(90 days)
No
The document describes a passive head coil for an MRI system and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
No.
The device is used for obtaining diagnostic images and yields information for diagnosis, not for therapeutic purposes.
Yes
The device obtains "diagnostic images" and the images "yield information that can be useful in the determination of a diagnosis" when interpreted by a trained physician.
No
The device description clearly describes a physical hardware component (coil elements, circuitry, rigid former) used in Magnetic Resonance Imaging, not a software-only device.
No, 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 Magnetom Trio Head Coil is a component of a Magnetic Resonance Imaging (MRI) system. It is used to acquire images of the inside of the body in vivo (within the living organism).
- Intended Use: The intended use clearly states it is for "obtaining diagnostic images of the head" and "provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest." This is an imaging device, not a device that analyzes biological samples.
The description and intended use clearly indicate that this is an imaging coil used in an MRI system to produce images of the body, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
- Proprietary Name: Magnetom Trio Head Coil
- Intended Use: Head Imaging including diffusion weighted imaging, angiography, functional MRI, CSI imaging, and 3D TOF imaging.
- The Magnetom Trio Head Coil is a quadrature transmit receive coil used for obtaining diagnostic images of the head at the 3.0Tesla field strength in Magnetic Resonance Imaging. The indications for use are the same as for standard MR imaging. The Magnetom Trio Head Coil is designed for use with the Siemens Magnetom Trio 3.0Tesla MRI Scanner.
- The Magnetom Trio Head Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Magnetom Trio Head Coil is designed for use with the Magnetom Trio 3.0Tesla scanner manufactured by Siemens Medical Systems.
- Anatomic Regions: Soft tissues and vasculature of the head, neck and upper chest. Nuclei Excited: Hydrogen
- The 3.0Tesla MRI 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 vield information that can be useful in the determination of a diagnosis.
Product codes
90 MOS
Device Description
The Magnetom Trio Head Coil is a 16 z-element quadrature transmit receive coil. The coil elements and associated circuitry are enclosed to prevent any exposure to patient or environment. The coil electronics are enclosed in a rigid former. The former is a split top design with latching device and a large open viewing window on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Head, brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest.
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
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
USA INSTRUMENTS, INC.
Magnetom Trio Quadrature T/R Head Coil
510(k) Application
SUMMARY OF SAFETY AND EFFECTIVENESS K021330
| 1-1 Device Name: | Magnetic Resonance Diagnostic Device | | Magnetom Trio Head Coil | Comparison to Predicate or other 510(k)
cleared products |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| 1-2 Proprietary Name: | Magnetom Trio Head Coil | | Intended Use: Head Imaging
including diffusion weighted imaging,
angiography, functional MRI, CSI
imaging, and 3D TOF imaging. | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) |
| 1-3 Classification: | Class II | Indications for Use: Identical to
routine MRI imaging | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) | |
| 1-4 Establishment Registration | 1529041 | Coil Enclosure Material:
Polyurethane Plastic, Vinyl coated
Foam | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) | |
| 1-5 Manufacture Facility Location | USA Instruments, 1515 Danner Drive
Aurora, Ohio 44202 USA
Telephone: 330-562-1000; Fax: 330-562-
1422 | Coil Design: 16 z-element transmit
receive Quadrature design | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) | |
| 1-6 Performance Standard: | No applicable performance standards have
been issued under Section 514 of the Food,
Drug and Cosmetic Act. | Decoupling: Actively switched PIN
diodes during transmit and receive
mode | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) | |
| 1-7 Intended Use: | The Magnetom Trio Head Coil is a
quadrature transmit receive coil used for
obtaining diagnostic images of the head at
the 3.0Tesla field strength in Magnetic
Resonance Imaging. The indications for
use are the same as for standard MR
imaging. The Magnetom Trio Head Coil is
designed for use with the Siemens
Magnetom Trio 3.0Tesla MRI Scanner. | Prevention of RF Burns: The coil's
transmit/receive switch uses pin
diodes to isolate the receive channel
from the transmit channel; coil
elements and circuitry are enclosed in
a non-conductive housing | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) | |
| 1-8 Device Description: | The Magnetom Trio Head Coil is a 16 z-
element quadrature transmit receive coil.
The coil elements and associated circuitry
are enclosed to prevent any exposure to
patient or environment. The coil electronics
are enclosed in a rigid former. The former
is a split top design with latching device and
a large open viewing window on the top.
The coil design facilitates the scanning of
patients with different head sizes and
maximizes patient comfort and ease of use. | Radio Frequency
Absorption:
Power deposition during imaging is
limited by SAR algorithm | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) | |
| Formation of Resonance Loops:
Active diodes and fast RF blowing
fuses isolate the coil elements from
RF fields; length of cable and stiffness
does not permit looping | -Similar to the Allegra 3.0Tesla Tx/Rx Head
Coil manufactured by USA Instruments, Inc.
(K002179) | | | |
Section 1, Page 1
1
1-9 Safety and Effectiveness:
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with three heads facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2002
Ms. Christie Shumaker Manager QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K021330 Trade/Device Name: Magnetom Trio Quadrature Tx/Rx Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 24, 2002 Received: April 26, 2002
Dear Ms. Shumaker:
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 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); 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): Ko21330
Device Name: Magnetom Trio Head Coil
Indications for Use: The Magnetom Trio Head Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Magnetom Trio Head Coil is designed for use with the Magnetom Trio 3.0Tesla scanner manufactured by Siemens Medical Systems.
Anatomic Regions: Soft tissues and vasculature of the head, neck and upper chest. Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.0Tesla MRI 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 vield 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)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021330
(Optional Format 1-2-96)