(58 days)
No
The summary describes a passive hardware component (an MRI coil) and does not mention any software or algorithms that would utilize AI/ML for image processing or analysis.
No.
The device is described as being used to "produce diagnostic images of the knee", indicating its purpose is for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use with GE 3.0T MR systems to produce diagnostic images of the knee". This indicates its purpose is to aid in diagnosis.
No
The device description clearly states it is a physical coil with enclosed elements in a rigid plastic housing, and includes accessories like patient comfort pads. It also details hardware testing like biocompatibility, electrical safety, and bench testing for SNR and uniformity.
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 18ch T/R Knee Coil is a component of an MRI system. Its purpose is to transmit and receive radiofrequency signals to create diagnostic 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." This is an in vivo (within the living organism) diagnostic process, not an in vitro one.
Therefore, the 18ch T/R Knee Coil is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 18ch T/R Knee Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 18ch T/R Knee Coil is a transmit/receive. 18-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3T MR systems. The 18ch T/R Knee Coil is intended to be used for imaging the knee.
The 18ch 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 18ch T/R Knee Coil 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
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: The only patient contact material on the Atlas SPEEDER Head/Neck is Lexan 940 polycarbonate painted with Polane T polyurethane enamel. Both the polycarbonate and the polyurethane enamel have a history of safe use in MR applications and other medical devices. For example, the Lexan 940 is a patient contact material in devices cleared through 510(k) numbers K072935 and K082636 and the Polane T is a patient contact material in devices cleared through 510(k) numbers K103327 and K142098.
Electrical Safety and Electromagnetic Compatibility: The 18ch 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 18ch T/R Knee Coil are below the IEC 60601-2-33 partial body limits.
Bench Testing: The SNR and uniformity of the 18ch T/R Knee Coil was analyzed per and found to conform to NEMA MS 1-2008 and NEMA MS 3-2008.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Measured temperature of the surface of the coil never exceeded the maximum limit of 41°C.
- Local SAR limits for the 18ch T/R Knee Coil are below the IEC 60601-2-33 partial body limits.
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.
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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are connected by a curved line that runs from the top of the head of the top profile to the bottom of the chin of the bottom profile. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
April 9, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Re: K150331
Quality Electrodynamics, LLC
Director, Regulatory and Quality Affairs
MAYFIELD VILLAGE OH 44143
% Ms. Kathleen Aras
700 Beta Drive, Suite 100
Trade/Device Name: 18ch T/R Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 6, 2015 Received: February 10, 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 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. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150331
Device Name 18ch T/R Knee Coil
Indications for Use (Describe)
The 18ch T/R Knee Coil is intended for use with GE 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) 700 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
06 February 2015
4. Tradenames
18ch T/R Knee Coil
5. Common name
Coil, magnetic resonance, specialty
Model Numbers 6.
QED Model Number: Q7000074
GE Model Number: 5561409-2
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
TxRx 15Ch Knee Coil 3T, Quality Electrodynamics, LLC., K082636
4
9. Device Description
The 18ch T/R Knee Coil is a transmit/receive. 18-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3T MR systems. The 18ch T/R Knee Coil is intended to be used for imaging the knee.
The 18ch 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 18ch T/R Knee Coil also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.
| QED Part
| Number | Description | Qty |
|---|---|---|
| 3003887 | 18ch T/R Knee Coil Foot Pad | 1 |
| 3003863 | TDI Knee Array 18Ch Thigh Ramp Pad | 1 |
| 3003896 | 18ch T/R Knee Coil Calf Pad | 1 |
| 3003885 | 18ch T/R Knee Coil Bottom Pad, 0.5" | 1 |
| 3003884 | 18ch T/R Knee Coil Bottom Pad, 0.25" | 1 |
| 3003888 | 18ch T/R Knee Coil Pad, Non-Imaged Knee | 1 |
Table 1: 18ch T/R Knee Coil Accessories
10. Indications for Use
The 18ch T/R Knee Coil is intended for use with GE 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 18ch 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 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 only in the MR systems the coils are intended to be used with; the predicate is intended to be used with a Siemens MR system while the proposed device is intended to be used with a GE MR system.
5
11. Summary of Technological Characteristics Compared to the Predicate Device
The proposed 18ch T/R Knee Coil and the predicate TxRx 15Ch Knee Coil 3T 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 (18 (subject) versus 15 (predicate)) ●
- Compatible MR system (3T GE SIGNA Pioneer (subject) versus 3T ● Siemens Trio/Verio (predicate))
- Surface coating (Sherwin Williams Polane T (subject) versus ● Sherwin Williams Polane S (predicate))
12. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testinq
The only patient contact material on the Atlas SPEEDER Head/Neck is Lexan 940 polycarbonate painted with Polane T polyurethane enamel. Both the polycarbonate and the polyurethane enamel have a history of safe use in MR applications and other medical devices. For example, the Lexan 940 is a patient contact material in devices cleared through 510(k) numbers K072935 and K082636 and the Polane T is a patient contact
6
material in devices cleared through 510(k) numbers K103327 and K142098.
Electrical Safety and Electromagnetic Compatibility
The 18ch 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 18ch T/R Knee Coil are below the IEC 60601-2-33 partial body limits.
Bench Testing
The SNR and uniformity of the 18ch T/R Knee Coil was analyzed per and found to conform to NEMA MS 1-2008 and NEMA MS 3-2008.
13. Conclusion
The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the 18ch T/R Knee Coil 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 18ch T/R Knee Coil performs as well as or better than the predicate device.