(85 days)
Not Found
No
The document describes a passive RF coil for MRI, with no mention of software, algorithms, or any technology related to AI/ML.
No
The device is described as a receive-only RF coil used for obtaining diagnostic images, which yields information useful for diagnosis, not directly for therapy.
No
The Alpha 7000 Quadrature Wrist Coil is a receive-only RF coil used to obtain images for diagnosis, but it does not perform the diagnosis itself. The diagnostic interpretation is done by a trained physician.
No
The device description clearly states it consists of physical components (RF coil elements, circuitry, housing) and is a hardware device used in conjunction with an MRI system.
Based on the provided information, the Alpha 7000 Quadrature Wrist Coil is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Alpha 7000 Quadrature Wrist 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 images of the wrist and hand anatomy.
- No Specimen Analysis: The device does not analyze any specimens taken from the body. It interacts directly with the patient's body to acquire imaging data.
Therefore, the Alpha 7000 Quadrature Wrist Coil falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alpha 7000 Quadrature Wrist Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the wrist and hand anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Wrist Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
The Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
Anatomic Regions: Wrist and hand anatomy 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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Alpha 7000 Quadrature Wrist Coil consists of two volume RF coil elements in a quadrature design. The elements and the associated circuitry are enclosed in a durable housing made of polyurethane material, which is fire rated and has high impact and tensile strength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
wrist and hand anatomy
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.
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
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | Alpha 7000 Quadrature Wrist Coil SEP - 5 1997 |
| 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 Alpha 7000 Quadrature Wrist Coil is a receive-only |
| quadrature RF coil, used for obtaining diagnostic images | |
| of the wrist and hand anatomy in Magnetic Resonance | |
| Imaging systems. The indications for use are the same as | |
| for standard MR Imaging. The Quadrature Wrist Coil is | |
| designed for use with GE Signa (1.5 Tesla) MRI scanner | |
| manufactured by GE Medical Systems. | |
| 8. Device Description: | The Alpha 7000 Quadrature Wrist Coil consists of two |
| volume RF coil elements in a quadrature design. The | |
| elements and the associated circuitry are enclosed in a | |
| durable housing made of polyurethane material, which | |
| is fire rated and has high impact and tensile strength. |
:
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please turn over
1
9. Safety and Effectiveness
)
| Parameter | Features of Alpha7000
Quadrature Wrist Coil | Same as Predicate Device |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Wrist and Hand Imaging
Applications | Quadrature Wrist and Hand Coil
MRI Devices Corp.
(K931008) |
| Indications for Use | Identical to routine MRI
imaging | Quadrature Wrist and Hand Coil
MRI Devices Corp.
(K931008)
Profile 7000 Quadrature Volume Neck Coil
USA Instruments, Inc.
(K964531) |
| Coil Body 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 design | Profile 7000 Quadrature Volume Neck Coil
USA Instruments, Inc.
(K964531) |
| Decoupling | RF Chokes with Switching
Diodes | Profile 7000 Quadrature Volume Neck Coil
USA Instruments, Inc.
(K964531) |
| 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 Quadrature Volume Neck Coil
USA Instruments, Inc.
(K964531) |
| Radio Frequency
Absorption | Coil is a receive only coil
and does not transmit RF
power | Profile 7000 Quadrature Volume Neck Coil
USA Instruments, Inc.
(K964531) |
| 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 Quadrature Volume Neck Coil
USA Instruments, Inc.
(K964531) |
2
Image /page/2/Picture/17 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three curved lines representing the wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1997
Rony Thomas Manager, Regulatory Affairs USA Instruments, Inc. 675-B Alpha Drive Highland Heights, Ohio 44143 Re:
K972205 Maximum 7000 Ouadrature Extremity Coil Dated: May 6, 1997 Received: June 12, 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 requirement, 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 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 yitzo 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 of the regulation of "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".
Sincerely yours,
h7liau Yi
Lillian 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
3
Page 1 of 1
510(k) Number (if known):
Device Name: Alpha 7000 Quadrature Wrist Coil
Indications for Use: The Alpha 7000 Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand anatomy. The Alpha 7000 Quadrature Wrist Coil is designed for use with the GE Signa (1.5 Tesla) MRI Scanner.
Anatomic Regions: Wrist and hand anatomy 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 K972205
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)