(76 days)
Not Found
No
The summary describes receive-only RF coils for MRI, which are hardware components for signal acquisition. There is no mention of software processing, algorithms, or any terms related to AI/ML in the device description, intended use, or performance studies. The testing focuses on hardware safety and performance.
No
The devices are receive-only RF coils for MRI systems, designed for imaging various body parts, not for treating conditions.
Yes
Magnetic resonance imaging (MRI) is a diagnostic imaging modality that uses strong magnetic fields and radio waves to create detailed images of organs and tissues within the body. While the device itself is a coil that receives RF signals, its intended use is for imaging various parts of the body, which directly contributes to the diagnostic process by providing visual information to clinicians.
No
The device description clearly states it is a receive-only RF coil, which is a hardware component used in MRI systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The AIR Anterior Array and AIR Posterior Array are RF coils used in Magnetic Resonance Imaging (MRI) systems. They are designed to receive radiofrequency signals from the patient's body during an MRI scan.
- Intended Use: The intended use is for imaging various anatomical sites within the body using MRI. This is an in vivo (within the living body) diagnostic imaging technique, not an in vitro (outside the living body) diagnostic test.
- No Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient.
Therefore, the function and intended use of these RF coils clearly fall outside the scope of In Vitro Diagnostics. They are components of an MRI system used for diagnostic imaging of the body, not diagnostic testing of specimens from the body.
N/A
Intended Use / Indications for Use
The AIR Anterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. When used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging. The nucleus detected is hydrogen.
The AIR Posterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. The indications for use include spine. When used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. The nucleus detected is hydrogen.
Product codes
MOS
Device Description
The AIR Anterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone. The AIR Anterior Array contains 30 elements and the housing of the AIR Anterior Array is made of a soft, pliable material that conforms to the patient's anatomy. The coil is padded with a soft material designed to maximize patient comfort.
The AIR Posterior Array is a receive-only coil designed to provide optimum signal-to noise ratio and uniform coverage of the spine, abdomen, torso, pelvis, prostate, cardiac, hips and long bone. The AIR Posterior Array contains 60 elements and is embedded within the patient table of the MR System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
AIR Anterior Array: chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging.
AIR Posterior Array: spine, abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 MS 6-2008 MS 9-2008 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 AIR Anterior Array and AIR Posterior Array, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 8, 2017
GE Healthcare Coils (USA Instruments, Inc.) Mary Mayka Regulatory Affairs Manager 1515 Danner Drive Aurora, Ohio 44202
Re: K172695
Trade/Device Name: AIR Anterior Array, AIR Posterior Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: November 3, 2017 Received: November 6, 2017
Dear Mary Mayka:
This letter corrects our substantially equivalent letter of November 22, 2017.
We have reviewed vour 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
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 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
2
Indications for Use
510(k) Number (if known)
Device Name AIR Anterior Array
Indications for Use (Describe)
The AIR Anterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. When used with other coils, the indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, peripheral vascular and long bone imaging. 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) |
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
Indications for Use
510(k) Number (if known)
Device Name AIR Posterior Array
Indications for Use (Describe)
The AIR Posterior Array is a receive-only RF coil designed for use with GE 3.0T MRI Systems. The indications for use include spine. When used with other coils, the indications for use also include abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging. 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) |
|---|---|
| --------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
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."
4
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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: | September 05, 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: | James D. McMahon |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Phone: 508-382-2858 | |
| Fax: 262-364-2785 |
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Image /page/5/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 letters are white, creating a contrast against the blue background. The logo is simple, recognizable, and represents the multinational conglomerate corporation.
GE Healthcare
510(k) Premarket Notification Submission
| AIR Anterior Array | AIR Posterior Array | |
|---|---|---|
| Device Trade Name: | AIR Anterior Array | AIR Posterior Array |
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty | Coil, Magnetic Resonance, Specialty |
| Classification Names: | Magnetic Resonance Diagnostic Device per | |
| 21 CFR 892.1000 | Magnetic Resonance Diagnostic Device per | |
| 21 CFR 892.1000 | ||
| Product Code: | MOS | MOS |
| Predicate Device(s): | 3.0T AA (K143345) | TDI Posterior Array (K143345) |
| Device Description: | The AIR Anterior Array is a receive-only coil | |
| designed to provide optimum signal-to noise | ||
| ratio and uniform coverage of the chest, cardiac, | ||
| abdomen, torso, pelvis, prostate, hips, peripheral | ||
| vascular and long bone. The AIR Anterior Array | ||
| contains 30 elements and the housing of the AIR | ||
| Anterior Array is made of a soft, pliable material | ||
| that conforms to the patient's anatomy. The coil | ||
| is padded with a soft material designed to | ||
| maximize patient comfort. | The AIR Posterior Array is a receive-only coil | |
| designed to provide optimum signal-to noise | ||
| ratio and uniform coverage of the spine, | ||
| abdomen, torso, pelvis, prostate, cardiac, hips | ||
| and long bone. The AIR Posterior Array contains | ||
| 60 elements and is embedded within the patient | ||
| table of the MR System. | ||
| Intended Use: | The AIR Anterior Array is a receive-only RF | |
| coil designed for use with GE 3.0T MRI | ||
| systems. When used with other coils, the | ||
| indications for use include chest, cardiac, | ||
| abdomen, torso, pelvis, prostate, hips, peripheral | ||
| vascular, and long bone imaging. The nucleus | ||
| detected is hydrogen. | The AIR Posterior Array is a receive-only RF | |
| coil designed for use with GE 3.0T MRI | ||
| Systems. The indications for use include spine. | ||
| When used with other coils, the indications for | ||
| use also include abdomen, torso, pelvis, prostate, | ||
| cardiac, hips, and long bone imaging. The | ||
| nucleus detected is hydrogen. |
Page 2 of 6
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GE Healthcare
510(k) Premarket Notification Submission
| AIR Anterior Array | AIR Posterior Array | |
|---|---|---|
| Comparison of | ||
| Intended Use: | Both the AIR Anterior Array 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 AIR | ||
| Anterior Array and the predicate device are | ||
| indicated for the same patient population, and | ||
| for the same clinical setting. The predicate | ||
| device, the 3.0T AA, is one coil as part of the | ||
| TDI Coil Suite and covers brachial-plexus, pelvis, | ||
| hips, prostate, abdominal, cardiac, lower extremities, | ||
| blood, vessels, or long bone anatomies. Therefore, | ||
| GE Healthcare believes that the AIR Anterior | ||
| Array 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. | Both the AIR Posterior Array 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 AIR | ||
| Posterior Array and the predicate device are | ||
| indicated for the same patient population, and for | ||
| the same clinical setting. The predicate device, | ||
| the 3.0T AA, is one coil as part of the TDI Coil | ||
| Suite and covers pelvis, hips, prostate, abdominal, | ||
| cardiac, lower extremities, or long bone anatomies. | ||
| Therefore, GE Healthcare believes that the AIR | ||
| Posterior Array 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 AIR Anterior Array employs the | |
| same fundamental scientific technology as its | ||
| predicate device. |
Coil Design: The most notable technological
differences between the AIR Anterior Array and
the predicate 3.0T AA is that | Overall, the AIR Posterior Array employs the
same fundamental scientific technology as its
predicate device.
Coil Design: The most notable technological
difference between the AIR Posterior Array and
the predicate TDI Posterior Array is that the AIR |
Page 3 of 6
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the space between the letters and the border is filled with a light blue color. The overall design is simple, recognizable, and conveys a sense of tradition and innovation.
GE Healthcare
510(k) Premarket Notification Submission
| AIR Anterior Array | AIR Posterior Array |
|---|---|
| 1) the AIR Anterior Array contains 30 | |
| elements as compared to the predicate's | |
| 16 elements and | Anterior Array contains 60 elements as |
| compared to the predicate's 32 elements. | |
| 2) The housing of the AIR Anterior Array | |
| is made of a soft, pliable material that | |
| conforms to the patient's anatomy as | |
| compared to the predicate's semi-rigid | |
| construction. | |
| Operating Principles: The AIR Anterior Array and AIR Posterior Array both operate on the same | |
| principles as the predicate devices. | |
| Materials: The AIR Anterior Array and AIR Posterior Array and the predicate devices use flame | |
| retardant materials. | |
| Safety and Performance Testing: The AIR Anterior Array and AIR Posterior Array and the | |
| predicate devices comply 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 | |
| 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 MS 6-2008 MS 9-2008 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 AIR | |
| Anterior Array and AIR Posterior Array, 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 AIR | |
| Anterior Array and AIR Posterior Array 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 AIR Anterior Array and AIR Posterior Array are | |
| substantially equivalent to the predicate devices to which | |
| they have been compared. | |
| Conclusion: | GE Healthcare considers the AIR Anterior Array and AIR |
| Posterior Array to be as safe, as effective, and performance | |
| is substantially equivalent to the predicate devices. |
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