(53 days)
Not Found
No
The summary describes a passive RF coil for MRI, which is a hardware component for signal acquisition. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No.
The device is used for obtaining diagnostic images and yields information for diagnosis, not for therapy.
No
The device is a component (a receive-only coil) of a Magnetic Resonance Imaging System, which is used for obtaining diagnostic images. The images themselves, when interpreted by a trained physician, yield information useful for diagnosis, but the coil itself is not the diagnostic device.
No
The device description explicitly states it is a "multi-element phased array receive-only coil" with physical components like "elements and associated circuitry are enclosed in a housing made of plastic materials." This indicates a hardware device, not software only.
Based on the provided information, the Magna 5000 Phased Array CTL Spine Coil is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Magna 5000 Phased Array CTL Spine Coil is a component of an MRI system used to obtain images directly from the patient's body.
- The intended use is for obtaining diagnostic images of the spine. This is a form of in vivo imaging, not in vitro testing of biological samples.
- The device description details a physical coil used in conjunction with an MRI scanner. This aligns with the nature of an imaging accessory, not a device for analyzing biological specimens.
Therefore, the Magna 5000 Phased Array CTL Spine Coil is an accessory for a medical imaging system, specifically an MRI scanner, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
90 MOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging Systems
Anatomical Site
spine region (cervical, thoracic and lumbar anatomy)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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, Inc |
| 1515 Danner Drive | |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-562-1000; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been issued |
| under Section 514 of the Food, Drug and Cosmetic Act. | |
| 7. Intended Use: | 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. | |
| 8. Device Description: | 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. |
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K994345
Page 2 of 2
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9. Safety and Effectiveness
| Magna 5000 Phased Array CTL Spine Coil
Product Features | Comparison to predicate device or other
510(k) cleared product |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the spine. | -Similar to the Premier 7000 Phased Array
C/T/L Spine Coil manufacture by USA
Instruments, Inc. (K980157) |
| Indications for Use: Identical to routine MRI
imaging | -Similar to the Premier 7000 Phased Array
C/T/L Spine Coil manufacture by USA
Instruments, Inc. (K980157) |
| Coil Material: 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 manufacture by USA
Instruments, Inc. (K980157) |
| Coil Design: Receive-only phased array design | -Similar to the Premier 7000 Phased Array
C/T/L Spine Coil manufacture by USA
Instruments, Inc. (K980157) |
| Decoupling: RF Chokes with Switching
Diodes | -Similar to the Premier 7000 Phased Array
C/T/L Spine Coil manufacture by USA
Instruments, Inc. (K980157) |
| Prevention of RF Burns: Does not transmit
RF Power, Decoupling isolates the 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 manufacture by USA
Instruments, Inc. (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 manufacture by USA
Instruments, Inc. (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 manufacture by USA
Instruments, Inc. (K980157) |
:
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2
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
3
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