(57 days)
Not Found
No
The summary describes a receive-only RF coil for MRI systems and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No
The device is described as a receive-only RF coil used with MRI systems to produce diagnostic images, not to treat any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed...to produce diagnostic images of general human anatomy." The "Summary of Performance Studies" also mentions that "Sample clinical images were assessed by a U.S. Board Certified Radiologist and determined to be of diagnostic quality."
No
The device description clearly outlines a physical hardware component (a receive-only RF coil with elements, preamplifiers, and a connector) designed for use with an MRI system. It is not solely software.
No, 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 function: The description clearly states that this device is a "receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities." It works by detecting hydrogen nuclei within the body during an MRI scan.
- No specimen analysis: The device does not analyze any specimens taken from the body. It interacts directly with the patient's body to generate images.
Therefore, based on the provided information, this device falls under the category of an in vivo diagnostic device (used within the living body) rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.
Product codes
MOS
Device Description
The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities. The coil has 16 elements tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T 16ch AIR AA is provided with a P-connector that is compatible with GE Healthcare 3.0T MR systems. The coils have a soft material to conforms to the patient's anatomy and maximize patient comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
general human anatomy, including extremities
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
- Study Type: Non-clinical tests, Clinical images
- Sample Size: Not explicitly stated for clinical images
- AUC: Not Found
- MRMC: Not Found
- Standalone Performance: Not Found
- Key Results:
- Non-clinical tests result: "The results of the non-clinical tests satisfy the performance criteria defined in the FDA guidance document Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway."
- Clinical tests result: "The sample images have been assessed by a U.S. Board Certified Radiologist and determined to be of diagnostic quality."
Key Metrics
Not Found
Predicate Device(s)
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 shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
January 3, 2023
GE Healthcare Coils (USA Instruments, Inc.) % Lauren Ross Regulatory Affairs Leader 1515 Danner Drive Aurora, Ohio 44202
Re: K223378
Trade/Device Name: 3.0T 16ch AIR AA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 4, 2022 Received: November 7, 2022
Dear Lauren Ross:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223378
Device Name 3.0T 16ch AIR AA
Indications for Use (Describe)
The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/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 four curved, white shapes that resemble water droplets or stylized leaves, positioned symmetrically around the circle.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | January 3, 2022 |
|---|---|
| Submitter: | GE Healthcare Coils (USA Instruments, Inc.) |
| 1515 Danner Drive | |
| Aurora, OH 44202 | |
| USA | |
| Primary Contact Person: | Lauren Ross |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: 262-399-5721 | |
| Secondary Contact Person: | Andrew Menden |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: 262-399-5721 | |
| Device Trade Name: | 3.0T 16ch AIR AA |
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty |
| Product Classification: | |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Regulation Number: | 21 CFR 892.1000 |
| Product Code: | MOS |
| Predicate Device: | 1.5T 16ch AIR AA (K182590) |
Device Description:
The 3.0T 16ch AIR AA is a receive-only coil designed to provide optimum signal-to noise and uniform coverage of general human anatomy including extremities. The coil has 16 elements tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. The 3.0T 16ch AIR AA is provided with a P-connector that is compatible with GE Healthcare 3.0T MR systems. The coils have a soft material to conforms to the patient's anatomy and maximize patient comfort.
4
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by three white, wave-like shapes, which give the impression of motion or energy.
Indications Use:
The 3.0T 16ch AIR AA is a receive-only RF coil designed for use with GE 3.0T MRI systems to produce diagnostic images of general human anatomy, including extremities. The nucleus detected is hydrogen.
Comparison of the Indications for Use:
Both the 3.0T 16ch AIR AA 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 3.0T 16ch AIR AA and the predicate device are indicated for the same patient population, and for the same clinical setting.
Therefore, GE Healthcare believes that the 3.0T 16ch AIR AA has the same intended use as the predicate device in accordance with the FDA's quidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", dated 28 July 2014.
Comparison of Technological Characteristics:
The most notable technological difference between the 3.0T 16ch AIR AA and the predicate device is that the 3.0T 16ch AIR AA is tuned to the frequency for imaging hydrogen nuclei (protons) at 3.0T. while the predicate device is intended for 1.5T. This technological difference does not raise any different questions of safety and effectiveness. Both devices must address questions of whether they provide appropriate mitigations for electrical, mechanical, thermal, and biocompatibility risks, and provide an adequate level of image quality for diagnostic use.
Summary of Non-Clinical Tests:
The 3.0T 16ch AIR AA has undergone the following testing:
- . Image Signal-to-Noise Ratio (SNR) in accordance with NEMA MS-9
- . Image Uniformity in accordance with NEMA MS-9
- . Surface heating in accordance with NEMA MS-14
- Inspection of decoupling circuitry
- . EMC testing for immunity from electrostatic discharge in accordance with applicable portions of IEC 60601-1-2
- . General electrical and mechanical safety in accordance with applicable portions of AAMI/ANSI ES 60601-1 and IEC 60601-2-33
- . Biocompatibility assessment in accordance with the ISO 10993 series of standards
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are three white flourishes or droplets surrounding the circle, positioned at roughly equal intervals. The logo is simple and recognizable, representing the multinational conglomerate.
The results of the non-clinical tests satisfy the performance criteria defined in the FDA guidance document Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway.
Summary of Clinical Tests:
In accordance with the FDA guidance document Magnetic Resonance (MR) Receiveonly Coil - Performance Criteria for Safety and Performance Based Pathway, sample clinical images have been obtained with the 3.0T 16ch AIR AA from various anatomies and using various pulse sequences. The sample images have been assessed by a U.S. Board Certified Radiologist and determined to be of diagnostic quality.
Substantial Equivalence Conclusion:
The indications for use of the proposed devices are comparable to the claimed predicate devices. The 3.0T 16ch AIR AA employs equivalent technology to the claimed predicate devices. Additionally, the results from the above non-clinical tests demonstrate that the devices perform as intended. Thus, the 3.0T 16ch AIR AA are substantially equivalent to the predicate device to which they have been compared.
Conclusion:
Based on the results of the non-clinical testing, GE Healthcare concludes that the 3.0T 16ch AIR AA is as safe, as effective, and performs as well as or better than the predicate device. The 3.0T 16ch AIR AA also meets the performance criteria outlined in the Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway guidance.