(25 days)
No
The description focuses on hardware modifications (increased channels, integrated preamplifiers, optimized geometry) and does not mention any software or algorithmic components related to AI or ML.
No
The device is described as an imaging coil for Magnetic Resonance imaging, which is used for diagnostic purposes (imaging) rather than for treating a disease or condition.
No
The device is described as an 8 Channel Cardiac Phased Array Coil for 2D and 3D Magnetic Resonance imaging of the heart and mediastinum. Its purpose is to acquire images, not to interpret them or provide a diagnosis. The "Intended Use" explicitly states it's for "imaging", which is a modality for data acquisition rather than diagnosis.
No
The device description clearly states it is a "Cardiac Phased Array Coil," which is a hardware component used in MRI systems. It describes physical modifications like increasing the number of channels and integrating preamplifiers.
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 on the patient, not a device used to test samples from the patient (which is the core function of an IVD).
- Device Description: The description details a "Cardiac Phased Array Coil" which is a component used in an MRI system to acquire images. This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
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 8 Channel Cardiac Phased Array Coil is a modification to the Cardiac Phased Array Coil (K971667), which utilizes an increase in the number of independent receive channels from four to eight, integrates preamplifiers, and utilizes ASSET optimized geometry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance imaging
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
Testing was performed to demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria.
Key Metrics
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.
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6 2002 SEP
Page 1 of 2
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Manager, Regulatory Programs |
| Telephone: | 262-544-3894 |
| Fax: | 262-548-4768 |
| Date Prepared: | August 7, 2002 |
Device Name:
8 Channel Cardiac Phased Array Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS
Marketed Device:
The 8 Channel Cardiac Phased Array Coil is substantially equivalent to the currently marketed GE Cardiac Phased Array Coil (K971667) and the MRI Devices Corporation HRH-63-8 Head Array Coil (K013159).
Device Description:
The 8 Channel Cardiac Phased Array Coil is a modification to the Cardiac Phased Array Coil (K971667), which utilizes an increase in the number of independent receive channels from four to eight, integrates preamplifiers, and utilizes ASSET optimized geometry.
Indications for Use:
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are in white against a black background, and the circle is surrounded by a decorative, swirling pattern.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Comparison with Predicate Device:
The 8 Channel Cardiac Phased Array Coil is a modification of the GE Cardiac Phased Array Coil (K971667) with the main differences being an increase in number of independent receive channels from four to eight, the integration of preamplifiers, and the optimization for ASSET applications. The technological similarities to the MRI Devices Corporation HRH-63-8 Head Array Coil (K013159) include 8 independent receive channels, integrated preamplifiers, and ASSET optimized geometry.
Summary of Studies:
Testing was performed to demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria.
Conclusion:
It is the opinion of GE that the 8 Channel Cardiac Phased Array Coil is substantially equivalent to the GE Cardiac Phased Array Coil and the MRI Devices Corporation HRH-63-8 Head Array Coil. Usage of the 8 Channel Cardiac Phased Array Coil does not result in any new potential hazards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract image of an eagle. The eagle is depicted with three stylized lines forming its body and wings, suggesting movement or flight.
Food and Drug Administration
Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K022669
Trade/Device Name: 8 Channel Cardiac Phased Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 MOS Dated: August 7, 2002 Received: August 12, 2002
Dear Dr. Kroger:
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 adultcration.
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.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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,
Henry 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):
Device Name: 8 Channel Cardiac Phased Array Coil
Indications For Use:
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)
Prescription Use_ (Per 21 CFR 801.109)
Over-The-Counter Use_ OR
Ehrid C. Bergman
(Division Sign-Off) Division of Reproductive, Ab and Radiological Device 510(k) Number -