(90 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description is for a standard MRI system and coil.
No
The device is used for imaging (diagnosis), not for treating a condition.
Yes
The intended use explicitly states "Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the brain, brain vasculature and other intracranial structures," which are diagnostic procedures used to visualize and assess medical conditions within these areas.
No
The device description explicitly states it is an MRI system and a brain coil, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- This device is an imaging system. The GE Signa Contour 0.5 T MRI system is used to create images of the inside of the body (brain, brain vasculature, etc.) while the patient is present. It does not involve the analysis of biological specimens.
The information provided clearly describes a medical imaging device used for diagnostic purposes, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the brain, brain vasculature and other intracranial structures.
Product codes
90LNH, 90MOS
Device Description
Model 340GE-21C Quadrature Brain Coil. Compatible with GE Signa Contour 0.5 T MRI systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Imaging (MRI) and Magnetic Resonance Angiography (MRA)
Anatomical Site
Brain, brain vasculature and other intracranial structures
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
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)
Not Found
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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K982978
NOY 2 3 1998
510(k) Summary of Safety and Effectiveness
| Device Name | Model 340GE-21C Quadrature Brain Coil |
|---|---|
| Applicability | Compatible with GE Signa Contour 0.5 T MRI systems |
| Reason for 510(k) | New device |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90LNH |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 340GE-21C Quadrature Brain Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | Medical Advances, Inc. |
| 10437 Innovation Drive | |
| Milwaukee, WI 53226 | |
| Point of Contact | Thomas E. Tynes |
| Vice President - Operations | |
| (414) 258-3808 Ext. 407 | |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2 weighted |
| imaging. 2D, 3D time of flight, phase contrast imaging, | |
| DWI and EPI imaging. | |
| Anatomic Regions | Brain, brain vasculature and other intracranial structures |
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Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 544 | Medical and Dental Equipment |
| UL 94 | Tests for Flammability of Plastic | |
| Materials | ||
| IEC 601-1 | General Safety Requirements for | |
| Medical Electrical Equipment |
Overview
The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The GE Signa Contour 0.5 T MRI system operated with the Medical Advances Quadrature Brain Coil is substantially equivalent to the same system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Maggetic Resonance Diagnostic Device with respect to the safety parameter action levels:
Safety Parameters
| Maximum Static Magnetic Field: | No change |
|---|---|
| Rate of Magnetic Field Strength Change: | No change |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change |
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Imaging Performance Parameters
| Specification Volume: | No change |
|---|---|
| Signal-to-Noise Ratio: | No change |
| Image Uniformity: | No change |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
General Safety and Effectiveness Concerns
The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device.
Substantial Equivalence Summary
The GE Signa Contour 0.5 T MRI system operated with the Medical Advances Quadrature Brain Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa Contour 0.5 T system safety parameter specifications.
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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 23 1998
Thomas E. Tynes Vice President-Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226
Re: K982978
Model 340GE-21C Quadrature Brain Coil Dated: August 24, 1998 Received: August 26, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Tynes:
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 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 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 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 vitn 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/cdrf/dsmadsmamain.html".
Sincerely yours,
Lillian Yih, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Model 340 Series: Quadrature Brain Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the brain, brain vasculature and other intracranial structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ehrid A. Seyenn
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De
510(k) Number K982978
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)