← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K181697

# 16ch Foot/ Ankle SPEEDER (K181697)

_Quality Electrodynamics, LLC · MOS · Jul 11, 2018 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K181697

## Device Facts

- **Applicant:** Quality Electrodynamics, LLC
- **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md)
- **Decision Date:** Jul 11, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Intended Use

The 16ch Foot/Ankle SPEEDER coil is intended for use with Canon 3.0T MR systems to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

## Device Story

The 16ch Foot/Ankle SPEEDER is a receive-only, 16-channel phased array RF coil; designed for use with Canon 3.0T MRI systems. The device captures radiofrequency signals from the foot and ankle anatomy; transforming these signals into diagnostic images for interpretation by a trained physician. It features a rigid, fire-rated plastic housing with flexible flaps to accommodate patient anatomy. Used in clinical imaging environments; the coil is operated by MRI technicians or radiologists. The resulting images assist physicians in diagnosing foot and ankle pathologies. The device benefits patients by providing high-quality diagnostic imaging for clinical decision-making.

## Clinical Evidence

Bench testing only. Performance verified via SNR and uniformity analysis per NEMA MS 6 and NEMA MS 9. Electrical safety and EMC verified per AAMI/ANSI ES60601-1 and IEC 60601-2-33; surface heating remained below 41°C. Clinical evidence consists of volunteer scanning to demonstrate diagnostic image quality.

## Technological Characteristics

Receive-only, 16-channel phased array RF coil. Materials: fire-rated, biocompatible plastic housing. Energy: RF signal reception for 3.0T MRI. Standards: AAMI/ANSI ES60601-1, IEC 60601-2-33, NEMA MS 6, NEMA MS 9. Connectivity: Dedicated interface for Canon 3.0T MR systems.

## Regulatory 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).

## Special Controls

*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.

## Predicate Devices

- Shoulder SPEEDER, Quality Electrodynamics ([K102489](/device/K102489.md))

## Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Quality Electrodynamics, LLC Eric Yeh Senior Regulatory Affairs Specialist 6655 Beta Drive Suite 100 Mayfield Village, Ohio 44143

Re: K181697

Trade/Device Name: 16ch Foot/ Ankle SPEEDER Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: June 26, 2018 Received: June 27, 2018

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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

July 10, 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 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,

Image /page/1/Picture/5 description: The image shows the name "Patrick Hintz -S" in a large font. Below the name is the word "for" in a smaller font. To the right of the name is a digital signature from Patrick Hintz -S, dated 2018.07.11 09:07:09-04'00'.

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) k181697

Device Name 16ch Foot/Ankle SPEEDER

Indications for Use (Describe)

The 16ch Foot/Ankle SPEEDER coil is intended for use with Canon 3.0T MR systems to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

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

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------|-----------------------------------------------------------|
|------------------------------------------------------------|-----------------------------------------------------------|

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# 510(k) Summary

#### 1. Applicant

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

#### 2. Contact

Eric Yeh Senior Regulatory Affairs Specialist (440) 484-2940 eric.yeh@qualedyn.com

#### 3. Date Prepared

26 June 2018

#### 4. Tradenames

16ch Foot/Ankle SPEEDER

#### 5. Common name

Coil, magnetic resonance, specialty

#### Model Numbers 6.

QED Model Number: Q7000073

Canon Model Number: MJAJ-262A

This device is manufactured and sold by QED to Canon. Canon 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

Shoulder SPEEDER, Quality Electrodynamics, K102489

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#### 9. Device Description

The 16ch Foot/Ankle SPEEDER is a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using Canon 3.0T MR systems. The 16ch Foot/Ankle SPEEDER is intended to be used for foot and ankle imaging.

The 16ch Foot/Ankle SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in either a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility, or fire-rated flexible flaps that do not come into direct contact but can be easily adjusted to accommodate patients.

#### 10. Indications for Use

The 16ch Foot/Ankle SPEEDER is intended for use with Canon 3.0T MR systems to produce diagnostic images of the foot and ankle that can be interpreted by a trained physician.

The Indications for Use statement for the 16ch Foot/Ankle SPEEDER 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 Foot/Ankle SPEEDER and predicate Shoulder SPEEDER indicate that the device is intended to be used in conjunction with a 3.0T MR scanner to produce images of intended anatomies that can be interpreted by a trained physician. The indications for use statements differ only in that the proposed 16ch Foot/Ankle SPEEDER is intended to provide images of foot and ankle anatomies (subject) versus shoulder (predicate) and channel count of 16 (subject) versus 6 (predicate).

### 11. Summary of Technological Characteristics Compared to the Predicate Device

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

- Field strength of MR system (3T) ●
- . Receive-only, phased array RF coil
- Rigid enclosure contoured to fit anatomy with flexible flaps adjusted to accommodate patients

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- · Housing materials are flame, impact resistant and biocompatible
The following technological differences exist between the proposed and predicate device:

- Intended to provide images of anatomies (foot and ankle (proposed) versus shoulder (predicate))
- . Channel Count (16 (proposed) versus 6 (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 Foot/Ankle SPEEDER 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 electrical safety and electromagnetic compatibility of the 16ch Foot/Ankle SPEEDER was verified in accordance 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.

### Performance Testing - Bench

The SNR and uniformity of the 16ch Foot/Ankle SPEEDER was analyzed per NEMA MS 6 and NEMA MS 9 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 foot and ankle were obtained from the 16ch Foot/Ankle SPEEDER. These images were used to demonstrate that the 16ch Foot/Ankle SPEEDER produces diagnostic quality images of the intended anatomy.

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#### 13. Conclusion

electrical safety and electromagnetic compatibility The and biocompatibility data support the safety of the 16ch Foot/Ankle SPEEDER 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 Foot/Ankle SPEEDER performs as well as or better than the predicate device.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K181697](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K181697)

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