(87 days)
No
The document describes a passive RF coil for MRI, which is a hardware component and does not inherently incorporate AI/ML for image processing or analysis. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for obtaining diagnostic images and aiding in diagnosis, not for treatment or therapy.
Yes
The device obtains "diagnostic images of the spine region" and these images, when "interpreted by a trained physician, ... yield information that can be useful in the determination of a diagnosis."
No
The device description explicitly states it is a "multi-element phased array receive-only coil" with physical components like elements, circuitry, and a plastic housing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Premier 7000 Phased Array CTL Spine Coil is an accessory for an MRI system. Its function is to receive radiofrequency signals from the body during an MRI scan to produce images. It does not analyze biological samples.
- Intended Use: The intended use is to obtain diagnostic images of the spine region using Magnetic Resonance Imaging. This is an in-vivo imaging technique, not an in-vitro diagnostic test.
Therefore, the Premier 7000 Phased Array CTL Spine Coil is a medical device used for diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Premier Phased Array CTL Spine Coil is a receiveonly 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 7000 Phased Array CTL Spine Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems.
The Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner. Anatomic Regions: Spine Nuclei Excited: Hydrogen. The indications for use are the same as for standard imaging: The Signa 1.5T 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 (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Premier 7000 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 an removable anterior section for imaging the anterior cervical region. The elements and associated circuitry are enclosed in a housing made of plastic materials which are fire rate 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), Head and whole body
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K964531, K971246, K962677, K972826, K944469, K972340
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
APR 1 3 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Magnetic Resonance Imaging Accessory 1. Device Name : Premier 7000 Phased Array CTL Spine Coil 2. Proprietary Name : Class II 3. Classification : 1529041 4. Establishment Registration #: USA Instruments, Inc., 675-B Alpha Drive, 5. Manufacture Facility Location: Highland Heights, Ohio 44143, USA Telephone: 216-442-5920; Fax: 216-442-5919. No applicable performance standards have been issued 6. Performance Standard: under Section 514 of the Food, Drug and Cosmetic Act. 7. Intended Use: The Premier Phased Array CTL Spine Coil is a receiveonly 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 7000 Phased Array CTL Spine Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems. 8. Device Description: The Premier 7000 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 an removable anterior section for imaging the anterior cervical region. The elements and associated circuitry are enclosed in a housing made of plastic materials which are fire rate and have high impact and tensile strength.
please turn over
1
9. Safety and Effectiveness
| Parameter | Premier 7000 Phased Array
Spine Coil | Same as Predicate Device |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Intended Use | Imaging of the spine. | Phased Array C/T/L Spine Coil, Edge MRI System
Picker International
(K932693) |
| | | Magnetic Resonance Diagnostic Accessory (CTL Phased Array
Spine Coil)
GE (General Electric)
(K911806) |
| Indications for Use | Identical to routine MRI
imaging | Phased Array C/T/L Spine Coil, Edge MRI System
Picker International
(K932693) |
| | | Magnetic Resonance Diagnostic Accessory (CTL Phased Array
Spine Coil)
GE (General Electric)
(K911806) |
| Coil Material | ABS/PVC Plastic alloy, | Profile 7000 Volume Neck Coil, USA Instruments
(K964531) |
| | Polyurethane Plastic | Leo 7000 Quadrature Knee Coil, USA Instruments
(K971246) |
| | Glass fiber reinforced polyester
(Flame retardant Fiberglass) | Head Coil for 1.5T Esteem MRI system, Elscint MR
(K962677 and K972826) |
| | Naughahyde (fabric material) | General Purpose Flex Coil, Picker International
(K944469) |
| Coil Design | Receive-only phased array design | Insight 7000 Phased Array Torso Coil, USA Instruments
(K972340) |
| | | Phased Array C/T/L Spine Coil, Edge MRI System
Picker International
(K932693) |
| Decoupling | RF Chokes with Switching Diodes | Insight 7000 Phased Array Torso Coil, USA Instruments
(K972340) |
| 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. | Insight 7000 Phased Array Torso Coil, USA Instruments
(K972340) |
| Radio Frequency
Absorption | Coil is a receive only coil and does
not transmit RF power | Insight 7000 Phased Array Torso Coil, USA Instruments
(K972340) |
| Formation of Resonant
Loops | Decoupling isolates coil elements
from RF fields during RF
transmission.
Length of cable and stiffness
does not permit looping | Insight 7000 Phased Array Torso Coil, USA Instruments
(K972340) |
2
Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three abstract human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1998
Rony Thomas Regulatory Affairs Manager USA Instruments, Inc. 675-B Alpha Dr. Highland Heights, Ohio 44143 Re:
Premier 7000 Phased Array CTL Spine Coil Dated: December 30, 1997 Received: January 16, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Thomas:
We have reviewed your Section 510%) notification of intent to market the device referenced above and we have desembled the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 Resulations, 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 (OS) 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 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 510ks) 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 80) 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 Magnifacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known):
Device Name: Premier 7000 Phased Array Spine Coil
Indications for Use: The Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner.
Anatomic Regions: Spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T 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) | |||
| Division of | Digestive, Gastrointestinal, ENT, and Radiological Devices | ||
| 510(k) Number | K980157 | ||
| Prescription Use | |||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
| (Optional Format 1-2-96) |