(76 days)
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.
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.
The provided text describes GE Healthcare's AIR Anterior Array and AIR Posterior Array, which are receive-only RF coils for GE 3.0T MRI Systems. The submission focuses on demonstrating substantial equivalence to predicate devices (3.0T AA for Anterior Array and TDI Posterior Array for Posterior Array, both K143345) rather than proving performance against specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and performance against those criteria as would be found in a study for a new clinical claim is not present.
However, I can extract the information that is available regarding the comparison to predicate devices and the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission demonstrating substantial equivalence to existing predicate devices, explicit, quantifiable "acceptance criteria" for a new clinical performance claim are not provided in the same way they would be for a de novo device or a device seeking a novel indication. Instead, the "acceptance criteria" are implied by compliance with established standards and comparable performance to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Safety and Electrical Standards Compliance | The AIR Anterior Array and AIR Posterior Array comply with relevant safety and performance testing, including:AAMI/ANSI ES60601-1IEC 60601-1-2IEC 60601-2-33MS 6-2008MS 9-2008Maximum B1 peakNetwork blocking analysisHeat Testing |
| Biocompatibility | 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. |
| Functional Equivalence (Imaging Quality) | The sample clinical images included in the submission, along with the conclusion of substantial equivalence, implicitly demonstrate comparable imaging quality to the predicate devices for their indicated uses. The statement: "The indications for use of the proposed devices are comparable to the claimed predicate devices. ... Additionally, the results from the above non-clinical tests demonstrate that the devices perform as intended" supports this. |
| Manufacturing Quality Assurance | The following quality assurance measures were applied: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level testing (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation). |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "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." This indicates that a formal test set, in the sense of a clinical trial or large-scale evaluation, was not conducted. The "sample clinical images" suggest a limited number of images were used for visual comparison, but the exact number, their provenance, or whether they constituted a formal "test set" for quantitative analysis is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that formal clinical studies were not required and "sample clinical images" were provided, it is highly unlikely that a formal ground truth establishment process involving multiple experts was undertaken for these images. The evaluation would have likely been internal to GE Healthcare’s regulatory and engineering teams, comparing the images to those obtained with the predicate device. Therefore, this information is not available.
4. Adjudication Method for the Test Set
As a formal test set and expert review for ground truth are not described, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The submission explicitly states "do not require clinical studies to support substantial equivalence." The focus is on demonstrating equivalence through technical comparison and non-clinical testing.
6. Standalone (Algorithm Only) Performance Study
These devices are MRI coils, which are hardware components, not algorithms. Therefore, a standalone (algorithm only) performance study is not applicable. The performance is intrinsically linked to the MRI system.
7. Type of Ground Truth Used
For the "sample clinical images," the ground truth implicitly would have been standard clinical interpretation by radiologists, but this was not part of a formal study with documented "ground truth" establishment. For the non-clinical tests, the ground truth was derived from the compliance with engineering standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, etc.) and successful completion of internal verification and validation activities.
8. Sample Size for the Training Set
There are no algorithms or AI described for these devices, so the concept of a "training set" is not applicable. The devices are hardware components (MRI coils).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for these devices.
{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 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}------------------------------------------------
Image /page/4/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 has a decorative border with wave-like patterns around the edge.
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 DriveAurora, OH 44202USA |
| Primary Contact Person: | Mary A. Mayka, Ph.D.Regulatory Affairs ManagerGE HealthcarePhone: 262-527-3148Fax: 262-364-2785 |
| Secondary Contact Person: | James D. McMahonRegulatory Affairs DirectorGE HealthcarePhone: 508-382-2858Fax: 262-364-2785 |
{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, 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 per21 CFR 892.1000 | Magnetic Resonance Diagnostic Device per21 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 coildesigned to provide optimum signal-to noiseratio and uniform coverage of the chest, cardiac,abdomen, torso, pelvis, prostate, hips, peripheralvascular and long bone. The AIR Anterior Arraycontains 30 elements and the housing of the AIRAnterior Array is made of a soft, pliable materialthat conforms to the patient's anatomy. The coilis padded with a soft material designed tomaximize patient comfort. | The AIR Posterior Array is a receive-only coildesigned to provide optimum signal-to noiseratio and uniform coverage of the spine,abdomen, torso, pelvis, prostate, cardiac, hipsand long bone. The AIR Posterior Array contains60 elements and is embedded within the patienttable of the MR System. |
| Intended Use: | The AIR Anterior Array is a receive-only RFcoil designed for use with GE 3.0T MRIsystems. When used with other coils, theindications for use include chest, cardiac,abdomen, torso, pelvis, prostate, hips, peripheralvascular, and long bone imaging. The nucleusdetected is hydrogen. | The AIR Posterior Array is a receive-only RFcoil designed for use with GE 3.0T MRISystems. The indications for use include spine.When used with other coils, the indications foruse also include abdomen, torso, pelvis, prostate,cardiac, hips, and long bone imaging. Thenucleus detected is hydrogen. |
Page 2 of 6
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The color of the letters and the border is a light blue.
GE Healthcare
510(k) Premarket Notification Submission
| AIR Anterior Array | AIR Posterior Array | |
|---|---|---|
| Comparison ofIntended Use: | Both the AIR Anterior Array and the predicatedevice are classified as coils for magneticresonance imaging devices and are intended fordiagnostic use. Both indications for usestatements are functional in nature, and do notlist specific diseases or conditions. The AIRAnterior Array and the predicate device areindicated for the same patient population, andfor the same clinical setting. The predicatedevice, the 3.0T AA, is one coil as part of theTDI 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 AnteriorArray has the same intended use as the predicatedevice in accordance with the FDA's guidancedocument "The 510(k) Program: EvaluatingSubstantial Equivalence in PremarketNotifications [510(k)]", dated 28 July 2014. | Both the AIR Posterior Array and the predicatedevice are classified as coils for magneticresonance imaging devices and are intended fordiagnostic use. Both indications for usestatements are functional in nature, and do notlist specific diseases or conditions. The AIRPosterior Array and the predicate device areindicated for the same patient population, and forthe same clinical setting. The predicate device,the 3.0T AA, is one coil as part of the TDI CoilSuite and covers pelvis, hips, prostate, abdominal,cardiac, lower extremities, or long bone anatomies.Therefore, GE Healthcare believes that the AIRPosterior Array has the same intended use as thepredicate device in accordance with the FDA'sguidance document "The 510(k) Program:Evaluating Substantial Equivalence in PremarketNotifications [510(k)]", dated 28 July 2014. |
| Comparison ofTechnologicalCharacteristics: | Overall, the AIR Anterior Array employs thesame fundamental scientific technology as itspredicate device.Coil Design: The most notable technologicaldifferences between the AIR Anterior Array andthe predicate 3.0T AA is that | Overall, the AIR Posterior Array employs thesame fundamental scientific technology as itspredicate device.Coil Design: The most notable technologicaldifference between the AIR Posterior Array andthe predicate TDI Posterior Array is that the AIR |
Page 3 of 6
{7}------------------------------------------------
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 30elements as compared to the predicate's16 elements and | Anterior Array contains 60 elements ascompared to the predicate's 32 elements. |
| 2) The housing of the AIR Anterior Arrayis made of a soft, pliable material thatconforms to the patient's anatomy ascompared to the predicate's semi-rigidconstruction. | |
| Operating Principles: The AIR Anterior Array and AIR Posterior Array both operate on the sameprinciples as the predicate devices. | |
| Materials: The AIR Anterior Array and AIR Posterior Array and the predicate devices use flameretardant materials. | |
| Safety and Performance Testing: The AIR Anterior Array and AIR Posterior Array and thepredicate devices comply with the same safety and performance testing (see Determination ofSubstantial Equivalence, below). | |
| These technological differences do not raise any different questions of safety and effectiveness. | |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests: |
| The predicate and modified devices have been subject tosimilar risk management testing to demonstrate substantialequivalence 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 asuccessful biocompatibility track record, as demonstratedby ISO 10993 testing and by their history of use inpreviously cleared devices. | |
| The following quality assurance measures were applied tothe 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 AIRAnterior Array and AIR Posterior Array, do not requireclinical studies to support substantial equivalence. Sampleclinical images have been included in this submission. | |
| Substantial Equivalence Conclusion: | |
| The indications for use of the proposed devices arecomparable to the claimed predicate devices. The AIRAnterior Array and AIR Posterior Array employsequivalent technology to the claimed predicate devices.Additionally, the results from the above non-clinical testsdemonstrate that the devices perform as intended. Thus,the AIR Anterior Array and AIR Posterior Array aresubstantially equivalent to the predicate devices to whichthey have been compared. | |
| Conclusion: | GE Healthcare considers the AIR Anterior Array and AIRPosterior Array to be as safe, as effective, and performanceis substantially equivalent to the predicate devices. |
{8}------------------------------------------------
Image /page/8/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 that has a swirling, decorative pattern around the edge. The logo is presented in a blue color.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by decorative swirls, also in blue, which add a sense of motion and elegance to the design.
§ 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.