(78 days)
Not Found
Not Found
No
The summary describes a physical coil for MRI and does not mention any software or processing capabilities that would suggest AI/ML.
No
Explanation: The device is described as a "receive only coil" for "2D and 3D Magnetic Resonance imaging." Its purpose is to acquire images, not to provide therapy or directly treat a disease or condition. The performance studies focus on imaging standards and comparability to other imaging coils.
No
The device is described as a "receive only coil" used for 2D and 3D Magnetic Resonance imaging. It is a component used in imaging, not a device that directly diagnoses conditions itself. Its purpose is to acquire image data, which can then be interpreted for diagnostic purposes by a clinician.
No
The device description explicitly states it is a "Cardiac Phased Array Coil," which is a hardware component used in MRI. The performance studies also refer to evaluating a physical coil.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "2D and 3D Magnetic Resonance imaging" of the heart and mediastinum. This describes an imaging device used in vivo (within the living body) to acquire images.
- Device Description: The description of a "receive only coil" for MRI further supports its role in image acquisition from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to examine samples outside the body to detect diseases, conditions, or infections.
Therefore, this device is an imaging accessory used in conjunction with an MRI system for acquiring images of the heart and mediastinum, not an IVD.
N/A
Intended Use / Indications for Use
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.
Product codes
90 MOS
Device Description
The Cardlac Phased Array Coil is a receive only coil with two separate coils matched with a front and a back (anterior and posterior) section.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance
Anatomical Site
heart and mediastinum regions
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
The Cardiac Phased Array Coil was evaluated to NEMA performance standard MS#6 for Special Purpose Coils as well as the IEC 601-1 International medical equipment safety standard. The Coil is comparable to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
ScanMed Cardiac/Vascular Coil, GE Pelvic Phased Array Coil
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
GE Medical Systems
P.O. Box 414. W-709 Milwaukee, WI 53201 USA
July 23, 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
- This 510(k) summary of safety and effectiveness information is submitted in o accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, April 29, 1997
- o Identification of the Product Cardiac Phased Array Coil
Manufacturer Address:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, Wi 53188
- o Marketed Device The Cardiac Phased Array Coil is substantially equivalent to the currently marketed ScanMed Cardiac/Vascular Coil and the GE Pelvic Phased Array Coil.
- 0 Device Description The Cardlac Phased Array Coil is a receive only coil with two separate coils matched with a front and a back (anterior and posterior) section.
- 0 Indications for Use It is intended to be used in the heart and mediastinum regions for 2D and 3D imaging.
- o Comparison with Predicate
The Cardiac Phased Array Coll is similar in construction to the both predicate devices. The circuitry on the Cardiac Phased Array Coil is similar to the circuitry of the GE Pelvic Phased Array Coil.
-
o Summary of Studies
The Cardiac Phased Array Coil was evaluated to NEMA performance standard MS#6 for Special Purpose Coils as well as the IEC 601-1 International medical equipment safety standard. The Coil is comparable to the predicate devices. -
0 Conclusions
It is the opinion of GE that the Cardiac Phased Array Coil is substantially equivalent to the ScanMed CardiacVascular Coll and the GE Pelvic Phased Array Coil. The use of this Coil does not result in any new potential hazards.
$\mathscr{H}$
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Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 1997
Larry A. Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201
Re: K971667
Cardiac Phased Array Surface Coil Dated: April 29, 1997 Received: May 6, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Dr. Kroger:
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 sgainst misbranding and adulteration.
If your device is classified (see above) into either class II (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 requirement, 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 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 market 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 yim 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/cdrh/dsmamain html".
Sincerely yours,
h. Niau Yu
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
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510(k) Number (if known): _ K 97 1467
Device Name: Cardiac Phased Array Coil
Indications For Use:
ﺎ ﺍﻟﻤﺠﺎ
It is intended to be used in the heart and mediastinum regions for 2D and 3D .. . . . . . . Magnetic Resonance imaging
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Grayson
(Division Sign-Off) (Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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