(29 days)
No
The description focuses on the hardware components of an MRI coil and its function in image acquisition, with no mention of AI or ML for image processing or analysis.
No
The device is an accessory for an MRI scanner used to produce images, not to treat any condition.
Yes
The device (GE 6-Channel Phased Array Flex Coil) is an accessory for an MRI scanner used to produce 2D and 3D images. These images are then used by a physician to diagnose medical conditions, making the device an integral part of the diagnostic process.
No
The device description explicitly states it is a "surface coil" comprised of "coil elements" and "integrated preamplifiers," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GE 6-Channel Phased Array Flex Coil is an accessory for an MRI scanner. Its function is to receive signals from the body during an MRI scan to produce images. It does not analyze samples taken from the body.
- Intended Use: The intended use is to produce 2D and 3D images in conjunction with an MRI scanner. This is a diagnostic imaging function, not an in vitro diagnostic function.
- Device Description: The description clearly states it's a surface coil used for Magnetic Resonance Imaging, tuned to image proton nuclei. This aligns with imaging technology, not laboratory testing.
Therefore, the GE 6-Channel Phased Array Flex Coil falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GE 6-Channel Phased Array Flex Coil is indicated for use, on the order of a physician in conjunction with an MR scanner, as an accessory to produce 2D and 3D images. The intended areas of interest to be scanned with the GE 6-Channel Phased Array Flex Coil include, but are not limited to: head, neck, knee, shoulder, foot, wrist, and hip.
The 1.5T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to produce 2D and 3D images.
The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
Product codes (comma separated list FDA assigned to the subject device)
90MOS
Device Description
The GE 6-Channel Phased Array Flex Coil is a surface coil used for Magnetic Resonance Imaging. It is tuned to image proton nuclei in a receive-only configuration. It is comprised of 6 individual phased array coil elements, each utilizing an integrated preamplifier to improve image quality. This coil is a receive-only, multi-coil array optimized for high-resolution examinations. The coil enables multi-oblique slice imaging. The coil is indicated for use, on the order of a physician in conjunction with an MR scanner, as an accessory to produce 2D and 3D images. The intended areas of interest to be scanned with the GE 6-Channel Phased Array Flex Coil include, but are not limited to: head, neck, knee, shoulder, foot, wrist, and hip. The 1.5T GE 6-Channel Phased Array Flex Coil is compatible with the Discovery MR450 (K083147) and the Optima MR450w (K091536). The 3.0T GE 6-Channel Phased Array Flex Coil is compatible with the Signa MR750 3T, now marketed as Discovery MR750 (K081028).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging / MRI
Anatomical Site
head, neck, knee, shoulder, foot, wrist, and hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
on the order of the physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, GE 6-Channel Phased Array Flex Coil, did not require clinical studies to support substantial equivalence. However, clinical images from validation have been included in DICOM format in Section 20 of the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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APR - 1 2011
GE Healthcare 510(k) Premarket Notification Submission
Section 5: 510(k) Summary
GE 6-Channel Phased Array Flex Coil
Image /page/0/Picture/5 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 in black and white and has a vintage look.
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APR - 1 2011
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: March 1, 2011
Submitter: GE Healthcare (GE Medical Systems, LLC) 3200 N. Grandview Blvd. Waukesha, WI 53188 USA
FDA Registration Number: 2183553
Primary Contact Person: Michelle Scheidt, Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC) 3200 N. Grandview Blvd., Mail Code: W-827 Waukesha, WI 53188 Phone: 262-521-6102 Fax: 414-918-8349
Secondary Contact Person: Glen Sabin, Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) 3200 N. Grandview Blvd., Mail Code: W-827 Waukesha, WI 53188 Phone: 262-320-6848 Fax: 414-918-8349
Device: Trade Name: GE 1.5T 6-Channel Phased Array Flex Coil and GE 3.0T 6-Channel Phased Array Flex Coil
Common/Usual Name: Coil, Magnetic Resonance, Specialty
Classification Names: 21 CFR 892.1000, Magnetic resonance diagnostic device
Product Code: 90MOS Predicate Device(s): K042844, GE Signa Excite 1.5T 6 Channel Phased Array Flex Coil and GE Signa Excite 3.0T 6 Channel Phased Array Flex Coil
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Image /page/2/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and have a vintage appearance. The image is somewhat pixelated, suggesting it may be a low-resolution scan or a small image that has been enlarged.
GE Healthcare 510(k) Premarket Notification Submission
Device Description:
The GE 6-Channel Phased Array Flex Coil is a surface coil used for Magnetic Resonance Imaging. It is tuned to image proton nuclei in a receive-only configuration. It is comprised of 6 individual phased array coil elements, each utilizing an integrated preamplifier to improve image quality. This coil is a receive-only, multi-coil array optimized for high-resolution examinations. The coil enables multi-oblique slice imaging. The coil is indicated for use, on the order of a physician in conjunction with an MR scanner, as an accessory to produce 2D and 3D images. The intended areas of interest to be scanned with the GE 6-Channel Phased Array Flex Coil include, but are not limited to: head, neck, knee, shoulder, foot, wrist, and hip. The 1.5T GE 6-Channel Phased Array Flex Coil is compatible with the Discovery MR450 (K083147) and the Optima MR450w (K091536). The 3.0T GE 6-Channel Phased Array Flex Coil is compatible with the Signa MR750 3T, now marketed as Discovery MR750 (K081028).
Indications For Use: The 1.5T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to produce 2D and 3D images.
The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
Technology: The GE 6-Channel Phased Array Flex Coil is a 6-element phased array RF receive-only coil with integrated preamplifiers. The coil design consists of RF chokes with switching diodes to provide decoupling to isolate the coil elements from RF fields during RF transmission. The device modification present in this GE 6-Channel Phased Array Flex Coil compared to the predicate device, GE Signa Excite 1.5T 6 Channel Phased Array Flex Coil and GE Signa Excite 3.0T 6 Channel Phased Array Flex Coil
5-3
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Image /page/3/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The letters are bold and have a slightly textured appearance, giving the logo a vintage or hand-drawn feel.
GE Healthcare 510(k) Premarket Notification Submission
(K042844) is the changed electrical components in the connector. The preamplifiers are now located in the connector for the coil (Quick Disconnect box), rather than in the Low Profile Carriage Assembly of the MR System. This enables the coil to be compatible with the Discovery MR450 (K083147), Optima MR450w (K091536), and Signa MR750 3T, now marketed as Discovery MR750, (K081028) Systems, rather than the GE 1.5T and 3.0T Signa HDx MR Systems (K052293). Overall, the GE 6-Channel Phased Array Flex Coil employs the same fundamental scientific technology as its predicate device.
Determination of Summary of Non-Clinical Tests: Substantial Equivalence:
The GE 6-Channel Phased Array Flex Coil and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- Performance testing (Verification) ●
- . Safety testing (Verification)
- . Simulated use testing (Validation)
Summary of Clinical Tests:
The subject of this premarket submission, GE 6-Channel Phased Array Flex Coil, did not require clinical studies to support substantial equivalence. However, clinical images from validation have been included in DICOM format in Section 20 of the submission.
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Image /page/4/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo is a circular emblem with the letters 'GE' intertwined in the center. The letters are stylized and connected, creating a unique monogram. The overall design is simple and recognizable, representing the brand identity of General Electric.
GE Healthcare 510(k) Premarket Notification Submission
Conclusion: GE Healthcare considers the GE 6-Channel Phased Array Flex Coil to be as safe, as effective, and performance is substantially equivalent to the predicate device.
.
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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle Scheidt Regulatory Affairs Leader GE Medical Systems, LLC 3200 N. Grandview Blvd. WAUKESHA WI 53188
APR - 1 201
Re: K110610
Trade/Device Name: 1.5T GE 6-Channel Phased Array Flex Coil and 3.0T GE 6-Channel Phased Array Flex Coil
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 1, 2011 Received: March 3, 2011
Dear Ms. Scheidt:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA is 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 Parts 801 and 809); medical device reporting (reporting of
6
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: 1.5T GE 6-Channel Phased Array Flex Coil and 3.0T GE 6-Channel Phased Array Flex Coil
Indications for Use:
The 1.5T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to produce 2D and 3D images.
The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
Prescription Use_X_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mury S Patel
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110616
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