(29 days)
Not Found
No
The summary describes a hardware component (an MRI coil) and its physical characteristics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an MRI receive-only RF coil used for imaging, not for treating a disease or condition.
No
This device is an RF coil used for MRI imaging. While MRI imaging is a diagnostic tool, the coil itself is a component that helps acquire images; it does not in itself perform the diagnostic interpretation or analysis of the images.
No
The device is a physical RF coil with integrated hardware components (preamplifiers, connectors, pads) designed for use with an MRI system, not a software-only application.
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 description clearly states that the 3.0T 48CH Head Coil is a receive-only RF coil designed for use with MRI systems for head imaging. It is a component of an imaging system used to acquire images of the inside of the body.
- No Sample Analysis: There is no mention of the device analyzing any biological samples taken from a patient. Its function is to receive radiofrequency signals emitted by the patient's head during an MRI scan.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
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. 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
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 the same 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 MS6-2008 Maximum B1 Peak Blocking Network Analysis Surface Temperature Testing The predicate and modified devices use the same patient.
Summary of Clinical Tests:
The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
48CH Head Coil (K163205)
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.
0
Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services USA logo, which features an abstract design of an eagle. The second logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text.
April 12, 2018
GE Healthcare Coils (USA Instruments, Inc.) Veronica Meridith Regulatory Affairs Leader 1515 Danner Drive Aurora, Ohio 44202
Re: K180666
Trade/Device Name: 48CH Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: March 12, 2018 Received: March 14, 2018
Dear Veronica Meridith:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 12, 2018 |
|---|---|
| Submitter: | GE Healthcare Coils (USA Instruments, Inc.) |
| 1515 Danner Drive | |
| Aurora, OH 44202 | |
| USA | |
| Primary Contact Person: | Veronica Meridith |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: 262-955-5427 | |
| Fax: 414-908-9585 | |
| Secondary Contact Person: | Andrew Menden |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 262-521-6223 | |
| Fax: 414-908-9585 | |
| 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): | 48CH Head Coil (K163205) |
| 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. 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: | The intended use statements are identical. |
| Comparison of Technological | |
| Characteristics: | The 48CH Head Coil employs the same fundamental scientific |
| technology as its predicate device. |
Coil Design: The 48CH Head Coil design is the same as the
predicate device but implements a design change to the
decoupling circuit.
Operating Principles: The 48CH Head Coil operates on the
same principles as the predicate device.
Materials: The 48CH Head Coil uses the same materials as the
predicate device.
Safety and Performance Testing: The 48CH Head Coil
complies with the same safety and performance testing as the
predicate device.
These technological differences do not raise any different
questions of safety and effectiveness. |
| Determination of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The predicate and modified devices have been subject to the
same 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 MS6-2008 Maximum B1 Peak Blocking Network Analysis Surface Temperature Testing The predicate and modified devices use the same patient
|
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5
| Summary of Clinical Tests: | The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence. |
|---|---|
| Substantial Equivalence Conclusion: | The indications for use of the proposed device are identical 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 and effective, and performs in a substantially equivalent manner to the predicate device. |