(23 days)
Not Found
No
The document describes a passive hardware component (an MRI coil) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a receive-only RF coil used for obtaining diagnostic images in MRI, not for treating any condition.
No
The device is a receive-only RF coil used in MRI systems for obtaining diagnostic images. It is a component that aids in the diagnostic process but is not a diagnostic device itself.
No
The device description explicitly states it is a "multi-element phased array receive only coil" with a "rigid enclosure" and "rigid plastic housing," indicating it is a hardware component for an MRI system, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain diagnostic images of various anatomical sites using Magnetic Resonance Imaging (MRI). This is an in vivo imaging technique, meaning it is performed on a living organism.
- Device Description: The description details a physical coil used in an MRI system, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on specimens outside of the body.
IVD devices are specifically designed for testing samples outside of the body to provide information about a person's health. This device is a component of an imaging system used to visualize structures inside the body.
N/A
Intended Use / Indications for Use
The 3.0T 16 Channel Brain-Spine (NV) Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar spine in Magnetic Resonance Imaging Systems. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems. The 3.0T Brain / Spine Array Coil is designed for use with the Excite 3.0T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.
Product codes
MOS
Device Description
The 3.0T 16 Channel Brain Spine () Array 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
Anatomical Site
brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed to demonstrate that the design modifications to the 3.0T Brain / Spine Array meet predetermined acceptance criteria.
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.
0
NOV - 9 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
- Magnetic Resonance Imaging Accessory 1. Device Name: 3.0T 16 Channel Brain-Spine () Array Coil 2. Proprietary Name: Class II 3. Classification: 4. Establishment Registration #: 1529041 USA Instruments, Inc. 5. Manufacture Facility Location: 1515 Danner Drive Aurora, Ohio 44202, USA Telephone: 330-562-1000; Fax: 330-562-1422. No applicable performance standards have been issued under 6. Performance Standard: Section 514 of the Food, Drug and Cosmetic Act. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is a receive-7. Intended Use: only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest, thorasic and lumbar spine in Magnetic Resonance Imaging Systems. The 3.0T 16 Channel Brain-Spine (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems. The 3.0T 16 Channel Brain Spine () Array Coil is a multi-8. Device Description: 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. 3.0T Brain / Spine Array 9. Marketed Device: The 3.0T Brain / Spine Array is a modification of the existing 10. Comparison with Predicate: cleared USA Instruments 3.OT 8 Channel Neurovascular Array coil (K032618) with the main difference being the physically integration of the antenna and shape of the Premier III Linear Phased Array CTL Spine Coil with the antenna and shape of the Millennium 9000 Phase Array Neurovascular coil. The integration increases the number of receive channels to 16 to make it compatible with the GE Healthcare Signa Excite 3.0T Magnetic Resonance Scanners. Both coils included spine
1
imaging in their indications, but this modification improves user workflow by allowing more comprehensive patient coverage with a single coil.
- Summary of Studies:
Testing was performed to demonstrate that the design modifications to the 3.0T Brain / Spine Array meet predetermined acceptance criteria.
Conclusion:
It is the opinion of USA Instruments that the 3.07 Brain / Spine Array is substantially equivalent to the USA Instruments 3.0T 8 Channel Neurovascular Array coil (K032618) Usage of the USA Instruments 3.0T Brain / Spine Array does not result in any new potential hazards.
2
Public Health Service
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert B. Smith Quality Assurance/ Regulatory Affairs Manager USA Instruments 1515 Danner Drive AURORA OH 44202
K052916 Re.:
Trade/Device Name: 3.0T 16 Channel Brain-Spine (Neurovascular) Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 12, 2005 Received: October 17, 2005
Dear Mr. Smith:
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 registrations, 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advices 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 he Act or any Federal statues 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.
NOV - 9 2005
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to begin manteling of substantial equivalence of your device to a legally premaired noutication: "The PDF maing of sailing or 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 If you desire spective advice for your derroo on the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entires on your responsibilities under the Act from the 807.97). Tou may obtain other general massage.
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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INTENDED USE
510(k) Number (if known):
3.0 T 16-Channel Brain-Spine (Neurovascular) Array Coil Device Name:
Indications for Use
The 3.0T Brain / Spine Array Coil is designed for use with the Excite 3.0T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen.
(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
Nancy C. Horton