(35 days)
The Premier III Linear Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier III Linear Phased Array CTL Coil is designed for use with the GE Signa 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 defermination of a diagnosis.
The Premier III Linear CTL Spine Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. 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, specifically a Magnetic Resonance Imaging accessory (Premier III Linear Phased Array CTL Spine Coil). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner you've requested.
Therefore, the information required to build the table and answer the study-related questions (sample size, experts, adjudication, MRMC, standalone, ground truth type and training set details) is not present in the provided text. The document is a regulatory submission for a device component, emphasizing its similarity in design and function to previously cleared devices. It does not contain clinical study data or performance metrics in the way a diagnostic AI device submission would.
Here's a breakdown of what could be extracted if such data were present, and why it's missing in this case:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable/Not provided. The document doesn't define specific performance acceptance criteria (e.g., sensitivity, specificity, image quality metrics) for the coil itself. Instead, it relies on demonstrating that the new coil's design and features are "similar to" or "identical to" predicate devices, implying that if the predicate devices meet performance standards (which they are presumed to as legally marketed devices), then this new device, being substantially equivalent, also implicitly meets those standards for its intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. There is no mention of a test set or any performance study involving patient data. This is a device component.
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 provided. No study or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided. No test set or adjudication process 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 document is for an MRI coil, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided. No ground truth establishment is described.
8. The sample size for the training set
Not provided. No training set is mentioned as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not provided. No training set or ground truth establishment is described.
In summary: The provided document is a 510(k) premarket notification for an MRI coil, which focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain the kind of performance study data (acceptance criteria, test/training sets, expert adjudication, etc.) that would typically be found in a submission for a diagnostic algorithm or a device requiring new clinical performance studies.
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MAY - 8 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
Ka3/056
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Premier III Linear 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 Linear CTL Spine Coil is a receiveonly RF coil, used for obtaining diagnostic images ofthe cervical, thoracic, and lumbar regions of thespine in Magnetic Resonance Imaging Systems. ThePremier III Linear CTL Spine Coil is designed for usewith the Signa 3.0T MRI system manufactured byGE Medical Systems. The indications for use are thesame as for standard MR Imaging. |
| 8. Device Description: | The Premier III Linear CTL Spine Coil is a multi-element phased array receive only coil. The coil hasa rigid enclosure. The open, patient friendly designeases patient handling and positioning andmaximizes patient comfort. The coil elements andaccessory electronics are enclosed in a rigid plastichousing, which is fire rated and has a high impactand tensile strength. |
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9. Safety and Effectiveness
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| Premier III Phased Array CTL SpineCoil Product Features | Comparison to predicate device or other 510(k)cleared products |
|---|---|
| Intended Use: Imaging of the cervical,thoracic, and lumbar regions of thespine. | -Similar to the Premier III CTL Spine Coilmanufactured by USA Instruments, Inc. (K013595) |
| Indications for Use: Identical to routineMRI imaging. | -Similar to the Premier III CTL Spine Coilmanufactured by USA Instruments, Inc. (K013595) |
| Coil Enclosure Material:Flame Retardant ABS PlasticFlame Retardant PolycarbonateFlame Retardant Kydex | -Similar to the Premier III CTL Spine Coilmanufactured by USA Instruments, Inc. (K013595)- Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments, Inc.(K001210) |
| Coil Design: receive only linear coil. | -Similar to the Premier 7000 Phased Array C/T/LSpine Coil manufactured by USA Instruments, Inc.(K980157) |
| Decoupling: RF chokes with SwitchingDiodes | -Similar to the Premier III CTL Spine Coilmanufactured by USA Instruments, Inc. (K013595) |
| Prevention of RF Burns: Does nottransmit RF Power, Decoupling isolatesthe coil elements from RF fields duringRF transmission, and Coil elements andcircuitry are enclosed in a non-conductive housing. | -Similar to the Premier III CTL Spine Coilmanufactured by USA Instruments, Inc. (K013595) |
| Radio Frequency Absorption: Coil isa receive only coil and does nottransmit RF power | -Similar to the Premier III CTL Spine Coilmanufactured by USA Instruments, Inc. (K013595) |
| Formation of Resonant Loop: Activediodes and fast RF blowing fusesisolate the coil elements from RF fields;length of cable and stiffness does notpermit looping | -Similar to the Premier III CTL Spine Coilmanufactured by USA Instruments, Inc. (K013595) |
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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 features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christie Shumaker Manager. OA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
MAY - 8 2003
Re: K031056 Trade/Device Name: Premier III Linear Phased Array CTL Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 2, 2003 Received: April 3, 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. Iisting 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.
Sincerelv vours.
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): کی ص ر 3 / کی ک
Device Name: Premier III Linear Phased Array CTL Coil
Indications for Use: The Premier III Linear Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier III Linear Phased Array CTL Coil is designed for use with the GE Signa 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 defermination 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. Lepson
Orvision of Reproductive. and Radiological Device 510(k) Numbe
§ 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.