(53 days)
The Magna 5000 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 Magna 5000 Phased Array CTL Spine Coil is designed for use with the Signa HFO/i 0.7T MRI scanner manufactured by GE Medical Systems.
The Magna 5000 Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Magna 5000 Phased Array CTL Spine Coil is designed for use with the GE Signa HFO/i 0.7T scanner.
The GE Signa HFO/i 0.7T 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 Magna 5000 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 a removable anterior section for imaging the anterior cervical region. The coil also has three bridges consisting of coil elements for enhanced imaging of the thoracic and lumbar spine. 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.
The provided text describes a 510(k) premarket notification for a medical device (Magna 5000 Phased Array CTL Spine Coil). However, it does not include detailed information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies typically associated with AI/algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Premier 7000 Phased Array C/T/L Spine Coil) based on intended use, indications for use, coil material, coil design, safety features (decoupling, RF burn prevention, RF absorption, prevention of resonant loops). This type of submission relies on the established safety and effectiveness of the predicate device.
Therefore, many of the requested details about acceptance criteria and a study to prove they are met are not present in this regulatory submission.
Here's a breakdown of what can be extracted and what is explicitly missing based on the provided text:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission for a passive medical device (a coil for an MRI machine), the "acceptance criteria" and "device performance" are framed in terms of similarity to a predicate device and adherence to basic safety principles, rather than quantitative performance metrics like sensitivity, specificity, or accuracy (which would be common for AI algorithms or diagnostic tests).
| Acceptance Criteria (inferred from comparison to predicate) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use: Imaging of the spine. | - Similar to the Premier 7000 Phased Array C/T/L Spine Coil (K980157).- Designed for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. |
| Indications for Use: Identical to routine MRI imaging. | - Similar to the Premier 7000 Phased Array C/T/L Spine Coil (K980157).- Same as for standard MRI imaging. (General indications for GE Signa HFO/i 0.7T system provided, including displaying soft tissue structure and aiding diagnosis when interpreted by a trained physician). |
| Coil Material: (Specified materials) | - ABS/PVC Plastic alloy, Polyurethane Plastic, Glass fiber reinforced polyester (Flame retardant Fiberglass), Naughahyde (fabric material).- Similar to the Premier 7000 Phased Array C/T/L Spine Coil (K980157). |
| Coil Design: Receive-only phased array design. | - Multi-element phased array receive-only coil, shaped to conform to spine contours, removable anterior section, three bridges with coil elements for enhanced imaging.- Similar to the Premier 7000 Phased Array C/T/L Spine Coil (K980157). |
| Decoupling: RF Chokes with Switching Diodes. | - RF Chokes with Switching Diodes.- Decoupling isolates the coil elements from RF fields during RF transmission.- Similar to the Premier 7000 Phased Array C/T/L Spine Coil (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 the Premier 7000 Phased Array C/T/L 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 C/T/L 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 C/T/L Spine Coil (K980157). |
| Compatibility: | - Designed for use with the Signa HFO/i 0.7T MRI scanner manufactured by GE Medical Systems.- Intended for use as an NMR device that produces images corresponding to proton distribution, depending on NMR parameters, and displaying soft tissue structure. (This is for the scanner, with the coil being compatible). |
Missing Information (Not Present in the Provided Document)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable/Not mentioned. This document describes a physical MRI coil, not an algorithmic device tested on patient data in the typical sense for AI. The "test" here is largely engineering-focused (safety features, material properties, design comparison) rather than clinical performance on a dataset.
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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/Not mentioned. Ground truth as typically defined for diagnostic image analysis (e.g., confirmed disease status) is not a component of this submission. The "truth" is based on engineering specifications and comparison to the predicate device.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
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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:
- No. This is a passive MRI coil, not an AI-enabled device requiring a multi-reader study of diagnostic interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not mentioned in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission revolves around the engineering design, materials, and safety profile meeting established standards and being equivalent to a predicate device.
-
The sample size for the training set:
- Not applicable/Not mentioned. This is not an AI device.
-
How the ground truth for the training set was established:
- Not applicable/Not mentioned. This is not an AI device.
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K994345
Page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Magna 5000 Phased Array CTL Spine 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 been issuedunder Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The Magna 5000 Phased Array CTL Spine Coil is areceive-only phased array RF coil, used for obtainingdiagnostic images of the spine region (cervical, thoracicand lumbar anatomy) in Magnetic Resonance ImagingSystems. The indications for use are the same as forstandard MR Imaging. The Magna 5000 Phased ArrayCTL Spine Coil is designed for use with the Signa HFO/i0.7T MRI scanner manufactured by GE Medical Systems. |
| 8. Device Description: | The Magna 5000 Phased Array CTL Spine Coil is amulti-element phased array receive-only coil. The coil isshaped to conform to the contours of the spine and has aremovable anterior section for imaging the anteriorcervical region. The coil also has three bridges consistingof coil elements for enhanced imaging of the thoracic andlumbar spine. The elements and associated circuitry areenclosed in a housing made of plastic materials, which arefire rated and have high impact and tensile strength. |
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K994345
Page 2 of 2
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9. Safety and Effectiveness
| Magna 5000 Phased Array CTL Spine CoilProduct 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 manufacture by USAInstruments, Inc. (K980157) |
| Indications for Use: Identical to routine MRIimaging | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufacture by USAInstruments, Inc. (K980157) |
| Coil Material: ABS/PVC Plastic alloy,Polyurethane Plastic, Glass fiber reinforcedpolyester (Flame retardant Fiberglass),Naughahyde (fabric material) | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufacture by USAInstruments, Inc. (K980157) |
| Coil Design: Receive-only phased array design | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufacture by USAInstruments, Inc. (K980157) |
| Decoupling: RF Chokes with SwitchingDiodes | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufacture by USAInstruments, Inc. (K980157) |
| Prevention of RF Burns: Does not transmitRF Power, Decoupling isolates the coilelements from RF fields during RFtransmission, Coil elements and circuitry areenclosed in a non-conductive housing. | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufacture by USAInstruments, Inc. (K980157) |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmit RFpower | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufacture by USAInstruments, Inc. (K980157) |
| Formation of Resonant Loops: Decouplingisolates coil elements from RF fields during RFtransmission. Length of cable and stiffnessdoes not permit looping | -Similar to the Premier 7000 Phased ArrayC/T/L Spine Coil manufacture by USAInstruments, Inc. (K980157) |
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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 consists of a stylized depiction of three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2000
Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive Aurora. Ohio 44202
Re:
Magna 5000 Phased Array CTL Spine Coil Dated: December 22, 1999 Received: December 23, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Thomas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 vour device is classified (see above) into either class II (Special Controls) or dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Capt. Daniel G. Schultz, M.D.
Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K994345 510(k) Number (if known):
Device Name: Magna 5000 Phased Array CTL Spine Coil
Indications for Use: The Magna 5000 Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Magna 5000 Phased Array CTL Spine Coil is designed for use with the GE Signa HFO/i 0.7T scanner.
Anatomic Regions: Spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The GE Signa HFO/i 0.7T 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)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K994345
§ 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.