(112 days)
Not Found
No
The summary describes RF coils, which are hardware components for MRI systems, and does not mention any software or algorithms that would incorporate AI/ML.
No
The device is described as "receive-only RF surface coils designed for use with 1.5T MRI systems" for "imaging," indicating its purpose is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging." The "Input Imaging Modality" is also listed as "Magnetic resonance diagnostic device." These statements clearly indicate its use in medical imaging for diagnostic purposes.
No
The device description explicitly states it consists of a set of integrated receive-only RF coils, 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the GEM Option is a set of receive-only RF surface coils designed for use with MRI systems. These coils are used to acquire images of the human body in vivo (within the living organism).
- Intended Use: The intended use is for imaging various anatomical sites within the body. This is a diagnostic imaging procedure, not an in vitro test.
The device is a component of an MRI system, which is a diagnostic imaging modality, not an IVD.
N/A
Intended Use / Indications for Use
The GEM Option for 1.5T MRI systems is a set of receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for I .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
Product codes (comma separated list FDA assigned to the subject device)
90LNH, 90MOS
Device Description
The GEM Option for 1.5T MRI systems consists of a set integrated receive-only RF coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. This coil set includes a head and neurovascular array, an anterior imaging array, a peripheral-vascular lower leg array, and a posterior imaging array integrated into the MR table for complete head-to-foot coverage. The coils can be used individually or combined to provide the anatomical coverage desired. The combined use of the entire GEM suite will facilitate high-resolution, high-SNR whole-body imaging from the top of the head down to the feet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Clinical images are used to demonstrate substantial equivalence of performance.
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.
Not Found
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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Image /page/0/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 letters and the border are solid black, creating a high-contrast design.
103335 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: 16 February 2011
GE Healthcare (GE Medical Systems, LLC) Submitter: Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI 53188, USA
Primary Contact Person: Mr. Michael S. Preto Regulatory Affairs Leader, MR GE Healthcare Coils (USA Instruments, Inc.) Phone: +1 330 995-8333 Fax: +1 330 562-1422 Email: michael.preto@ge.com
Secondary Contact Person: Mr. Glen Sabin Regulatory Affairs Director, MR GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI 53188, USA Phone: 262-521-6848 Fax: 262-521-6439 Email: glen.sabin@ge.com
Device: Trade Name: GEM Option for 1.5T MRI systems
Common/Usual Name: Magnetic resonance diagnostic device
Classification Names: 21 CFR 892.1000 Product Code: 90LNH, 90MOS
Predicate Device(s): K091536, Optima MR450w
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are three small, stylized swirls or dots evenly spaced around the perimeter of the circle, adding a decorative element to the design.
GE Healthcare 510(k) Premarket Notification Submission
Device Description: The GEM Option for 1.5T MRI systems consists of a set integrated receive-only RF coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. This coil set includes a head and neurovascular array, an anterior imaging array, a peripheral-vascular lower leg array, and a posterior imaging array integrated into the MR table for complete head-to-foot coverage. The coils can be used individually or combined to provide the anatomical coverage desired. The combined use of the entire GEM suite will facilitate high-resolution, high-SNR whole-body imaging from the top of the head down to the feet.
The GEM Option for 1.5T MRI systems is a set of Intended Use: receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for 1.5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
Technology: Comparison with Optima MR450w (K091536): The GEM Option for 1.5T MRI systems replaces the existing MR table with the GEM table. The system operates on the same principles with workflow improvement by reducing the need to change coils.
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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The letters are enclosed within a circular border, which has three small, decorative swirls evenly spaced around its perimeter. The logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The GEM Option for 1.5T MRI systems has integrated surface coils to accommodate the improved workflow. The same non-clinical voluntary standards are used to demonstrate substantial equivalence of safety and performance:
IEC 60601-1: Electrical Safety - compliant with all applicable sections
IEC 60601-1-2: Electromagnetic Compatibility -
compliant with all applicable sections (i.e. electrostatic discharge)
IEC 60601-2-33: Electrical Safety – compliant with all applicable sections
ISO 10993-1: Biocompatibility -- determination of post market acceptability of materials
Clinical images are used to demonstrate substantial equivalence of performance.
Conclusion: GE Healthcare considers the GEM Option for 1.5T MRI systems to be as safe, as effective, and performance is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
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
GE Healthcare (GE Medical Systems, LLC) Mr. Michael S. Preto Regulatory Affairs Leader, MR GE Healthcare Coils (USA Instruments, Inc.) 1515 Danner Drive AURORA OH 44202
MAR - 7 2011
Re: K103335
Trade/Device Name: GEM Option for 1.5T MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 16, 2011 Received: February 18, 2011
Dear Mr. Preto:
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'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 Parts 801 and 809); medical device reporting (reporting of
4
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 S Postel
Mary Pastel. ScD. 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: GEM Option for 1.5T MRI systems
Indications for Use:
The GEM Option for 1.5T MRI systems is a set of receive-only RF surface coils designed for use with 1.5T MRI systems manufactured by GE Healthcare. The GEM Option for I .5T MRI systems is indicated for use for: head, neck, brachial-plexus, spine, pelvis, hips, prostate, abdominal, cardiac, lower extremities, blood vessels, and long bone imaging. The nucleus detected is hydrogen.
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)
Mary Statt
Division Sign-Off Office of In Vitto Diagnostic Device Evaluation and Safety
510(k) K123335
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