(72 days)
No
The document describes a passive RF coil for MRI, which is a hardware component for signal reception. 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, which aids in diagnosis rather than directly treating a condition.
Yes
The device is used to obtain "diagnostic images" and the resulting 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 "twelve element receive only phased array coil" with "coil elements and accessory electronics enclosed in a rigid 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 9000 8 Channel 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 samples taken from the body.
- Intended Use: The intended use is to obtain diagnostic images of the spine using MRI. This is an in vivo (within the living body) imaging technique, not an in vitro diagnostic test.
The device is a medical device used for diagnostic imaging, but it falls under the category of imaging equipment accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Premier 9000 8 Channel Phased Array CTL Spine Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier 9000 8 Channel Phased Array CTL Spine Coil is designed for use with the Excite 1.5T MRI system manufactured by GE Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T 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 1.5T 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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Premier 9000 8 Channel 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging Systems
Anatomical Site
cervical, thoracic, and lumbar regions of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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.
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.
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Ko3 1366
JUL 1 1 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Premier 9000 8 Channel 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 Premier 9000 8 Channel Phased Array CTL |
| Spine Coil is a receive- only phased array RF coil, | |
| used for obtaining diagnostic images of the cervical, | |
| thoracic, and lumbar regions of the spine in | |
| Magnetic Resonance Imaging Systems. The | |
| Premier 9000 8 Channel Phased Array CTL Spine | |
| Coil is designed for use with the Excite 1.5T MRI | |
| system manufactured by GE Medical Systems, Inc. | |
| The indications for use are the same as for standard | |
| MR Imaging. | |
| 8. Device Description: | The Premier 9000 8 Channel 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. |
Please turn over
1
9. Safety and Effectiveness
| Premier III 8 Channel 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 CTL
Spine Coil manufactured by USA Instruments,
Inc. (K980157) |
| Indications for Use:
Identical to routine MRI imaging | -Similar to the Premier 7000 Phased Array CTL
Spine Coil manufactured by USA Instruments,
Inc. (K980157) |
| Coil Material:
Flame Retardant Kydex
Flame Retardant PVC
Flame Retardant Polyurethane | -Similar to the Hi-Res 9000 Carotid Coil,
manufactured by USA Instruments, Inc.
(K001210). |
| Coil Design:
Receive-only phased array design | -Similar to the Premier 7000 Phased Array CTL
Spine Coil manufactured by USA Instruments,
Inc. (K980157) |
| Decoupling:
Switching diode decoupling. | -Similar to the Premier 7000 Phased Array CTL
Spine Coil manufactured 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 CTL
Spine Coil manufactured 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 CTL
Spine Coil manufactured 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 CTL
Spine Coil manufactured by USA Instruments,
Inc. (K980157) |
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like lines extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2003
Ms. Christie Shumaker Manager, QA and Regulatory USA Instuments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K031366
Trade/Device Name: Premier 9000 8 Channel Phased Array CTI Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: April 28, 2003 Received: May 5, 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 i 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.
3
Page 2
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
. ඇ
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Premier 9000 8 Channel Phased Array CTL Coil
Indications for Use: The Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T 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 1.5T 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)
Prescription Use
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031366
OR