The 16ch T/R Hand Wrist Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the hand and wrist that can be interpreted by a trained physician.

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 3.0T 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.

AI/ML Overview

The provided text describes the performance data for the 16ch T/R Hand Wrist Coil, a magnetic resonance diagnostic device. Below is a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	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	Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Electromagnetic Compatibility	Compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Surface Heating	Measured temperature of the surface of the coil never exceeded the maximum limit of 41°C, in accordance with AAMI/ANSI ES60601-1.
Local SAR Limits	Finite-difference time-domain electromagnetic simulation showed local SAR limits for the coil are below the IEC 60601-2-33 partial body limits.
Signal-to-Noise Ratio (SNR)	Analyzed per NEMA MS 1 and found to conform to predetermined acceptance criteria.
Uniformity	Analyzed per NEMA MS 3 and found to conform to predetermined acceptance criteria.
Diagnostic Image Quality	Clinical images from volunteer scanning of the hand and wrist demonstrated that the 16ch T/R Hand Wrist coil produces diagnostic quality images of the intended anatomy.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for the "clinical images from volunteer scanning." The term "volunteer scanning" suggests a prospective collection of data.
Data Provenance: The document states "clinical images from volunteer scanning of the hand and wrist were obtained from the 16ch T/R Hand Wrist coil." The specific country of origin is not mentioned, but the manufacturing company (Quality Electrodynamics, LLC.) is based in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: The document states images "can be interpreted by a trained physician," but does not specify the qualifications of the physician(s) who established ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It mentions images were used to "demonstrate that the 16ch T/R Hand Wrist coil produces diagnostic quality images," implying an assessment of image quality, but not a specific adjudication process involving multiple readers or complex diagnostic decision-making.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention that an MRMC comparative effectiveness study was done.
The study focuses on the coil's performance in isolation ("standalone") to demonstrate its ability to produce diagnostic quality images.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance assessment was conducted for the device itself and its physical and image quality characteristics. The bench testing (SNR, uniformity) and the clinical imaging demonstrating diagnostic quality are evaluations of the device's inherent performance. There's no AI algorithm mentioned, so "algorithm only" isn't directly applicable in the usual sense for AI/ML devices. Instead, it's the raw performance of the imaging hardware.

7. Type of Ground Truth Used for the Test Set

The ground truth for the clinical image quality assessment appears to be based on an expert assessment of "diagnostic quality." This implies a qualitative judgment by a presumably trained physician (as per the Indications for Use) that the images are sufficient for diagnosis. It is not pathology, or explicit outcomes data.

8. Sample Size for the Training Set

No training set is applicable or mentioned in the context of this device. This is a medical device for MR imaging hardware (a coil), not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for this device.

Summary

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

December 16, 2016

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

Re: K162623

Trade/Device Name: 16ch T/R Hand Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 19, 2016 Received: September 20, 2016

Dear Ms. Aras:

This letter corrects our substantially equivalent letter of December 9, 2016.

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/ResourcesforYou/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'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) K162623

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 3.0T 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)

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

1. Applicant

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@gualedyn.com

3. Date Prepared

19 September 2016

Tradenames 4.

16ch T/R Hand Wrist Coil

5. Common name

Coil, magnetic resonance, specialty

6. Model Numbers

QED Model Number: Q7000152

GE Model Number: 5561531-2

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

1.5T 16-Channel Hand-Wrist Coil, Invivo Corporation, K103149 (Primary Predicate)

18Ch T/R Knee Coil, Quality Electrodynamics, LLC., K150331 (Secondary Predicate)

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9. Device Description

10. Indications for Use

The 16ch T/R Hand Wrist Coil is intended for use with GE 3.0T 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 devices; 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 predicates. Both Indications for Use statements for the 16ch T/R Hand Wrist coil and primary predicate 1.5T 16-Channel 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 3.0T MR systems rather than 1.5T MR systems.

The secondary predicate 18ch T/R Knee Coil utilizes the same transmitreceive technology, utilizes same materials, and is similarly compatible with 3.0T MR systems as the proposed 16ch T/R Hand Wrist coil.

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:

Intended to provide images of the hand and wrist (primary predicate) .
16 channels (primary predicate) .
Transmit/receive, phased array RF coils (secondary predicate) ●

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Hinged "clamshell" mechanical design (primary predicate) .
Housing materials are flame, impact resistant and biocompatible . (secondary predicate)
Compatible with GE 3.0T MR systems (secondary predicate) o

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

The electrical safety and electromagnetic compatibility and 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.

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.