(78 days)
Not Found
No
The device description and intended use focus solely on the hardware component (RF coil) for image acquisition, with no mention of software, algorithms, or AI/ML capabilities for image processing or analysis.
No
The device is described as a "receive-only quadrature RF coil, used for obtaining diagnostic images of the knee anatomy" and its purpose is to "yield information that can be useful in the determination of a diagnosis." It is an imaging device used for diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is "used for obtaining diagnostic images of the knee anatomy in Magnetic Resonance Imaging systems" and that these images, "When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis." This explicitly links the device's output to diagnostic purposes.
No
The device is described as a physical RF coil with electrical circuitry and a housing assembly, which are hardware components.
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 Leo 7000 Quadrature Knee Coil is an accessory for an MRI system. Its function is to receive radiofrequency signals from the knee during an MRI scan to produce images. It does not analyze biological samples.
- Intended Use: The intended use is to obtain diagnostic images of the knee anatomy using MRI. This is an in-vivo imaging procedure, not an in-vitro diagnostic test.
Therefore, the Leo 7000 Quadrature Knee Coil falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Leo 7000 Quadrature Knee Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the knee anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Knee Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
The Leo 7000 Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee anatomy. The Leo 7000 Quadrature Knee Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
The indications for use are the same as for standard imaging:
The GE Signa 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 (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Leo 7000 Quadrature Knee Coil is a bird-cage resonator. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane material, which is fire rated and has high impact and tensile strength. The Leo 7000 Quadrature Knee Coil is a quadrature volume coil with a split-top design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
knee; 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): 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.
K914263, K945827, K943440, K944724, K960497
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.
0
JUN 20 1997
SUMMARY OF SAFETY AND EFFECTIVENESS K971246
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Leo 7000 Quadrature Knee Coil |
| 3. Classification : | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 675-B Alpha Drive, |
| Highland Heights, Ohio 44143, USA | |
| Telephone: 216-442-5920; Fax: 216-442-5919. | |
| 6. Performance Standard: | No applicable performance standards have been issued |
| under Section 514 of the Food, Drug and Cosmetic Act. | |
| 7. Intended Use: | The Leo 7000 Quadrature Knee Coil is a receive-only |
| quadrature RF coil, used for obtaining diagnostic images | |
| of the knee anatomy in Magnetic Resonance Imaging | |
| systems. The indications for use are the same as for | |
| standard MR Imaging. The Quadrature Knee Coil is | |
| designed for use with GE Signa (1.5 Tesla) MRI scanner | |
| manufactured by GE Medical Systems. | |
| 8. Device Description: | The Leo 7000 Quadrature Knee Coil is a bird-cage |
| resonator. The electrical circuitry is enclosed in a | |
| durable housing assembly made of polyurethane | |
| material, which is fire rated and has high impact and | |
| tensile strength. The Leo 7000 Quadrature Knee Coil is a | |
| quadrature volume coil with a split-top design. |
please turn over
.
1
9. Safety and Effectiveness
(
| Parameter | LEO 7000 Quadrature
Knee Coil | Same as Predicate Device |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Knee Imaging Applications | MR Quadrature Knee Coils
Hitachi Medical Systems
(K914263)
Lower Extremity Coil,
OUTLOOK MRI System
Picker International, Inc.
(K945827) |
| Indications for Use | Identical to routine MRI
imaging | Lower Extremity Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827)
Profile 7000 C-Spine Coils,
US ASIA Instruments, Inc.
(K943440) |
| Coil Body Former Material | Flame retardant Polyurethane | Lower Extremity Coil, Head Coil, and Vascular Head and Neck
Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827) |
| Coil Design | Quadrature receive-only, bird-cage
resonator | Quadrature head coil and Quadrature MRA coil, HI-STAR MRI
system, Health Images, Inc.
(K944724) |
| Decoupling | RF Chokes with Switching Diodes | Lower Extremity Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827)
Flexible Phased Array Spine Coil, Picker International, Inc.
(K960497) |
| 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. | Profile 7000 C-Spine Coils
US ASIA Instruments, Inc.
(K943440)
Lower Extremity Coil, OUTLOOK MRI System
Picker International, Inc.
(K945827) |
| Radio Frequency
Absorption | Coil is a receive only coil and does not
transmit RF power | Profile 7000 C-Spine Coils,
US ASIA Instruments, Inc.
(K943440) |
| Formation of Resonant
Loops | Decoupling isolates coil elements from
RF fields during RF transmission.
Length of cable and stiffness
do not permit looping. | Profile 7000 C-Spine Coils,
US ASIA Instruments, Inc.
(K943440)
Flexible Phased Array Spine Coil
Picker International, Inc.
(K960497) |
1-2
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2
Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle, there is a stylized symbol that appears to be three overlapping human profiles or figures. The image is black and white and has a slightly grainy texture.
JUN 20 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 675-B Alpha Drive Highland Heights, Ohio 44143 Re: K971246 Leo 7000 Quadrature Knee Coil Dated: April 2, 1997 Received: April 3, 1997 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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device in be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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 10(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 this, 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 vite diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 entiled, "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/dsmamain.html". i
Sincerely yours,
Lillian Yin, Ph.D.
Lilian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) Number (if known):
Device Name: Leo 7000 Quadrature Knee Coil
Indications for Use: The Leo 7000 Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee anatomy. The Leo 7000 Quadrature Knee Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
Anatomic Regions: Knee Joint Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The GE Signa 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 | K971246 | ||
| Prescription Use | |||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
| (Optional Format 1-2-96) |