(29 days)
No
The description focuses on the physical and electrical characteristics of the MRI coils and their intended use for image acquisition, with no mention of AI or ML for image processing or analysis.
No.
The device is a receive-only RF coil for MRI systems, designed to produce diagnostic images, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed for use with GE 1.5T MRI systems to produce diagnostic images".
No
The device description clearly states it is a physical RF coil with integrated preamplifiers and connectors, designed to be used with an MRI system. It is a hardware component, not software.
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 this device is a receive-only RF coil designed for use with GE 1.5T MRI systems to produce diagnostic images. It works by detecting hydrogen nuclei within the body using magnetic resonance.
- No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the patient's body to generate images.
Therefore, this device falls under the category of a medical imaging device, specifically an accessory for an MRI system, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA are receive only RF coils designed for use with GE 1.5T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected is hydrogen.
Product codes
MOS
Device Description
The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA and 1.5T 30ch AIR AA are receive-only coils designed to provide optimum signal-to noise ratio and uniform coverage of general human anatomy including extremities and are designed for use with GE 1.5T MRI Systems. These are 20, 21, 16, and 30 element coils tuned to image proton nuclei. Each coil element has an integrated preamplifier to improve image quality. These coils are provided with P-connectors. The coils have a soft material to conform to the patient's anatomy and maximize patient comfort. Due to the flexibility of the coils, a coil holder may be used to assist in securing the coil in place.
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, sample size, AUC, MRMC, standalone performance, key results)
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 NEMA MS 6 NEMA MS 9 Maximum B1 peak Network blocking 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 devices:
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 subjects of this premarket submission, the 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA, do not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare Coils (USA Instruments, Inc.) Veronica Meridith Regulatory Affairs Leader 1515 Danner Drive AURORA OH 44202
October 19, 2018
Re: K182590
Trade/Device Name: 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: September 19, 2018 Received: September 20, 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. 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 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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K182590
Device Name 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
Indications for Use (Describe)
The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA are receive only RF coils designed for use with GE 1.5T MRI systems to produce diagnostic images on general human anatomy including extremities. The nucleus detected 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: | Sept 19, 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 |
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Image /page/4/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized, cursive font in the center. The circle is surrounded by a series of swirling lines, which give the impression of movement or energy. The logo is simple, yet recognizable, and it is associated with a well-known and established company.
| Device Trade Name: | 1.5T AIR MP M
1.5T AIR MP L
1.5T 16ch AIR AA
1.5T 30ch AIR AA |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual
Name: | Coil, Magnetic Resonance, Specialty |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 |
| Product Code: | MOS |
| Predicate Device(s): | 3.0T Anterior Array (K172695) |
| Device Description: | The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA and 1.5T 30ch AIR
AA are receive-only coils designed to provide optimum signal-to noise ratio and
uniform coverage of general human anatomy including extremities and are
designed for use with GE 1.5T MRI Systems. These are 20, 21, 16, and 30
element coils tuned to image proton nuclei. Each coil element has an integrated
preamplifier to improve image quality. These coils are provided with P-
connectors. The coils have a soft material to conform to the patient's anatomy
and maximize patient comfort. Due to the flexibility of the coils, a coil holder
may be used to assist in securing the coil in place. |
| Intended Use: | The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR
AA are receive only RF coils designed for use with GE 1.5T MRI systems to
produce diagnostic images on general human anatomy including extremities. The
nucleus detected is hydrogen. |
| Comparison of
Intended Use: | The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch 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 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and
1.5T 30ch AIR AA and the predicate device are indicated for the same patient
population, and for the same clinical setting. |
| | The proposed Indications for use are simplified to reflect current coil intent,
similar to the Siemens Contour 24 coil K173446, 510k cleared 11/17/2017. The
Siemens Contour 24 coil Indications for Use is: "The Contour 24 is intended for
use with Siemens 3.0T MR systems to produce diagnostic images of general
human anatomy that can be interpreted by a trained physician." |
| | Therefore, GE Healthcare believes that the 1.5T AIR MP M, 1.5T AIR MP L,
1.5T 16ch AIR AA, and 1.5T 30ch AIR AA 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: | The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR
AA and the predicate device share many common technological characteristics.
Details can be found in the table below, which shows the high-level device
description for all four new coils as compared to the predicate device:
The most notable technological differences between the new coils and the
predicate device is that the new devices contain (respectively):
20 elements
21 elements
16 elements
30 elements
Predicate: 30 elements
The predicate is used on GE 3.0T MRI Systems while the new devices are for
use with GE 1.5T MRI systems.
These technological differences do not raise any different questions of safety and
effectiveness. All devices must address questions of whether they provide an
adequate level of image quality appropriate for diagnostic use. The performance
data described in this submission include results of both bench testing and
clinical testing that show the image quality performance of the 1.5T AIR MP M,
1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA compared to the
predicate device.
Operating Principles: The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR
AA, and 1.5T 30ch AIR AA operate on the same principles as the predicate
devices.
Materials: The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and
1.5T 30ch AIR AA electrical elements and associated circuitry are supported
throughout the coil by flame rated V2 co-polyester injection mold enclosure and
V0 equivalent flame rated enclosures.
Both coils and the predicate device are certified to AAMI/ANSI ES60601-1,
which includes flammability requirements.
Safety and Performance Testing: The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T
16ch AIR AA, and 1.5T 30ch AIR AA and the predicate devices comply with
the same safety and performance testing (see Determination of Substantial
Equivalence, below). |
| Determination of
Substantial
Equivalence: | 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 NEMA MS 6 NEMA MS 9 Maximum B1 peak Network blocking 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 devices: |
| | 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 subjects of this premarket submission, the 1.5T AIR MP M, 1.5T AIR MP
L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA, do 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 devices are comparable to the claimed
predicate devices. The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA,
and 1.5T 30ch 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 1.5T AIR MP M and 1.5T AIR
MP L are substantially equivalent to the predicate devices to which they have
been compared. |
| Conclusion: | GE Healthcare considers the 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR
AA, and 1.5T 30ch AIR AA to be as safe, as effective, and performance is
substantially equivalent to the predicate devices. |
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GE Healthcare 510(k) Premarket Notification Submission
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