(59 days)
Not Found
No
The device description and performance studies focus on the hardware components (coil design, materials) and electrical/safety testing of an MRI coil. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as an MRI coil intended to produce diagnostic images, not to treat a condition or disease.
Yes
The device is intended for use with MRI systems to produce diagnostic images of the knee, wrist, hand, and forefoot that can be interpreted by a trained physician. The term "diagnostic images" directly indicates its role in diagnosis.
No
The device description clearly states it is a transmit/receive coil, which is a hardware component used in MRI systems. The summary also details biocompatibility, electrical safety, and performance testing related to the physical coil.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "produce diagnostic images of the knee, wrist, hand, and forefoot that can be interpreted by a trained physician." This describes a device used for in vivo imaging (imaging within a living organism).
- Device Description: The description details a "transmit/receive coil designed for magnetic resonance imaging (MRI)." MRI is an imaging modality that works by interacting with the body's tissues directly, not with samples taken from the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for diagnosis, monitoring, or screening.
This device is clearly an accessory for an MRI system, which is used for imaging the body directly, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The 16ch Tx/Rx Knee SPEEDER is intended for use with Toshiba 3T MR systems to produce diagnostic images of the knee, wrist, hand, and forefoot that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 16ch Tx/Rx Knee SPEEDER is a transmit/receive coil designed for magnetic resonance imaging (MRI) using Toshiba 3T MRI systems. The device contains a 1-channel birdcage transmitter. Receive mode can be switched between 15-channel receive array and 1-channel birdcage receiver. The 16ch Tx/Rx Knee SPEEDER is intended to be used for imaging the knee, hand, wrist, and forefoot.
The 16ch Tx/Rx Knee 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 a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
The 16ch Tx/Rx Knee SPEEDER also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI)
Anatomical Site
knee, wrist, hand, and forefoot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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
Performance testing included Biocompatibility Testing, Electrical Safety and Electromagnetic Compatibility, Performance Testing - Bench (SNR and uniformity per NEMA MS 6-2008), and Performance Testing - Clinical.
For clinical performance, images from volunteer scanning of the knee, hand, wrist, and forefoot were obtained to demonstrate that the 16ch Tx/Rx Knee SPEEDER produces diagnostic quality images of the intended anatomies.
Key Metrics
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a design that resembles a caduceus or staff with a serpent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
Quality Electrodynamics, LLC % Kathleen Aras Director, Regulatory and Quality Affairs 700 Beta Drive Suite 100 MAYFIELD VILLAGE, OH 44143
Re: K151753
Trade/Device Name: 16ch Tx/Rx Knee SPEEDER Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: June 26, 2015 Received: June 29, 2015
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 devicerelated 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.
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
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Page 2 - Kathleen Aras
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,
Robert A Ochs
Robert Ochs, Ph.D. Acting 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) K151753
Device Name 16ch Tx/Rx Knee SPEEDER
Indications for Use (Describe)
The 16ch Tx/Rx Knee SPEEDER is intended for use with Toshiba 3T MR systems to produce diagnostic images of the knee, wrist, hand, and forefoot 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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510(k) Summary
1. Applicant
Quality Electrodynamics, LLC. (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143
2. Contact
Kathleen Aras Director, Requlatory and Quality Affairs (440) 484-2964 kathleen.aras@qualedyn.com
Date Prepared 3.
26 June 2015
4. Tradenames
16ch Tx/Rx Knee SPEEDER
5. Common name
Coil, magnetic resonance, specialty
6. Model Numbers
QED Model Number: Q7000147
Toshiba Model Number: MJAJ-232A
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
18ch T/R Knee Coil, Quality Electrodynamics, LLC., K150331
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9. Device Description
The 16ch Tx/Rx Knee SPEEDER is a transmit/receive coil designed for magnetic resonance imaging (MRI) using Toshiba 3T MRI systems. The device contains a 1-channel birdcage transmitter. Receive mode can be switched between 15-channel receive array and 1-channel birdcage receiver. The 16ch Tx/Rx Knee SPEEDER is intended to be used for imaging the knee, hand, wrist, and forefoot.
The 16ch Tx/Rx Knee 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 a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.
The 16ch Tx/Rx Knee SPEEDER also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.
| 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 |
Table 1: 16ch Tx/Rx Knee SPEEDER Accessories
10. Indications for Use
The 16ch Tx/Rx Knee SPEEDER is intended for use with Toshiba 3T MR systems to produce diagnostic images of the knee, wrist, hand, and forefoot that can be interpreted by a trained physician.
The Indications for Use statement for the 16ch Tx/Rx Knee SPEEDER 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 indicate that the device is intended to be used in conjuction with a 3T 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 in two ways. First, they differ in the manufacturer of MR systems the coils are intended to be used with; the predicate is intended to be used with a GE MR system while the proposed device is
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intended to be used with a Toshiba MR system. Second, the proposed device is intended to be used to produce diagnostic images of the wrist, hand, and forefoot, in addition to the knee.
11. Summary of Technological Characteristics Compared to the Predicate Device
The proposed 16ch Tx/Rx Knee SPEEDER and the predicate 18ch T/R Knee Coil are both transmit/receive phased array RF coils intended to be used with a 3T MR system to provide images of the knee.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Transmit/receive phased array RF coils ●
- Compatible with 3T MR systems ●
- 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
- Polycarbonate housing material
The following technological differences exist between the subject and predicate devices:
- Number of channels (16 (subject) versus 18 (predicate)) ●
- . Compatible MR system (3T Toshiba Vantage Titan (subject) versus 3T GE SIGNA Pioneer (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 Tx/Rx Knee SPEEDER and its accessories that are intended to come into direct or indirect contact with patient biological tissues, cells or body fluids either have a history of safe use in previously-cleared devices or have been assessed for biocompatibility according to ISO 10993-1. Per ISO 10993-1, all patient
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contacting materials on the 16ch Tx/Rx Knee SPEEDER are classified as surface-contacting, limited exposure (A) devices. Therefore, where testing was performed, the materials were tested for cytotoxicity per ISO 10993-5 and for irritation and sensitization per ISO 10993-10.
Electrical Safety and Electromagnetic Compatibility
The 16ch Tx/Rx Knee SPEEDER 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
Specific Absorption Rate (SAR) is controlled by the MR system, which estimates the total power delivered to the imaging volume with respect to whole body mass and estimated mass present in the imaging volume. SAR was tested in conjuction with the intended MR system; results showed that the whole body SAR for the 16ch Tx/Rx Knee SPEEDER is below the IEC 60601-2-33 whole body SAR limit. Head and partial body SAR are controlled under the Toshiba scanner SAR management using the whole body SAR data.
Performance Testing - Bench
The SNR and uniformity of the 16ch Tx/Rx Knee SPEEDER was analyzed per NEMA MS 6-2008 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, hand, wrist, and forefoot were obtained from the 16ch Tx/Rx Knee SPEEDER. These images were used to demonstrate that the 16ch Tx/Rx Knee SPEEDER produces diagnostic quality images of the intended anatomies.
13. Conclusion
The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the 16ch Tx/Rx Knee SPEEDER and the bench testing per the NEMA standards demonstrates the performance and effectiveness of the device under the specified use
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conditions. This testing demonstrates that the 16ch Tx/Rx Knee SPEEDER performs as well as or better than the predicate device.