(58 days)
Not Found
No
The document describes a hardware component (an MRI coil) and its physical characteristics and testing, with no mention of software, algorithms, or AI/ML capabilities.
No
This device is a receive-only RF coil for MRI systems, used for imaging the head. Its purpose is diagnostic, not therapeutic.
No
This device is an RF coil used in MRI for image acquisition, not for interpreting those images or providing a diagnosis. Its function is to improve image quality and signal reception.
No
The device description clearly details physical hardware components (coil elements, preamplifiers, MEMS switches, P-connectors, pads) and the performance studies focus on hardware-related testing (electrical safety, heat testing, biocompatibility). There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "head imaging" using an MRI system. This is a diagnostic imaging procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is an RF coil for an MRI system. It interacts with the patient's body to receive signals for image formation. It does not analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information about a patient's health status based on sample analysis
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a component of an imaging system used to visualize the internal structures of the head.
N/A
Intended Use / Indications for Use
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.
Product codes
MOS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
head, brain
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
Summary of Non-Clinical Tests: The predicate and modified devices have been subject to similar risk management testing to demonstrate substantial 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 a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices.
The following quality assurance measures were applied to the 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 Head Coil, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission.
Key Metrics
Not Found
Predicate Device(s)
TDI Head Neck Unit (K143345)
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.
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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.
1
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
2
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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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a wavy or swirling pattern around the letters, giving it a dynamic and recognizable appearance.
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 Drive | |
| Aurora, OH 44202 | |
| USA | |
| Primary Contact Person: | Mary A. Mayka, Ph.D. |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 262-527-3148 | |
| Fax: 262-364-2785 | |
| Secondary Contact Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Phone: 262-521-6848 | |
| Fax: 262-364-2785 | |
| Device Trade Name: | 48CH Head Coil |
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR |
| 892.1000 | |
| Product Code: | MOS |
| Predicate Device(s): | TDI Head Neck Unit (K143345) |
| Device Description: | 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. | |
| Intended Use: | 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. | |
| Comparison of | |
| Intended Use: | Both the 48CH Head Coil and the predicate device are |
| classified as coils for magnetic resonance imaging devices | |
| and are intended for diagnostic use. Both indications for | |
| use statements are functional in nature, and do not list | |
| specific diseases or conditions. The 48CH Head Coil and | |
| the predicate device are indicated for the same patient | |
| population, and for the same clinical setting. The | |
| predicate device, the TDI Head Neck Unit is one coil as | |
| part of the TDI Coil Suite, and covers head, neck, | |
| brachial-plexus and vessel anatomies. The 48CH Head | |
| Coil also references head anatomy. Therefore, GE | |
| Healthcare believes that the 48CH Head Coil has the same | |
| intended use as the predicate device in accordance with | |
| the FDA's guidance document "The 510(k) Program: | |
| Evaluating Substantial Equivalence in Premarket | |
| Notifications [510(k)]", dated 28 July 2014. | |
| Comparison of | |
| Technological | |
| Characteristics: | Overall, the 48CH Head Coil employs the same |
| fundamental scientific technology as its predicate device. | |
| Coil Design: The most notable technological difference | |
| between the 48CH Head Coil and the predicate device is | |
| that the 48CH Head Coil contains 48 elements and utilizes | |
| MEMS technology for decoupling as compared to the | |
| predicate's 21 elements and hybrid decoupling. | |
| Operating Principles: The 48CH Head Coil operates on the | |
| same principles as the predicate device. | |
| Materials: The 48CH Head Coil and the predicate device | |
| both use flame retardant materials. | |
| Safety and Performance Testing: Both the 48CH Head | |
| Coil and the predicate device complies with the same | |
| safety and performance testing (see Determination of | |
| Substantial Equivalence, below). | |
| These technological differences do not raise any different | |
| questions of safety and effectiveness. | |
| Determination of | Summary of Non-Clinical Tests: |
| Substantial Equivalence: | The predicate and modified devices have been subject to |
| similar risk management testing to demonstrate | |
| substantial 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 a | |
| successful biocompatibility track record, as demonstrated | |
| by ISO 10993 testing and by their history of use in | |
| previously cleared devices. | |
| The following quality assurance measures were applied to | |
| the 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 Head | |
| Coil, did not require clinical studies to support substantial | |
| equivalence. Sample clinical images have been included | |
| in this submission. | |
| Substantial Equivalence Conclusion: | |
| The indications for use of the proposed device are | |
| comparable to the claimed predicate device. The 48CH | |
| Head Coil employs equivalent technology to the claimed | |
| predicate device. Additionally, the results from the above | |
| non-clinical tests demonstrate that the device performs as | |
| intended. Thus, the 48CH Head Coil is substantially | |
| equivalent to the predicate device to which it has been | |
| compared. | |
| Conclusion: | GE Healthcare considers the 48CH Head Coil to be as |
| safe, as effective, and performance is substantially | |
| equivalent to the predicate devices. |
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Image /page/4/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 white swirls around the letters. The logo is simple and recognizable.
5
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
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by swirling, wave-like elements, also in blue, which give the impression of motion or energy. The overall design is simple, clean, and recognizable, representing the brand identity of General Electric.
GE Healthcare
510(k) Premarket Notification Submission