(84 days)
The Premier III Phased Array CTL Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.
The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner.
The indications for use are the same as for standard imaging:
The GE Medical Systems 3.0Tesla 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 III Phased Array CTL Spine 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Premier III Phased Array CTL Spine Coil:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Intended Use: Imaging of the spine. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345), both manufactured by USA Instruments, Inc. |
| Indications for Use: Identical to routine MRI imaging, specifically for the spine anatomy. The GE Medical Systems 3.0Tesla system is indicated for producing images of proton distribution, NMR parameters (proton density, T1, T2), and soft tissue structure, providing diagnostic information when interpreted by a trained physician. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). The device is designed for use with the GE Medical Systems 3.0Tesla MRI scanner, implying it meets the performance characteristics specific to that system. |
| Safety: | 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. |
| Radio Frequency Absorption: | Coil is a receive-only coil and does not transmit RF power. |
| Formation of Resonant Loops: | Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness does not permit looping. |
| Coil Material: ABS Plastic, Polycarbonate Plastic. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). |
| Coil Design: Receive-only phased array design. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). The device is described as a multi-element phased array receive-only coil, shaped to conform to the contours of the spine, designed to maximize comfort and ease of use. |
| Decoupling: RF Chokes with Switching Diodes. | Similar to predicate devices: Premier 7000 C/T/L Spine Coil (K980157) and Magna 5000 CTL Spine Coil (K994345). |
| Compatibility: | Specifically designed for use with the GE Medical Systems 3.0Tesla MRI scanner. This implies compatibility and performance equivalence with that specific system. |
| Overall substantial equivalence to predicate devices. | The device was found by the FDA to be substantially equivalent to legally marketed predicate devices (K980157 and K994345) for the stated indications for use. This is the overarching acceptance criterion and performance demonstration. |
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with explicit performance metrics against predefined acceptance criteria. The "reported device performance" is primarily a statement of similarity to predicate devices already cleared by the FDA.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or test data in the way one would for a clinical performance study of a diagnostic algorithm or new technology. The safety and effectiveness information is presented as a comparison to predicate devices. There is no mention of a specific sample size of images or patients used for performance testing.
Therefore:
- Sample size for test set: Not applicable/not provided in this document.
- Data provenance: Not applicable/not provided in this document. The comparison is feature-based against existing cleared devices, not data-driven.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for a test set. This type of evaluation is characteristic of studies assessing the diagnostic accuracy of AI or interpretive devices, which is not the nature of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable, as no test set or ground truth establishment process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This submission is for an accessory (an RF coil) to an MRI system, not a diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not conducted or described. This device is a passive RF coil; it does not perform any algorithmic analysis or interpretation.
7. The Type of Ground Truth Used
Not applicable, as no ground truth was established for performance testing of this device. The regulatory pathway here is substantial equivalence based on physical and functional characteristics compared to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware accessory; it does not involve machine learning algorithms that require training sets.
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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JAN 2 2 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
K013595
Page 1 of 2
- Device Name :
Magnetic Resonance Imaging Accessory
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Proprietary Name :
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Classification :
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Establishment Registration #:
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Manufacture Facility Location:
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Performance Standard:
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Intended Use:
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Device Description:
Premier III Phased Array CTL Spine Coil
Class II
1529041
USA Instruments, Inc 1515 Danner Drive Aurora, Ohio 44202, USA Telephone: 330-562-1000; Fax: 330-562-1422.
No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
The Premier III Phased Array CTL Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.
The Premier III Phased Array CTL Spine 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.
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9. Safety and Effectiveness
| Premier III Phased Array CTL SpineCoil Product Features | Comparison to predicate device or other 510(k)cleared product |
|---|---|
| Intended Use: Imaging of the spine. | -Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| Indications for Use: Identical to routineMRI imaging | -Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| Coil Material:ABS PlasticPolycarbonate Plastic | -Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| Coil Design: Receive-only phased arraydesign | -Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| Decoupling: RF Chokes with SwitchingDiodes | -Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| 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 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power | -Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission. Lengthof cable and stiffnessdoes not permit looping | -Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345) |
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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 features a stylized depiction of an eagle with three lines forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Mr. Rony Thomas Vice President, Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K013595 Trade/Device Name: Premier III Phased Array CTL Spine Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 26, 2001 Received: October 30, 2001
Dear Mr. Thomas:
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 for associated in the encreased of 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 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 this 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" (21 CFR Part 807.97). 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 III Phased Array CTL Spine Coil
Indications for Use: The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier III Phased Array CTL Spine Coil is designed for use with the GE Medical Systems 3.0Tesla scanner.
Anatomic Regions: Spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The GE Medical Systems 3.0Tesla 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 | V |
|---|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use (Optional Format 1-2-96)
Nancy Brodkin
(Division Sign-Off)
OR
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.