(50 days)
No
The description focuses on the physical design and function of an RF coil for MRI, with no mention of AI or ML for image processing, analysis, or any other function.
No.
The device is described as a "specialty receive-only RF coil, used for obtaining diagnostic images" and its purpose is to "provide Magnetic Resonance Images," which are then "interpreted by a trained physician" to "yield information that can be useful in the determination of a diagnosis." This indicates it is a diagnostic tool, not a therapeutic one.
No
Explanation: The device is a "Phased Array Knee and Foot Coil" which is a receive-only RF coil used to obtain diagnostic images with an MR imaging system. It is explicitly stated that the "Knee and Foot Coil assists in image creation" but the "Signa HFO/i 0.7T system is indicated for use as an NMR device that produces images that... [can be] useful in the determination of a diagnosis." This indicates the coil is an accessory for image acquisition and not the diagnostic device itself.
No
The device description explicitly details physical components made of polyurethane, fiberglass, and plastic, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Phased Array Knee and Foot Coil is a component of an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to create diagnostic images. It does not analyze biological specimens.
- Intended Use: The intended use is to obtain diagnostic images of the knee and foot anatomy using MRI. This is an in-vivo imaging procedure, not an in-vitro diagnostic test.
The device is a medical device used in conjunction with an MRI scanner for diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Phased Array Knee and Foot Coil is a specialty receive-only RF coil, used for obtaining diagnostic images of the knee and foot anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Phased Array Knee and Foot Coil is designed for use with GE Signa HFO/i (0.7 Tesla) MRI scanner (K992746) manufactured by GE Medical Systems.
The Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner.
Anatomic Regions: Knee and Foot
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa HFO/i 0.7T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes
90 MOS
Device Description
The Knee and Foot Coil package consists of a knee coil (two sizes: small and large) and an attachable foot coil. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane, fiberglass, and ABS/PVC plastic alloy, which are fire rated and have high impact and tensile strength. The Knee Coil is mechanically split into two halves for easier coil handling and more accurate positioning of the patient's knee in the coil. The Foot Coil is contoured to accommodate the foot and is mechanically attached to the knee coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
knee and foot anatomy, knee and foot anatomies, Knee and Foot, head and whole body
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971246, K982496, K980157, K983143
Reference Device(s)
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
K9G 4C 40
JAN 18 2000 SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Legend 5000 Phased Array Knee and Foot Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc. |
| 1515 Danner Drive | |
| Aurora, Ohio 44202 | |
| Telephone: 330-562-1000; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been issued |
| under Section 514 of the Food, Drug and Cosmetic Act. | |
| 7. Intended Use: | The Phased Array Knee and Foot Coil is a specialty |
| receive-only RF coil, used for obtaining diagnostic images | |
| of the knee and foot anatomy in Magnetic Resonance | |
| Imaging systems. The indications for use are the same as | |
| for standard MR Imaging. The Phased Array Knee and | |
| Foot Coil is designed for use with GE Signa HFO/i (0.7 | |
| Tesla) MRI scanner (K992746) manufactured by GE | |
| Medical Systems. | |
| 8. Device Description: | The Knee and Foot Coil package consists of a knee coil |
| (two sizes: small and large) and an attachable foot coil. | |
| The electrical circuitry is enclosed in a durable housing | |
| assembly made of polyurethane, fiberglass, and | |
| ABS/PVC plastic alloy, which are fire rated and have | |
| high impact and tensile strength. The Knee Coil is | |
| mechanically split into two halves for easier coil | |
| handling and more accurate positioning of the patient's | |
| knee in the coil. The Foot Coil is contoured to | |
| accommodate the foot and is mechanically attached to | |
| the knee coil. |
Please turn over
.
1
9. Safety and Effectiveness
| Phased Array Knee and Foot Coil Product
Features | Comparison to predicate device or other 510(k)
cleared product |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: Knee and Foot Imaging
Applications | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246)
-Similar to the Model 473SI-42D Quadrature Lower
Extremity Coil manufactured by Medical Advances, Inc.
(K982496) |
| Indications for Use: Identical to routine MRI
imaging | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) |
| Coil Body Former Material: Flame retardant
Polyurethane, ABS/PVC Plastic Alloy, Glass
fiber reinforced polyester (Fiberglass) | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246)
-Similar to the Premier 7000 P/A CTL Spine Coil
manufactured by USA Instruments, Inc. (K980157) |
| Coil Design: Two Channel Phased Array
Receive Only Design | -Similar to the Mark 5000 Phased Array Shoulder Coil
manufactured by USA Instruments, Inc. (K983143) |
| Decoupling: RF Chokes with Switching Diodes | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) |
| Prevention of RF Burns: Does not transmit RF
Power, Decoupling isolates the coil elements
from RF fields during RF transmission, Coil
elements and circuitry are enclosed in a non-
conductive housing. | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) |
| Radio Frequency Absorption: Coil is a receive
only coil and does not transmit RF power | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) |
| Formation of Resonant Loops: Decoupling
isolates coil elements from RF fields during RF
transmission, Length of cable and stiffness does
not permit looping. | -Similar to the Leo 7000 Quadrature Knee Coil
manufactured by USA Instruments, Inc. (K971246) |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive Aurora, Ohio 44202
Re:
Legend 5000 Phased Array Knee and Foot Coil Dated: November 22, 1999 Received: November 29, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Thomas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 dass III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CART Daniel O. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _ K99 40 40 40
Device Name: Phased Array Knee and Foot Coil
Indications for Use: The Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner.
Anatomic Regions: Knee and Foot Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa HFO/i 0.7T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K994040 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |