(62 days)
The 16ch T/R Hand Wrist Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.
The 16ch T/R Hand Wrist Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 1.5T MR systems. The 16ch T/R Hand Wrist Coil is intended to be used for imaging the hand and wrist.
The 16ch T/R Hand Wrist Coil is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing, which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
The provided text is a 510(k) summary for a medical device (16ch T/R Hand Wrist Coil) and does not describe an AI/ML powered device or a study involving such a device where acceptance criteria are set for AI performance metrics. Instead, it describes performance testing for a magnetic resonance imaging (MRI) coil.
Therefore, I cannot extract the requested information regarding AI device acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document discusses various performance tests relevant to an MRI coil, which are outlined below for completeness, but these do not directly address the prompt's request for AI device specific information.
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):
| Performance Metric | Acceptance Criteria | Reported Performance |
|---|---|---|
| Biocompatibility | Materials have a history of safe use in cleared devices | All surface materials a history of safe use |
| Electrical Safety | Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33 | Found to be compliant |
| Surface Heating | Measured temperature not to exceed 41°C | Never exceeded 41°C |
| SAR Limits | Local SAR limits below IEC 60601-2-33 partial body limits | Simulation showed local SAR limits are below IEC 60601-2-33 partial body limits |
| SNR and Uniformity | Conform to predetermined acceptance criteria | Found to conform to predetermined acceptance criteria per NEMA MS 1 and NEMA MS 3 |
| Diagnostic Quality Images | Produce diagnostic quality images of the intended anatomy | Clinical images from volunteer scanning demonstrated diagnostic quality images |
The following information cannot be extracted from the provided text as it pertains to AI/ML powered devices, which is not the subject of this 510(k) summary:
- Sample sizes used for the test set and the data provenance: Not applicable to a physical MRI coil. Clinical images were obtained from volunteer scanning, but the sample size is not specified for the diagnostic quality assessment.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for an MRI coil is its ability to produce good images for clinical interpretation, not an AI-derived diagnosis. The images are interpreted by a "trained physician".
- Adjudication method: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For the clinical image assessment of the coil, the "ground truth" is that the images are of "diagnostic quality" as interpreted by a trained physician. This is an outcome of the coil's performance, not a predefined ground truth for an algorithm.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Quality Electrodynamics, LLC Eric Yeh Regulatory Affairs Specialist 6655 Beta Drive Suite 100 Mayfield Village, Ohio 44143
Re: K173469
Trade/Device Name: 16ch T/R Hand Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 8, 2017 Received: November 8, 2017
Dear Eric Yeh:
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. 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 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.
January 9, 2018
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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'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) K173469
Device Name 16ch T/R Hand Wrist Coil
Indications for Use (Describe)
The 16ch T/R Hand Wrist Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.
| 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)
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510(k) Summary
Applicant 1.
Quality Electrodynamics, LLC. (QED) 6655 Beta Drive, Suite 100 Mayfield Village, OH 44143
2. Contact
Eric Yeh Regulatory Affairs Specialist (440) 484-2940 eric.yeh@qualedyn.com
3. Date Prepared
10 November 2017
4. Tradenames
16ch T/R Hand Wrist Coil
5. Common name
Coil, magnetic resonance, specialty
6. Model Numbers
QED Model Number: Q7000180
GE Model Number: 5768098-2
This device is manufactured and sold by QED to GE. GE sells the device to end users under their own model number.
7. Classification
Magnetic resonance diagnostic device (21 CFR 892.1000, Product Code MOS, Class II)
8. Predicate Devices
16ch T/R Hand Wrist Coil, Quality Electrodynamics, K162623
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9. Device Description
The 16ch T/R Hand Wrist Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 1.5T MR systems. The 16ch T/R Hand Wrist Coil is intended to be used for imaging the hand and wrist.
The 16ch T/R Hand Wrist Coil is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing, which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
10. Indications for Use
The 16ch T/R Hand Wrist Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.
The Indications for Use statement for the 16ch T/R Hand Wrist coil is not identical to that of the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both Indications for Use statements for the 16ch T/R Hand Wrist coil and predicate 16ch T/R Hand Wrist coil indicate that the device is intended to be used in conjunction with a MR scanner to produce images of the hand and wrist that can be interpreted by a trained physician. The indications for use statements differ only in that the proposed 16ch T/R Hand Wrist coil is intended to be used with 1.5T MR systems rather than 3.0T MR systems.
Summary of Technological Characteristics Compared to the 11. Predicate Device
At a high level, the proposed and predicate devices are based on the following same technological elements:
- Intended to provide images of the hand and wrist
- . 16 channels
- Transmit/receive, phased array RF coil
- Hinged "clamshell" mechanical design ●
- Housing materials are flame, impact resistant and biocompatible
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The following technological differences exist between the proposed and predicate device:
- Field strength of MR system (1.5T (proposed) versus 3.0T (predicate)) ●
12. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
All surface materials on the 16ch T/R Hand Wrist coil that are intended to come into direct or indirect contact with patient biological tissues, cells or body fluids have a history of safe use in previously-cleared devices.
Electrical Safety and Electromagnetic Compatibility
The 16ch T/R Hand Wrist coil was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Surface heating was tested in accordance with AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41°C.
A finite-difference time-domain electromagnetic simulation was performed to provide data supporting that the partial body limits for SAR are controlled within the limits described in IEC 60601-2-33. The simulation showed that the local SAR limits for the 16ch T/R Hand Wrist coil are below the IEC 60601-2-33 partial body limits.
Performance Testing - Bench
The SNR and uniformity of the 16ch T/R Hand Wrist coil was analyzed per NEMA MS 1 and NEMA MS 3 and was found to conform to predetermined acceptance criteria.
Performance Testing - Clinical
In accordance with the FDA Guidance for Industry: Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of the hand and wrist were obtained from the 16ch T/R Hand Wrist coil. These images were used to demonstrate that the 16ch T/R Hand Wrist coil produces diagnostic quality images of the intended anatomy.
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13. Conclusion
electrical safety and electromagnetic compatibility and The biocompatibility data support the safety of the 16ch T/R Hand Wrist coil and the bench testing per the NEMA standards and diagnostic quality sample clinical images demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the 16ch T/R Hand Wrist coil performs as well as or better than the predicate devices.
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TRUTHFUL AND ACCURATE STATEMENT
[As Required by 21 CFR 807.87(k)]
I certify that, in my capacity as Regulatory Affairs Specialist of Quality Electrodynamics, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
(Signature) Eric Yeh
10 November 2017
(Date) 510(k) number
Quality Electrodynamics, LLC. Traditional 510(k) 16ch T/R Hand Wrist Coil
CONFIDENTIAL Page | 6-2
§ 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.