(77 days)
Not Found
No
The summary describes a passive MRI coil and does not mention any AI/ML components or image processing capabilities.
No.
The device is clearly stated as intended "to produce diagnostic images" of various anatomical sites for interpretation by a physician. It is a receive-only coil for MRI, which is used for imaging, not for treatment.
Yes
The device is an MRI coil that produces "diagnostic images of the knee, wrist, hand, foot and ankle that can be interpreted by a trained physician." Its purpose is to aid in diagnosis.
No
The device is described as a physical coil with a rigid plastic housing and comfort pads, intended for use with an MRI system. It undergoes hardware-specific testing like biocompatibility, electrical safety, and surface heating.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The 8ch Knee-Foot SPEEDER Coil is a component of an MRI system. Its purpose is to receive radiofrequency signals from the body during an MRI scan to produce diagnostic images. This is an in vivo (within the living body) process.
- Intended Use: The intended use clearly states it's for producing diagnostic images of specific anatomical sites within the body.
- Device Description: The description reinforces its role as a receive-only coil for MRI, a non-invasive procedure.
The device is a medical device used for diagnostic imaging, but it does not perform testing on samples taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The 8ch Knee-Foot SPEEDER Coil is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the knee, wrist, hand, foot and ankle that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 8ch Knee-Foot SPEEDER coil is a receive-only, 8-channel phased array coil designed for magnetic resonance imaging (MRI) using the Toshiba 1.5T MR systems. The 8ch Knee-Foot SPEEDER coil is intended to be used for imaging the knee, wrist, hand, foot and ankle. The 8ch Knee-Foot SPEEDER 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 flame and impact resistant, and has been tested for biocompatibility. The 8ch Knee-Foot SPEEDER coil also includes the comfort pads listed in Table 10-1, which are provided with the coil shipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Knee, wrist, hand, foot, and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / 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 on the 8ch Knee-Foot SPEEDER 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 electrical safety and electromagnetic compatibility of the 8ch Knee-Foot SPEEDER coil 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 8ch Knee-Foot 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 knee, wrist, hand, foot and ankle were obtained from the 8ch Knee-Foot SPEEDER. These images were used to demonstrate that the 8ch Knee-Foot SPEEDER produces diagnostic quality images of the intended anatomies.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
Quality Electrodynamics, LLC (QED) % Ms. Kathleen Aras Director, Regulatory & Quality Affairs 6655 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143
Re: K162946
Trade/Device Name: 8ch Knee-Foot SPEEDER Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 19, 2016 Received: October 21, 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'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) K162946
Device Name 8ch Knee-Foot SPEEDER
Indications for Use (Describe)
The 8ch Knee-Foot SPEEDER Coil is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the knee, wrist, hand, 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)
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@qualedyn.com
3. Date Prepared
19 October 2016
4. Tradenames
8ch Knee-Foot SPEEDER
5. Common name
coil, magnetic resonance, specialty
Model Numbers 6.
QED Model Number: Q7000172
Toshiba Model Number: MJAJ-257A
This device is manufactured and sold by QED to Toshiba. Toshiba 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
8ch Knee SPEEDER, Quality Electrodynamics, K152695
9. Device Description
The 8ch Knee-Foot SPEEDER coil is a receive-only, 8-channel phased array coil designed for magnetic resonance imaging (MRI) using the
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Toshiba 1.5T MR systems. The 8ch Knee-Foot SPEEDER coil is intended to be used for imaging the knee, wrist, hand, foot and ankle.
The 8ch Knee-Foot SPEEDER 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 flame and impact resistant, and has been tested for biocompatibility.
The 8ch Knee-Foot SPEEDER coil also includes the comfort pads listed in Table 10-1, which are provided with the coil shipment.
| QED Part Number | Description | Qty |
|---|---|---|
| 3003890 | Anterior Knee Pad (1/4" Thick Pad) | 1 |
| 3003864 | Posterior Knee Support Pad (Bottom | |
| Thermoformed Pad) | 1 | |
| 3003866 | Free Leg Pad (Non-Imaged Knee Pad) | 1 |
| 3003865 | Inferior Leg Pad (Foot/Ankle Pad) | 1 |
| 3004802 | Ankle / Heel support pad for foot imaging | 1 |
| 3004823 | Wedge pad for foot imaging | 1 |
Table 10-1: 8ch Knee-Foot SPEEDER Coil Comfort Pads
10. Indications for Use
The 8ch Knee-Foot SPEEDER Coil is intended for use with Toshiba 1.5T MR systems to produce diagnostic images of the knee, wrist, hand, foot and ankle that can be interpreted by a trained physician.
The Indications for Use statement for the 8ch Knee-Foot SPEEDER 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. The proposed 8ch Knee-Foot SPEEDER coil is a modification to the predicate 8ch Knee SPEEDER coil that expands the intended use from knee, wrist, hand and forefoot to knee, wrist, hand, foot and ankle; thereby encompassing the whole foot and ankle. This is accomplished by adding a second anterior piece used for foot and ankle imaging. The posterior and knee anterior piece remain identical to the predicate 8ch Knee SPEEDER coil cleared under K152695.
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:
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- Intended to provide images of the knee, wrist and hand regions ●
- 8-channel, receive-only, phased array RF coils
- . Split-top mechanical design
- . Housing materials are flame, impact resistant and biocompatible
- Knee, wrist, and hand imaging accomplished through 8ch Knee ● SPEEDER configuration
- Compatible with Toshiba 1.5T MR systems ●
The following technological differences exist between the subject and predicate device:
- Intended to provide images of the foot and ankle regions (subject) . versus forefoot region (predicate) in addition to knee, wrist and hand
- Two anterior pieces with split-top mechanical design shaped to fit . the knee and foot (subject) versus single split-top mechanical design shaped to fit the knee (predicate)
12. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
All surface materials on the 8ch Knee-Foot SPEEDER 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 previouslycleared devices.
Electrical Safety and Electromagnetic Compatibility
The electrical safety and electromagnetic compatibility of the 8ch Knee-Foot SPEEDER coil 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
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The SNR and uniformity of the 8ch Knee-Foot 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 knee, wrist, hand, foot and ankle were obtained from the 8ch Knee-Foot SPEEDER. These images were used to demonstrate that the 8ch Knee-Foot SPEEDER produces diagnostic quality images of the intended anatomies.
13. Conclusion
The electrical safety and electromagnetic compatibilitv and biocompatibility data support the safety of the 8ch Knee-Foot SPEEDER and the bench testing per the NEMA standards demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the 8ch Knee-Foot SPEEDER performs as well as or better than the predicate device.