(88 days)
Not Found
No
The description focuses on the physical and electrical characteristics of an MRI coil, with no mention of AI, ML, or image processing capabilities.
No
The device is described as producing diagnostic images of the knee and is an accessory to an MRI system; it does not claim to treat or cure any condition.
No
The device is a knee coil for an MRI system, which produces images. The diagnostic interpretation is performed by a trained physician, not by the device itself.
No
The device description clearly states it is a physical coil with a rigid plastic housing and patient comfort pads, indicating it is a hardware device.
No, 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. They are used outside of the body (in vitro).
- Device Function: The 16ch T/R Knee Coil is a component of an MRI system. It is used on the patient's body to generate images of the knee. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "produce diagnostic images of the knee," which is a function of an imaging device, not an IVD.
The information provided clearly describes a medical imaging accessory used in conjunction with an MRI system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The 16ch T/R Knee Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 16ch T/R Knee Coil is a transmit/receive, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 1.5T MR systems. The 16ch T/R Knee Coil is intended to be used for imaging the knee.
The 16ch T/R Knee 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 fire-rated, has impact and tensile strength, and has been tested for biocompatibility. The 16ch T/R Knee Coil is provided with 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
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
Bench Testing: The SNR and uniformity of the 16ch T/R Knee Coil was analyzed per NEMA MS 1 and NEMA MS 3 and was found to conform to predetermined acceptance criteria.
Clinical Testing: 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 16ch T/R Knee Coil. These images were used to demonstrate that the 16ch T/R Knee Coil produces diagnostic quality images of the intended anatomy.
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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 6655 Beta Drive. Suite 100 MAYFIELD VILLAGE OH 44143
Re: K162029
Trade/Device Name: 16ch T/R Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 22, 2016 Received: July 22, 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. O'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) K162029
Device Name 16ch T/R Knee Coil
Indications for Use (Describe)
The 16ch T/R Knee Coil is intended for use with GE 1.5T 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
Applicant 1.
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
22 July 2016
4. Tradenames
16ch T/R Knee Coil
5. Common name
Coil, magnetic resonance, specialty
6. Model Numbers
QED Model Number: Q7000075
GE Model Number: 5718233-2
This device is manufactured and sold by QED to GE. GE 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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Device Description 9.
The 16ch T/R Knee Coil is a transmit/receive. 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 1.5T MR systems. The 16ch T/R Knee Coil is intended to be used for imaging the knee.
The 16ch T/R Knee 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 fire-rated, has impact and tensile strength, and has been tested for biocompatibility. The 16ch T/R Knee Coil is provided with patient comfort pads.
10. Indications for Use
The 16ch T/R Knee Coil is intended for use with GE 1.5T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
The Indications for Use statement for the 16ch T/R Knee Coil 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 for the 16ch T/R Knee Coil and predicate 18ch T/R Knee Coil indicate that the device is intended to be used in conjunction with a 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 only in MR scanner field strength and number of channels; the predicate is intended to be used with a 3T GE MR system and has 18 channels while the proposed device is intended to be used with a 1.5T GE MR system and has 16 channels.
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:
- 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
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-
Polycarbonate housing material .
The following technological differences exist between the subject and predicate devices: -
Number of channels (16 (subject) versus 18 (predicate)) ●
-
Field Strength of MR system (1.5T (subject) versus 3.0T (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 T/R Knee 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 16ch T/R Knee Coil 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.
A finite-difference time-domain electromagnetic simulation was performed to provide data supporting that the partial body limits for SAR are controlled within the limits described in IEC 60601-2-33. The simulation showed that the local SAR limits for the 16ch T/R Knee Coil are below the IEC 60601-2-33 partial body limits.
Performance Testing - Bench
The SNR and uniformity of the 16ch T/R Knee Coil was analyzed per NEMA MS 1 and NEMA MS 3 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 16ch T/R Knee Coil. These images were used to
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demonstrate that the 16ch T/R Knee Coil produces diagnostic quality images of the intended anatomy.
13. Conclusion
The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the 16ch T/R Knee Coil 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 T/R Knee Coil performs as well as or better than the predicate device.