(14 days)
Not Found
No
The summary describes a passive MRI coil and does not mention any software or processing capabilities that would involve AI/ML.
No.
This device is for diagnostic imaging (MRI) and not for treating conditions.
No
The device is a coil that produces diagnostic images, but it does not interpret or diagnose conditions itself. It is a tool for image acquisition, not diagnosis. The "Intended Use" states that the images "can be interpreted by a trained physician," implying the device's role is to generate the images, not to perform the interpretation.
No
The device description clearly states it is a "receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI)". This describes a physical hardware component used in MRI systems, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The 16ch Foot/Ankle SPEEDER coil is a component used in a Magnetic Resonance Imaging (MRI) system. Its purpose is to receive signals from the body during an MRI scan to produce diagnostic images.
- Nature of Use: This device is used externally and non-invasively on the patient's foot and ankle. It does not involve the analysis of samples taken from the body.
Therefore, the device falls under the category of a medical imaging accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI)
Anatomical Site
foot and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing: All surface materials 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: Verified in accordance with AAMI/ANSI ES60601-1 and IEC 60601-2-33. Surface heating tested in accordance with AAMI/ANSI ES60601-1, with measured temperature never exceeding 41°C.
Performance Testing - Bench: SNR and uniformity analyzed per NEMA MS 6 and NEMA MS 9 and conformed to predetermined acceptance criteria.
Performance Testing - Clinical: Clinical images from volunteer scanning of the foot and ankle were obtained to demonstrate that the 16ch Foot/Ankle SPEEDER produces diagnostic quality images of the intended anatomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) | 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.