(29 days)
The Magnetom Symphony Quadrature Head Coil is a quadrature transmit receive coil used for obtaining diagnostic images of the head at the 1.5Tesla field strength in Magnetic Resonance Imaging. The indications for use are the same as for standard MR imaging. The Magnetom Symphony Head Coil is designed for use with the Siemens Magnetom Symphony 1.5Tesla MRI Scanner.
The Magnetom Symphony Head Coil is designed to manoutions retic Resonance Images of the brain, cervical spine, soft tissues and provide wagnetie head, neck and upper chest. The Magnetom Symphony Head Coil is designed for use with the Magnetom Symphony 1.5Tesla scanner manufactured by Siemens Medical Systems.
The 1.5Tesla MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, Intagoo that: (1) conceptrameters (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.
The Magnetom Symphony 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 medical device, the Magnetom Symphony Head Coil, and its substantial equivalence to previously cleared devices. It does not contain information about a study with acceptance criteria and device performance in the way typically associated with AI/ML diagnostic devices. The submission indicates the device's adherence to established safety and performance characteristics of similar MRI coils, rather than a clinical trial validating a diagnostic algorithm.
Therefore, the requested information elements (1-9) regarding acceptance criteria, study details, human-in-the-loop performance, and training set information are not available in the provided text.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on comparing the new coil's features and safety aspects to predicate devices.
- 2. Sample sized used for the test set and the data provenance: Not provided. The review is based on device specifications and comparison to predicates, not a clinical test set.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no diagnostic test set in this context.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware component (MRI coil).
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The provided text details the regulatory clearance (510(k)) of an MRI head coil, focusing on its technical specifications, intended use, and comparison to predicate devices, rather than a performance study of a diagnostic algorithm.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| 1-1 Device Name: | Magnetic Resonance Diagnostic Device |
|---|---|
| 1-2 Proprietary Name: | Magnetom Symphony Head Coil |
| 1-3 Classification: | Class II |
| 1-4 Establishment Registration | 1529041 |
| 1-5 Manufacture Facility Location | USA Instruments, 1515 Danner DriveAurora, Ohio 44202 USATelephone: 330-562-1000; Fax: 330-562-1422 |
| 1-6 Performance Standard: | No applicable performance standards havebeen issued under Section 514 of the Food,Drug and Cosmetic Act. |
| 1-7 Intended Use: | The Magnetom Symphony Quadrature HeadCoil is a quadrature transmit receive coil usedfor obtaining diagnostic images of the head atthe 1.5Tesla field strength in MagneticResonance Imaging. The indications for useare the same as for standard MR imaging. TheMagnetom Symphony Head Coil is designed foruse with the Siemens Magnetom Symphony1.5Tesla MRI Scanner. |
| 1-8 Device Description: | The Magnetom Symphony Head Coil is a 16 z-element quadrature transmit receive coil. Thecoil elements and associated circuitry areenclosed to prevent any exposure to patient orenvironment. The coil electronics are enclosedin a rigid former. The former is a split topdesign with latching device and a large openviewing window on the top. The coil designfacilitates the scanning of patients with differenthead sizes and maximizes patient comfort andease of use. |
Section 1, Page 1
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1-9 Safety and Effectiveness:
| Magnetom Symphony Head Coil | Comparison to Predicate or other 510(k)cleared products |
|---|---|
| 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) |
| Indications for Use: Identical toroutine MRI imaging | -Similar to the Vision 1.5Tesla Tx/Rx HeadCoil manufactured by Siemens MedicalSystems. (K932271) |
| Coil Enclosure Material:Polyurethane Plastic, Vinyl coatedFoam | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) |
| Coil Design: 16 z-element transmitreceive Quadrature design | -Similar to the Allegra 3.0Tesla Tx/Rx HeadCoil manufactured by USA Instruments, Inc.(K002179) |
| Decoupling: Active and Passiveswitched diodes; sensitivity when coilis switched off is ≤ -55db. | -Similar to the Vision 1.5Tesla Tx/Rx HeadCoil manufactured by Siemens MedicalSystems. (K932271) |
| 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 Vision 1.5Tesla Tx/Rx HeadCoil manufactured by Siemens MedicalSystems. (K932271) |
| Radio Frequency Absorption:Power deposition during imaging islimited by SAR algorithm | -Similar to the Vision 1.5Tesla Tx/Rx HeadCoil manufactured by Siemens MedicalSystems. (K932271) |
| Formation of Resonance Loops:Active diodes and fast blowing RFfuses isolate the coil elements fromRF fields; length of cable and stiffnessdoes not permit looping. | -Similar to the Vision 1.5Tesla Tx/Rx HeadCoil manufactured by Siemens MedicalSystems. (K932271) |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2002
Ms. Christie Shumaker Manager QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K021262
Trade/Device Name: Magnetom Symphony 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 17, 2002 Received: April 22, 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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Page 2
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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USA INSTRUMENTS, INC.
MAGNETOM SYMPHONY T/R HEAD COIL 510(K) APPLICATION
Page 1 of 1
510(k) Number (if known):_长02ノ262
Device Name: Magnetom Symphony Head Coil
Indications for Use: The Magnetom Symphony Head Coil is designed to manoutions retic Resonance Images of the brain, cervical spine, soft tissues and provide wagnetie head, neck and upper chest. The Magnetom Symphony Head Coil is designed for use with the Magnetom Symphony 1.5Tesla scanner manufactured by Siemens Medical Systems.
Anatomic Regions: Soft tissues and vasculature of the head, neck and upper chest. Hydrogen Nuclei Excited:
The indications for use are the same as for standard imaging:
The 1.5Tesla MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, Intagoo that: (1) conceptrameters (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)
Prescription Use _
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
David A. Larson
(Division Sign-Ofm-
Division of Reproductive, Abdominal,
and Radiological Devices:
510(k) Number K021262
§ 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.