(49 days)
The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Siemens 3.0T Magnetom Trio MR scanner manufactured by Siemens Medical Solutions, 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 Premier III 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.
The provided text is a 510(k) premarket notification for a medical device: the Premier III Phased Array CTL Spine Coil. This document establishes substantial equivalence to a predicate device, not through a clinical performance study with acceptance criteria, but by demonstrating that its technical characteristics and intended use are similar to a previously cleared device.
Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert involvement, ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document focuses on comparing the new device's features to a predicate device to prove it is equally safe and effective.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as performance metrics in the way one might expect for a diagnostic algorithm. For a device like an MRI coil, "acceptance criteria" are typically related to meeting established engineering and safety standards, and demonstrating performance comparable to a predicate device. The primary "performance" here is its ability to produce diagnostic images.
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Reported Device Performance:
- Intended Use: Imaging of the spine.
- Indications for Use: Identical to routine MRI imaging (same as standard MR Imaging).
- Coil Design: Receive-only phased array design, twelve elements.
- Safety Features: Switching diode decoupling, additional RF fuses, enclosed in a non-conductive housing, does not transmit RF power, decoupling isolates elements during RF transmission, cable length/stiffness prevents looping.
- Compatibility: Designed for use with the Magnetom Trio 3.0T MRI system (Siemens Medical Solutions, Inc.).
The document asserts that these features are "Similar to the Premier 7000 Phased Array C/T/L Spine Coil manufactured by USA Instruments, Inc. (K980157)." This "similarity" is the core of its demonstrated performance and safety for regulatory purposes, implying it performs equivalently to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) notification does not describe a clinical performance study with a test set of patient data. The evaluation is based on technical comparisons to a predicate device.
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. No test set or ground truth established by experts is described in this document for the purpose of a clinical performance evaluation.
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, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth for a clinical performance study is described. The "ground truth" for regulatory clearance is the established safety and effectiveness of the predicate device (Premier 7000 Phased Array C/T/L Spine Coil).
8. The sample size for the training set
- Not Applicable. There is no mention of a training set as this is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
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KO300 42
FEB 2 4 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Premier III Phased Array CTL Spine Coil |
| 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 III Phased Array CTL Spine Coil is areceive- only phased array RF coil, used forobtaining diagnostic images of the cervical, thoracic,and lumbar regions of the spine in MagneticResonance Imaging Systems. The Premier IIIPhased Array CTL Spine Coil is designed for usewith the Magnetom Trio 3.0T MRI systemmanufactured by Siemens Medical Solutions, Inc.The indications for use are the same as for standardMR Imaging. |
| 8. Device Description: | The Premier III Phased Array CTL Spine Coil is atwelve element receive only phased array coil. Thecoil is shaped to conform to the contours of thespine and has been designed to maximize comfortand ease of use. The coil elements and accessoryelectronics are enclosed in a rigid plastic housing,which is fire rated and has a high impact and tensilestrength. |
Please turn over
USA Instruments, Inc.
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9. Safety and Effectiveness
| Premier III Phased Array CTL SpineCoil Product Features | Comparison to predicate device or other510(k) cleared product |
|---|---|
| Intended Use:Imaging of the spine. | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufactured by USAInstruments, Inc. (K980157) |
| Indications for Use:Identical to routine MRI imaging | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufactured by USAInstruments, Inc. (K980157) |
| Coil Material:Rovalite ABS PlasticPolycarbonate PlasticFlame Retardant Polyurethane | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Coil Design:Receive-only phased array design | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufactured by USAInstruments, Inc. (K980157) |
| Decoupling:Switching diode decoupling.Additional RF fuses incorporated. | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufactured by USAInstruments, 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 ArravC/T/L Spine Coil manufactured by USAInstruments, Inc. (K980157) |
| Radio Frequency Absorption:Coil is a receive only coil and does nottransmit RF power | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufactured by USAInstruments, 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 ArrayC/T/L Spine Coil manufactured by USAInstruments, Inc. (K980157) |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head with three profiles overlapping each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle's head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2003
Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K030042 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: January 3, 2003 Received: January 6, 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 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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Page 1 of 1
510(k) Number (if known): K030042
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 cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Siemens 3.0T Magnetom Trio MR scanner manufactured by Siemens Medical Solutions, Inc.
Anatomic Regions: cervical, thoracic, and lumbar regions of the spine. Nuclei Excited: Hvdrogen
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)
(Division Sign-Off 4
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030042
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.