(15 days)
Not Found
No
The 510(k) summary describes a passive hardware component (an MRI coil) and does not mention any software or processing capabilities that would involve AI or ML.
No
The device is used to produce diagnostic images, not for therapeutic purposes.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "For use... to produce diagnostic images of the knee".
No
The device description explicitly details hardware components like coils, housing, base, and foam pads, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce diagnostic images of the knee" using magnetic resonance. This is a medical imaging device used in vivo (on a living patient) to visualize internal structures.
- Device Description: The description details a coil used with an MRI scanner, which is consistent with an imaging device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to directly image the human body.
N/A
Intended Use / Indications for Use
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio/Verio magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 1.5T and 3T array coils consist of a birdcage volume transmit coil and an array of 15 local receive coils. The 3T CP Knee coil consists of a birdcage coil, which is used as a volume transmit coil and also as a receive coil.
The coil elements are enclosed in a rigid plastic housing which is fire-rated and has impact and tensile strength. The split-top mechanical housing is designed to accommodate patients of various sizes. The knee coil is mounted on a rigid base which allows the coil to move freely in the left-to-right direction to accommodate imaging of both patient knees. Foam pads also aid in positioning and enhance patient comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance
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)
Not Found
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 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS 510(k)
1. Applicant
Quality Electrodynamics (QED) 777 Beta Drive Mayfield Village, OH 44143 Phone (440) 484-2228
SEP 2 5 2008
2. Contact
Christie Zydyk, MBA VP & GM, Regulatory Affairs, Quality Assurance, & Corporate Communications
3. Date prepared:
August 21, 2008
4. Tradename
TxRx 15Ch Knee Coil 1.5T TxRx 15Ch Knee Coil 3T TxRx CP Extremity Coil 3T
5. Common name
Coil, magnetic resonance, specialty
6. Classification
21 CFR 892.1000
7. Equivalent Device
HRK-63 Knee Array Coil and HRK-123 Knee Array Coil by MRI Devices Leo III Tx/Rx Quadrature Knee Coil by USA Instruments
8. Device Description
The 1.5T and 3T array coils consist of a birdcage volume transmit coil and an array of 15 local receive coils. The 3T CP Knee coil consists of a birdcage coil, which is used as a volume transmit coil and also as a receive coil.
The coil elements are enclosed in a rigid plastic housing which is fire-rated and has impact and tensile strength. The split-top mechanical housing is designed to accommodate patients of various sizes. The knee coil is mounted on a rigid base which allows the coil to move freely in the left-to-right direction to accommodate imaging of both patient knees. Foam pads also aid in positioning and enhance patient comfort.
9. Intended Use
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio/Verio magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
1
| 510(k) # | Device | Manufacturer |
|---|---|---|
| K032633 | HRK-63 Knee Array Coil | MRI Devices |
| K050299 | HRK-123 Knee Array Coil | MRI Devices |
| K023982 | Leo III Tx/Rx Quadrature Knee Coil | USA Instruments |
10. Comparison with Predicate Devices
The 1.5T and 3T Siemens knee coils and predicate devices are designed for use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician. The 1.5T and 3T Siemens knee coils and the predicate devices have similar designs and are constructed of similar materials. The main differences are the number of channels in the array coils.
11. Conclusion
It is the opinion of Quality Electrodynamics that the 1.5T and 3T Siemens knee coils are substantially equivalent to the above-listed legally marketed predicate devices. Use of the Quality Electrodynamics coils does not result in any new potential hazards
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an abstract human form, with three wing-like shapes extending from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2008
Quality ElectroDynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K082636
Trade/Device Name: TxRx 15Ch Knee Coil 1.5T, TxRx 15Ch Knee Coil 3T, and TxRx CP Extremitv Coil 3T
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II
Product Code: MOS
Dated: September 9, 2008 Received: September 10, 2008
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | . | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
forque M. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K082636
Device Name:
TxRx 15Ch Knee Coil 1.5T TxRx 15Ch Knee Coil 3T TxRx CP Extremity Coil 3T
Indications for Use:
For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio/Verio magnetic resonance scanner to produce diagnostic images of the knee that can be interpreted by t a trained physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082636
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