(25 days)
The 3.0T 8-Channel CTL Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine (cervical, thoracic and lumbar regions) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The 3.0T 8-Channel CTL Array Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.
The 3.0T 8-Channel CTL Array Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 8-Channel CTL Array Coil is designed for use with the GE 3.0T 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 3.0T 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 3.0T 8-Channel CTL Array Coil is a multi-element phased array receive-only 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 elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.
This document describes a 510(k) premarket notification for a medical device, specifically a "3.0T 8-Channel CTL Array Coil" for Magnetic Resonance Imaging. The information provided heavily focuses on proving "substantial equivalence" to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device. Therefore, many of the requested sections (2-9) cannot be fully populated as they pertain to a detailed clinical or standalone performance study, which is not present in this submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from comparative equivalence) | Reported Device Performance (as demonstrated by equivalence) |
|---|---|
| Intended Use: Imaging of the spine. | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595). |
| Indications for Use: Identical to routine MRI imaging (cervical, thoracic, and lumbar regions of the spine; Hydrogen nuclei excited; soft tissue structure of the head and whole body for diagnosis by a trained physician). | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) and the 3.0T MRI system itself. |
| Coil Material: Flame Retardant Kydex, Flame Retardant PVC, Flame Retardant Polyurethane, Flame Retardant Polycarbonate. | Similar to predicate devices (Premier 9000 8 Channel Phased Array CTL Spine Coil, K031366; Premier III Phased Array CTL Spine Coil, K030042). |
| Coil Design: Receive-only phased array design. | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595). |
| Decoupling: RF Chokes with Switching Diodes. | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595). |
| 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 predicate device (Premier III Phased Array CTL Spine Coil, K013595). |
| Radio Frequency Absorption: Coil is a receive only coil and does not transmit RF power. | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595). |
| 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 predicate device (Premier III Phased Array CTL Spine Coil, K013595). |
Note: The document provided is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics. The "acceptance criteria" here are essentially the characteristics and safety features of the predicate devices. The "reported device performance" is the statement that the new device shares similar characteristics and capabilities with these predicate devices. The submission essentially argues that because the new device is "similar to" already approved devices in key safety and functional aspects, it is equally safe and effective.
Detailed breakdown of study information (where available):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated. The submission relies on demonstrating similarity to predicate devices rather than a direct performance study with a test set of images/patients. There is no information on a specific test set, its size, or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no mention of a test set with ground truth established by experts in this submission. The "ground truth" for this 510(k) is effectively the established safety and efficacy profiles of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication is described.
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 coil, a hardware component. The submission does not describe any AI component or any MRMC study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware component (MRI coil), not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of a new device performance study. The 'ground truth' for this 510(k) is the legal and scientific consensus that the predicate devices are safe and effective for their intended use. The new device is deemed safe and effective because it is substantially equivalent.
8. The sample size for the training set
- Not applicable. This submission does not describe a training set as it's not an AI/algorithm-based device.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set described.
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SEP 1 2 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | 3.0T 8-Channel CTL Array Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc1515 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 3.0T 8-Channel CTL Array Coil is a receive-onlyphased array RF coil, used for obtaining diagnosticimages of the spine (cervical, thoracic and lumbarregions) in Magnetic Resonance Imaging Systems.The indications for use are the same as for standardMR Imaging. The 3.0T 8-Channel CTL Array Coil isdesigned for use with the GE Medical Systems3.0Tesla MRI scanner. |
| 8. Device Description: | The 3.0T 8-Channel CTL Array Coil is a multi-element phased array receive-only coil. The coil isshaped to conform to the contours of the spine andhas been designed to maximize comfort and ease ofuse. The elements and associated circuitry areenclosed in a housing made of plastic materials,which are fire rated and have high impact and tensilestrength. |
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9. Safety and Effectiveness
| 3.0T 8 Channel CTL Array Coil ProductFeatures | Comparison to predicate device or other 510(k)cleared product |
|---|---|
| Intended Use: Imaging of the spine. | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Indications for Use: Identical to routineMRI imaging | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Coil Material:Flame Retardant KydexFlame Retardant PVCFlame Retardant PolyurethaneFlame Retardant Polycarbonate | -Similar to the Premier 9000 8 Channel PhasedArray CTL Spine Coil manufactured by USAInstruments, Inc. (K031366)-Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| Coil Design: Receive-only phased arraydesign | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Decoupling: RF Chokes with SwitchingDiodes | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Prevention of RF Burns: Does nottransmit RF Power, Decoupling isolatesthe coil elements from RF fields duringRF transmission, Coil elements andcircuitry are enclosed in a non-conductive housing. | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission. Lengthof cable and stiffnessdoes not permit looping | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three curved lines representing its body and wings. The bird is facing right. The logo is surrounded by text that forms a circle around the bird. The text is oriented so that it follows the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2003
Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K032538
Trade/Device Name: 3.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: August 15, 2003 Received: August 19, 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 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 vours.
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): K032538
Device Name: 3.0T 8-Channel Cervical-Thoracic-Lumbar (CTL) Array Coil
Indications for Use: The 3.0T 8-Channel CTL Array Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 8-Channel CTL Array Coil is designed for use with the GE 3.0T 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 3.0T 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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
David A. Legum
510(k) Numb
§ 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.