(35 days)
Not Found
No
The summary describes a passive receive-only coil for MRI, with no mention of any software or processing capabilities that would incorporate AI/ML. The device description focuses on the physical characteristics and intended use for image acquisition, not analysis or interpretation.
No
The device is designed to provide Magnetic Resonance Images for diagnostic purposes, not to treat a condition.
No
The device is a coil for an MRI system, which produces images. The MRI system itself is indicated for use as an NMR device that produces images that, when interpreted by a trained physician, yield information useful in determining a diagnosis. The coil is a component of that system, not a diagnostic device on its own.
No
The device description clearly states it is a "multi-element phased array receive only coil" with a "rigid enclosure" and "rigid plastic housing," indicating it is a physical hardware component used in an MRI system.
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 III Linear Phased Array CTL Coil is a component of an MRI system. Its function is to receive magnetic resonance signals from the patient's body to create images. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for providing Magnetic Resonance Images of the spine for diagnostic purposes when interpreted by a trained physician. This is an in vivo (within the living body) imaging process, not an in vitro diagnostic test.
Therefore, the device described is an imaging coil for an MRI system, which 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 III Linear CTL Spine Coil is a receive only RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier III Linear CTL Spine Coil is designed for use with the Signa 3.0T MRI system manufactured by GE Medical Systems. The indications for use are the same as for standard MR Imaging.
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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
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.
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
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.
Not Found
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
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 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 III Linear CTL Spine Coil is a receive |
| only RF coil, used for obtaining diagnostic images of | |
| the cervical, thoracic, and lumbar regions of the | |
| spine in Magnetic Resonance Imaging Systems. The | |
| Premier III Linear CTL Spine Coil is designed for use | |
| with the Signa 3.0T MRI system manufactured by | |
| GE Medical Systems. The indications for use are the | |
| same 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 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. |
Please turn over
:
1
9. Safety and Effectiveness
.
| Premier III Phased Array CTL Spine
Coil Product Features | Comparison to predicate device or other 510(k)
cleared products |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Imaging of the cervical,
thoracic, and lumbar regions of the
spine. | -Similar to the Premier III CTL Spine Coil
manufactured by USA Instruments, Inc. (K013595) |
| Indications for Use: Identical to routine
MRI imaging. | -Similar to the Premier III CTL Spine Coil
manufactured by USA Instruments, Inc. (K013595) |
| Coil Enclosure Material:
Flame Retardant ABS Plastic
Flame Retardant Polycarbonate
Flame Retardant Kydex | -Similar to the Premier III CTL Spine Coil
manufactured by USA Instruments, Inc. (K013595)
- Similar to the Hi-Res 9000 Phased Array Carotid
Coil manufactured by USA Instruments, Inc.
(K001210) |
| Coil Design: receive only linear coil. | -Similar to the Premier 7000 Phased Array C/T/L
Spine Coil manufactured by USA Instruments, Inc.
(K980157) |
| Decoupling: RF chokes with Switching
Diodes | -Similar to the Premier III CTL Spine Coil
manufactured by USA Instruments, Inc. (K013595) |
| Prevention of RF Burns: Does not
transmit RF Power, Decoupling isolates
the coil elements from RF fields during
RF transmission, and Coil elements and
circuitry are enclosed in a non-
conductive housing. | -Similar to the Premier III CTL Spine Coil
manufactured by USA Instruments, Inc. (K013595) |
| Radio Frequency Absorption: Coil is
a receive only coil and does not
transmit RF power | -Similar to the Premier III CTL Spine Coil
manufactured by USA Instruments, Inc. (K013595) |
| Formation of Resonant Loop: Active
diodes and fast RF blowing fuses
isolate the coil elements from RF fields;
length of cable and stiffness does not
permit looping | -Similar to the Premier III CTL Spine Coil
manufactured by USA Instruments, Inc. (K013595) |
·
.
2
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.
3
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
4
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