(14 days)
Not Found
No
The summary describes a passive MR coil and does not mention any software or processing capabilities, let alone AI/ML.
No
The device is described as facilitating MR imaging, which is a diagnostic procedure, not a therapeutic one. It helps in obtaining images for diagnosis, not in treating a condition.
No
The device is a coil used for MR imaging, which is a tool for obtaining images, not for interpreting them or making a diagnosis.
No
The device description explicitly states it is a "coil" which is a hardware component used in MR imaging. It also describes physical characteristics like size and flexibility.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE 3.0T General Purpose Flex Coil is an accessory for an MRI system. Its purpose is to facilitate the acquisition of MR images of specific anatomical sites within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "facilitat[ing] MR imaging." This is an in-vivo (within the living body) imaging process, not an in-vitro diagnostic test.
The information provided describes a component of an imaging system used to acquire images directly from a patient's body, which is fundamentally different from the function of an IVD.
N/A
Intended Use / Indications for Use
The GE 3.0T General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.0T General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5" x 6.5" surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa® 3.0T whole body MR System.
Product codes
90 MOS
Device Description
The GE 3.0T General Purpose Flex Coil is a modification of the existing 1.5T GP Flex Coil (K923264), to increase the field strength from 1.5T to 3.0T. In addition, two passive blocking networks are added to improve reliability and patient safety.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
Brachial Plexus, Unilateral Hip and Thigh, joints of lower extremity (Knee and Ankle)
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 1.5T general Purpose Flex 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.
0
Kó 3.0953
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The border has a decorative, swirling design around the letters.
GE Medical Systems
Page 1 of 2
General Electric Company P.O. Box 414, Milwaukee, WI 53201
APR 1 0 2003
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: | March 24.2003 |
Device Name:
GE 3.0T General Purpose Flex Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS
Marketed Device:
The GE 3.0T General Purpose Flex Coil is substantially equivalent to the currently marketed GE Medical Systems 1.5T GP Flex coil M1085GP (K923264)
Device Description:
The GE 3.0T General Purpose Flex Coil is a modification of the existing 1.5T GP Flex Coil (K923264), to increase the field strength from 1.5T to 3.0T. In addition, two passive blocking networks are added to improve reliability and patient safety.
Indications for Use:
The GE 3.0T General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.0T General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5" x 6.5" surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa® 3.0T whole body MR System.
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 within a circular border. The logo is black and white.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Comparison with Predicate Device:
The GE 3.0T General Purpose Flex Coil is a modification of the existing cleared 1.5T General Purpose Flex Coil (K923264), with the main difference being the coil has been retuned for operation in a 3.0T magnetic field instead of a 1.5T field strength. In addition, two passive blocking networks are added to improve reliability, and patient safety.
Summary of Studies:
Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria.
Conclusion:
It is the opinion of GE that the 3.0T General Purpose Flex Coil is substantially equivalent to the GE 1.5T general Purpose Flex coil (K923264). Usage of the GE 3.0T General Purpose Flex Coil does not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three flowing lines above it, symbolizing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2003
Larry Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K030953
Trade/Device Name: GE 3.0T General Purpose Flex Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 24, 2003 Received: March 27, 2003
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 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.
Sincerely yours,
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
Page 2
4
510(k) Number (if known): _ 大 o 3
Device Name: GE 3.0T General Purpose Flex Coil
Indications For Use:
The GE 3.0T General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.0T General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5" x 6.5" surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa® 3.0T whole body MR System.
(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(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________