(29 days)
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.
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.
This document describes the 510(k) premarket notification for GE Healthcare Coils. It focuses on establishing substantial equivalence for several new 1.5T MRI receive-only RF coils: 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA, compared to a predicate device (3.0T Anterior Array, K172695).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical performance metrics for the new coils that are then compared against specific thresholds. Instead, it describes compliance with various safety and performance testing standards and states a general conclusion of substantial equivalence in performance to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety Testing | |
| AAMI/ANSI ES60601-1 | Complies |
| IEC 60601-1-2 | Complies |
| IEC 60601-2-33 | Complies |
| NEMA MS 6 | Complies |
| NEMA MS 9 | Complies |
| Maximum B1 peak | Tested |
| Network blocking analysis | Tested |
| Heat Testing | Tested |
| Biocompatibility (ISO 10993) | Successful track record |
| Performance Testing | |
| Adequate Image Quality | Clinical images included that support diagnostic use; non-clinical tests demonstrate devices perform as intended, comparable to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" with a defined sample size for quantitative evaluation in the same way a clinical trial would. Clinical images were included in the submission, implying a small set for demonstration, but no specific count or details of patient cases used for formal performance evaluation are provided.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal GE Healthcare evaluations rather than external multi-center trials. The clinical images are for demonstration, not a formal prospective or retrospective study for device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states that the new coils produce "diagnostic images...that can be interpreted by a trained physician" (referencing the Siemens predicate's IFU), but it doesn't detail external expert review for the submitted clinical images or the "ground truth" establishment process.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the lack of a formally described "test set" and expert review process for ground truth, an adjudication method is not mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This submission is for MRI coils, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This submission is for MRI coils, which are hardware components, not an algorithm. Therefore, no standalone algorithm performance was evaluated.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology as ground truth for a CAD system) is not directly applicable here. The submission focuses on demonstrating the functional equivalence of image quality and safety for the coils. Clinical images were included, presumably to visually demonstrate acceptable image quality, but without a formal ground truth comparison for diagnostic accuracy of specific conditions. The ground truth for safety and performance is based on compliance with established engineering and medical device standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. These are hardware devices (MRI coils), not machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for these hardware devices.
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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
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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 DriveAurora, OH 44202USA |
| Primary Contact Person: | Veronica MeridithRegulatory Affairs LeaderGE HealthcarePhone: 262-955-5427Fax: 414-908-9585 |
| Secondary Contact Person: | Andrew MendenRegulatory Affairs ManagerGE HealthcarePhone: 262-521-6223Fax: 414-908-9585 |
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| Device Trade Name: | 1.5T AIR MP M1.5T AIR MP L1.5T 16ch AIR AA1.5T 30ch AIR AA |
|---|---|
| Common/UsualName: | 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 AIRAA are receive-only coils designed to provide optimum signal-to noise ratio anduniform coverage of general human anatomy including extremities and aredesigned for use with GE 1.5T MRI Systems. These are 20, 21, 16, and 30element coils tuned to image proton nuclei. Each coil element has an integratedpreamplifier to improve image quality. These coils are provided with P-connectors. The coils have a soft material to conform to the patient's anatomyand maximize patient comfort. Due to the flexibility of the coils, a coil holdermay 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 AIRAA are receive only RF coils designed for use with GE 1.5T MRI systems toproduce diagnostic images on general human anatomy including extremities. Thenucleus detected is hydrogen. |
| Comparison ofIntended Use: | The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIRAA and the predicate device are classified as coils for magnetic resonanceimaging devices and are intended for diagnostic use. Both indications for usestatements are functional in nature, and do not list specific diseases orconditions. The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and1.5T 30ch AIR AA and the predicate device are indicated for the same patientpopulation, 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. TheSiemens Contour 24 coil Indications for Use is: "The Contour 24 is intended foruse with Siemens 3.0T MR systems to produce diagnostic images of generalhuman 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 thepredicate 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 ofTechnologicalCharacteristics: | The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and 1.5T 30ch AIRAA and the predicate device share many common technological characteristics.Details can be found in the table below, which shows the high-level devicedescription for all four new coils as compared to the predicate device:The most notable technological differences between the new coils and thepredicate device is that the new devices contain (respectively):20 elements21 elements16 elements30 elementsPredicate: 30 elementsThe predicate is used on GE 3.0T MRI Systems while the new devices are foruse with GE 1.5T MRI systems.These technological differences do not raise any different questions of safety andeffectiveness. All devices must address questions of whether they provide anadequate level of image quality appropriate for diagnostic use. The performancedata described in this submission include results of both bench testing andclinical 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 thepredicate device.Operating Principles: The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIRAA, and 1.5T 30ch AIR AA operate on the same principles as the predicatedevices.Materials: The 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, and1.5T 30ch AIR AA electrical elements and associated circuitry are supportedthroughout the coil by flame rated V2 co-polyester injection mold enclosure andV0 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, 1.5T16ch AIR AA, and 1.5T 30ch AIR AA and the predicate devices comply withthe same safety and performance testing (see Determination of SubstantialEquivalence, below). |
| Determination ofSubstantialEquivalence: | Summary of Non-Clinical Tests:The predicate and modified devices have been subject to similar riskmanagement testing to demonstrate substantial equivalence of safety andperformance. 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 successfulbiocompatibility track record, as demonstrated by ISO 10993 testing and by theirhistory of use in previously cleared devices. | |
| The following quality assurance measures were applied to the development ofthe 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 MPL, 1.5T 16ch AIR AA, and 1.5T 30ch AIR AA, do not require clinical studies tosupport substantial equivalence. Sample clinical images have been included inthis submission. | |
| Substantial Equivalence Conclusion:The indications for use of the proposed devices are comparable to the claimedpredicate 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 predicatedevices. Additionally, the results from the above non-clinical tests demonstratethat the devices perform as intended. Thus, the 1.5T AIR MP M and 1.5T AIRMP L are substantially equivalent to the predicate devices to which they havebeen compared. | |
| Conclusion: | GE Healthcare considers the 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIRAA, and 1.5T 30ch AIR AA to be as safe, as effective, and performance issubstantially equivalent to the predicate devices. |
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GE Healthcare 510(k) Premarket Notification Submission
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§ 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.