(27 days)
Not Found
No
The summary describes a passive MR coil and does not mention any AI/ML components or image processing capabilities.
No
The device is described as producing "diagnostic images" and is intended for use with MRI systems, indicating its purpose is for diagnosis rather than therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee".
No
The device description explicitly states it is a "transmit/receive, 15-channel phased array coil" with a "rigid plastic housing" and mentions testing for biocompatibility, electrical safety, and electromagnetic compatibility, all of which are characteristics of a physical hardware device, not software.
Based on the provided information, 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 for diagnosis, monitoring, or screening.
- Device Function: The TxRx Knee 15 Flare MR Coil 3.0T is a component of an MRI system. Its purpose is to generate and receive radiofrequency signals to create images of the knee within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "produce diagnostic images of the knee" for interpretation by a physician. This is a function of an imaging device, not an IVD.
The description clearly indicates it's a non-invasive device used for imaging the knee directly on the patient.
N/A
Intended Use / Indications for Use
The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The TxRx Knee 15 Flare MR Coil 3.0T is a transmit/receive, 15-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 3.0T MR systems. The TxRx Knee 15 Flare MR Coil 3.0T is intended to be used for imaging the knee.
The TxRx Knee 15 Flare MR Coil 3.0T 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Knee
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 on the TxRx Knee 15 Flare MR Coil 3.0T 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 TxRx Knee 15 Flare MR Coil 3.0T 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.
SAR measurement testing was performed per NEMA MS-8 to provide data supporting that the partial body limits for SAR are controlled within the limits described in IEC 60601-2-33. The testing showed that the system controls the SAR limits for the TxRx Knee 15 Flare MR Coil 3.0T such that they remain below the IEC 60601-2-33 partial body limits.
Performance Testing - Bench
The SNR and uniformity of the TxRx Knee 15 Flare MR Coil 3.0T was analyzed per IEC 62464 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 were obtained from the TxRx Knee 15 Flare MR Coil 3.0T. These images were used to demonstrate that the TxRx Knee 15 Flare MR Coil 3.0T produces diagnostic quality images of the intended anatomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, 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
November 29, 2016
Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 6655 Beta Drive. Suite 100 MAYFIELD VILLAGE OH 44143
Re: K163066
Trade/Device Name: TxRx Knee 15 Flare MR Coil 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 31, 2016 Received: November 2, 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.
1
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) K163066
Device Name TxRx Knee 15 Flare MR Coil 3.0T
Indications for Use (Describe)
The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
Type of Use (Select one or both, as applicable)
2 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
31 October 2016
4. Tradenames
TxRx Knee 15 Flare MR Coil 3.0T
5. Common name
Coil, magnetic resonance, specialty
Model Numbers 6.
QED Model Number: Q7000168
7. Classification
Magnetic resonance diagnostic device (21 CFR 892.1000, Product Code MOS, Class II)
8. Unmodified Device
3.0T TxRx 15Ch Knee Coil, Quality Electrodynamics, LLC., K082636
9. Device Description
The TxRx Knee 15 Flare MR Coil 3.0T is a transmit/receive, 15-channel phased array coil designed for magnetic resonance imaging (MRI) using the Siemens 3.0T MR systems. The TxRx Knee 15 Flare MR Coil 3.0T is intended to be used for imaging the knee.
4
The TxRx Knee 15 Flare MR Coil 3.0T 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.
10. Indications for Use
The TxRx Knee 15 Flare MR Coil 3.0T is intended for use with Siemens 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
The Indications for Use statement for the modified TxRx Knee 15 Flare MR Coil 3.0T is not identical to the unmodified device (3.0T TxRx 15Ch Knee Coil); 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 unmodified device. Both Indications for Use statements for the modified TxRx Knee 15 Flare MR Coil 3.0T and unmodified 3.0T TxRx 15Ch Knee Coil indicate that the device is intended to be used in conjunction with a 3.0T MR system to produce images of the knee and that the images can be interpreted by a trained physician.
11. Summary of Technological Characteristics Compared to the Unmodified Device
At a high level, the modified device and unmodified device are based on the following same technological elements:
- . Transmit/receive phased array RF coils
- 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 modified device and unmodified device:
- Changes to ergonomics of patient-user interface such as modified . system cable connector and the use of one system cable (modified device) in comparison to two system cables (unmodified device)
- Changes to dimensional specifications of the mechanical design of the . enclosure
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12. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
All surface materials on the TxRx Knee 15 Flare MR Coil 3.0T 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 TxRx Knee 15 Flare MR Coil 3.0T 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.
SAR measurement testing was performed per NEMA MS-8 to provide data supporting that the partial body limits for SAR are controlled within the limits described in IEC 60601-2-33. The testing showed that the system controls the SAR limits for the TxRx Knee 15 Flare MR Coil 3.0T such that they remain below the IEC 60601-2-33 partial body limits.
Performance Testing - Bench
The SNR and uniformity of the TxRx Knee 15 Flare MR Coil 3.0T was analyzed per IEC 62464 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 were obtained from the TxRx Knee 15 Flare MR Coil 3.0T. These images were used to demonstrate that the TxRx Knee 15 Flare MR Coil 3.0T produces diagnostic quality images of the intended anatomy.
13. Conclusion
The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the TxRx Knee 15 Flare MR
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Coil 3.0T and the bench testing per the IEC 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 TxRx Knee 15 Flare MR Coil 3.0T performs as well as or better than the unmodified device.