(86 days)
Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremittes. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used.
These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
Your MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Software syngo MR XA12M is the latest software version for MAGNETOM Amira and MAGNETOM Sempra. It supports the existing "A Tim+Dot system" configuration for MAGNETOM Amira and MAGNETOM Sempra, and the newly introducted "A BioMatrix system" configuration for MAGNETOM Amira. Software version syngo MR XA12M for MAGNETOM Amira and MAGNETOM Sempra includes software applications migrated from the secondary predicate device MAGNETOM Sola with syngo MR XA11A (K181322). Only minor adaptations were needed to support the system specific hardware and optimize the sequences/protocols. In addition, new software features, Segmented TOF, HASTE with variable flip angle, SMS in RESOLVE and QDWI, are also introduced in syngo XA12M. The device also includes hardware updates such as new/modified coils and other components.
This document describes the 510(k) premarket notification for the Siemens MAGNETOM Amira and MAGNETOM Sempra Magnetic Resonance Diagnostic Devices (MRDD) with software syngo MR XA12M. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on adherence to recognized standards, verification and validation testing, and image quality assessments. The reported device performance is broadly presented as performing "as intended" and exhibiting an "equivalent safety and performance profile" to the predicate devices.
The table below summarizes the technological changes and the general assessment of their performance as described in the submission:
| Feature Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Updates | Equivalent safety and performance to predicate software. Compliance with IEC 62304. | - New features (Segmented TOF, HASTE with variable flip angle, SMS in RESOLVE and QDWI) confirmed to perform as intended. |
| - Migrated features from K181322 (e.g., SliceAdjust, Compressed Sensing GRASP-VIBE, SPACE with CAIPIRINHA) included unchanged and function as intended. | ||
| - Functionality of modified features (e.g., Dixon fat/water separation, iPAT/TSE Reference Scan) maintained or improved. | ||
| Hardware Updates | Equivalent safety and performance to predicate hardware. | - New coils (ITX Extremity 18 Flare, BM Body 13) and modified hardware components (e.g., Magnet, Patient Table, Body Coil) confirmed to perform as intended. |
| Overall Device | Substantial equivalence to predicate devices, performing as intended with equivalent safety and performance profile. | - All features (software and hardware) verified and/or validated. |
| - Adherence to applicable FDA recognized and international IEC, ISO, and NEMA standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 14971, IEC 62366, IEC 62304, NEMA MS 6, NEMA MS 4, DICOM, ISO 10993-1). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a quantifiable sample size (e.g., number of patients or images). The evaluation relies on "sample clinical images" for the new coils and software features. The provenance of this data (e.g., country of origin, retrospective or prospective collection) is also not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for the "sample clinical images." The indication for use mentions that "images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." This implies that the interpretation of images, including those used in performance testing, would be by a "trained physician," but no specific details are provided about the number or expertise of such individuals in the context of validating the device features.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the "sample clinical images" used in performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and adherence to standards, rather than evaluating the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The primary purpose of the device (MAGNETOM MR system) is to produce images, and the software features enhance image acquisition and processing. The performance testing described (image quality assessments, software verification and validation) evaluates the algorithm's output (images) in a standalone manner prior to a physician's interpretation. However, the device's indications for use inherently involve human interpretation ("when interpreted by a trained physician"). The document does not describe a purely "algorithm-only" performance assessment in the context of clinical decision-making, as the device's function is to aid diagnosis by a human.
7. The Type of Ground Truth Used
The type of ground truth for the "sample clinical images" is not explicitly stated. Given that no clinical trials were conducted, it's highly probable that qualitative "image quality assessments" were made by internal experts or against known phantom/in-vivo characteristics, and potentially compared to images from the predicate device. There is no mention of pathology, expert consensus (beyond general physician interpretation), or outcomes data being used as ground truth for this submission.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI algorithms. The changes are largely software and hardware updates, along with the integration of existing features from a predicate device. If any of the new features (e.g., Segmented ToF, HASTE with variable flip angle) involve learned components, the training set size and characteristics are not disclosed.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed or implied for machine learning, the method for establishing ground truth for a training set is not described. The software and hardware updates appear to be based on engineering development and optimization rather than machine learning model training.
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February 14, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Mr. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355
Re: K183221
Trade/Device Name: MAGNETOM Amira, MAGNETOM Sempra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: November 19, 2018 Received: November 20, 2018
Dear Mr. Rajchel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
Robert 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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Indications for Use
510(k) Number (if known)
Device Name
MAGNETOM Amira, MAGNETOM Sempra
Indications for Use (Describe)
Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremittes. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used.
These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
Your MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Date Prepared November 19, 2018
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR § 807.92.
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Sites:
Siemens Shenzhen Magnetic Resonance Ltd. Siemens MRI Center, Gaoxin C. Ave., 2nd Hi-Tech Industrial Park 518057 Shenzhen PEOPLE'S REPUBLIC OF CHINA Establishment Registration Number: 3004754211
Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Establishment Registration Number: 3002808157
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2. Contact Information
Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 E-mail: martin.rajchel@siemens-healthineers.com
3. Device Name and Classification
| Trade Names | MAGNETOM AmiraMAGNETOM Sempra |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
4. Legally Marketed Predicate Devices
| Trade Names | MAGNETOM AmiraMAGNETOM SempraMAGNETOM Sola |
|---|---|
| 510(k) Numbers | K173600, Cleared on December 19, 2017K163211, Cleared on January 27, 2017K181322, Cleared on October 5, 2018 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNHSecondary: LNI, MOS |
5. Device Description
Software syngo MR XA12M is the latest software version for MAGNETOM Amira and MAGNETOM Sempra. It supports the existing "A Tim+Dot system" configuration for MAGNETOM Amira and MAGNETOM Sempra, and the newly introducted "A BioMatrix system" configuration for MAGNETOM Amira.
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Software Updates
Software version syngo MR XA12M for MAGNETOM Amira and MAGNETOM Sempra includes software applications migrated from the secondary predicate device MAGNETOM Sola with syngo MR XA11A (K181322). Only minor adaptations were needed to support the system specific hardware and optimize the sequences/protocols. In addition, new software features, Segmented TOF, HASTE with variable flip angle, SMS in RESOLVE and QDWI, are also introduced in syngo XA12M.
Compared to the previously cleared software version syngo MR E11S, the following software applications are made available for the subject devices:
| 1. MAGNETOM Amira | 2. MAGNETOM Sempra | |
|---|---|---|
| A Tim+Dot System | A BioMatrix System(New configuration) | |
| 1. MAGNETOM Amira | 2. MAGNETOM Sempra | |
| A Tim+Dot System | A BioMatrix System(New configuration) | A Tim+Dot System |
| > Features available for the previously cleared syngo MR E11S (K173600 / K163211),modified and cleared with syngo MR XA11A (K181322), and included unchanged in thesubject devices: | ||
| - Dixon fat/water separation (improvement for a more robust assignment of local fat and waterregions to the respective image) | - Pre-Scan-Normalize (improvement to correct MRI images for local coil sensitivity variationsand to generate homogenous MRI images) | |
| - iPAT / TSE Reference Scan (Improvements in VIBE and HASTE pulse sequence types toimprove the image quality) | ||
| - MRCP in SPACE (improvement of the image quality for MR Cholangiopancreatography(MRCP) acquisitions based on the SPACE pulse sequence type) | ||
| - MR Elastography | ||
| - Replacement of existing masking by a masking performed on the pre-scan imagesused within the pre-scan normalize (PSN) functionality | ||
| - Optimization of pulse sequence type timing | ||
| - Changes in MEG time period (no longer fixed to the wavelength of the MEG andimplementation of a reduced MEG period) | ||
| Software / PlatformModifications to the general software / platform that have been cleared with thesecondary predicate device with syngo MR XA11A (K181322) and included unchanged inthe subject devices with syngo MR XA12M: | ||
| - Patient Registration and Scheduler consolidated | ||
| - Spectroscopy Add-in (enables planning on non-distortion corrected images forspectroscopy) | ||
| - MR View&GO (Addition of Mosaic View (view mode to scroll through dimensions instead ofspace) and 4D Movie Toolbar (movie toolbar to navigate the 4th dimension)) | ||
| - Prior Handling (for the display of available priors) | ||
| - System shutdown unattended by the user | ||
| - Dot Cockpit (additional features for handling scan pulse sequences and offline Dot Cockpit) | ||
| - Teamplay Protocols Interface (interface to support external pulse sequence managementsystems) | ||
| Other Modifications and / or Minor Changes | ||
| Other modifications that have been cleared with the secondary predicate device withsyngo MR XA11A (K181322) and are included unchanged in the subject devices withsyngo MR XA12M: | ||
| - SAR Assistant (two additional options for selection) | ||
| - Improved Adjustments (frequency adjustment optimized for more reliable water peakdetection, and FastView adjustments extended to all data selectable in the user interface) | ||
| - Unilateral Hip (added in Large Joint Dot Engine - user workflow optimized) | ||
| 1. MAGNETOM Amira | 2. MAGNETOM Sempra | |
| A Tim+Dot System | A BioMatrix System(New configuration) | A Tim+Dot System |
| GRE RefScan (external GRE RefScan extended to multiple pulse sequence types)Asymmetric saturation pulses (support for regional saturation with an asymmetric shape added for BOLD imaging)CP Mode modification ("RF Transmit Mode" provided as part of patient registration based on the IEC 60601-2-33 standard) | ||
| The following are only applicable for MAGNETOM Amira (both configurations). | n/a | |
| Completely new feature:- SMS in RESOLVE and QDWI (SMS imaging utilized to either speed up 2D acquisitions with multiple slices or to increase the number of acquired slices without increasing the measurement time with the RESOLVE / QDWI sequence) | ||
| Migrated Features from syngo MR XA11A (K181322)included unchanged in the subject device:- GOKnee3D (examination which comprises the AutoAlign knee localizer and two SPACE with CAIPIRINHA sequences to support fast high-resolution 3D exams of the knee)- Whole-Body Dot Engine (supports multi-region examinations with consistent settings for spatial resolution, image contrast, and breath-hold capacity)- SMS in TSE (Simultaneous Multi Slice (SMS) support for TSE) |
Completely new features:
The following new features for syngo MR XA12M are not previously cleared:
- । Segmented ToF (feature to reduce scan time compared to conventional ToF acquisition)
- । HASTE with variable flip angle (technique for improving the acquisition efficiency in Turbo Spin-Echo (TSE) via lengthening turbo factors)
Migrated features from the secondary predicate device, MAGNETOM Sola with syngo MR ХА11А (К181322):
Software features
- A Features from syngo MR XA11A (K181322) now made available unchanged for the subject devices:
- SliceAdjust (framework for pulse sequence types that allow dynamic adjustments to measured sub-volumes)
- Compressed Sensing GRASP-VIBE (conduct dynamic contrast-enhanced abdominal exams in free breathing)
- । Compressed Sensing Cardiac Cine (free breathing Cardiac Cine scaning which is integrated into the BEAT pulse sequence type)
- । RetroGating (Compressed Sensing Cardiac Cine acquisitions which splits data acquisition over multiple heartbeats configured to perform complete sampling of the cardiac cycle without prior definition of an acquisition window)
- । SPACE with CAIPIRINHA (3D SPACE pulse sequence type with iPAT mode CAIPIRINHA)
- । Cardiac Dot Flow Add-In (extension of Cardiac Dot Engine to support blood flow measurements)
- -PCASL mode (extension of ASL pulse sequence types with a new blood labeling mode)
- BEAT IRTTT (extension of BEAT IRT sequence with a multi-slice functionality and additional parameters)
- -Noise masking (feature to remove the noise floor in outer regions)
- -Turbo Suite (marketing bundle of components for accelerated MR imaging offered for the subiect devices)
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Hardware Updates
The hardware updates to the subject devices are listed below:
| 1. MAGNETOM Amira | 2. MAGNETOM Sempra | |
|---|---|---|
| A Tim+Dot System | A BioMatrix System(New configuration) | A Tim+Dot System |
| New/Modified Hardware | ||
| Hardware updates which are the same as that of the secondary predicate device MAGNETOMSola with syngo MR XA11A (K181322): | ||
| - syngo Acquisition Workplace and monitor | ||
| - System Start Timer (implemented in Electronics and Power Cabinet (EPC)) | ||
| Modified from the previously cleared syngo MR E11S (K173600/ K163211) for MAGNETOM | ||
| 1. MAGNETOM Amira | 2. MAGNETOM Sempra | |
| A Tim+Dot System | A BioMatrix System(New configuration) | A Tim+Dot System |
| Amira and MAGNETOM Sempra:- Magnet- Patient Table- Body Coil- MaRS- Intercom | ||
| Local Coils (See details below) | ||
| ITX Extremity 18 Flare(Completely new coil) | ITX Extremity 18 Flare(Completely new coil) | n/a |
| n/a | BM Body 13 (A 1.5T BioMatrixCoil)(Completely new coil) | n/a |
| Shoulder Shape 16(Cleared with K181322) | Shoulder Shape 16(Cleared with K181322) | n/a |
| UltraFlex Large 18(Cleared with K181322) | UltraFlex Large 18(Cleared with K181322) | UltraFlex Large 18(Cleared with K181322) |
| UltraFlex Small 18(Cleared with K181322) | UltraFlex Small 18(Cleared with K181322) | UltraFlex Small 18(cleared with K181322) |
| n/aNote: Body 13 coil has been cleared with MAGNETOM Amira (K152283) | Body 13(cleared with K152283) | |
| Others (See details below) | ||
| n/a | Modified from the previouslycleared syngo MR E11S(K173600/ K163211)- New system Cover withTouch UI and Control- New Siemens Branding:"Siemens Healthineers"logo- Respiratory Sensor (newrespiratory sensor loopsintegrated into the BM Body13 coil for measuring thechange of electro-magneticsignal resulting from theshifting of the tissue andorgans).To support the respiratorysensor, the followingcomponents are modified:- RFIS (Radio Frequency | n/a |
| 1. MAGNETOM Amira | 2. MAGNETOM Sempra | |
| A Tim+Dot System | A BioMatrix System(New configuration) | A Tim+Dot System |
| Infrastructure System) | ||
| - RCCS (Receive Coil | ||
| Channel Selector) |
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6. Indication for Use
The indications for use for the subject devices are the same as the predicate devices:
Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used.
These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Your MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
7. Substantial Equivalence
MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA12M are substantially equivalent to the following predicate devices:
| Primary Predicate Device | FDA ClearanceNumber | FDA Clearance Date | Productcode |
|---|---|---|---|
| MAGNETOM Amira with syngoMR E11S | K173600 | December 19, 2017 | LNHLNI,MOS |
| Secondary Predicate Device | FDA ClearanceNumber | FDA Clearance Date | Product code |
| MAGNETOM Sola with softwaresynqo MR XA11A | K181322 | October 5, 2018 | LNHLNI,MOS |
| Reference Device | FDA ClearanceNumber | FDA Clearance Date | Product code |
| syngo.via VB30Abased on syngo.via VB10A | K150843 | April 24, 2015 | LLZ |
| Subject device: MAGNETOM Amira with syngo MR XA12M |
|---|
| ---------------------------------------------------- |
Subject device: MAGNETOM Sempra with syngo MR XA12M
| Primary Predicate Device | FDA Clearance Number and Date | FDA Clearance Date | Product code |
|---|---|---|---|
| -------------------------- | ------------------------------- | -------------------- | -------------- |
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| MAGNETOM Sempra with syngoMR E11S | K163211 | January 27, 2017 | LNHLNI,MOS |
|---|---|---|---|
| Secondary Predicate Device | FDA ClearanceNumber and Date | FDA Clearance Date | Product code |
| MAGNETOM Sola with softwaresyngo MR XA11A | K181322 | October 5, 2018 | LNHLNI,MOS |
| Reference Device | FDA ClearanceNumber | FDA Clearance Date | Product code |
| syngo.via VB30Abased on syngo.via VB10A | K150843 | April 24, 2015 | LLZ |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The subject devices. MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA12M, are substantially equivalent to the predicate devices with regard to the operational environment, programming language, operating system, and performance.
MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA12M conforms to the standard for medical device software (IEC 62304:2006) and other relevant IEC and NEMA standards.
While there are some differences in technological characteristics (see Section 5 -Device Description above) between the subject devices and predicate devices, including
- completely new software applications (Seqmented TOF, HASTE with variable । flip angle, SMS in RESOLVE and QDWI)
- two completely new coils and hardware modified from the previously cleared syngo MR E11S (K173600/ K163211)
these differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate devices.
9. Nonclinical Performance Testing
The following performance testing was conducted on the subject devices
- Sample clinical images were taken for the new coils, new and modified software features, and pulse sequence types.
- । Image quality assessments of all new/modified pulse sequence types and alqorithms were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
- 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," dated May 11, 2005.
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- Performance testing was completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," dated November 18, 2016.
The results from each set of tests demonstrate that the subject devices perform as intended and are thus substantially equivalent to the predicate devices to which they have been compared.
MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA12M conform to the applicable FDA recognized and international IEC, ISO and NEMA standards:
| RecognitionNumber | Product Area | Title of Standard | Reference Numberand date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General | Medical electrical equipment - part1: general requirements for basicsafety and essential performance | ES60601-1:2005/(R)2012 and A1:2012 | AAMI / ANSI |
| 19-8 | General | Medical electrical equipment -Part 1-2: General requirements forbasic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirements andtests | 60601-1-2 Edition4.0:2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment -Part 2-33: Particular requirementsfor the basic safety and essentialperformance of magneticresonance equipment for medicaldiagnosis | 60601-2-33 Ed.3.2:2015 | IEC |
| 5-40 | General | Medical devices - Application ofrisk management to medicaldevices | 14971:2007/(R) 2010(Corrected 4 October2007). | ISO |
| 5-96 | General | Medical devices - Application ofusability engineering to medicaldevices | 62366 Edition 1.02015 | AAMI ANSIIEC |
| 13-32 | Software | Medical device software -Software life cycle processes | 62304 Edition 1.12015-06 | AAMIANSIIEC |
| 12-195 | Radiology | NEMA MS 6-2008 (R2014)Determination of Signal-to-NoiseRatio and Image Uniformity forSingle-Channel Non-Volume Coilsin Diagnostic MR Imaging | MS 6-2008 (R2014) |
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| RecognitionNumber | Product Area | Title of Standard | Reference Numberand date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 12-232 | Radiology | Acoustic Noise MeasurementProcedure for DiagnosingMagnetic Resonance ImagingDevices | MS 4-2010 | NEMA |
| 12-300 | Radiology | Digital Imaging andCommunications in Medicine(DICOM) Set 03/16/2012Radiology | PS 3.1 - 3.20 (2016) | NEMA |
| 2-156 | Biocompatibility | Biological evaluation of medicaldevices - part 1: evaluation andtesting within a risk managementprocess. (Biocompatibility) | 10993-1:2009/(R)2013 | AAMIANSIISO |
No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device. Sample clinical images have been provided in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," dated November 18, 2016.
10.General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device. Risk management is ensured via ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, 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 risks. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
11.Conclusion as to Substantial Equivalence
The subject devices, MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA12M, have the same intended use and different technological characteristics compared to the predicate devices with respect to the magnetic resonance features and functionalities. While the new and modified software and hardware features provide additional capabilities compared to the primary predicate devices, MAGNETOM Amira and MAGNETOM Sempra with syngo MR E11S (K173600; K163211), most of the them have been migrated from the secondary predicate device, MAGNETOM Sola with software syngo MR XA11A (cleared with K181322).The new
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features that were not migrated from syngo MR XA11A do not raise new questions of safety and effectiveness. All features have been verified and/or validated to support the claim of substantial equivalence to the predicate devices.
Siemens believes that MAGNETOM Amira and MAGNETOM Sempra with software syngo MR XA12M are substantially equivalent to the predicate devices MAGNETOM Amira (K173600), MAGNETOM Sempra (K163211), and MAGNETOM Sola (K181322).
§ 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.