(58 days)
The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.
The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality and a custom MEMS (Micro Electro Mechanical System) switch to decouple the receive coil from the MR System body coil. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.
The provided document describes a 510(k) premarket notification for the GE Healthcare 48CH Head Coil. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria for diagnostic performance.
Therefore, the information you requested about acceptance criteria and how a study proves the device meets them, particularly regarding AI performance, human reader improvement, and ground truth establishment, is largely not present in this submission. This is typical for a device like an MRI coil, where the focus is on safety, technical performance (signal-to-noise ratio, uniformity, etc.), and demonstrating that it operates similarly to existing approved devices.
Here's a breakdown of what can be extracted from the document, and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of clinical acceptance criteria for diagnostic imaging performance (e.g., sensitivity, specificity for detecting specific conditions). Instead, it focuses on non-clinical technical performance and safety.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Summary) |
|---|---|
| Compliance with AAMI/ANSI ES60601-1 (Electrical safety) | Complies |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Complies |
| Compliance with IEC 60601-2-33 (MRI specific safety) | Complies |
| Compliance with MS 6-2008 (Specific standard, likely internal GE) | Complies |
| Maximum B1 peak (Safety parameter) | Tested |
| Blocking Network Analysis (Technical performance) | Tested |
| Heat Testing (Safety parameter) | Tested |
| Biocompatibility (ISO 10993) | Successful track record, demonstrated by testing and history of use |
| Risk Analysis | Applied |
| Requirements Reviews | Applied |
| Design Reviews | Applied |
| Testing on unit level (Module verification) | Applied |
| Integration testing (System verification) | Applied |
| Performance testing (Verification) | Applied |
| Safety testing (Verification) | Applied |
| Simulated use testing (Validation) | Applied |
| Signal-to-noise ratio (Implied from description) | Designed to provide optimum signal-to-noise |
| Uniformity (Implied from description) | Designed for uniform coverage |
| High acceleration capability | Designed for high acceleration including multiband imaging |
| Decoupling of receive coil from MR System body coil | Achieved via custom MEMS switch |
2. Sample size used for the test set and the data provenance
- Test set for clinical performance: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that there was no formal clinical test set for diagnostic performance as would be used for an AI device. The included "sample clinical images" are likely illustrative rather than for formal evaluation.
- Data provenance: Not applicable for a separate clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no dedicated clinical test set with ground truth was required for this submission.
4. Adjudication method for the test set
Not applicable, as no dedicated clinical test set with ground truth was required for this submission.
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 MRMC study was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an MRI coil, not an algorithm.
7. The type of ground truth used
Not applicable for clinical performance. For non-clinical tests, the ground truth would be based on engineering specifications, physical measurements, and compliance with established safety standards.
8. The sample size for the training set
Not applicable. This is a hardware device (MRI coil), not a software algorithm requiring a training set in the AI sense.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2017
GE Healthcare Coils (USA Instruments, Inc.) % Mary A. Mayka, Ph.D. Regulatory Affairs Manager 1515 Danner Drive AURORA OH 44202
Re: K163205
Trade/Device Name: 48CH Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 14, 2016 Received: November 15, 2016
Dear Dr. Mayka:
This letter corrects our substantially equivalent letter of January 12, 2016
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name 48CH Head Coil
Indications for Use (Describe)
The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | January 5, 2017 |
|---|---|
| Submitter: | GE Healthcare Coils (USA Instruments, Inc.)1515 Danner DriveAurora, OH 44202USA |
| Primary Contact Person: | Mary A. Mayka, Ph.D.Regulatory Affairs ManagerGE HealthcarePhone: 262-527-3148Fax: 262-364-2785 |
| Secondary Contact Person: | Glen SabinRegulatory Affairs DirectorGE HealthcarePhone: 262-521-6848Fax: 262-364-2785 |
| Device Trade Name: | 48CH Head Coil |
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR892.1000 |
| Product Code: | MOS |
| Predicate Device(s): | TDI Head Neck Unit (K143345) |
| Device Description: | The 48CH Head Coil is a phased-array receive-only coildesigned to provide optimum signal-to noise, uniformcoverage and high acceleration including multibandimaging of the head and brain. It is a 48-element coiltuned to image proton nuclei and designed for use withGE 3.0T MRI Systems. Each coil element has anintegrated preamplifier to improve image quality and acustom MEMS (Micro Electro Mechanical System)switch to decouple the receive coil from the MR Systembody coil. The 48CH Head Coil has an anterior coil and aposterior coil with P-connectors. The coil has optimizedpads to maximize patient comfort and image uniformity. |
| Intended Use: | The 3.0T 48CH Head Coil is a receive-only RF coildesigned for use with select 3.0T MRI systemsmanufactured by GE Healthcare. The coil is indicated foruse for head imaging. The nucleus excited is hydrogen. |
| Comparison ofIntended Use: | Both the 48CH Head Coil and the predicate device areclassified as coils for magnetic resonance imaging devicesand are intended for diagnostic use. Both indications foruse statements are functional in nature, and do not listspecific diseases or conditions. The 48CH Head Coil andthe predicate device are indicated for the same patientpopulation, and for the same clinical setting. Thepredicate device, the TDI Head Neck Unit is one coil aspart of the TDI Coil Suite, and covers head, neck,brachial-plexus and vessel anatomies. The 48CH HeadCoil also references head anatomy. Therefore, GEHealthcare believes that the 48CH Head Coil has the sameintended use as the predicate device in accordance withthe FDA's guidance document "The 510(k) Program:Evaluating Substantial Equivalence in PremarketNotifications [510(k)]", dated 28 July 2014. |
| Comparison ofTechnologicalCharacteristics: | Overall, the 48CH Head Coil employs the samefundamental scientific technology as its predicate device.Coil Design: The most notable technological differencebetween the 48CH Head Coil and the predicate device isthat the 48CH Head Coil contains 48 elements and utilizesMEMS technology for decoupling as compared to thepredicate's 21 elements and hybrid decoupling.Operating Principles: The 48CH Head Coil operates on thesame principles as the predicate device.Materials: The 48CH Head Coil and the predicate deviceboth use flame retardant materials.Safety and Performance Testing: Both the 48CH HeadCoil and the predicate device complies with the samesafety and performance testing (see Determination ofSubstantial Equivalence, below).These technological differences do not raise any differentquestions of safety and effectiveness. |
| Determination of | Summary of Non-Clinical Tests: |
| Substantial Equivalence: | The predicate and modified devices have been subject tosimilar risk management testing to demonstratesubstantial equivalence of safety and performance.Testing included: |
| AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 MS 6-2008 Maximum B1 peak Blocking Network Analysis Heat Testing | |
| Additionally, both predicate and modified devices have asuccessful biocompatibility track record, as demonstratedby ISO 10993 testing and by their history of use inpreviously cleared devices. | |
| The following quality assurance measures were applied tothe development of the device: 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, the 48CH HeadCoil, did not require clinical studies to support substantialequivalence. Sample clinical images have been includedin this submission. | |
| Substantial Equivalence Conclusion: | |
| The indications for use of the proposed device arecomparable to the claimed predicate device. The 48CHHead Coil employs equivalent technology to the claimedpredicate device. Additionally, the results from the abovenon-clinical tests demonstrate that the device performs asintended. Thus, the 48CH Head Coil is substantiallyequivalent to the predicate device to which it has beencompared. | |
| Conclusion: | GE Healthcare considers the 48CH Head Coil to be assafe, as effective, and performance is substantiallyequivalent to the predicate devices. |
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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font inside. There are also some curved lines around the letters, which give the logo a dynamic and modern look. The blue color is vibrant and eye-catching.
GE Healthcare 510(k) Premarket Notification Submission
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GE Healthcare
510(k) Premarket Notification Submission
§ 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.