(205 days)
The MAGNETOM Terra system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced. These images and the physical parameters derived from the interpreted by a trained physician vield information that may assist in diagnosis.
The device is intended for patients > 30 kg/66 lbs.
MAGNETOM Terra is a 60 cm bore Magnetic Resonance Imaging system with an actively shielded 7T superconducting magnet. With the interplay of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil and software this magnetic resonance scanner produces transverse, sagittal, coronal and oblique cross sectional images that represent the spatial distribution of protons with spin. The MAGNETOM Terra uses two local coils 1Tx32Rx Head Coil 7T Clinic and 1Tx28Rx Knee Coil 7T Clinic for head and knee imaging.
The provided text describes the Siemens MAGNETOM Terra, a 7T Magnetic Resonance Imaging (MRI) system. However, it focuses on demonstrating substantial equivalence to a predicate device (MAGNETOM Trio A Tim System with syngo MR B19A) rather than establishing novel safety and effectiveness through specific acceptance criteria and a dedicated study demonstrating the device meets those criteria for a new clinical indication or outcome.
The text outlines various non-clinical tests and a clinical study primarily to ensure the device's fundamental safety and performance within the established framework for MRI devices, especially given the increased magnetic field strength (7T). It does not present a study designed to prove the device meets specific acceptance criteria related to a new clinical performance claim or diagnostic accuracy.
Therefore, many of the requested sections (Table of acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used for test set, training set details) are not applicable or extractable from this document as the submission does not detail a study aimed at proving a specific clinical performance criterion for this device as a new clinical claim.
Below is a summary of the information that can be extracted or inferred based on the document's content:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" table for a specific clinical performance claim is provided. The submission focuses on demonstrating compliance with recognized standards and substantial equivalence to a predicate device. Performance is generally assessed via image quality and safety parameters.
| Criteria/Test | Performance/Compliance |
|---|---|
| Sample clinical images acquired | All available clinical pulse sequences and local coils |
| Image quality assessments | Completed during system test |
| Acoustic noise measurements | According to NEMA standard |
| Performance Tests | According to IEC 62464-1 |
| Surface heating test for local coils | Completed |
| Software verification and validation | In accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" |
| Nerve stimulation thresholds | Set based on clinical study, within required IEC 60601-2-33 limits |
| Risk management | In compliance with ISO 14971:2007 |
| Applicable standards | Conforms to IEC, ISO, NEMA standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 14971, IEC 62366-1, IEC 62304, NEMA MS 4-2010, NEMA PS 3.1-3.20, ISO 10993-1) |
| Local SAR estimation | Based on computational modeling on FDTD algorithm using human models (Virtual Population and MIDA Model), mesh size 2mm |
| Substantial Equivalence | Considered substantially equivalent to MAGNETOM Trio A Tim System (K123938) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for nerve stimulation threshold study: 35 individuals.
- Data provenance: Not explicitly stated whether retrospective or prospective, or country of origin. It is a "clinical study" performed to set PNS thresholds.
- Sample images for image quality assessment: Not specified beyond "sample clinical images were acquired for all available clinical pulse sequences and local coils."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For nerve stimulation threshold study: Not applicable, as this study determines physiological thresholds, not ground truth for diagnostic imaging interpretation.
- For image quality assessment: "reports from two U.S. board-certified radiologists have been provided after the radiologists reviewed image pairs comparing the subject and the predicate device." Their specific experience level is not mentioned beyond "board-certified." This implies a qualitative assessment, not a formal ground truth establishment for a diagnostic study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For image quality review: Not explicitly detailed beyond "two U.S. board-certified radiologists... reviewed image pairs comparing the subject and the predicate device [and their] comments on any observed artifacts and concerns have also been included." This suggests a qualitative comparison rather than a formal adjudication process for diagnostic accuracy.
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
- No MRMC comparative effectiveness study is mentioned, nor is there any AI component described in the device. This device is an MRI scanner, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is an MRI scanner, not an algorithm being evaluated for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For nerve stimulation threshold study: The "ground truth" is the empirically observed nerve stimulation thresholds in the 35 individuals, which defines the physiological limits for setting the PNS threshold level.
- For image quality assessment: The "ground truth" or reference is implied to be the qualitative assessment and comparison by board-certified radiologists against the predicate device, focusing on image characteristics and artifacts. No objective ground truth (e.g., pathology, clinical outcomes) is stated as being used to assess diagnostic accuracy.
8. The sample size for the training set
- Not applicable/provided. This submission does not describe a machine learning algorithm that requires a training set. The software development is based on an existing software line and adapted for 7T parameters. The SAR control software enhancements are based on simulations with human models.
9. How the ground truth for the training set was established
- Not applicable, as no training set for a machine learning algorithm is described. The SAR control software relies on computational modeling and simulation data using established human models (Virtual Population, MIDA Model) to estimate local SAR.
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October 12, 2017
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.
Siemens Medical Solutions USA, Inc. Milind Dhamankar Senior Clinical Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A Malvern, Pennsylvania 19355
Re: K170840
Trade/Device Name: MAGNETOM Terra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: September 5, 2017 Received: April 5, 2017
Dear Milind Dhamankar:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 - Milind Dhamankar
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| Indications for Use |
| 510(k) Number (if known) | K170840 |
|---|---|
| Device Name | MAGNETOM Terra |
Indications for Use (Describe)
The MAGNETOM Terra system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced. These images and the physical parameters derived from the interpreted by a trained physician vield information that may assist in diagnosis.
The device is intended for patients > 30 kg/66 lbs.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary: MAGNETOM Terra
| Company: | Siemens Medical Solutions USA, Inc.40 Liberty Boulevard, 65-1AMalvern, PA 19355 |
|---|---|
| Date Prepared: | March 20, 2017 |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
1. General Information
Importer/Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Site: Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Establishment Registration Number: 3002808157
Contract Manufaturers:
Quality Electrodynamics for 1Tx28Rx Knee Coil 7T Clinic coil 6655 Beta Drive, Suite 100 Mayfield Village, OH 44143, USA Establishment Registration Number: 3007350713
Nova Medical, Inc. for 1Tx32Rx Head Coil 7T Clinic coil 150 West Street Suite 201 Wilmington, MA 01887, USA
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SIEMENS
2. Contact Person:
Milind Dhamankar, M.D. Senior Clinical Affairs Specialist Siemens Medical Solutions USA, Inc. Phone: (610) 448-6467 E-mail: mailto:milind.dhamankar@siemens-healthineers.com
3. Device Name and Classification:
| Common / Usual Name | 7T Magnetic Resonance Imaging system |
|---|---|
| Trade Name | MAGNETOM Terra |
| Classification Name | Magnetic Resonance Diagnostic Device(MRDD), |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Primary Product Code: | LNH |
| Secondary Product Code: | LNI, MOS |
4. Intended Use
The indications for use of the subject device fall within the intended use of the predicate device. The intended use for the MAGNETOM Terra is as follows:
The MAGNETOM Terra system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.
The device is intended for patients > 30 kg/66 lbs.
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5. Predicate and Reference Device Information:
| Predicate Device | FDA ClearanceNumber | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Trio A TimSystem with syngo MR B19APlease note the following parts of theMAGNETOM Trio A Tim System are thepredicate device parts related to:• System Architecture• RF transmit/receive system | K123938 clearedFebruary 12,2013 | LNH, LNI,MOS | Siemens AG /SiemensHealthcareGmbH |
| Reference Devices | FDA ClearanceNumber | Product Code | Manufacturer |
| MAGNETOM Verio withsyngo MR D13APlease note the following parts of theMAGNETOM Verio are the referencedevice parts related to:• SAR Management and ControlSystem• Gradient Power Amplifier• Computer Systems | K121434 clearedNovember 5,2012 | LNH, LNI,MOS | Siemens AG /SiemensHealthcareGmbH |
| MAGNETOM Prisma withsyngo MR E11CPlease note the following parts of theMAGNETOM Prisma are the referencedevice parts related to:• Software syngo MR E11K• Patient table• Magnet• Gradient Coil• Cover• Physiological Measurement Devices• Patient communication devices | K153343, clearedApril 15, 2016 | LNH, LNI,MOS | Siemens AG /SiemensHealthcareGmbH |
6. Device Description:
MAGNETOM Terra is a 60 cm bore Magnetic Resonance Imaging system with an actively shielded 7T superconducting magnet. With the interplay of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil and software this magnetic resonance scanner produces transverse, sagittal, coronal and oblique cross sectional images that represent the spatial distribution of protons with spin. The MAGNETOM Terra uses two local coils 1Tx32Rx Head Coil 7T Clinic and 1Tx28Rx Knee Coil 7T Clinic for head and knee imaging.
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Device Modifications
The subject device, MAGNETOM Terra, has the same fundamental technological characteristics as the predicate device, MAGNETOM Trio A Tim System with syngo MR B19A, (K123938 cleared February 12, 2013). Components such as: magnet, gradient coil, RF Subsystem, software and local Tx/Rx coils have been modified for 7T. Specific details are listed in the Predicate and Reference Device Information table (# 5) above.
The modifications that are new to the subject device are not cleared on other systems and are discussed in detail within the submission. The list below describes the new features and components followed by the modified components.
Hardware
- New Magnet: The new magnet, OR 107, is based on the 트 already cleared magnet design OR 65 of the reference device MAGNETOM Prisma. The magnet electronics developed for the MAGNETOM Prisma were modified for the subject device magnet. Unlike OR 65, the OR 107 magnet does not support the mounting of the RF components on the magnet. The subject device has a separate RF cabinet instead. OR 107 has two cold heads due to the higher volume of helium in the maqnet.
- I New Gradient Coil: The mechanical dimensions and design of the gradient coil (GC) of the reference device, MAGNETOM Prisma were modified to create the subject device GC to accommodate the wider magnet bore diameter and the additional 3rd order shims. The subject device Gradient svstem 80/200 (80mT/m @@ slewrate 200T/ms simultaneous) has a new Gradient Coil and the Gradient Power Amplifier used in the reference device, MAGNETOM Verio has been modified.
- I New Coils: Two new Tx/Rx local coils for head and knee examinations designed for 7T
- -1Tx32Rx Head Coil 7T Clinic from Nova Medical, Inc. .
- . -1Tx28Rx Knee Coil 7T Clinic from Quality Electrodynamics LLC
- The subject device does not have an integrated body ■ resonator. Only local transmit (Tx) and receive (Rx) coils are used for RF excitation.
- 트 Modified RF Subsystem 1ch Tx: The RF transmit/receive system of the subject device is based on Siemens' Tim technology of the predicate device MAGNETOM Trio A Tim System. The RF Subsystem of the subject device was
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modified to accommodate the 7T System frequency of 297.18 MHz. The RF amplifier, receive electronics and the new MaRS computer are located in separate cabinets.
- 트 Modified patient table: The patient table of the reference device, MAGNETOM Prisma was modified. The horizontal movement speed of the 7T subject device patient table is limited to 35 mm/s compared to 200 mm/s of the 3T reference device to maintain the maximum dB/dt value of 3 T/s defined in IEC 60601-2-33 Ed3, 2010. The subject device patient table has no vertical movement. Coil plugs and patient infrastructure (vacuum, headphone, squeeze ball) are moved to a separate Coil Interface Box. The subject device includes enhancements to the software that controls Specific Absorption Rate (SAR) based on simulations for adult humans only. Therefore the subject device patient table fits the needs for patients from 30 kg up to 200 kg.
Software
The subject device software, syngo MR E11K, was developed based on the commercially available MAGNETOM software line E11, latest cleared with syngo MR E11C for the reference device MAGNETOM Prisma (K153343, cleared April 15, 2016).
- । There are no new applications available with syngo MR E11K in comparison to syngo MR E11C.
- । Pulse sequence types were adapted according to the different conditions caused by the 7T system frequency of 297.18 MHz. No new 7T specific clinical pulse sequence types were developed.
- One new non-clinical pulse sequence type for B0 field mapping has been added. This sequence is not used for clinical imaging.
- । The subject device includes enhancements to the software that controls Specific Absorption Rate (SAR) based on simulations for adult humans only. Therefore the MAGNETOM Terra is intended for patients > 30 kg/66 lbs. This weight limitation is not there for the 3T predicate device.
The subject device, MAGNETOM Terra is substantially equivalent to the predicate device, MAGNETOM Trio A Tim System with syngo MR B19A.
7. Technological Characteristics
The subject device, MAGNETOM Terra, has the same fundamental technological characteristics as the predicate device, MAGNETOM Trio A Tim System with syngo MR B19A, (K123938 cleared February 12, 2013).
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7T specific components such as: magnet, gradient coil, RF Subsystem, software and local Tx/Rx coils have been modified as described in Device Description (#6) above. The subject device includes enhancements to the software that controls Specific Absorption Rate (SAR) based on simulations for adult humans only. Therefore the MAGNETOM Terra is intended for patients > 30 kg/66 lbs. This weight limitation is not there for the 3T predicate device.
The subject device is substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance. MAGNETOM Terra conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
8. Nonclinical Tests
The following performance testing was conducted on the subject device
- Sample clinical images were acquired for all available clinical pulse . sequences and local coils,
- . Image quality assessments of all clinical pulse sequences types, were completed during system test,
- . Acoustic noise measurements according to NEMA standard were performed.
- . Performance Tests according to IEC 62464-1 as well as surface heating test for the local coils were completed,
- Software verification and validation testing was completed in . accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
9. Clinical Tests
A clinical study of 35 individuals was conducted to determine the nerve stimulation thresholds used to limit the gradient system output. The observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level which is required in IEC 60601-2-33.
No animal testing has been performed on this device.
In addition to providing clinical sample images for all clinical sequences and coils of the subject device, reports from two U.S. board-certified radiologists have been provided after the radiologists reviewed image pairs comparing the subject and the predicate device Their comments on any observed artifacts and concerns have also been included.
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10. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
The MAGNETOM Terra conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document as stated in the following table.
| Recognition Number | ProductArea | Title of Standard | ReferenceNumber anddate | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General | Medical electrical equipment - part 1:general requirements for basic safetyand essential performance | ES60601-1:2005/(R)2012 andA1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance -collateral standard: electromagneticdisturbances - requirements andtests. | 60601-1-2Edition 4.02014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment - Part 2-33: Particular requirements for thebasic safety and essentialperformance of magnetic resonanceequipment for medical diagnosis | 60601-2-33Ed. 3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application of riskmanagement to medical devices | 14971 Secondedition 2007-03-01 | ISO |
| 5-96 | General | Medical devices - Application ofusability engineering to medicaldevices | 62366-1:2015 | AAMI ANSIIEC |
| 13-79 | Software | Medical device software - Softwarelife cycle processes | 62304 Edition1.1 2015-06 | IEC |
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| Recognition Number | ProductArea | Title of Standard | ReferenceNumber anddate | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 12-232 | Radiology | Acoustic Noise MeasurementProcedure for Diagnosing MagneticResonance Imaging Devices | MS 4-2010 | NEMA |
| 12-300 | Radiology | Digital Imaging and Communicationsin Medicine (DICOM) Set 03/16/2012Radiology | PS 3.1 - 3.20(2016) | NEMA |
| 2-156 | Biocom-patibility | Biological evaluation of medicaldevices -- part 1: evaluation andtesting within a risk managementprocess. (Biocompatibility) | 10993-1:2009/(R)2013 | AAMIANSIISO |
The local transmit coils available with the MAGNETOM Terra are supervised as local transmit coils. The estimation of local (10g average) SAR is based on results of computational modeling on finite-difference time domain (FDTD) algorithm, using eight Human models of the Virtual Population (Christ et al, PhysMedBiol 2010, Gosselin et al, PhysMedBiol 2014) and the MIDA Model (lacono et al, Plos One 2015). The models include male and female models, ages ranging from 6 years to 84 years, weights ranging from 18.6 kg to 119 kg. The FDTD modeling used a mesh size of 2 mm, which has been determined to accurately evaluate the local SAR in the different structures of the human head and reproduce the constructive/destructive interference between anatomical structures.
This local SAR limit effectively also limits whole body SAR, partial body SAR and head SAR to a value that is lower than required by IEC 60601-2-33 for volume coils.
11. Substantial Equivalence
The subject device, MAGNETOM Terra, has the same fundamental technological characteristics as the predicate device, MAGNETOM Trio A Tim System with syngo MR B19A, (K123938 cleared February 12, 2013). 7T specific components such as: magnet, gradient coil, RF Subsystem, software and local Tx/Rx coils have been modified as described in Device Description (#6) above. The subject device is substantially equivalent to the predicate device with regard to the operational environment. programming language, operating system and performance.
The subject device software, syngo MR E11K, was developed based on the commercially available MAGNETOM software line E11, latest cleared with syngo MR E11C for the reference device MAGNETOM Prisma (K153343, cleared April 15, 2016).
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- । There are no new applications available with syngo MR E11K in comparison to syngo MR E11C.
- Pulse sequence types were adapted according to the different conditions caused by the 7T system frequency of 297.18 MHz. No new 7T specific clinical pulse sequence types were developed.
- One new non-clinical pulse sequence type for B0 field mapping has been added. This sequence is not used for clinical imaging.
- The subject device includes enhancements to the software that controls Specific Absorption Rate (SAR) based on simulations for adult humans only. Therefore the MAGNETOM Terra is intended for patients > 30 kg/66 lbs. This weight limitation is not there for the 3T predicate device.
12. Conclusion as to Substantial Equivalence
The MAGNETOM Terra has the same fundamental technological characteristics as the predicate device MAGNETOM Trio A Tim System with syngo MR B19A (K123938).
7T specific components such as: magnet, gradient coil RF Subsystem, software and local Tx/Rx coils have been modified and this gives the subject device greater capabilities in terms of image quality in the available body regions. All of the modifications do not introduce any new issues of safety or effectiveness. The modifications to the MAGNETOM Terra do not change the fundamental scientific technology of the Magnetic Resonance Diagnostic device and the indications for use of the subject device fall within the intended use of the predicate device.
The subject device includes enhancements to the software that controls Specific Absorption Rate (SAR) based on simulations for adult humans only. Therefore the MAGNETOM Terra is intended for patients > 30 kg/66 lbs. This weight limitation is not there for the 3T predicate device.
believes that the subject device, MAGNETOM Terra is Siemens substantially equivalent to the predicate device, MAGNETOM Trio A Tim System with syngo MR B19A.
§ 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.