(112 days)
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.
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.
This document describes a 510(k) premarket notification for the "GEM Option for 1.5T MRI systems" by GE Healthcare. The device consists of integrated receive-only RF coils for 1.5T MRI systems. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K091536, Optima MR450w) through non-clinical tests and clinical imaging, rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics of a novel AI device.
Therefore, many of the requested elements for describing the acceptance criteria and a study proving device performance, particularly those related to AI algorithm performance (e.g., sample size for test/training sets, ground truth establishment, expert consensus, MRMC studies, standalone performance), are not applicable to the content provided. The document focuses on regulatory compliance, electrical safety, EMC, biocompatibility, and qualitative substantial equivalence for a hardware component rather than a diagnostic AI software.
Based on the provided text, here is what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 (all applicable sections) | Compliant with all applicable sections |
| Compliance with IEC 60601-2-33 (all applicable sections) | Compliant with all applicable sections | |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (all applicable sections including electrostatic discharge) | Compliant with all applicable sections (i.e. electrostatic discharge) |
| Biocompatibility | Compliance with ISO 10993-1 (determination of post market acceptability of materials) | Determination of post market acceptability of materials (implies compliance) |
| Performance/Substantial Equivalence | Clinical images demonstrate substantial equivalence of performance to predicate device (Optima MR450w, K091536) | Clinical images are used to demonstrate substantial equivalence of performance. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document states "Clinical images are used to demonstrate substantial equivalence of performance," but no details on the number of cases or subjects are provided.
- Data provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as the reported study relies on clinical image review for qualitative substantial equivalence, not a quantitative measure requiring expert-established ground truth for an AI algorithm. No "ground truth" as typically understood for AI evaluation is mentioned.
4. Adjudication method for the test set
- Not applicable for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a hardware component (RF coils) for an MRI system, not an AI software. The provided text does not describe any human-in-the-loop AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The substantial equivalence is determined by comparing clinical images produced by the new coils to those from a predicate device, focusing on image quality and the ability to perform the intended use. There is no mention of a specific ground truth (like pathology or outcomes data) typically associated with diagnostic accuracy studies of AI. The assessment seems to be qualitative based on engineering and imaging principles.
8. The sample size for the training set
- Not applicable. This is a hardware device submission, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. This is a hardware device submission, not an AI algorithm, so there is no "training set" or associated ground truth establishment process.
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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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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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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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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
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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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§ 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.