(90 days)
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.
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.
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.
This document describes a 510(k) premarket notification for a medical device, specifically the Magnetom Trio Quadrature T/R Head Coil. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics traditionally associated with AI or advanced diagnostic devices.
Therefore, the requested information elements (acceptance criteria, specific study details like sample size for test sets, expert-established ground truth, MRMC studies, standalone performance, training set details) are not applicable to this document as it pertains to a traditional medical device (an MRI coil) and its submission for market clearance based on substantial equivalence.
Here's an explanation based on the provided text:
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1. A table of acceptance criteria and the reported device performance:
- N/A. This document doesn't present a specific set of performance-based acceptance criteria for a diagnostic output in the way one might expect for an AI algorithm (e.g., sensitivity, specificity, AUC). The coil's "performance" is implicitly tied to its ability to produce diagnostic images that are equivalent to those produced by its predicate device. The acceptance criteria for a 510(k) of this nature relate to safety, efficacy, and intended use being substantially equivalent to a predicate device.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. There is no "test set" in the context of clinical performance evaluation for this 510(k). The regulatory submission focuses on demonstrating the technical and functional equivalence of the new head coil to an existing, legally marketed head coil (the Allegra 3.0Tesla Tx/Rx Head Coil). This typically involves engineering tests, compatibility assessments with the MRI system, and potentially phantom imaging, rather than patient-level test sets.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. See point 2. No clinical test set with ground truth established by experts is described or implied in this 510(k) summary.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. See point 2.
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5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a hardware component (an MRI head coil), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was conducted or is relevant here.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware component.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No clinical ground truth is discussed in the context of this 510(k) submission. The "ground truth" for the submission itself is the predicate device and its established safety and effectiveness.
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8. The sample size for the training set:
- N/A. This device does not involve machine learning or a "training set."
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9. How the ground truth for the training set was established:
- N/A. This device does not involve machine learning or ground truth for a training set.
Summary of Safety and Effectiveness (as presented):
The document provides a "SUMMARY OF SAFETY AND EFFECTIVENESS K021330" which establishes substantial equivalence to a predicate device (Allegra 3.0Tesla Tx/Rx Head Coil, K002179).
The key aspects of safety and effectiveness are addressed by comparing the new device against the predicate. The document highlights the following similarities to the predicate device, implying these represent the "criteria" for substantial equivalence:
- Intended Use: Head Imaging including diffusion weighted imaging, angiography, functional MRI, CSI imaging, and 3D TOF imaging. (Identical to routine MRI imaging indications).
- Indications for Use: Identical to routine MRI imaging.
- Coil Enclosure Material: Polyurethane Plastic, Vinyl coated Foam.
- Coil Design: 16 z-element transmit receive Quadrature design.
- Decoupling: Actively switched PIN diodes during transmit and receive mode.
- 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.
- Radio Frequency Absorption: Power deposition during imaging is limited by the SAR algorithm.
- 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.
The letter from the FDA confirms that "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This is the ultimate "acceptance criterion" for a 510(k) submission. The study proving this is the 510(k) submission itself, which details the comparison to the predicate device across various parameters (design, materials, intended use, functionality, safety mechanisms).
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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 Imagingincluding diffusion weighted imaging,angiography, functional MRI, CSIimaging, and 3D TOF imaging. | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) | |
| 1-3 Classification: | Class II | Indications for Use: Identical toroutine MRI imaging | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) | |
| 1-4 Establishment Registration | 1529041 | Coil Enclosure Material:Polyurethane Plastic, Vinyl coatedFoam | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) | |
| 1-5 Manufacture Facility Location | USA Instruments, 1515 Danner DriveAurora, Ohio 44202 USATelephone: 330-562-1000; Fax: 330-562-1422 | Coil Design: 16 z-element transmitreceive Quadrature design | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) | |
| 1-6 Performance Standard: | No applicable performance standards havebeen issued under Section 514 of the Food,Drug and Cosmetic Act. | Decoupling: Actively switched PINdiodes during transmit and receivemode | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) | |
| 1-7 Intended Use: | The Magnetom Trio Head Coil is aquadrature transmit receive coil used forobtaining diagnostic images of the head atthe 3.0Tesla field strength in MagneticResonance Imaging. The indications foruse are the same as for standard MRimaging. The Magnetom Trio Head Coil isdesigned for use with the SiemensMagnetom Trio 3.0Tesla MRI Scanner. | Prevention of RF Burns: The coil'stransmit/receive switch uses pindiodes to isolate the receive channelfrom the transmit channel; coilelements and circuitry are enclosed ina non-conductive housing | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil 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 circuitryare enclosed to prevent any exposure topatient or environment. The coil electronicsare enclosed in a rigid former. The formeris a split top design with latching device anda large open viewing window on the top.The coil design facilitates the scanning ofpatients with different head sizes andmaximizes patient comfort and ease of use. | Radio FrequencyAbsorption:Power deposition during imaging islimited by SAR algorithm | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) | |
| Formation of Resonance Loops:Active diodes and fast RF blowingfuses isolate the coil elements fromRF fields; length of cable and stiffnessdoes not permit looping | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) |
Section 1, Page 1
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1-9 Safety and Effectiveness:
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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.
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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)
§ 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.