instead, the "study" is a comparative analysis of the device's design, materials, and functional principles against previously cleared predicate devices. The data provenance is based on the design specifications and safety features of the new coil, compared to the established specifications and safety features of the predicate devices. This type of submission relies on engineering and design control documentation rather than clinical data from a test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "test set" in the context of clinical images or patient data requiring expert ground truth establishment for this 510(k) submission. The ground truth, in a broader sense of regulatory approval, is the established safety and effectiveness of the predicate devices, which were previously cleared by the FDA based on their own submissions and assessments (which may or may not have involved expert review of clinical data).
4. Adjudication Method for the Test Set
Not applicable. Since there was no clinical test set for independent review requiring adjudication, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is an MRI accessory (a coil), not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical MRI coil, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document focuses on demonstrating substantial equivalence in terms of safety and intended use rather than diagnostic accuracy. Therefore, the "ground truth" used is regulatory compliance through comparison to predicate devices, referencing their established safety profiles, design characteristics, and intended uses. This is primarily based on engineering specifications, material safety data, and functional design principles proven safe and effective in previously cleared devices.
8. The Sample Size for the Training Set
Not applicable. This device is an MRI accessory, not a learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Ko3 1366
JUL 1 1 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Premier 9000 8 Channel Phased Array CTL SpineCoil |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc.,1515 Danner DriveAurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422. |
| 6. Performance Standard: | No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act. |
| 7. Intended Use: | The Premier 9000 8 Channel Phased Array CTLSpine Coil is a receive- only phased array RF coil,used for obtaining diagnostic images of the cervical,thoracic, and lumbar regions of the spine inMagnetic Resonance Imaging Systems. ThePremier 9000 8 Channel Phased Array CTL SpineCoil is designed for use with the Excite 1.5T MRIsystem manufactured by GE Medical Systems, Inc.The indications for use are the same as for standardMR Imaging. |
| 8. Device Description: | The Premier 9000 8 Channel Phased Array CTLSpine Coil is a twelve element receive only phasedarray coil. The coil is shaped to conform to thecontours of the spine and has been designed tomaximize comfort and ease of use. The coilelements and accessory electronics are enclosed ina rigid plastic housing, which is fire rated and has ahigh impact and tensile strength. |
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9. Safety and Effectiveness
| Premier III 8 Channel Phased ArrayCTL Spine Coil Product Features | Comparison to predicate device or other510{k) cleared product |
|---|---|
| Intended Use:Imaging of the spine. | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Indications for Use:Identical to routine MRI imaging | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Coil Material:Flame Retardant KydexFlame Retardant PVCFlame Retardant Polyurethane | -Similar to the Hi-Res 9000 Carotid Coil,manufactured by USA Instruments, Inc.(K001210). |
| Coil Design:Receive-only phased array design | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Decoupling:Switching diode decoupling. | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Prevention of RF Burns:Does not transmit RF Power,Decoupling isolates the coil elementsfrom RF fields during RF transmission,Coil elements and circuitry are enclosedin a non-conductive housing. | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Radio Frequency Absorption:Coil is a receive only coil and does nottransmit RF power | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission.Length of cable and stiffnessdoes not permit looping | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2003
Ms. Christie Shumaker Manager, QA and Regulatory USA Instuments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K031366
Trade/Device Name: Premier 9000 8 Channel Phased Array CTI Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: April 28, 2003 Received: May 5, 2003
Dear Ms. Shumaker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal 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: Premier 9000 8 Channel Phased Array CTL Coil
Indications for Use: The Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T scanner manufactured by GE Medical Systems, Inc.
Anatomic Regions: cervical, thoracic and lumbar regions of the spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T MRI 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031366
OR
§ 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.