The 16ch T/R Knee Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

Device Description

The 16ch T/R Knee 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 Knee Coil is intended to be used for imaging the knee.

The 16ch T/R Knee 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 16ch T/R Knee Coil is provided with patient comfort pads.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "16ch T/R Knee Coil." It is a regulatory submission to the FDA proving substantial equivalence to a predicate device. As such, it does not contain the detailed study information typically found in a clinical trial report or a performance study for AI/CADe devices.

Specifically, this submission is for an imaging coil for an MRI system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device, nor one that interprets images. Therefore, many of the requested categories related to AI/CADe performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this device are focused on engineering performance, safety, and imaging quality, rather than diagnostic accuracy by an algorithm.

Here's the relevant information that can be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied/Stated)	Reported Device Performance
Biocompatibility	Materials in human contact must be safe.	All surface materials have a history of safe use in previously-cleared devices.
Electrical Safety	Compliance with AAMI/ANSI ES60601-1.	Tested to and found to be compliant with AAMI/ANSI ES60601-1.
Electromagnetic Compatibility	Compliance with IEC 60601-2-33.	Tested to and found to be compliant with IEC 60601-2-33.
Surface Heating	Surface temperature not exceeding 41°C.	Measured temperature never exceeded the maximum limit of 41°C.
Local SAR Limits	Local SAR (Specific Absorption Rate) within IEC 60601-2-33 partial body limits.	Simulation showed local SAR limits are below IEC 60601-2-33 partial body limits.
Image Signal-to-Noise Ratio (SNR)	Conformance to predetermined acceptance criteria per NEMA MS 1 and MS 3.	Analyzed per NEMA MS 1 and MS 3 and found to conform to predetermined acceptance criteria.
Image Uniformity	Conformance to predetermined acceptance criteria per NEMA MS 1 and MS 3.	Analyzed per NEMA MS 1 and MS 3 and found to conform to predetermined acceptance criteria.
Diagnostic Image Quality	Production of diagnostic quality images of the knee.	Clinical images from volunteer scanning demonstrated the production of diagnostic quality images.

Study that proves the device meets the acceptance criteria:

The document describes the following "Performance data" or studies:

Biocompatibility Testing: Demonstrated via history of safe use of materials.
Electrical Safety and Electromagnetic Compatibility Testing: Device was tested to and found compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33 standards.
Surface Heating Testing: Measurements showed the surface temperature did not exceed 41°C.
Finite-Difference Time-Domain Electromagnetic Simulation: Performed to confirm SAR limits were met.
Bench Performance Testing (SNR and Uniformity): Analyzed per NEMA MS 1 and NEMA MS 3 standards, conforming to predetermined acceptance criteria.
Clinical Performance Testing: Clinical images from volunteer scanning of the knee were obtained and used to demonstrate diagnostic quality. This was done in accordance with the FDA Guidance for Industry: Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: For the "Clinical Performance Testing," the document mentions "clinical images from volunteer scanning." It does not specify the number of volunteers or images (sample size).
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable in the context of this device. The "ground truth" here is about the physical characteristics and image quality of the coil itself, not diagnostic interpretations from images by experts in a comparative study. The device produces images "that can be interpreted by a trained physician," implying the images enable diagnosis, but it does not claim to make diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a study requiring expert adjudication of diagnostic outcomes.

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

Not applicable. This is not an AI/CADe device, and no MRMC study, or study involving human readers' diagnostic improvement with AI assistance, was performed or presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Clinical Performance Testing" related to diagnostic image quality, the "ground truth" is simply the visual assessment that the images are of "diagnostic quality." This is typically a qualitative assessment by qualified personnel (not necessarily a formal "expert consensus" in the sense of a clinical study, but rather a determination that the images fulfill their purpose). For the bench tests (SNR, uniformity, safety), the ground truth is defined by the standards (NEMA, IEC) and physical measurements.

8. The sample size for the training set

Not applicable. This device does not have a "training set" as it is an MRI coil, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 18, 2016

Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 6655 Beta Drive. Suite 100 MAYFIELD VILLAGE OH 44143

Re: K162029

Trade/Device Name: 16ch T/R Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 22, 2016 Received: July 22, 2016

Dear Ms. Aras:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

For

Robert 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) K162029

Device Name 16ch T/R Knee Coil

Indications for Use (Describe)

The 16ch T/R Knee Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Applicant 1.

Quality Electrodynamics, LLC. (QED) 6655 Beta Drive, Suite 100 Mayfield Village, OH 44143

2. Contact

Kathleen Aras Director, Regulatory and Quality Affairs (440) 484-2964 kathleen.aras@qualedyn.com

3. Date Prepared

22 July 2016

4. Tradenames

16ch T/R Knee Coil

5. Common name

Coil, magnetic resonance, specialty

6. Model Numbers

QED Model Number: Q7000075

GE Model Number: 5718233-2

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 Device

18Ch T/R Knee Coil, Quality Electrodynamics, LLC., K150331

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Device Description 9.

10. Indications for Use

The 16ch T/R Knee Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

The Indications for Use statement for the 16ch T/R Knee Coil is not identical to 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 Knee Coil and predicate 18ch T/R Knee Coil indicate that the device is intended to be used in conjunction with a MR system to produce images of the knee and that the images can be interpreted by a trained physician. The Indications for Use statements differ only in MR scanner field strength and number of channels; the predicate is intended to be used with a 3T GE MR system and has 18 channels while the proposed device is intended to be used with a 1.5T GE MR system and has 16 channels.

11. Summary of Technological Characteristics Compared to the Predicate Device

At a high level, the subject and predicate devices are based on the following same technological elements:

Transmit/receive phased array RF coils .
Active PIN diode switching blocking circuitry. Passive blocking . circuitry.
Split-top mechanical design with an inner cross section shaped to fit ● the knee and leg

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Polycarbonate housing material .
The following technological differences exist between the subject and predicate devices:
Number of channels (16 (subject) versus 18 (predicate)) ●
Field Strength of MR system (1.5T (subject) 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 Knee 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 Knee 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 Knee Coil are below the IEC 60601-2-33 partial body limits.

Performance Testing - Bench

The SNR and uniformity of the 16ch T/R Knee 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 knee were obtained from the 16ch T/R Knee Coil. These images were used to

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demonstrate that the 16ch T/R Knee Coil produces diagnostic quality images of the intended anatomy.

13. Conclusion

The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the 16ch T/R Knee 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 Knee Coil performs as well as or better than the predicate device.

Regulation Number and Section

§ 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.